Phase 2
N=49
Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria
Chronic Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT00481676 ↗Enrolled (actual)
49
Serious AEs
4.1%
Results posted
Oct 2011
Primary outcome: Primary: Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24) — -17.8; -5.8 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Omalizumab 75-375 mg (Drug); Placebo to omalizumab (Drug); Loratadine (Drug); Clemastine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24) |
-17.8; -5.8 | — |
| SECONDARY Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study |
19; 1; 3; 11; 1; 3 | — |
| SECONDARY Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24) |
1.0; 2.5 | — |
| SECONDARY Use of Concomitant and Rescue Medications |
0.7; 3.7; 1.3; 4.2; 1.3; 2.4 | — |
| SECONDARY Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24) |
10.1; 9.8; 3.7; 8.1; -6.3; -1.5 | — |
| SECONDARY Change in the Skindex Score From Baseline to the End of the Study (Week 24) |
1.8; 1.6; 0.9; 1.5; -0.9; -0.1 | — |
| SECONDARY Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) |
31.5; 34.5; 21.8; 26.7; 45.8; 46.6 | — |
| SECONDARY Patient's Global Assessment of Their Chronic Urticaria Symptoms |
0; 0; 3; 0; 13; 13 | — |
| SECONDARY Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms |
1; 0; 1; 0; 7; 9 | — |
Summary
This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.
Eligibility Criteria
Inclusion criteria
- Males or females from 18-70 years of age
- Body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 IU/mL and ≤ 700 IU/mL
- Specific serum IgE anti-TPO level ≥ 8.0 IU/mL, documented within 3 months prior to randomization or time of pre-screening
- Diagnosis of moderate to severe chronic urticaria
- Subject's current episode of chronic urticaria according to the European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum (EAACI/GA2LEN/EDF) guideline at the time of screening
- Current episode of chronic urticaria has not responded to the approved marketed dose of antihistamine for 2 weeks or longer
- Urticaria activity score (UAS) ≥ 0 at any of the 7 days of the first section of the screening period
- UAS7 ≥ 10 at the time of randomization
Exclusion criteria
- Females of child-bearing potential or breast feeding
- Present or past medical conditions that could have interfered with the study results
- Randomized into any other omalizumab study or who had received omalizumab
- Received investigational drugs within 30 days of enrollment
Data sourced from ClinicalTrials.gov (NCT00481676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.