Guselkumab Clinical Trials (2026): 91 Studies for Psoriasis & Arthritis, Psoriatic
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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91 Guselkumab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 39 indications (including Psoriasis & Arthritis, Psoriatic) and 22,876 total planned enrollment. 30 Phase 3 Guselkumab trials and 14 Phase 2, 15 Phase 4 are listed. 27 Guselkumab clinical trials are actively recruiting at 67 U.S. sites across 27 states. Most recent activity: NCT06663332 (Feb 2032).
Where to Participate: All Guselkumab Trial Sites in the U.S. (67 sites across 27 states)
Every actively recruiting Guselkumabtrial 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 |
|---|---|---|---|---|
| AL | Digestive Health Specialists of the Southeast | Dothan36305 | NCT07499232 | Map |
| AZ | GI Alliance - Sun City | Sun City85351 | NCT06249555 | Map |
| CA | Clinnova Research | Anaheim92805 | NCT07499232 | Map |
| CA | University of California, San Diego | La Jolla92093 | NCT02103361 | Map |
| CA | United Gastroenterologists | Los Alamitos90720 | NCT07499232 | Map |
| CA | Cedars Sinai Medical Center | Los Angeles90048 | NCT05923073 | Map |
| CA | TLC Clinical Research Inc | Los Angeles90048 | NCT07499232 | Map |
| CA | University of California, San Diego | San Diego92037 | NCT06586281 | Map |
| CA | University of California San Francisco | San Francisco94115 | NCT05858632 | Map |
| CO | Peak Gastroenterology Associates | Colorado Springs80907 | NCT07499232 | Map |
| CT | Connecticut Children's Medical Center | Hartford06106 | NCT05923073 | Map |
| CT | Church Street Research Unit, Yale Center for Clinical Investigation | New Haven06520 | NCT06651489 | Map |
| FL | Family Arthritis Center | Loxahatchee Groves33470 | NCT05669833 | Map |
| FL | Sanchez Clinical Research, Inc | Miami33157-6575 | NCT07499232 | Map |
| FL | Healing Rheumatology | Plant City33563 | NCT05669833 | Map |
| FL | Southwest Florida Rheumatology | Riverview33569 | NCT05669833 | Map |
| FL | GCP Clinical Research | Tampa33609 | NCT07499232 | Map |
| GA | Children's Center for Digestive Health Care | Atlanta30342 | NCT05923073 | Map |
| GA | Children's Center for Digestive Healthcare | Atlanta30342 | NCT06663332 | Map |
| GA | Emory University | Atlanta30322 | NCT06663332 | Map |
| GA | Parris and Associates | Lilburn30047 | NCT05669833 | Map |
| IL | Northwestern University | Evanston60611 | NCT06249555 | Map |
| IN | Riley Hospital for Children | Indianapolis46202-5225 | NCT05923073 | Map |
| IN | Riley Hospital for Children | Indianapolis46202 | NCT06663332 | Map |
| IA | University of Iowa | Iowa City52242 | NCT06249555 | Map |
| KS | Cotton-O'Neil Clinical Research Center | Topeka66606 | NCT07499232 | Map |
| LA | University Medical Center New Orleans | New Orleans70112 | NCT06249555 | Map |
| MA | Boston Childrens Hospital | Boston02115 | NCT05923073 | Map |
| MA | Brigham and Women's Hospital | Boston02115 | NCT05004727 | Map |
| MA | Brigham and Women's Hospital | Chestnut Hill02467 | NCT06249555 | Map |
| MA | University of Massachusetts Chan Medical School | Worcester01655 | NCT05669833 | Map |
| NE | University of Nebraska Medical Center | Omaha68198 | NCT05669833 | Map |
| NJ | Goryeb Children's Hospital | Morristown07960 | NCT05923073 | Map |
| NY | Westchester Putnam Gastroenterology | Carmel10512 | NCT07499232 | Map |
| NY | Columbia University Medical Center | New York10032 | NCT05923073 | Map |
| NY | Icahn School of Medicine at Mount Sinai | New York10029 | NCT05923073 | Map |
| NY | New York Gastroenterology Associates | New York10075 | NCT07499232 | Map |
| NY | New York University | New York10016 | NCT05669833 | Map |
| NY | NYU Langone Health | New York10016 | NCT05004727 | Map |
| NY | Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center | New York10021-5663 | NCT05923073 | Map |
| NY | University of Rochester Medical Center (URMC) | Rochester14623 | NCT05004727 | Map |
| NC | University of North Carolina | Chapel Hill27599 | NCT06249555 | Map |
| NC | Charlotte Gastroenterology and Hepatology, PLLC | Charlotte28207 | NCT07499232 | Map |
| OH | Cincy Arthritis | Blue Ash45242 | NCT05669833 | Map |
| OH | Cincinnati Children's Hospital Medical Center | Cincinnati45229 | NCT06663332 | Map |
| OH | Cleveland Clinic Foundation | Cleveland44195 | NCT06249555 | Map |
| OH | Ohio State Dermatology | Columbus43215 | NCT06563323 | Map |
| OH | The Children's Medical Center of Dayton | Dayton45404 | NCT05923073 | Map |
| OH | Great Lakes Gastroenterology Research, LLC | Mentor44060 | NCT07499232 | Map |
| OH | Southern Ohio Rheumatology | Wheelersburg45694 | NCT05669833 | Map |
| OK | Digestive Disease Specialists Inc | Oklahoma City73114 | NCT07499232 | Map |
| OR | OR Clinic - East - GI | Portland97220 | NCT06249555 | Map |
| PA | Children's Hospital of Philadelphia | Philadelphia19104 | NCT05923073 | Map |
| PA | Hospital at the University of Pennsylvania | Philadelphia19104 | NCT05669833 | Map |
| PA | Frontier Clinical Research | Uniontown15401 | NCT07499232 | Map |
| SC | Palmetto Primary and Specialty Care Physicians, Charleston | Summerville29486 | NCT07499232 | Map |
| TN | Cumberland Rheumatology | Crossville38555 | NCT05669833 | Map |
| TX | Heritage Rheumatology and Arthritis Care | Colleyville76034 | NCT05669833 | Map |
| TX | Texas Arthritis Center | El Paso79902 | NCT05669833 | Map |
| TX | Cook Childrens Medical Center | Fort Worth76104 | NCT05923073 | Map |
| TX | GI Alliance Research Fort Worth | Fort Worth76104 | NCT06249555 | Map |
| TX | GI Alliance Research Mansfield | Mansfield76063 | NCT06249555 | Map |
| TX | Southern Star Research Institute, LLC | San Antonio78229 | NCT07499232 | Map |
| UT | University of Utah | Salt Lake City84132 | NCT05669833 | Map |
| UT | University of Utah | Salt Lake City84113 | NCT06663332 | Map |
| VT | University of Vermont Medical Center | Colchester05446 | NCT05923073 | Map |
| WA | GI Alliance - Bellevue - Washington Gastroenterology | Bellevue98004 | NCT06249555 | Map |
Guselkumab clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | terminated | withdrawn | not yet recruiting | no longer available | Total |
|---|---|---|---|---|---|---|---|---|
| Early P1 | 1 | 1 | ||||||
| P1 | 9 | 1 | 1 | 11 | ||||
| P2 | 2 | 2 | 7 | 2 | 1 | 14 | ||
| P2/P3 | 3 | 3 | ||||||
| P3 | 4 | 9 | 16 | 1 | 30 | |||
| P4 | 7 | 2 | 3 | 2 | 1 | 15 | ||
| N/A | 10 | 1 | 1 | 1 | 1 | 2 | 1 | 17 |
Recruiting Guselkumab clinical trials (27)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06663332 | TRILOGYA Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants | P3 | Crohns Disease | 196 | Oct 2024 |
| NCT07448402 | Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease | — | Psoriasis | 50 | May 2026 |
| NCT02103361 | Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project | — | Psoriasis | 200 | Nov 2013 |
| NCT07499232 | CHARGEA Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease | P3 | Crohn Disease | 530 | Apr 2026 |
| NCT07352566 | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis | P4 | Psoriasis | 10 | Aug 2026 |
| NCT07444060 | Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease | — | CD - Crohn's Disease | 100 | Mar 2026 |
| NCT07528040 | POST-CDAn Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection | — | Crohn's Disease (CD) | 88 | Apr 2026 |
| NCT06916390 | GUARDIANGUselkumAb inteRvention and DIet evaluAtioN for Pouchitis | P4 | Pouchitis | 20 | Apr 2026 |
| NCT07487311 | GUSA Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD) | — | Inflamatory Bowel Disease | 80 | Jan 2026 |
| NCT05004727 | PAMPAMulti-Center PAMPA Study | P4 | Psoriasis | 176 | Feb 2022 |
| NCT07245394 | SHIFT-IBDSwitching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD) | — | Inflammatory Bowel Disease (IBD) | 200 | Jan 2026 |
| NCT05923073 | MACARONI-23A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease | P3 | Crohn's Disease | 120 | Mar 2024 |
| NCT05858632 | Immune Spatial Features of Guselkumab Cutaneous Response | P4 | Psoriasis of Scalp | 10 | Jul 2023 |
| NCT06398106 | HELIOSProactive TDM Versus Standard Use of Biologics in Psoriasis | P4 | Psoriasis Vulgaris | 210 | Dec 2024 |
| NCT05503875 | Immunoclassification of Psoriasis: a Strategy for Precision Medicine | N/A | Immunoclassification | 100 | Jan 2023 |
| NCT06586281 | Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy | N/A | Psoriatic Arthritis | 20 | Jun 2025 |
| NCT07246460 | UPGRADEUltrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE). | — | Crohn's Disease of Both Small and Large Intestine | 90 | Oct 2025 |
| NCT07310095 | CDA Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) | P4 | Crohn Disease | 78 | Dec 2025 |
| NCT07138898 | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty | P2 | Rheumatic Disease | 80 | Sep 2025 |
| NCT07141004 | A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA) | P4 | Arthritis, Psoriatic | 100 | Aug 2025 |
| NCT06563323 | GEORGEGuselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG) | P2 | Pyoderma Gangrenosum | 17 | Feb 2025 |
| NCT07532486 | A Study to Evaluate Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Participants of Moderate-to-severe Plaque Psoriasis | N/A | Psoriasis | 400 | Jul 2024 |
| NCT06974474 | GUPAINPotential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study. | P4 | Psoriasis Arthritis | 26 | Jun 2024 |
| NCT06249555 | VOICEVOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study | — | Crohn's Disease | 300 | Mar 2024 |
| NCT05669833 | EVOLUTIONGuselkumab vs Golimumab in PsA TNF Inadequate Responder Patients | P3 | Psoriatic Arthritis | 63 | Jul 2023 |
| NCT06651489 | Efficacy of Guselkumab in Treating Hailey Hailey Disease | P2 | Hailey Hailey Disease | 10 | Mar 2025 |
| NCT07430319 | Real-Life Evaluation of Guselkumab Dosing Interval Adjustments | — | Psoriasis | 100 | Oct 2025 |
Guselkumab clinical trials by indication
Psoriasis (20)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07448402 | — | N/A | not yet recruiting | Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease |
| NCT02103361 | — | N/A | recruiting | Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project |
| NCT07352566 | — | P4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT05004727 | PAMPA | P4 | recruiting | Multi-Center PAMPA Study |
| NCT07532486 | — | N/A | recruiting | A Study to Evaluate Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Participants of Moderate-to-severe Plaque Psoriasis |
| NCT03451851 | PROTOSTAR | P3 | active not recruiting | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants |
| NCT07430319 | — | N/A | recruiting | Real-Life Evaluation of Guselkumab Dosing Interval Adjustments |
| NCT04340076 | BeNeBio | P4 | completed | Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis |
| + 12 more, see All trials below. | ||||
Arthritis, Psoriatic (10)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04882098 | APEX | P3 | active not recruiting | A Study of Guselkumab in Participants With Active Psoriatic Arthritis |
| NCT07141004 | — | P4 | recruiting | A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA) |
| NCT05049798 | PsABIOnd | N/A | active not recruiting | A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice |
| NCT04929210 | STAR | P4 | active not recruiting | A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease |
| NCT04936308 | SOLSTICE | P3 | active not recruiting | Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent |
| NCT05071664 | AFFINITY | P2 | completed | A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis |
| NCT05083078 | — | P1 | terminated | A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis |
| NCT03796858 | COSMOS | P3 | completed | A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy |
| + 2 more, see All trials below. | ||||
Crohn's Disease (6)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05242471 | DUET-CD | P2 | active not recruiting | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease |
| NCT05923073 | MACARONI-23 | P3 | recruiting | A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease |
| NCT06408935 | REASON | P3 | active not recruiting | Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients |
| NCT03466411 | GALAXI | P2/P3 | active not recruiting | A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease |
| NCT06249555 | VOICE | N/A | recruiting | VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study |
| NCT05784129 | PROGRESS | P3 | terminated | A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection |
Healthy (6)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04147338 | — | P1 | completed | A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants |
| NCT04617691 | — | P1 | completed | A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants |
| NCT04030533 | — | P1 | completed | Study of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Participants |
| NCT03536325 | — | P1 | completed | A Study to Assess the Safety, Tolerability and Pharmacokinetics of Guselkumab Following a Single Intravenous Administration in Healthy Japanese Participants |
| NCT02570373 | — | P1 | completed | A Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Participants |
| NCT01866007 | CNTO1959 | P1 | completed | A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants |
Colitis, Ulcerative (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05242484 | DUET-UC | P2 | active not recruiting | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT05528510 | ASTRO | P3 | active not recruiting | A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT06260163 | QUASAR Jr | P3 | active not recruiting | A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT03662542 | VEGA | P2 | completed | A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis |
Crohn Disease (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07499232 | CHARGE | P3 | recruiting | A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease |
| NCT05197049 | GRAVITI | P3 | active not recruiting | A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease |
| NCT07310095 | CD | P4 | recruiting | A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) |
Psoriatic Arthritis (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06586281 | — | N/A | recruiting | Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy |
| NCT05669833 | EVOLUTION | P3 | recruiting | Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients |
| NCT02319759 | — | P2 | completed | Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA) |
Plaque Psoriasis (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05272150 | VISIBLE | P3 | completed | Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis |
| NCT04533737 | COBRA | P4 | terminated | Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab |
| NCT03573323 | IXORA-R | P4 | completed | A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis |
Hidradenitis Suppurativa (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04061395 | HiGUS | P2 | completed | Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. |
| NCT04084665 | — | Early P1 | withdrawn | Biomarkers in Participants With Hidradenitis Suppurativa Receiving Guselkumab. |
| NCT03628924 | NOVA | P2 | completed | A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS) |
Psoriasis Vulgaris (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06398106 | HELIOS | P4 | recruiting | Proactive TDM Versus Standard Use of Biologics in Psoriasis |
| NCT04394936 | — | N/A | terminated | An Explorative Psoriasis Biomarker Study |
Crohns Disease (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06663332 | TRILOGY | P3 | recruiting | A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants |
| NCT04397263 | — | P3 | completed | A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease |
Adenomatous Polyposis Coli (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03649971 | — | P1 | completed | A Study of Guselkumab in Participants With Familial Adenomatous Polyposis |
| NCT04948398 | — | N/A | no longer available | Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis |
Pouchitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06916390 | GUARDIAN | P4 | recruiting | GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis |
Crohn's Disease (CD) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07528040 | POST-CD | N/A | not yet recruiting | An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection |
CD - Crohn's Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07444060 | — | N/A | recruiting | Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease |
Inflammatory Bowel Disease (IBD) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07245394 | SHIFT-IBD | N/A | recruiting | Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD) |
Inflamatory Bowel Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07487311 | GUS | N/A | recruiting | A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD) |
Psoriasis (PsO) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07255781 | EMERGE | N/A | withdrawn | Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy |
Crohn's Disease of Both Small and Large Intestine (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07246460 | UPGRADE | N/A | recruiting | Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE). |
Rheumatic Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07138898 | — | P2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
Hailey Hailey Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06651489 | — | P2 | recruiting | Efficacy of Guselkumab in Treating Hailey Hailey Disease |
Pyoderma Gangrenosum (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06563323 | GEORGE | P2 | recruiting | Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG) |
Psoriasis Arthritis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06974474 | GUPAIN | P4 | recruiting | Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study. |
Moderate Plaque Psoriasis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06039189 | SPECTREM | P3 | completed | Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis |
Psoriasis of Scalp (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05858632 | — | P4 | recruiting | Immune Spatial Features of Guselkumab Cutaneous Response |
Immunoclassification (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05503875 | — | N/A | recruiting | Immunoclassification of Psoriasis: a Strategy for Precision Medicine |
Skin Inflammation (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05535738 | — | P2/P3 | active not recruiting | Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation |
Fistulizing Crohns Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05347095 | FUZION CD | P3 | active not recruiting | A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease |
Arthritis, Juvenile (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05083182 | PSUMMIT-Jr | P3 | active not recruiting | A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis |
Celiac Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04704843 | — | P1 | withdrawn | A Study of Guselkumab in Adult Participants With Celiac Disease |
Alcoholic Liver Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04736966 | — | P1 | completed | Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease |
Psoriasis Guttate (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04645355 | TIG | P4 | active not recruiting | Guselkumab Immunogenetics |
Scleroderma, Systemic (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04683029 | — | P2 | completed | A Study of Guselkumab in Participants With Systemic Sclerosis |
Giant Cell Arteritis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04633447 | THEIA | P2 | terminated | A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis |
Lupus Nephritis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04376827 | ORCHID-LN | P2 | terminated | A Study of Guselkumab in Participants With Active Lupus Nephritis |
Pityriasis Rubra Pilaris (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03975153 | PRP | P2 | completed | Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP) |
Ulcerative Colitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04033445 | QUASAR | P2/P3 | active not recruiting | A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis |
Palmoplantar Pustulosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02641730 | — | P3 | completed | An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis |
Pustular Psoriasis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02343744 | — | P3 | completed | An Efficacy and Safety Study of CNTO1959 (Guselkumab) in the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis |
Guselkumab 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 |
|---|---|---|---|---|---|---|
| GUARDIAN | NCT06916390 | P4 | recruiting | Pouchitis | 20 | — |
| PAMPA | NCT05004727 | P4 | recruiting | Psoriasis | 176 | PMID 36564123 |
| HELIOS | NCT06398106 | P4 | recruiting | Psoriasis Vulgaris | 210 | — |
| CD | NCT07310095 | P4 | recruiting | Crohn Disease | 78 | — |
| GUPAIN | NCT06974474 | P4 | recruiting | Psoriasis Arthritis | 26 | — |
| STAR | NCT04929210 | P4 | active not recruiting | Arthritis, Psoriatic | 411 | PMID 36064592 |
| TIG | NCT04645355 | P4 | active not recruiting | Psoriasis Guttate | 25 | — |
| BeNeBio | NCT04340076 | P4 | completed | Psoriasis | 244 | PMID 34656148 |
| TREMFYA | NCT04914429 | P4 | completed | Psoriasis | 327 | PMID 40921728 |
| G-CARE | NCT05125679 | P4 | terminated | Psoriasis | 15 | — |
| COBRA | NCT04533737 | P4 | terminated | Plaque Psoriasis | 113 | PMID 38300408 |
| IXORA-R | NCT03573323 | P4 | completed | Plaque Psoriasis | 1,027 | PMID 38332436 |
| TRILOGY | NCT06663332 | P3 | recruiting | Crohns Disease | 196 | — |
| CHARGE | NCT07499232 | P3 | recruiting | Crohn Disease | 530 | — |
| GRAVITI | NCT05197049 | P3 | active not recruiting | Crohn Disease | 350 | — |
| ASTRO | NCT05528510 | P3 | active not recruiting | Colitis, Ulcerative | 418 | PMID 41544637 |
| MACARONI-23 | NCT05923073 | P3 | recruiting | Crohn's Disease | 120 | — |
| REASON | NCT06408935 | P3 | active not recruiting | Crohn's Disease | 120 | — |
| APEX | NCT04882098 | P3 | active not recruiting | Arthritis, Psoriatic | 1,054 | PMID 36627711 |
| QUASAR Jr | NCT06260163 | P3 | active not recruiting | Colitis, Ulcerative | 112 | — |
| FUZION CD | NCT05347095 | P3 | active not recruiting | Fistulizing Crohns Disease | 288 | — |
| PROTOSTAR | NCT03451851 | P3 | active not recruiting | Psoriasis | 120 | PMID 39708367 |
| EVOLUTION | NCT05669833 | P3 | recruiting | Psoriatic Arthritis | 63 | PMID 40102973 |
| SOLSTICE | NCT04936308 | P3 | active not recruiting | Arthritis, Psoriatic | 453 | PMID 38773563 |
| PSUMMIT-Jr | NCT05083182 | P3 | active not recruiting | Arthritis, Juvenile | 50 | — |
| VISIBLE | NCT05272150 | P3 | completed | Plaque Psoriasis | 213 | PMID 40560554 |
| SPECTREM | NCT06039189 | P3 | completed | Moderate Plaque Psoriasis | 338 | — |
| GUIDE | NCT03818035 | P3 | completed | Psoriasis | 880 | PMID 34518264 |
| PROGRESS | NCT05784129 | P3 | terminated | Crohn's Disease | 4 | — |
| G-PLUS | NCT03998683 | P3 | completed | Psoriasis | 117 | — |
| COSMOS | NCT03796858 | P3 | completed | Arthritis, Psoriatic | 285 | PMID 37587493 |
| VOYAGE 2 | NCT02207244 | P3 | completed | Psoriasis | 992 | PMID 37715294 |
| VOYAGE 1 | NCT02207231 | P3 | completed | Psoriasis | 837 | PMID 39153060 |
| Discover-1 | NCT03162796 | P3 | completed | Arthritis, Psoriatic | 383 | PMID 33934076 |
| POLARIS | NCT02951533 | P3 | completed | Psoriasis | 119 | — |
| ECLIPSE | NCT03090100 | P3 | completed | Psoriasis | 1,048 | PMID 31402114 |
| NAVIGATE | NCT02203032 | P3 | completed | Psoriasis | 872 | PMID 37906417 |
| DUET-CD | NCT05242471 | P2 | active not recruiting | Crohn's Disease | 703 | — |
| DUET-UC | NCT05242484 | P2 | active not recruiting | Colitis, Ulcerative | 577 | — |
| GEORGE | NCT06563323 | P2 | recruiting | Pyoderma Gangrenosum | 17 | PMID 35146098 |
| AFFINITY | NCT05071664 | P2 | completed | Arthritis, Psoriatic | 91 | — |
| THEIA | NCT04633447 | P2 | terminated | Giant Cell Arteritis | 53 | — |
| PRP | NCT03975153 | P2 | completed | Pityriasis Rubra Pilaris | 15 | PMID 38598229 |
| ORCHID-LN | NCT04376827 | P2 | terminated | Lupus Nephritis | 33 | PMID 37528520 |
| HiGUS | NCT04061395 | P2 | completed | Hidradenitis Suppurativa | 20 | — |
| VEGA | NCT03662542 | P2 | completed | Colitis, Ulcerative | 214 | PMID 38488354 |
| NOVA | NCT03628924 | P2 | completed | Hidradenitis Suppurativa | 184 | PMID 37317022 |
Terminated and withdrawn Guselkumab trials (10)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT07255781withdrawnShared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy
- NCT04633447terminatedA Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
- NCT05784129terminatedA Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
- NCT05125679terminatedEffect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis
- NCT04394936terminatedAn Explorative Psoriasis Biomarker Study
- NCT04376827terminatedA Study of Guselkumab in Participants With Active Lupus Nephritis
- NCT04533737terminatedEfficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab
- NCT05083078terminatedA Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
- NCT04704843withdrawnA Study of Guselkumab in Adult Participants With Celiac Disease
- NCT04084665withdrawnBiomarkers in Participants With Hidradenitis Suppurativa Receiving Guselkumab.
All Guselkumab trials (91)
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 |
|---|---|---|---|---|---|---|---|
| NCT06663332 | TRILOGY | A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants | P3 | recruiting | 196 | Janssen Research & Development, LLC | Oct 2024 |
| NCT07448402 | Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease | — | not yet recruiting | 50 | Caja Costarricense de Seguro Social | May 2026 | |
| NCT02103361 | Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project | — | recruiting | 200 | University of California, San Diego | Nov 2013 | |
| NCT07499232 | CHARGE | A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease | P3 | recruiting | 530 | Janssen Research & Development, LLC | Apr 2026 |
| NCT07352566 | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis | P4 | not yet recruiting | 10 | University of California, San Francisco | Aug 2026 | |
| NCT07444060 | Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease | — | recruiting | 100 | Second Affiliated Hospital, School of Medicine, Zhejiang University | Mar 2026 | |
| NCT05242471 | DUET-CD | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease | P2 | active not recruiting | 703 | Janssen Research & Development, LLC | Jul 2022 |
| NCT07528040 | POST-CD | An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection | — | not yet recruiting | 88 | Shanghai 10th People's Hospital | Apr 2026 |
| NCT06916390 | GUARDIAN | GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis | P4 | recruiting | 20 | Universitaire Ziekenhuizen KU Leuven | Apr 2026 |
| NCT05242484 | DUET-UC | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | P2 | active not recruiting | 577 | Janssen Research & Development, LLC | Sep 2022 |
| NCT07487311 | GUS | A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD) | — | recruiting | 80 | Second Affiliated Hospital, School of Medicine, Zhejiang University | Jan 2026 |
| NCT05004727 | PAMPA | Multi-Center PAMPA Study | P4 | recruiting | 176 | NYU Langone Health | Feb 2022 |
| NCT07245394 | SHIFT-IBD | Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD) | — | recruiting | 200 | TIDHI Innovation Inc. | Jan 2026 |
| NCT05197049 | GRAVITI | A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease | P3 | active not recruiting | 350 | Janssen Research & Development, LLC | Jan 2022 |
| NCT05528510 | ASTRO | A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis | P3 | active not recruiting | 418 | Janssen Research & Development, LLC | Sep 2022 |
| NCT05923073 | MACARONI-23 | A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease | P3 | recruiting | 120 | Janssen Research & Development, LLC | Mar 2024 |
| NCT05858632 | Immune Spatial Features of Guselkumab Cutaneous Response | P4 | recruiting | 10 | University of California, San Francisco | Jul 2023 | |
| NCT06408935 | REASON | Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients | P3 | active not recruiting | 120 | Janssen-Cilag Ltd. | Apr 2024 |
| NCT06398106 | HELIOS | Proactive TDM Versus Standard Use of Biologics in Psoriasis | P4 | recruiting | 210 | University Hospital, Ghent | Dec 2024 |
| NCT03466411 | GALAXI | A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease | P2/P3 | active not recruiting | 1,409 | Janssen Research & Development, LLC | Apr 2018 |
| NCT05503875 | Immunoclassification of Psoriasis: a Strategy for Precision Medicine | N/A | recruiting | 100 | Second Affiliated Hospital, School of Medicine, Zhejiang University | Jan 2023 | |
| NCT05535738 | Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation | P2/P3 | active not recruiting | 45 | Wei-Che Ko | Nov 2022 | |
| NCT06586281 | Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy | N/A | recruiting | 20 | University of California, San Diego | Jun 2025 | |
| NCT07246460 | UPGRADE | Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE). | — | recruiting | 90 | University of Calgary | Oct 2025 |
| NCT07310095 | CD | A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) | P4 | recruiting | 78 | Xian-Janssen Pharmaceutical Ltd. | Dec 2025 |
| NCT04882098 | APEX | A Study of Guselkumab in Participants With Active Psoriatic Arthritis | P3 | active not recruiting | 1,054 | Janssen Research & Development, LLC | Jun 2021 |
| NCT07138898 | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty | P2 | not yet recruiting | 80 | NYU Langone Health | Sep 2025 | |
| NCT04033445 | QUASAR | A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis | P2/P3 | active not recruiting | 1,064 | Janssen Research & Development, LLC | Sep 2019 |
| NCT07141004 | A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA) | P4 | recruiting | 100 | Johnson & Johnson Private Limited | Aug 2025 | |
| NCT06563323 | GEORGE | Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG) | P2 | recruiting | 17 | Oregon Health and Science University | Feb 2025 |
| NCT05049798 | PsABIOnd | A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice | — | active not recruiting | 1,314 | Janssen Pharmaceutica N.V., Belgium | Aug 2021 |
| NCT07532486 | A Study to Evaluate Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Participants of Moderate-to-severe Plaque Psoriasis | N/A | recruiting | 400 | Second Affiliated Hospital, School of Medicine, Zhejiang University | Jul 2024 | |
| NCT06974474 | GUPAIN | Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study. | P4 | recruiting | 26 | Fondazione Policlinico Universitario Campus Bio-Medico | Jun 2024 |
| NCT06260163 | QUASAR Jr | A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | P3 | active not recruiting | 112 | Janssen Research & Development, LLC | Jan 2024 |
| NCT04929210 | STAR | A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease | P4 | active not recruiting | 411 | Janssen Research & Development, LLC | Aug 2021 |
| NCT05347095 | FUZION CD | A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease | P3 | active not recruiting | 288 | Janssen-Cilag Ltd. | Sep 2022 |
| NCT06249555 | VOICE | VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study | — | recruiting | 300 | Alimentiv Inc. | Mar 2024 |
| NCT03451851 | PROTOSTAR | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants | P3 | active not recruiting | 120 | Janssen Research & Development, LLC | Jul 2018 |
| NCT05669833 | EVOLUTION | Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients | P3 | recruiting | 63 | University of Pennsylvania | Jul 2023 |
| NCT04936308 | SOLSTICE | Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent | P3 | active not recruiting | 453 | Janssen Research & Development, LLC | Sep 2021 |
| NCT05083182 | PSUMMIT-Jr | A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis | P3 | active not recruiting | 50 | Janssen Research & Development, LLC | Aug 2022 |
| NCT06651489 | Efficacy of Guselkumab in Treating Hailey Hailey Disease | P2 | recruiting | 10 | Yale University | Mar 2025 | |
| NCT07430319 | Real-Life Evaluation of Guselkumab Dosing Interval Adjustments | — | recruiting | 100 | Centre Hospitalier Universitaire de Nice | Oct 2025 | |
| NCT04645355 | TIG | Guselkumab Immunogenetics | P4 | active not recruiting | 25 | University of California, San Francisco | Mar 2021 |
| NCT07255781 | EMERGE | Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy | — | withdrawn | 0 | University of California, San Diego | Nov 2025 |
| NCT04397263 | A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease | P3 | completed | 38 | Janssen Pharmaceutical K.K. | Jun 2020 | |
| NCT05272150 | VISIBLE | Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis | P3 | completed | 213 | Janssen Research & Development, LLC | Jul 2022 |
| NCT06039189 | SPECTREM | Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis | P3 | completed | 338 | Janssen Research & Development, LLC | Aug 2023 |
| NCT04340076 | BeNeBio | Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis | P4 | completed | 244 | Radboud University Medical Center | Aug 2020 |
| NCT03818035 | GUIDE | A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis | P3 | completed | 880 | Janssen-Cilag International NV | Feb 2019 |
| NCT05071664 | AFFINITY | A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis | P2 | completed | 91 | Janssen Research & Development, LLC | Oct 2021 |
| NCT04683029 | A Study of Guselkumab in Participants With Systemic Sclerosis | P2 | completed | 56 | Janssen Pharmaceutical K.K. | Feb 2021 | |
| NCT04633447 | THEIA | A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis | P2 | terminated | 53 | Janssen Research & Development, LLC | Dec 2020 |
| NCT04736966 | Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease | P1 | completed | 13 | University of California, San Diego | Mar 2021 | |
| NCT03975153 | PRP | Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP) | P2 | completed | 15 | Oregon Health and Science University | Oct 2019 |
| NCT04439526 | GULLIVER | A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis | — | completed | 356 | Janssen-Cilag S.p.A. | Jun 2020 |
| NCT05784129 | PROGRESS | A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection | P3 | terminated | 4 | Janssen Research & Development, LLC | Feb 2023 |
| NCT04914429 | TREMFYA | A Study of Guselkumab (TREMFYA) in Chinese Participants With Moderate to Severe Plaque Psoriasis | P4 | completed | 327 | Janssen Research & Development, LLC | Aug 2021 |
| NCT05125679 | G-CARE | Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis | P4 | terminated | 15 | Janssen-Cilag Ltd. | Nov 2021 |
| NCT04394936 | An Explorative Psoriasis Biomarker Study | N/A | terminated | 37 | Centre for Human Drug Research, Netherlands | Sep 2020 | |
| NCT04376827 | ORCHID-LN | A Study of Guselkumab in Participants With Active Lupus Nephritis | P2 | terminated | 33 | Janssen Research & Development, LLC | Sep 2020 |
| NCT04533737 | COBRA | Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab | P4 | terminated | 113 | LEO Pharma | Dec 2020 |
| NCT05083078 | A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis | P1 | terminated | 11 | Janssen Research & Development, LLC | Nov 2021 | |
| NCT04061395 | HiGUS | Guselkumab for Hidradenitis Suppurativa, a Mode of Action Study. | P2 | completed | 20 | University Medical Center Groningen | Oct 2019 |
| NCT03649971 | A Study of Guselkumab in Participants With Familial Adenomatous Polyposis | P1 | completed | 77 | Janssen Research & Development, LLC | Nov 2018 | |
| NCT04147338 | A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants | P1 | completed | 440 | Janssen Research & Development, LLC | Oct 2019 | |
| NCT03998683 | G-PLUS | A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis | P3 | completed | 117 | Janssen-Cilag Ltd. | Sep 2019 |
| NCT03662542 | VEGA | A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | P2 | completed | 214 | Janssen Research & Development, LLC | Nov 2018 |
| NCT04704843 | A Study of Guselkumab in Adult Participants With Celiac Disease | P1 | withdrawn | 0 | Janssen Research & Development, LLC | Jun 2021 | |
| NCT04617691 | A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants | P1 | completed | 140 | Janssen Research & Development, LLC | Nov 2020 | |
| NCT04948398 | Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis | — | no longer available | 0 | Janssen Research & Development, LLC | — | |
| NCT04030533 | Study of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Participants | P1 | completed | 60 | Janssen Research & Development, LLC | Nov 2019 | |
| NCT03796858 | COSMOS | A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy | P3 | completed | 285 | Janssen Pharmaceutica N.V., Belgium | Mar 2019 |
| NCT03158285 | A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis | P3 | completed | 741 | Janssen Research & Development, LLC | Jul 2017 | |
| NCT04084665 | Biomarkers in Participants With Hidradenitis Suppurativa Receiving Guselkumab. | Early P1 | withdrawn | 0 | Rockefeller University | Jun 2020 | |
| NCT02207244 | VOYAGE 2 | A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment | P3 | completed | 992 | Janssen Research & Development, LLC | Nov 2014 |
| NCT02207231 | VOYAGE 1 | A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis | P3 | completed | 837 | Janssen Research & Development, LLC | Nov 2014 |
| NCT03628924 | NOVA | A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS) | P2 | completed | 184 | Janssen Research & Development, LLC | Sep 2018 |
| NCT03573323 | IXORA-R | A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis | P4 | completed | 1,027 | Eli Lilly and Company | Nov 2018 |
| NCT03162796 | Discover-1 | A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s) | P3 | completed | 383 | Janssen Research & Development, LLC | Aug 2017 |
| NCT02951533 | POLARIS | A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis | P3 | completed | 119 | Janssen-Cilag G.m.b.H | Dec 2016 |
| NCT02343744 | An Efficacy and Safety Study of CNTO1959 (Guselkumab) in the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis | P3 | completed | 21 | Janssen Pharmaceutical K.K. | Jan 2015 | |
| NCT03536325 | A Study to Assess the Safety, Tolerability and Pharmacokinetics of Guselkumab Following a Single Intravenous Administration in Healthy Japanese Participants | P1 | completed | 24 | Janssen Pharmaceutical K.K. | May 2018 | |
| NCT03090100 | ECLIPSE | A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis | P3 | completed | 1,048 | Janssen Research & Development, LLC | Apr 2017 |
| NCT02641730 | An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis | P3 | completed | 159 | Janssen Pharmaceutical K.K. | Dec 2015 | |
| NCT02905331 | Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis | P3 | completed | 78 | Janssen Research & Development, LLC | Feb 2017 | |
| NCT02319759 | Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA) | P2 | completed | 149 | Janssen Research & Development, LLC | Mar 2015 | |
| NCT02397382 | CNTO 1959 | Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis | P1 | completed | 16 | Janssen Research & Development, LLC | Jun 2015 |
| NCT02203032 | NAVIGATE | A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab | P3 | completed | 872 | Janssen Research & Development, LLC | Oct 2014 |
| NCT02570373 | A Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Participants | P1 | completed | 8 | Janssen Research & Development, LLC | Sep 2015 | |
| NCT01866007 | CNTO1959 | A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants | P1 | completed | 141 | Janssen Research & Development, LLC | May 2013 |
Guselkumab clinical trials: frequently asked questions
- How many Guselkumab clinical trials are there?
- 91 Guselkumab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 23 are actively recruiting participants. 36 are marked completed.
- Are Guselkumab clinical trials recruiting in 2026?
- Yes — 23 Guselkumab trials are actively recruiting in 2026, with 67 U.S. sites across 27 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Guselkumab being studied for?
- Guselkumab is being studied for Psoriasis, Arthritis, Psoriatic, Healthy, Crohn's Disease, Colitis, Ulcerative and 50 more. The trials are grouped by indication on this page.
- What phase is Guselkumab in?
- Guselkumab clinical trials span 15 Phase 4, 30 Phase 3, 14 Phase 2, 11 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Guselkumab clinical trials?
- The lead sponsor across the most Guselkumab trials is Janssen Research & Development, LLC, with 31 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 Guselkumabas 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: