Phase 2
N=90
A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)
Chronic Idiopathic Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT00866788 ↗Enrolled (actual)
90
Serious AEs
1.1%
Results posted
Sep 2011
Primary outcome: Primary: Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 — -6.91; -9.79; -19.93; -14.56 scores on a scale — p=0.1601
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- omalizumab (Drug); placebo (Drug); H1 antihistamines (Drug); Diphenhydramine (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 |
-6.91; -9.79; -19.93; -14.56 | 0.1601 |
| SECONDARY Change in the Weekly Pruritus Score From Baseline to Week 4 |
-3.45; -4.50; -9.22; -6.46 | 0.1640 |
| SECONDARY Change in the Weekly Score for Number of Hives From Baseline to Week 4 |
-3.46; -5.28; -10.71; -8.10 | 0.1411 |
| SECONDARY Change in the Weekly Score for Sleep Interference From Baseline to Week 4 |
-3.23; -3.90; -5.81; -6.85 | 0.5507 |
| SECONDARY Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4 |
-1.38; -1.74; -2.64; -1.69 | 0.7261 |
| SECONDARY Number of Patients With Adverse Events by Severity |
10; 8; 12; 10; 8; 4 | — |
| SECONDARY Number of Participants With Immunogenicity |
0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of Omalizumab |
11.4; 33.1; 67 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of Omalizumab |
7.37; 8.01; 6.24 | — |
| SECONDARY Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf) |
317; 1260; 2800 | — |
| SECONDARY Terminal Half-Life (t1/2) of Omalizumab |
18.2; 17.1; 22.5 | — |
Summary
The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll approximately 76 patients at approximately 45 study centers in the United States and Germany.
Eligibility Criteria
Inclusion Criteria
- CIU diagnosis > 3 months (by history)
- No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria)
Exclusion Criteria
- Pregnant, breastfeeding, or women not taking contraception
- Patients < 40kg
- Treatment with any investigational agent within 30 days of screening
- Recent history of drug or alcohol abuse
- Atopic dermatitis or other skin disease associated with pruritus
- Clinically relevant major systemic disease (making interpretation of the study results difficult)
- Previously treated with omalizumab (< 12 months since last injection)
- Patients may not take during treatment period or have been taking within the past 3 months any of the following medications/treatments: regular (daily/every other day) hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, IVIG, or plasmapheresis
- Patients may not have been taking doxepin within the past 6 weeks regular (daily/every other day).
Data sourced from ClinicalTrials.gov (NCT00866788). 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.