Omalizumab Clinical Trials (2026): 180 Studies for Asthma & Allergic Asthma
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
180 Omalizumab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 72 indications (including Asthma & Allergic Asthma) and 42,811 total planned enrollment. 37 Phase 3 Omalizumab trials and 45 Phase 2, 48 Phase 4 are listed. 13 Omalizumab clinical trials are actively recruiting at 7 U.S. sites across 6 states. Most recent activity: NCT07059091 (May 2031).
Where to Participate: All Omalizumab Trial Sites in the U.S. (7 sites across 6 states)
Every actively recruiting Omalizumabtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| CO | National Jewish Health | Denver80206 | NCT06618963 | Map |
| DC | Children's National Hospital | Washington D.C.20010 | NCT05332067 | Map |
| MD | Johns Hopkins | Baltimore21287 | NCT06934200 | Map |
| MD | Johns Hopkins University | Baltimore21231 | NCT07059091 | Map |
| MA | Massachusetts General Hospital | Boston02114 | NCT06943534 | Map |
| NC | University of North Carolina at Chapel Hill | Chapel Hill27599 | NCT06943534 | Map |
| TX | University of Texas Southwestern | Dallas75390 | NCT06943534 | Map |
Omalizumab clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | terminated | withdrawn | not yet recruiting | unknown | Total |
|---|---|---|---|---|---|---|---|---|
| Early P1 | 2 | 1 | 3 | |||||
| P1 | 1 | 17 | 1 | 1 | 20 | |||
| P1/P2 | 4 | 4 | ||||||
| P2 | 6 | 3 | 29 | 2 | 2 | 3 | 45 | |
| P2/P3 | 4 | 1 | 5 | |||||
| P3 | 1 | 33 | 1 | 2 | 37 | |||
| P4 | 2 | 2 | 31 | 5 | 2 | 1 | 5 | 48 |
| N/A | 2 | 1 | 7 | 2 | 1 | 5 | 18 |
Recruiting Omalizumab clinical trials (13)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07059091 | COPD-OMAClinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD | P2 | Chronic Obstructive Pulmonary Disease (COPD) | 334 | Feb 2026 |
| NCT07342803 | Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients | P2 | Allergic Asthma | 200 | Jan 2025 |
| NCT07425639 | ROLL'YN-OMAROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar | — | Chronic Spontaneous Urticaria (CSU) | 225 | Oct 2025 |
| NCT06943534 | OWED-TOmalizumab Weight-Based Dosing Efficacy Trial | P2 | Allergies | 30 | Jul 2025 |
| NCT06027073 | BSIPLBiologics and Sublingual Immunotherapy | P4 | Asthma, Allergic | 150 | May 2024 |
| NCT05332067 | OBOEOmalizumab Before Onset of Exacerbations | P2 | Asthma in Children | 300 | May 2022 |
| NCT07073404 | OmlycloOmalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin | — | Food Allergies | 37 | Jan 2026 |
| NCT06934200 | Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels | P2 | Food Hypersensitivity | 32 | May 2025 |
| NCT06618963 | Effect of Omalizumab in the Skin of Food Allergy Patients | P4 | Food Allergy | 40 | Oct 2024 |
| NCT06683261 | RELIBIOReal-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) | — | Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) | 300 | Sep 2022 |
| NCT07356713 | A Study to Find a Suitable Dose of Exl-111 for Further Research | P1 | Allergic Disease | 70 | Jan 2026 |
| NCT06509334 | Trial of JYB1904 in Chronic Spontaneous Urticaria. | P2 | Chronic Spontaneous Urticaria | 135 | Aug 2024 |
| NCT05916937 | EXOTICExtending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria | P4 | Chronic Spontaneous Urticaria | 40 | Jan 2024 |
Omalizumab clinical trials by indication
Asthma (43)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02570984 | PARK | P2 | active not recruiting | Preventing Asthma in High Risk Kids |
| NCT03727971 | PRO_ART | P2 | completed | Treatment With the Anti-IgE Monoclonal Antibody Omalizumab in Women With Asthma Undergoing Fertility Treatment. - A Proof of Concept Study. |
| NCT04585997 | — | P4 | unknown | Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - "Choosebetweenamab". |
| NCT04665141 | — | N/A | unknown | Similarities and Differences of Biological Therapies for Severe Asthma. |
| NCT04778137 | — | P1 | completed | The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety |
| NCT05157087 | — | N/A | completed | XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States |
| NCT04158050 | BiSA | N/A | completed | Comparison of Biologicals in Treatment of Severe Asthma |
| NCT02658877 | — | P4 | terminated | Sputum-derived Cellular Targets After Xolair (Omalizumab) |
| + 35 more, see All trials below. | ||||
Allergic Asthma (17)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07342803 | — | P2 | recruiting | Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients |
| NCT06438757 | — | P2 | active not recruiting | Trial of JYB1904 in Patients With Allergic Asthma |
| NCT06771934 | — | N/A | active not recruiting | Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma |
| NCT05813470 | — | P3 | completed | Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma |
| NCT05424523 | — | N/A | completed | Effectiveness and Safety of Omalizumab in Children With Allergic Asthma. |
| NCT02023151 | — | P4 | completed | Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils |
| NCT01976208 | AA007 | P2/P3 | completed | Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma |
| NCT01328886 | — | P3 | completed | Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children |
| + 9 more, see All trials below. | ||||
Chronic Spontaneous Urticaria (12)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06042478 | — | P3 | active not recruiting | Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension. |
| NCT06509334 | — | P2 | recruiting | Trial of JYB1904 in Chronic Spontaneous Urticaria. |
| NCT05916937 | EXOTIC | P4 | recruiting | Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria |
| NCT06228560 | H1 | P2 | completed | Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment |
| NCT04944602 | — | P3 | unknown | Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria |
| NCT04833855 | INCEPTION | P2 | completed | Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria |
| NCT03580356 | — | P3 | completed | A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. |
| NCT03580369 | — | P3 | completed | A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines |
| + 4 more, see All trials below. | ||||
Food Allergy (9)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06618963 | — | P4 | recruiting | Effect of Omalizumab in the Skin of Food Allergy Patients |
| NCT06437171 | — | P4 | active not recruiting | FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA |
| NCT04037176 | — | P4 | completed | Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair) |
| NCT06103656 | FAHF-2 | P2 | completed | E-B-FAHF-2, Multi OIT and Xolair for Food Allergy |
| NCT03964051 | — | P4 | terminated | Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana). |
| NCT02879006 | — | P2 | unknown | E-B-FAHF-2, Multi OIT and Xolair (Omalizumab) for Food Allergy |
| NCT03181009 | — | P2 | completed | Multi OIT to Test Immune Markers After Minimum Maintenance Dose |
| NCT02626611 | M-TAX | P2 | completed | Multi Immunotherapy to Test Tolerance and Xolair |
| + 1 more, see All trials below. | ||||
Chronic Idiopathic Urticaria (5)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05774639 | — | P3 | completed | Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria |
| NCT01264939 | CIU | P3 | completed | A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists |
| NCT01287117 | CIU | P3 | completed | A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment |
| NCT01292473 | CIU | P3 | completed | A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1) |
| NCT00866788 | CIU | P2 | completed | A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1) |
Nasal Polyps (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05405478 | — | P4 | unknown | Omalizumab Efficacy in Patients With Refractory Nasal Polyps |
| NCT03478930 | — | P3 | completed | An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps |
| NCT03280550 | POLYP 1 | P3 | completed | A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps |
| NCT03280537 | POLYP 2 | P3 | completed | A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps |
Peanut Allergy (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03881696 | OUtMATCH | P3 | completed | Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants |
| NCT01781637 | PRROTECT | P1/P2 | completed | Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial |
| NCT02402231 | FASTX | P2 | unknown | Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy |
| NCT01290913 | — | P1/P2 | completed | Xolair Enhances Oral Desensitization in Peanut Allergic Patients |
Urticaria (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02742805 | — | P4 | withdrawn | Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation |
| NCT02392624 | — | P4 | completed | A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria |
| NCT02191072 | — | N/A | unknown | Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria |
| NCT00130234 | — | P2 | completed | Effect of Anti-IgE in Chronic Urticaria |
Chronic Urticaria (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01701583 | — | P4 | completed | Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria |
| NCT01713725 | — | P2 | completed | Efficacy and Safety Study of Omalizumab (Xolair®) to Treat Chronic Urticaria |
| NCT01803763 | — | P2/P3 | completed | Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients |
| NCT00481676 | — | P2 | completed | Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria |
Atopic Dermatitis (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01179529 | AMB-WEI-1052-I | P2 | completed | Atopic Dermatitis Biomarker Identification Trial in Omalizumab Usage |
| NCT01678092 | OXAD | P1 | completed | Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis |
| NCT00822783 | — | P4 | completed | Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients |
Allergic Disease (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07356713 | — | P1 | recruiting | A Study to Find a Suitable Dose of Exl-111 for Further Research |
| NCT05960708 | — | P1 | completed | A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases |
Healthy (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05564611 | PK | P1 | completed | PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects |
| NCT05449535 | — | P1 | completed | Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects |
Atopic Healthy Subjects (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05564221 | — | P1 | completed | A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases |
| NCT05061524 | — | P1 | completed | A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases |
Sinusitis (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05390255 | — | P3 | unknown | Establishment of Precise Diagnosis and Treatment System for Refractory Chronic Rhinosinusitis |
| NCT00117611 | — | P4 | completed | Xolair in Patients With Chronic Sinusitis |
Healthy Volunteers (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05053334 | — | P1 | completed | Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair |
| NCT04601389 | NAP | P1 | completed | Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair® |
Chronic Rhinosinusitis With Nasal Polyps (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04998604 | EVEREST | P4 | completed | EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients |
| NCT04583501 | CRSwNP | Early P1 | completed | Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis |
Seasonal Allergic Rhinitis (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04489121 | — | N/A | completed | The Efficacy of Preseasonal Omalizumab Treatment |
| NCT03369704 | — | P3 | completed | Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients |
Allergic Rhinitis (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06806826 | rhinitis | P4 | completed | The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study |
| NCT00604786 | — | N/A | completed | The Effect of Omalizumab on Responses to Cat Allergen Challenge |
Bullous Pemphigoid (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04128176 | — | P3 | withdrawn | Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid |
| NCT00472030 | — | P4 | completed | Efficacy and Safety of Omalizumab in Bullous Pemphigoid |
Allergy (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02968394 | — | N/A | unknown | Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions |
| NCT00086606 | — | P2 | terminated | A Safety and Efficacy Study of Xolair in Peanut Allergy |
Persistent Allergic Asthma (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01202903 | — | P3 | completed | Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy |
| NCT00870584 | — | P4 | completed | Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma |
Milk Allergy (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00968110 | — | Early P1 | completed | Xolair Treatment for Milk Allergic Children |
| NCT01157117 | — | P2 | completed | OIT and Xolair® (Omalizumab) in Cow's Milk Allergy |
Peanut Hypersensitivity (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00932282 | PAIE/Xolair | P1/P2 | completed | Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy |
| NCT00382148 | — | P2 | completed | A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g |
Chronic Obstructive Pulmonary Disease (COPD) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07059091 | COPD-OMA | P2 | recruiting | Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD |
Food Allergies (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07073404 | Omlyclo | N/A | not yet recruiting | Omalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin |
Chronic Spontaneous Urticaria (CSU) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07425639 | ROLL'YN-OMA | N/A | recruiting | ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar |
Allergies (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06943534 | OWED-T | P2 | recruiting | Omalizumab Weight-Based Dosing Efficacy Trial |
Food Hypersensitivity (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06934200 | — | P2 | recruiting | Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels |
Asthma, Allergic (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06027073 | BSIPL | P4 | not yet recruiting | Biologics and Sublingual Immunotherapy |
Healthy Volunteers (HV) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07246252 | — | P1 | completed | Compare the PK, Safety, and Immunogenicity of Process-Changed CMAB007 and Xolair in Healthy Adult Male Subjects |
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06683261 | RELIBIO | N/A | recruiting | Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) |
Asthma in Children (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05332067 | OBOE | P2 | recruiting | Omalizumab Before Onset of Exacerbations |
Chronic Urticaria, Idiopathic (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04774315 | — | P4 | active not recruiting | Molecular Endotypes of Chronic Idiopathic Urticaria |
Allergic Bronchopulmonary Aspergillosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05129033 | — | N/A | unknown | A Prospective Study on Optimizing Treatment for ABPA |
Covid19 (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04720612 | CIAO | P2 | unknown | COVID-19 Immunologic Antiviral Therapy With Omalizumab |
Eosinophilic Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04943744 | STRING | Early P1 | terminated | Gastrointestinal STRING Test With Oral Immunotherapy |
Autism Spectrum Disorder (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04535817 | — | P1 | withdrawn | Xolair Interventional Study in ASD Patients With Comorbid Atopy |
Moderate-to-severe Allergic Asthma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04195958 | EDURO | P4 | terminated | A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma |
Similarity of Pharmacokinetics and Safety (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04361812 | — | P1 | terminated | Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection |
Hypersensitivity (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03679676 | COMBINE | P2 | completed | Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE) |
Food IgE-mediated Allergy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04045301 | BOOM | P2 | active not recruiting | Omalizumab to Accelerate a Symptom-driven Multi-food OIT |
Severe Asthma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03476109 | PREDICTUMAB | P4 | unknown | Study of Magnitude and Prediction of Response to Omalizumab and Mepolizumab in Adult Severe Asthma. |
Acute Interstitial Nephritis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01893658 | AIN | P2 | withdrawn | Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN) |
Food; Allergy, Anaphylactic Shock (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06316414 | OSAFA | N/A | completed | Omalizumab in Severe Asthmatics With Food Allergy |
Urticaria Chronic (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03111628 | CIU | P4 | completed | Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU) |
Idiopathic Angioedema (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02966314 | — | P4 | completed | Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy |
CHRONIC SPONTANEOUS URTICARIA (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02550106 | SUNRISE | P4 | completed | Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment |
Chronic Spontaneous Uriticaria (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02329223 | — | P3 | completed | Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients |
Colon Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02266355 | — | P1 | completed | Role of Omalizumab in Reducing the Incidence of Oxaliplatin-induced Hypersensitivity Reaction |
Solar Urticaria (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02262130 | XOLUS | P2 | completed | Omalizumab in Severe and Refractory Solar Urticaria |
Drug Allergy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02118987 | — | P1 | completed | Study of Omalizumab as Adjuvant Therapy in Chemotherapy Desensitization |
Steroid and/or Prednisone Dependent Asthma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02049294 | — | P2/P3 | completed | Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis |
Systemic Lupus Erthematosus (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01716312 | — | P1 | completed | Omalizumab for Lupus |
Severe IgE-mediated Asthma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01912872 | MEXIC | P4 | terminated | Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma |
Symptomatic Dermographism (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02169115 | UFO | P2 | completed | Urticaria Facticia Treatment With Omalizumab (UFO) |
Cold Contact Urticaria (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01580592 | CUTEX | P2 | completed | Cold Urticaria Treatment With Xolair |
Immune System Diseases (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01510626 | — | P1 | completed | Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center |
Bronchial Asthma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01113437 | — | P2/P3 | unknown | Omalizumab in Non-atopic Asthma |
Chronic Rhinosinusitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01066104 | — | P2 | completed | Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis |
Cat Allergy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01003301 | — | P2 | completed | The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge |
Eosinophilic Esophagitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01040598 | — | P1 | completed | Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model |
Anaphylaxis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00890162 | — | P2 | completed | A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis |
Interstitial Cystitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01294878 | IComaliz | P3 | completed | Omalizumab in Interstitial Cystitis/Bladder Pain Syndrome |
Pulmonary Disease, Chronic Obstructive (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00851370 | — | P2 | withdrawn | Exploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels |
Cystic Fibrosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00787917 | ABPA | P4 | terminated | An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA) |
Nasal Polyposis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01393340 | — | P2 | completed | Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma |
Aspirin Sensitivity (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00555971 | — | P4 | completed | Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization |
Esophagitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00123630 | — | P2 | completed | A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab |
Allergy Induced Asthma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00242359 | — | P4 | withdrawn | A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma |
Hyper-IgE Syndrome (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00260702 | — | P1 | completed | Omalizumab to Treat Hyper-IgE (Job's) Syndrome |
Gastroenteritis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00084097 | — | P2 | completed | Omalizumab to Treat Eosinophilic Gastroenteritis |
Hay Fever (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT00078195 | — | P2 | completed | Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies |
Omalizumab pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| BSIPL | NCT06027073 | P4 | not yet recruiting | Asthma, Allergic | 150 | PMID 39363801 |
| EXOTIC | NCT05916937 | P4 | recruiting | Chronic Spontaneous Urticaria | 40 | PMID 39762098 |
| PREDICTUMAB | NCT03476109 | P4 | unknown | Severe Asthma | 100 | — |
| EVEREST | NCT04998604 | P4 | completed | Chronic Rhinosinusitis With Nasal Polyps | 360 | PMID 35837739 |
| EDURO | NCT04195958 | P4 | terminated | Moderate-to-severe Allergic Asthma | 3 | — |
| CIU | NCT03111628 | P4 | completed | Urticaria Chronic | 18 | PMID 33713769 |
| rhinitis | NCT06806826 | P4 | completed | Allergic Rhinitis | 50 | — |
| SUNRISE | NCT02550106 | P4 | completed | CHRONIC SPONTANEOUS URTICARIA | 136 | — |
| MEXIC | NCT01912872 | P4 | terminated | Severe IgE-mediated Asthma | 112 | — |
| PROSE | NCT01430403 | P4 | completed | Asthma | 478 | PMID 26518090 |
| XPORT | NCT01125748 | P4 | completed | Allergic Asthma | 176 | — |
| Xolair | NCT00367016 | P4 | completed | Asthma | 6 | — |
| eXplore | NCT00670930 | P4 | completed | Allergic Asthma | 36 | — |
| EXACT | NCT00096954 | P4 | completed | Asthma | 333 | — |
| ABPA | NCT00787917 | P4 | terminated | Cystic Fibrosis | 14 | PMID 26302738 |
| ICATA | NCT00377572 | P4 | completed | Asthma | 419 | PMID 21410369 |
| AERO | NCT00495612 | P4 | completed | Asthma | 69 | — |
| OUtMATCH | NCT03881696 | P3 | completed | Peanut Allergy | 471 | PMID 38407394 |
| POLYP 1 | NCT03280550 | P3 | completed | Nasal Polyps | 138 | PMID 33710614 |
| POLYP 2 | NCT03280537 | P3 | completed | Nasal Polyps | 127 | PMID 33548517 |
| OPTIMA | NCT02161562 | P3 | completed | Chronic Spontaneous Urticaria | 314 | PMID 32272284 |
| X-ACT | NCT01723072 | P3 | completed | Chronic Spontaneous Urticaria | 91 | PMID 27010957 |
| CIU | NCT01264939 | P3 | completed | Chronic Idiopathic Urticaria | 336 | PMID 27939380 |
| CIU | NCT01287117 | P3 | completed | Chronic Idiopathic Urticaria | 319 | PMID 27424128 |
| CIU | NCT01292473 | P3 | completed | Chronic Idiopathic Urticaria | 323 | PMID 23432142 |
| NATAIR | NCT01007149 | P3 | completed | Asthma | 79 | PMID 23579324 |
| IComaliz | NCT01294878 | P3 | completed | Interstitial Cystitis | 3 | — |
| EXTRA | NCT00314574 | P3 | completed | Asthma | 850 | PMID 34303017 |
| ALTO | NCT00401596 | P3 | completed | Asthma | 1,899 | — |
| COPD-OMA | NCT07059091 | P2 | recruiting | Chronic Obstructive Pulmonary Disease (COPD) | 334 | — |
| OWED-T | NCT06943534 | P2 | recruiting | Allergies | 30 | — |
| PARK | NCT02570984 | P2 | active not recruiting | Asthma | 200 | PMID 33242697 |
| OBOE | NCT05332067 | P2 | recruiting | Asthma in Children | 300 | — |
| BOOM | NCT04045301 | P2 | active not recruiting | Food IgE-mediated Allergy | 90 | PMID 32328115 |
| H1 | NCT06228560 | P2 | completed | Chronic Spontaneous Urticaria | 202 | — |
| COMBINE | NCT03679676 | P2 | completed | Hypersensitivity | 130 | PMID 38814736 |
| PRO_ART | NCT03727971 | P2 | completed | Asthma | 66 | PMID 33184076 |
| INCEPTION | NCT04833855 | P2 | completed | Chronic Spontaneous Urticaria | 183 | PMID 39956278 |
| CIAO | NCT04720612 | P2 | unknown | Covid19 | 40 | PMID 38560604 |
| FAHF-2 | NCT06103656 | P2 | completed | Food Allergy | 33 | PMID 37087097 |
| FASTX | NCT02402231 | P2 | unknown | Peanut Allergy | 23 | PMID 31329313 |
| AIN | NCT01893658 | P2 | withdrawn | Acute Interstitial Nephritis | 0 | — |
| M-TAX | NCT02626611 | P2 | completed | Food Allergy | 70 | PMID 31193674 |
| XOLUS | NCT02262130 | P2 | completed | Solar Urticaria | 10 | — |
| CUTEX | NCT01580592 | P2 | completed | Cold Contact Urticaria | 31 | PMID 28389393 |
| UFO | NCT02169115 | P2 | completed | Symptomatic Dermographism | 61 | PMID 28389391 |
| AMB-WEI-1052-I | NCT01179529 | P2 | completed | Atopic Dermatitis | 0 | — |
| CIU | NCT00866788 | P2 | completed | Chronic Idiopathic Urticaria | 90 | — |
| AQUA | NCT00434434 | P2 | completed | Allergic Asthma | 61 | — |
Terminated and withdrawn Omalizumab trials (17)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT04943744terminatedGastrointestinal STRING Test With Oral Immunotherapy
- NCT04128176withdrawnEfficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid
- NCT04535817withdrawnXolair Interventional Study in ASD Patients With Comorbid Atopy
- NCT04361812terminatedComparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection
- NCT04195958terminatedA Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma
- NCT03964051terminatedProtection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).
- NCT02742805withdrawnSustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation
- NCT01893658withdrawnXolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)
- NCT02658877terminatedSputum-derived Cellular Targets After Xolair (Omalizumab)
- NCT01912872terminatedStudy to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma
- NCT00851370withdrawnExploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels
- NCT00787917terminatedAn Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
- NCT00162773terminatedEffect of Anti-IgE in Non-Allergic Asthma
- NCT00242359withdrawnA Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
- NCT00226200terminatedSoluble CD23 Expression in Asthma Patients Treated With OMA
- NCT00287378terminatedEffect of Ozone on Airway Inflammation in Allergic Asthmatics Treated With Omalizumab
- NCT00086606terminatedA Safety and Efficacy Study of Xolair in Peanut Allergy
All Omalizumab trials (180)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT07059091 | COPD-OMA | Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD | P2 | recruiting | 334 | Johns Hopkins University | Feb 2026 |
| NCT07342803 | Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients | P2 | recruiting | 200 | Longbio Pharma | Jan 2025 | |
| NCT07425639 | ROLL'YN-OMA | ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar | — | recruiting | 225 | Celltrion HealthCare France | Oct 2025 |
| NCT06943534 | OWED-T | Omalizumab Weight-Based Dosing Efficacy Trial | P2 | recruiting | 30 | Massachusetts General Hospital | Jul 2025 |
| NCT02570984 | PARK | Preventing Asthma in High Risk Kids | P2 | active not recruiting | 200 | Boston Children's Hospital | Nov 2018 |
| NCT06027073 | BSIPL | Biologics and Sublingual Immunotherapy | P4 | not yet recruiting | 150 | Medical University of Silesia | May 2024 |
| NCT05332067 | OBOE | Omalizumab Before Onset of Exacerbations | P2 | recruiting | 300 | Children's National Research Institute | May 2022 |
| NCT07073404 | Omlyclo | Omalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin | — | not yet recruiting | 37 | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | Jan 2026 |
| NCT06934200 | Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels | P2 | recruiting | 32 | Johns Hopkins University | May 2025 | |
| NCT06042478 | Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension. | P3 | active not recruiting | 470 | Novartis Pharmaceuticals | Nov 2023 | |
| NCT06618963 | Effect of Omalizumab in the Skin of Food Allergy Patients | P4 | recruiting | 40 | National Jewish Health | Oct 2024 | |
| NCT06437171 | FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA | P4 | active not recruiting | 20 | AAADRS Clinical Research Center | Jun 2024 | |
| NCT06683261 | RELIBIO | Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) | — | recruiting | 300 | Universitaire Ziekenhuizen KU Leuven | Sep 2022 |
| NCT07356713 | A Study to Find a Suitable Dose of Exl-111 for Further Research | P1 | recruiting | 70 | Excellergy Inc. | Jan 2026 | |
| NCT06509334 | Trial of JYB1904 in Chronic Spontaneous Urticaria. | P2 | recruiting | 135 | Jemincare | Aug 2024 | |
| NCT04045301 | BOOM | Omalizumab to Accelerate a Symptom-driven Multi-food OIT | P2 | active not recruiting | 90 | Philippe Bégin | Nov 2019 |
| NCT05916937 | EXOTIC | Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria | P4 | recruiting | 40 | Simon Francis Thomsen | Jan 2024 |
| NCT06228560 | H1 | Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment | P2 | completed | 202 | Longbio Pharma | Jan 2024 |
| NCT06438757 | Trial of JYB1904 in Patients With Allergic Asthma | P2 | active not recruiting | 69 | Jemincare | Jun 2024 | |
| NCT03881696 | OUtMATCH | Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants | P3 | completed | 471 | National Institute of Allergy and Infectious Diseases (NIAID) | Jul 2019 |
| NCT06771934 | Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma | — | active not recruiting | 60 | Qianfoshan Hospital | Jun 2024 | |
| NCT03679676 | COMBINE | Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE) | P2 | completed | 130 | Stanford University | Feb 2020 |
| NCT04774315 | Molecular Endotypes of Chronic Idiopathic Urticaria | P4 | active not recruiting | 15 | University of Colorado, Denver | Jan 2022 | |
| NCT05774639 | Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria | P3 | completed | 600 | Kashiv BioSciences, LLC | Aug 2023 | |
| NCT05390255 | Establishment of Precise Diagnosis and Treatment System for Refractory Chronic Rhinosinusitis | P3 | unknown | 87 | Beijing Tongren Hospital | May 2022 | |
| NCT03476109 | PREDICTUMAB | Study of Magnitude and Prediction of Response to Omalizumab and Mepolizumab in Adult Severe Asthma. | P4 | unknown | 100 | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | May 2019 |
| NCT03727971 | PRO_ART | Treatment With the Anti-IgE Monoclonal Antibody Omalizumab in Women With Asthma Undergoing Fertility Treatment. - A Proof of Concept Study. | P2 | completed | 66 | Rigshospitalet, Denmark | Jan 2019 |
| NCT04998604 | EVEREST | EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients | P4 | completed | 360 | Sanofi | Sep 2021 |
| NCT07246252 | Compare the PK, Safety, and Immunogenicity of Process-Changed CMAB007 and Xolair in Healthy Adult Male Subjects | P1 | completed | 114 | Taizhou Mabtech Pharmaceutical Co.,Ltd | Mar 2024 | |
| NCT05564221 | A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases | P1 | completed | 46 | Yuhan Corporation | Nov 2022 | |
| NCT05960708 | A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases | P1 | completed | 30 | Yuhan Corporation | Aug 2023 | |
| NCT04583501 | CRSwNP | Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis | Early P1 | completed | 21 | Johns Hopkins University | Dec 2020 |
| NCT04943744 | STRING | Gastrointestinal STRING Test With Oral Immunotherapy | Early P1 | terminated | 13 | Stanford University | May 2021 |
| NCT05053334 | Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair | P1 | completed | 165 | Syneos Health | Feb 2022 | |
| NCT05129033 | A Prospective Study on Optimizing Treatment for ABPA | N/A | unknown | 100 | Shanghai Zhongshan Hospital | Nov 2021 | |
| NCT04128176 | Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid | P3 | withdrawn | 0 | University of California, Davis | Mar 2017 | |
| NCT05564611 | PK | PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects | P1 | completed | 204 | Kashiv BioSciences, LLC | Nov 2022 |
| NCT04944602 | Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria | P3 | unknown | 340 | CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Jul 2021 | |
| NCT04833855 | INCEPTION | Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria | P2 | completed | 183 | Amgen | Apr 2021 |
| NCT06316414 | OSAFA | Omalizumab in Severe Asthmatics With Food Allergy | — | completed | 65 | Bambino Gesù Hospital and Research Institute | Jan 2018 |
| NCT05061524 | A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases | P1 | completed | 68 | Yuhan Corporation | Sep 2021 | |
| NCT05405478 | Omalizumab Efficacy in Patients With Refractory Nasal Polyps | P4 | unknown | 2 | Shiraz University of Medical Sciences | Jun 2022 | |
| NCT05813470 | Efficacy and Safety of Zerafil® (Omalizumab) in Participants With Uncontrolled Moderate to Severe Allergic Asthma | P3 | completed | 256 | Cinnagen | Jan 2021 | |
| NCT05449535 | Study of JYB1904 (an Anti-immunoglobulin E Antibody) in Healthy Chinese Subjects | P1 | completed | 56 | Jemincare | May 2022 | |
| NCT04585997 | Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - "Choosebetweenamab". | P4 | unknown | 200 | University of Newcastle, Australia | Nov 2018 | |
| NCT04720612 | CIAO | COVID-19 Immunologic Antiviral Therapy With Omalizumab | P2 | unknown | 40 | McGill University Health Centre/Research Institute of the McGill University Health Centre | Oct 2021 |
| NCT04665141 | Similarities and Differences of Biological Therapies for Severe Asthma. | — | unknown | 600 | Clinica Universidad de Navarra, Universidad de Navarra | Apr 2021 | |
| NCT03580356 | A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. | P3 | completed | 1,078 | Novartis Pharmaceuticals | Oct 2018 | |
| NCT03580369 | A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines | P3 | completed | 1,072 | Novartis Pharmaceuticals | Oct 2018 | |
| NCT01781637 | PRROTECT | Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial | P1/P2 | completed | 36 | Boston Children's Hospital | Jan 2013 |
| NCT04037176 | Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair) | P4 | completed | 20 | Carsten Bindslev-Jensen | Nov 2019 | |
| NCT04535817 | Xolair Interventional Study in ASD Patients With Comorbid Atopy | P1 | withdrawn | 0 | Beth Israel Deaconess Medical Center | Jan 2021 | |
| NCT04361812 | Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection | P1 | terminated | 1 | BioRay Pharmaceutical Co., Ltd. | Oct 2020 | |
| NCT04195958 | EDURO | A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma | P4 | terminated | 3 | Genentech, Inc. | Nov 2020 |
| NCT05424523 | Effectiveness and Safety of Omalizumab in Children With Allergic Asthma. | — | completed | 200 | Novartis Pharmaceuticals | Feb 2021 | |
| NCT04778137 | The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety | P1 | completed | 114 | Taizhou Mabtech Pharmaceutical Co.,Ltd | Dec 2020 | |
| NCT06103656 | FAHF-2 | E-B-FAHF-2, Multi OIT and Xolair for Food Allergy | P2 | completed | 33 | New York Medical College | Aug 2016 |
| NCT03964051 | Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana). | P4 | terminated | 7 | Carsten Bindslev-Jensen | Jul 2019 | |
| NCT05157087 | XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States | — | completed | 16,246 | Novartis Pharmaceuticals | Mar 2020 | |
| NCT02879006 | E-B-FAHF-2, Multi OIT and Xolair (Omalizumab) for Food Allergy | P2 | unknown | 33 | Xiu-Min Li | Aug 2016 | |
| NCT04158050 | BiSA | Comparison of Biologicals in Treatment of Severe Asthma | — | completed | 64 | Helsinki University Central Hospital | Jan 2018 |
| NCT02402231 | FASTX | Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy | P2 | unknown | 23 | Caroline Nilsson | Oct 2013 |
| NCT04489121 | The Efficacy of Preseasonal Omalizumab Treatment | N/A | completed | 31 | Beijing Tongren Hospital | Jul 2020 | |
| NCT03111628 | CIU | Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU) | P4 | completed | 18 | Johns Hopkins University | Oct 2017 |
| NCT03478930 | An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps | P3 | completed | 249 | Hoffmann-La Roche | May 2018 | |
| NCT06806826 | rhinitis | The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study | P4 | completed | 50 | Yuzuncu Yil University | Jan 2019 |
| NCT02966314 | Treatment of Idiopathic Angioedema With Xolair as Add-on Therapy | P4 | completed | 12 | University of Wisconsin, Madison | Mar 2017 | |
| NCT02742805 | Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation | P4 | withdrawn | 0 | Selina Gierer, D.O. | Feb 2016 | |
| NCT03328897 | Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria | P3 | completed | 418 | Novartis Pharmaceuticals | Apr 2017 | |
| NCT00890162 | A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis | P2 | completed | 16 | National Institute of Allergy and Infectious Diseases (NIAID) | Apr 2009 | |
| NCT03280550 | POLYP 1 | A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps | P3 | completed | 138 | Hoffmann-La Roche | Nov 2017 |
| NCT03280537 | POLYP 2 | A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps | P3 | completed | 127 | Hoffmann-La Roche | Nov 2017 |
| NCT03181009 | Multi OIT to Test Immune Markers After Minimum Maintenance Dose | P2 | completed | 60 | Andrew Long, PharmD | Jul 2017 | |
| NCT03369704 | Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients | P3 | completed | 337 | Novartis Pharmaceuticals | Dec 2017 | |
| NCT01893658 | AIN | Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN) | P2 | withdrawn | 0 | Mayo Clinic | Jun 2018 |
| NCT02658877 | Sputum-derived Cellular Targets After Xolair (Omalizumab) | P4 | terminated | 3 | NYU Langone Health | Jan 2016 | |
| NCT02266355 | Role of Omalizumab in Reducing the Incidence of Oxaliplatin-induced Hypersensitivity Reaction | P1 | completed | 9 | Yale University | Nov 2014 | |
| NCT02118987 | Study of Omalizumab as Adjuvant Therapy in Chemotherapy Desensitization | P1 | completed | 5 | Dana-Farber Cancer Institute | Jul 2014 | |
| NCT01701583 | Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria | P4 | completed | 10 | University of Colorado, Denver | Apr 2013 | |
| NCT02049294 | Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis | P2/P3 | completed | 11 | McMaster University | Mar 2014 | |
| NCT04601389 | NAP | Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair® | P1 | completed | 84 | AO GENERIUM | Apr 2017 |
| NCT01716312 | Omalizumab for Lupus | P1 | completed | 17 | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Jan 2014 | |
| NCT01713725 | Efficacy and Safety Study of Omalizumab (Xolair®) to Treat Chronic Urticaria | P2 | completed | 20 | Clinica Universidad de Navarra, Universidad de Navarra | Mar 2012 | |
| NCT02477332 | Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU | P2 | completed | 382 | Novartis Pharmaceuticals | Jul 2015 | |
| NCT02654145 | Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients | P4 | completed | 145 | GlaxoSmithKline | Mar 2016 | |
| NCT02388997 | Treatment With Omalizumab to Improve the Asthmatic Response to Rhinovirus Experimental Infection With Rhinovirus | P2 | completed | 31 | University of Virginia | Feb 2013 | |
| NCT00968110 | Xolair Treatment for Milk Allergic Children | Early P1 | completed | 10 | Boston Children's Hospital | Mar 2009 | |
| NCT02392624 | A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria | P4 | completed | 206 | Genentech, Inc. | May 2015 | |
| NCT02626611 | M-TAX | Multi Immunotherapy to Test Tolerance and Xolair | P2 | completed | 70 | Kari Christine Nadeau | Dec 2015 |
| NCT02161562 | OPTIMA | OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients | P3 | completed | 314 | Novartis Pharmaceuticals | Aug 2014 |
| NCT02023151 | Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils | P4 | completed | 17 | Johns Hopkins University | Feb 2013 | |
| NCT02191072 | Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria | N/A | unknown | 20 | National Taiwan University Hospital | Jul 2014 | |
| NCT01922037 | A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair) | P4 | completed | 806 | Hoffmann-La Roche | Jun 2013 | |
| NCT00555971 | Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization | P4 | completed | 16 | David Lang | May 2006 | |
| NCT01716754 | Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma | P2 | completed | 471 | Novartis Pharmaceuticals | Dec 2012 | |
| NCT02550106 | SUNRISE | Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment | P4 | completed | 136 | Novartis Pharmaceuticals | Apr 2015 |
| NCT01912872 | MEXIC | Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma | P4 | terminated | 112 | Novartis Pharmaceuticals | Nov 2013 |
| NCT02329223 | Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients | P3 | completed | 218 | Novartis Pharmaceuticals | Dec 2014 | |
| NCT01510626 | Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center | P1 | completed | 35 | Stanford University | Nov 2011 | |
| NCT01976208 | AA007 | Safety and Efficacy Study of Omalizumab to Treat Allergic Asthma | P2/P3 | completed | 630 | Shanghai Zhangjiang Biotechnology Limited Company | Dec 2010 |
| NCT01157117 | OIT and Xolair® (Omalizumab) in Cow's Milk Allergy | P2 | completed | 77 | Hugh A Sampson, MD | Aug 2010 | |
| NCT02262130 | XOLUS | Omalizumab in Severe and Refractory Solar Urticaria | P2 | completed | 10 | Centre Hospitalier Universitaire de Besancon | Sep 2014 |
| NCT00932282 | PAIE/Xolair | Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy | P1/P2 | completed | 13 | University of North Carolina, Chapel Hill | Jul 2009 |
| NCT01066104 | Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis | P2 | completed | 27 | Massachusetts General Hospital | Dec 2009 | |
| NCT01580592 | CUTEX | Cold Urticaria Treatment With Xolair | P2 | completed | 31 | Charite University, Berlin, Germany | Apr 2012 |
| NCT02169115 | UFO | Urticaria Facticia Treatment With Omalizumab (UFO) | P2 | completed | 61 | Charite University, Berlin, Germany | Dec 2012 |
| NCT01723072 | X-ACT | Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy | P3 | completed | 91 | Novartis Pharmaceuticals | Jan 2013 |
| NCT02968394 | Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions | N/A | unknown | 11 | The University Clinic of Pulmonary and Allergic Diseases Golnik | Mar 2014 | |
| NCT01803763 | Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients | P2/P3 | completed | 30 | Insel Gruppe AG, University Hospital Bern | Sep 2012 | |
| NCT01430403 | PROSE | Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations | P4 | completed | 478 | National Institute of Allergy and Infectious Diseases (NIAID) | Sep 2011 |
| NCT01328886 | Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children | P3 | completed | 38 | Novartis Pharmaceuticals | Mar 2011 | |
| NCT01703312 | A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma | P1/P2 | completed | 37 | Novartis Pharmaceuticals | Nov 2012 | |
| NCT01202903 | Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy | P3 | completed | 616 | Novartis Pharmaceuticals | Sep 2010 | |
| NCT01290913 | Xolair Enhances Oral Desensitization in Peanut Allergic Patients | P1/P2 | completed | 13 | Lynda Schneider | Feb 2011 | |
| NCT01003301 | The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge | P2 | completed | 19 | Johns Hopkins University | Oct 2009 | |
| NCT01125748 | XPORT | A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy | P4 | completed | 176 | Genentech, Inc. | May 2010 |
| NCT01544348 | A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL | P1 | completed | 295 | MedImmune LLC | Jan 2012 | |
| NCT01584687 | mRNA Expression as a Biomarker of Omalizumab Response | P4 | unknown | 6 | Instituto de Investigação em Imunologia | Jun 2012 | |
| NCT01264939 | CIU | A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists | P3 | completed | 336 | Genentech, Inc. | Feb 2011 |
| NCT01287117 | CIU | A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment | P3 | completed | 319 | Genentech, Inc. | Feb 2011 |
| NCT00367016 | Xolair | Immunologic Basis of Anti-IgE Therapy (Study II: On Patients With Asthma) | P4 | completed | 6 | University of California, Davis | Feb 2004 |
| NCT01292473 | CIU | A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1) | P3 | completed | 323 | Genentech, Inc. | Mar 2011 |
| NCT01155700 | Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years) | P3 | completed | 51 | Novartis Pharmaceuticals | Jun 2010 | |
| NCT00180011 | Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma | P2/P3 | completed | 18 | DiMango, Emily, M.D. | Sep 2005 | |
| NCT00639691 | A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy | P4 | completed | 48 | Novartis | Jan 2005 | |
| NCT00670930 | eXplore | Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists | P4 | completed | 36 | Novartis Pharmaceuticals | Apr 2008 |
| NCT00208234 | Effect of Xolair on Airway Hyperresponsiveness | P4 | unknown | 22 | Creighton University | Jan 2004 | |
| NCT00949078 | Omalizumab in the Treatment of Peanut Allergy | P2 | completed | 51 | Johns Hopkins University | Jul 2009 | |
| NCT01007149 | NATAIR | Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma | P3 | completed | 79 | Novartis Pharmaceuticals | Sep 2009 |
| NCT00851370 | Exploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels | P2 | withdrawn | 0 | National Jewish Health | Jan 2009 | |
| NCT00472030 | Efficacy and Safety of Omalizumab in Bullous Pemphigoid | P4 | completed | 2 | University of Iowa | Aug 2007 | |
| NCT01294878 | IComaliz | Omalizumab in Interstitial Cystitis/Bladder Pain Syndrome | P3 | completed | 3 | Fondazione IRCCS Policlinico San Matteo di Pavia | Mar 2009 |
| NCT00096954 | EXACT | A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT) | P4 | completed | 333 | Genentech, Inc. | Feb 2006 |
| NCT01179529 | AMB-WEI-1052-I | Atopic Dermatitis Biomarker Identification Trial in Omalizumab Usage | P2 | completed | 0 | Technical University of Munich | — |
| NCT00787917 | ABPA | An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA) | P4 | terminated | 14 | Novartis Pharmaceuticals | Nov 2008 |
| NCT01113437 | Omalizumab in Non-atopic Asthma | P2/P3 | unknown | 40 | King's College London | Apr 2010 | |
| NCT00567476 | Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma | P4 | completed | 116 | Novartis | Nov 2007 | |
| NCT00870584 | Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma | P4 | completed | 271 | Novartis Pharmaceuticals | Mar 2009 | |
| NCT00260702 | Omalizumab to Treat Hyper-IgE (Job's) Syndrome | P1 | completed | 1 | National Institute of Allergy and Infectious Diseases (NIAID) | Nov 2005 | |
| NCT00866788 | CIU | A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1) | P2 | completed | 90 | Genentech, Inc. | Mar 2009 |
| NCT00123630 | A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab | P2 | completed | 30 | University of Utah | Nov 2005 | |
| NCT01393340 | Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma | P2 | completed | 23 | University Hospital, Ghent | Dec 2006 | |
| NCT00377390 | ICATA Asthma Mechanistic Study | — | completed | 224 | National Institute of Allergy and Infectious Diseases (NIAID) | Oct 2006 | |
| NCT00377572 | ICATA | Inner-City Anti-IgE Therapy for Asthma | P4 | completed | 419 | National Institute of Allergy and Infectious Diseases (NIAID) | Oct 2006 |
| NCT00314574 | EXTRA | A Study of Omalizumab (Xolair) in Subjects With Moderate to Severe Persistent Asthma (EXTRA) | P3 | completed | 850 | Genentech, Inc. | Dec 2005 |
| NCT00162773 | Effect of Anti-IgE in Non-Allergic Asthma | P2 | terminated | 29 | Johns Hopkins University | Apr 2005 | |
| NCT01040598 | Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model | P1 | completed | 19 | O & O Alpan LLC | Jun 2009 | |
| NCT00434434 | AQUA | A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma | P2 | completed | 61 | Genentech, Inc. | Oct 2007 |
| NCT00495612 | AERO | A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma | P4 | completed | 69 | Genentech, Inc. | Sep 2007 |
| NCT00481676 | Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria | P2 | completed | 49 | Novartis | May 2007 | |
| NCT00604786 | The Effect of Omalizumab on Responses to Cat Allergen Challenge | N/A | completed | 18 | Johns Hopkins University | Jul 2007 | |
| NCT00242359 | A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma | P4 | withdrawn | 0 | Bernstein Clinical Research Center | Nov 2005 | |
| NCT00117611 | Xolair in Patients With Chronic Sinusitis | P4 | completed | 14 | University of Chicago | Jul 2005 | |
| NCT00500539 | Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation. | P3 | completed | 155 | Novartis | Jul 2007 | |
| NCT00264849 | Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma | P4 | completed | 406 | Novartis | Nov 2005 | |
| NCT00396409 | Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis | P3 | completed | 128 | Novartis Pharmaceuticals | Feb 2006 | |
| NCT00286416 | Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma | N/A | unknown | 60 | Scripps Clinic | Jan 2006 | |
| NCT00382148 | A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g | P2 | completed | 11 | Genentech, Inc. | Nov 2006 | |
| NCT00267202 | Study to Evaluate the Effect of Omalizumab on Improving the Tolerability of Specific Immunotherapy in Patients With Persistent Allergic Asthma | P4 | completed | 275 | Novartis | Dec 2005 | |
| NCT00454051 | Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma | P4 | completed | 31 | Novartis Pharmaceuticals | Dec 2006 | |
| NCT00079937 | Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma | P3 | completed | 628 | Novartis Pharmaceuticals | Apr 2004 | |
| NCT00657891 | The Effect of Xolair (Omalizumab) on Allergy Blood Cells | P4 | completed | 49 | Creighton University | Mar 2007 | |
| NCT00226200 | Soluble CD23 Expression in Asthma Patients Treated With OMA | N/A | terminated | 80 | University of Mississippi Medical Center | Nov 2004 | |
| NCT00130234 | Effect of Anti-IgE in Chronic Urticaria | P2 | completed | 20 | Johns Hopkins University | Nov 2004 | |
| NCT00546143 | Safety and Tolerability of Omalizumab in Patients With Mild to Moderate Asthma | P4 | completed | 32 | Novartis | Jul 2007 | |
| NCT00287378 | Effect of Ozone on Airway Inflammation in Allergic Asthmatics Treated With Omalizumab | N/A | terminated | 1 | University of North Carolina, Chapel Hill | Mar 2006 | |
| NCT00084097 | Omalizumab to Treat Eosinophilic Gastroenteritis | P2 | completed | 30 | National Institute of Allergy and Infectious Diseases (NIAID) | Jun 2004 | |
| NCT00133042 | The Effect of Omalizumab on Airway Responsiveness to Adenosine in Patients With Poorly Controlled Asthma | P4 | completed | 16 | University of Florida | Dec 2004 | |
| NCT01678092 | OXAD | Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis | P1 | completed | 8 | Stanford University | May 2004 |
| NCT00482248 | Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma | P3 | completed | 132 | Novartis | Jun 2003 | |
| NCT00086606 | A Safety and Efficacy Study of Xolair in Peanut Allergy | P2 | terminated | 150 | Genentech, Inc. | Jun 2004 | |
| NCT00219323 | Long-Term Study of IGE025 in Moderate to Severe Bronchial Asthma. | P3 | completed | 133 | Novartis | Nov 2003 | |
| NCT00482508 | Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients | P3 | completed | 95 | Novartis | May 2003 | |
| NCT00078195 | Omalizumab (Xolair) and Allergy Shots For the Treatment of Seasonal Allergies | P2 | completed | 168 | National Institute of Allergy and Infectious Diseases (NIAID) | Apr 2003 | |
| NCT00232050 | Study of Omalizumab in Moderate to Severe Bronchial Asthma | P3 | completed | 327 | Novartis | Oct 2002 | |
| NCT00046748 | Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma | P3 | completed | 484 | Novartis Pharmaceuticals | Dec 2001 | |
| NCT00109200 | A Continued Access Protocol to Provide Xolair to Patients With Severe Allergic Asthma | P3 | completed | 0 | Genentech, Inc. | May 2003 | |
| NCT00109187 | An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g | P3 | completed | 0 | Genentech, Inc. | Jun 2002 | |
| NCT00822783 | Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients | P4 | completed | 0 | Medical University of Vienna | Oct 2001 | |
| NCT00401596 | ALTO | A Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Patients (ALTO) | P3 | completed | 1,899 | Genentech, Inc. | Jul 2000 |
Omalizumab clinical trials: frequently asked questions
- How many Omalizumab clinical trials are there?
- 180 Omalizumab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 11 are actively recruiting participants. 127 are marked completed.
- Are Omalizumab clinical trials recruiting in 2026?
- Yes — 11 Omalizumab trials are actively recruiting in 2026, with 7 U.S. sites across 6 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Omalizumab being studied for?
- Omalizumab is being studied for Asthma, Allergic Asthma, Chronic Spontaneous Urticaria, Food Allergy, Chronic Idiopathic Urticaria and 93 more. The trials are grouped by indication on this page.
- What phase is Omalizumab in?
- Omalizumab clinical trials span 48 Phase 4, 37 Phase 3, 45 Phase 2, 20 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Omalizumab clinical trials?
- The lead sponsor across the most Omalizumab trials is Novartis Pharmaceuticals, with 88 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Omalizumabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
Related pages on Hipa.ai: