Phase 3
N=323
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)
Chronic Idiopathic Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT01292473 ↗Enrolled (actual)
323
Serious AEs
2.8%
Results posted
Sep 2013
Primary outcome: Primary: Change From Baseline in the Weekly Itch Severity Score at Week 12 — -5.14; -5.87; -8.14; -9.77 Units on a scale — p=0.4637
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Omalizumab (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Weekly Itch Severity Score at Week 12 |
-5.14; -5.87; -8.14; -9.77 | 0.4637 |
| SECONDARY Change From Baseline in the Weekly Urticaria Activity Score (UAS7) at Week 12 |
-10.36; -13.08; -17.89; -21.74 | 0.1575 |
| SECONDARY Change From Baseline in the Weekly Number of Hives Score at Week 12 |
-5.22; -7.21; -9.75; -11.97 | 0.0603 |
| SECONDARY Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12 |
4.0; 2.0; 2.0; 1.0 | 0.0478 sig |
| SECONDARY Percentage of Participants With a UAS7 Less Than or Equal to 6 at Week 12 |
19.0; 26.8; 42.7; 65.8 | 0.3419 |
| SECONDARY Percentage of Weekly Itch Severity Score MID Responders at Week 12 |
48.1; 56.1; 69.5; 78.5 | 0.4366 |
| SECONDARY Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12 |
-4.04; -6.52; -7.84; -11.00 | 0.0082 sig |
| SECONDARY Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) at Week 12 |
-6.09; -7.50; -8.29; -10.15 | 0.1207 |
| SECONDARY Percentage of Angioedema-free Days From Week 4 to Week 12 |
89.2; 93.5; 91.6; 95.5 | 0.1361 |
Summary
The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) CIU/CSU refractory to H1 antihistamines at the time of randomization.
Exclusion Criteria
- Treatment with an investigational agent within 30 days prior to screening.
- Weight 40 milli-international units per milliliter (mIU/mL) or 6 weeks post surgical bilateral oophorectomy (with or without hysterectomy) or hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization, hormonal contraception, and double-barrier methods.
Data sourced from ClinicalTrials.gov (NCT01292473). 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.