Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT00079937 | Asthma | Percentage of Participants With at Least 1 Adverse Event Baseline to end of the study (Week 68) | Omalizumab | 90.3 Percentage of participants |
| Placebo | 93.7 Percentage of participants | |||
| NCT00079937 | Asthma | Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period Baseline to end of the fixed-dose steroid treatment period (Week 24) | Omalizumab | 0.45 Exacerbations per patient per 24-weeks |
| Placebo | 0.64 Exacerbations per patient per 24-weeks | |||
| NCT00314574 | Asthma | Rate of Asthma Exacerbations Over the 48 Week Treatment Period 48 weeks | Placebo | 0.88 exacerbation/patient-week |
| Xolair | 0.66 exacerbation/patient-week | |||
| NCT00396409 | — | Daily Symptom Load Recorded daily during the 2007 and 2008 pollen season | Depigoid + Omalizumab | 1.32 units on a scale (±1.74 Standard Deviation) |
| Depigoid + Omalizumab | 1.25 units on a scale (±0.99 Standard Deviation) | |||
| Depigoid + Placebo | 0.97 units on a scale (±1.02 Standard Deviation) | |||
| Depigoid + Placebo | 1.10 units on a scale (±0.99 Standard Deviation) | |||
| NCT00500539 | Asthma | The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period 16 weeks after last dose | Follow-up Period | 0 participants |
| Follow-up Period | 0 participants | |||
| Follow-up Period | 0 participants | |||
| Follow-up Period | 0 participants | |||
| Follow-up Period | 0 participants | |||
| Follow-up Period | 0 participants | |||
| Follow-up Period | 0 participants | |||
| Follow-up Period | 0 participants | |||
| NCT01007149 NATAIR | Asthma | Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils Baseline and 16 weeks | Omalizumab | -84.4 Percent change in MFI (±17.80 Standard Deviation) |
| Placebo | 27.7 Percent change in MFI (±87.90 Standard Deviation) | |||
| NCT01007149 NATAIR | Asthma | Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells Baseline and 16 weeks | Omalizumab | -56.7 Percent change in MFI (±19.74 Standard Deviation) |
| Placebo | 24.8 Percent change in MFI (±111.71 Standard Deviation) | |||
| NCT01202903 | Asthma | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period Baseline, 24 weeks | Omalizumab | 27.03 L/min (±20.865 Standard Error) |
| Placebo | 18.18 L/min (±21.086 Standard Error) | |||
| NCT01264939 | Chronic Urticaria | Percentage of Participants With Adverse Events Baseline to the end of study (up to 40 weeks) | Omalizumab 300 mg | 83.7 Percentage of participants |
| Placebo | 78.3 Percentage of participants | |||
| NCT01287117 | Chronic Urticaria | Change From Baseline to Week 12 in the Weekly Itch Severity Score Baseline to Week 12 | Omalizumab 150 mg | -6.66 Units on a scale (±6.28 Standard Deviation) |
| Omalizumab 300 mg | -9.40 Units on a scale (±5.73 Standard Deviation) | |||
| Omalizumab 75 mg | -6.46 Units on a scale (±6.14 Standard Deviation) | |||
| Placebo | -3.63 Units on a scale (±5.22 Standard Deviation) | |||
| NCT01292473 | Chronic Urticaria | Change From Baseline in the Weekly Itch Severity Score at Week 12 Baseline, Week 12 | Omalizumab 150 mg | -8.14 Units on a scale (±6.44 Standard Deviation) |
| Omalizumab 300 mg | -9.77 Units on a scale (±5.95 Standard Deviation) | |||
| Omalizumab 75 mg | -5.87 Units on a scale (±6.45 Standard Deviation) | |||
| Placebo | -5.14 Units on a scale (±5.58 Standard Deviation) | |||
| NCT01723072 X-ACT | Chronic Urticaria | Mean Change From Baseline Using Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Total Scores During the Study: Unadjusted Analysis and ANCOVA (LOCF) (FAS) Baseline, 4, 12, 20, 28 and 36 weeks | Omalizumab | -31.4 score (±23.7 Standard Deviation) |
| Omalizumab | -32.1 score (±21.8 Standard Deviation) | |||
| Omalizumab | -23.9 score (±23.0 Standard Deviation) | |||
| Omalizumab | -35.1 score (±24.2 Standard Deviation) | |||
| Omalizumab | -25.5 score (±21.3 Standard Deviation) | |||
| Placebo | -14.7 score (±19.2 Standard Deviation) | |||
| Placebo | -13.9 score (±17.7 Standard Deviation) | |||
| Placebo | -16.2 score (±18.8 Standard Deviation) | |||
| Placebo | -12.1 score (±20.3 Standard Deviation) | |||
| Placebo | -6.4 score (±15.9 Standard Deviation) | |||
| NCT02161562 OPTIMA | Chronic Urticaria | Number of Participants Who Were Clinically Well-controlled (UAS7<=6) After the Initial Dosing Period, Relapsed (UAS7>=16) When Treatment Was Discontinued, and Who Achieved a UAS7 Score <=6 at the End of the Second Dosing Period (Retreatment A2 and B2) Last 7 days of second dosing period, 44 weeks | All Retreatment (A2&B2) | 43 Participants |
| Retreatment (A2) | 10 Participants | |||
| Retreatment (B2) | 33 Participants | |||
| NCT02329223 | — | Change From Baseline in the Weekly Itch Severity Score at Week 12 Baseline to Week 12 | Omalizumab 150 mg | -8.80 Units on a scale (±0.591 Standard Error) |
| Omalizumab 300 mg | -10.22 Units on a scale (±0.571 Standard Error) | |||
| Placebo | -6.51 Units on a scale (±0.581 Standard Error) | |||
| NCT03280537 POLYP 2 | Nasal Polyps | Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 24 Baseline, Week 24 (Study Days 155 to 186) | Omalizumab | -0.70 Score on a scale |
| Placebo | -0.20 Score on a scale | |||
| NCT03280537 POLYP 2 | Nasal Polyps | Change From Baseline in Nasal Polyp Score (NPS) at Week 24 Baseline, Week 24 | Omalizumab | -0.90 Score on a scale |
| Placebo | -0.31 Score on a scale | |||
| NCT03280550 POLYP 1 | Nasal Polyps | Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 24 Baseline, Week 24 (Study Days 155 to 186) | Omalizumab | -0.89 Score on a scale |
| Placebo | -0.35 Score on a scale | |||
| NCT03280550 POLYP 1 | Nasal Polyps | Change From Baseline in Nasal Polyp Score (NPS) at Week 24 Baseline, Week 24 | Omalizumab | -1.08 Score on a scale |
| Placebo | 0.06 Score on a scale | |||
| NCT03328897 | Chronic Urticaria | Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment Baseline, Week 12 | Omalizumab 150mg | -9.66 Score on a scale (±0.424 Standard Error) |
| Omalizumab 300mg | -10.11 Score on a scale (±0.430 Standard Error) | |||
| Placebo | -5.87 Score on a scale (±0.604 Standard Error) | |||
| NCT03369704 | Rhinitis, Allergic, Seasonal | Mean Nasal Symptom Score Severe symptom period (from 23Feb2018 to 24March2018) | Omalizumab | 3.66 score (±0.151 Standard Error) |
| Placebo | 4.69 score (±0.144 Standard Error) | |||
| NCT03478930 | Nasal Polyps | Change From Baseline in Average Daily Nasal Congestion Score (NCS) Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76 | Received Omalizumab in GA39688 or GA39855 | -0.39 Score on a scale |
| Received Omalizumab in GA39688 or GA39855 | -0.73 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.81 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.88 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.85 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.85 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.88 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.90 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.98 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -1.02 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -1.04 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -1.04 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -1.12 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.98 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.88 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.88 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.78 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.71 Score on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.65 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.80 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.61 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.72 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.74 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.73 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.89 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.94 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.99 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.71 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.17 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.25 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.31 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.32 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.34 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.58 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.56 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.64 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.63 Score on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.31 Score on a scale | |||
| NCT03478930 | Nasal Polyps | Change From Baseline in Nasal Polyp Score (NPS) Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76 | Received Omalizumab in GA39688 or GA39855 | -0.85 Sore on a scale |
| Received Omalizumab in GA39688 or GA39855 | -1.06 Sore on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -1.09 Sore on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -1.01 Sore on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -1.09 Sore on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -1.31 Sore on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.85 Sore on a scale | |||
| Received Omalizumab in GA39688 or GA39855 | -0.54 Sore on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.17 Sore on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.48 Sore on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.40 Sore on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.97 Sore on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.83 Sore on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.19 Sore on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.17 Sore on a scale | |||
| Received Placebo in GA39688 or GA39855 | -0.26 Sore on a scale | |||
| NCT03478930 | Nasal Polyps | Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) From Start to End (Weeks 24 to 52) of OLE Study | Received Omalizumab in GA39688 or GA39855 | 43.5 Percentage of Participants |
| Received Omalizumab in GA39688 or GA39855 | 2.4 Percentage of Participants | |||
| Received Placebo in GA39688 or GA39855 | 49.6 Percentage of Participants | |||
| Received Placebo in GA39688 or GA39855 | 4.8 Percentage of Participants | |||
| NCT03478930 | Nasal Polyps | Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab From Start to End (Weeks 24 to 76) of OLE Study | Received Omalizumab in GA39688 or GA39855 | 0.0 Percentage of Participants |
| Received Placebo in GA39688 or GA39855 | 0.8 Percentage of Participants | |||
| NCT03580356 | Chronic Urticaria | Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects Baseline, Week 12 | Ligelizumab 120 mg | -20.312 Scores on a scale (±0.654 Standard Error) |
| Ligelizumab 72 mg | -19.218 Scores on a scale (±0.651 Standard Error) | |||
| Omalizumab 300 mg | -19.632 Scores on a scale (±0.652 Standard Error) | |||
| Placebo | -9.221 Scores on a scale (±1.135 Standard Error) | |||
| NCT03580356 | Chronic Urticaria | Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS) Baseline, Week 12 | Ligelizumab 120 mg | -24.83 scores on a scale (±12.640 Standard Deviation) |
| Ligelizumab 72 mg | -14.92 scores on a scale (±13.479 Standard Deviation) | |||
| Omalizumab 300 mg | -18.16 scores on a scale (±10.246 Standard Deviation) | |||
| Placebo | -11.94 scores on a scale (±14.278 Standard Deviation) | |||
| NCT03580369 | Chronic Urticaria | Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects Baseline, Week 12 | Ligelizumab 120 mg | -19.330 Score (±0.660 Standard Error) |
| Ligelizumab 72 mg | -19.368 Score (±0.668 Standard Error) | |||
| Omalizumab 300 mg | -20.040 Score (±0.663 Standard Error) | |||
| Placebo | -11.366 Score (±1.129 Standard Error) | |||
| NCT03580369 | Chronic Urticaria | Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS) Baseline, Week 12 | Ligelizumab 120 mg | -14.64 Score (±14.662 Standard Deviation) |
| Ligelizumab 72 mg | -17.39 Score (±13.070 Standard Deviation) | |||
| Omalizumab 300 mg | -13.84 Score (±15.343 Standard Deviation) | |||
| Placebo | -12.75 Score (±18.738 Standard Deviation) | |||
| NCT03881696 OUtMATCH | Peanut Hypersensitivity | Number of Participants by Stage 1 Treatment Assignment, Omalizumab Versus Placebo, Who Successfully Consume a Single Dose of ≥600 mg of Peanut Protein Without Dose-Limiting Symptoms During the DBPCFC Conducted at the End of Treatment Stage 1 During the DBPCFC at the end of Stage 1: 16 to 20 weeks after Stage 1 treatment initiation | Omalizumab | 79 Participants |
| Omalizumab | 39 Participants | |||
| Placebo for Omalizumab | 4 Participants | |||
| Placebo for Omalizumab | 55 Participants |