Phase 3
N=319
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
Chronic Idiopathic Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT01287117 ↗Enrolled (actual)
319
Serious AEs
4.4%
Results posted
Oct 2013
Primary outcome: Primary: Change From Baseline to Week 12 in the Weekly Itch Severity Score — -3.63; -6.46; -6.66; -9.40 Units on a scale — p=0.0010
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omalizumab (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in the Weekly Itch Severity Score |
-3.63; -6.46; -6.66; -9.40 | 0.0010 sig |
| SECONDARY Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7) |
-8.01; -13.82; -14.44; -20.75 | 0.0035 sig |
| SECONDARY Change From Baseline to Week 12 in the Weekly Number of Hives Score |
-4.37; -7.36; -7.78; -11.35 | 0.0149 sig |
| SECONDARY Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12 |
4.0; 3.0; 2.0; 1.0 | 0.0879 |
| SECONDARY Percentage of Participants With a UAS7 Score ≤ 6 at Week 12 |
11.3; 26.0; 40.0; 51.9 | 0.0148 sig |
| SECONDARY Percentage of Weekly Itch Severity Score MID Responders at Week 12 |
36.3; 55.8; 56.3; 75.3 | 0.0118 sig |
| SECONDARY Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score |
-3.93; -6.20; -6.96; -9.79 | 0.0124 sig |
| SECONDARY Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12 |
-6.13; -6.33; -8.00; -10.29 | 0.7956 |
| SECONDARY Percentage of Angioedema-free Days From Week 4 to Week 12 |
88.2; 86.5; 89.6; 96.1 | 0.4867 |
| SECONDARY Percentage of Complete Responders (UAS7 = 0) at Week 12 |
8.8; 11.7; 15.0; 35.8 | 0.4580 |
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-dose H1 antihistamine treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (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 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 (NCT01287117). 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.