Phase 3
N=336
A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
Chronic Idiopathic Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT01264939 ↗Enrolled (actual)
336
Serious AEs
6.9%
Results posted
Nov 2013
Primary outcome: Primary: Percentage of Participants With Adverse Events — 78.3; 83.7 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omalizumab (Drug); Placebo (Drug); H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist (Drug); Diphenhydramine (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events |
78.3; 83.7 | — |
| SECONDARY Change From Baseline to Week 12 in the Weekly Itch Severity Score |
-4.01; -8.55 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7) |
-8.50; -19.01 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 12 in the Weekly Number of Hives Score |
-4.49; -10.46 | <0.0001 sig |
| SECONDARY Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12 |
5.0; 2.0 | <0.0001 sig |
| SECONDARY Percentage of Participants With a UAS7 Score ≤ 6 at Week 12 |
12.0; 52.4 | <0.0001 sig |
| SECONDARY Percentage of Weekly Itch Severity Score MID Responders at Week 12 |
39.8; 69.8 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score |
-3.09; -8.82 | <0.0001 sig |
| SECONDARY Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12 |
-5.11; -9.69 | <0.0001 sig |
| SECONDARY Percentage of Angioedema-free Days From Week 4 to Week 12 |
88.1; 91.0 | 0.0006 sig |
| SECONDARY Percentage of Complete Responders (UAS7 = 0) at Week 12 |
4.8; 33.7 | <0.0001 sig |
Summary
The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy 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 chronic idiopathic urticaria (CIU) who remain symptomatic despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of chronic idiopathic urticaria (CIU) refractory to H1 antihistamines, H2 blockers, and/or leukotriene receptor antagonists (LTRA) at the time of randomization.
- The presence of itch and hives for > 6 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine (up to 4 times the approved dosage), H2 blocker, and/or LTRA treatment during this time.
- Urticaria activity score over 7 days (UAS7) score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to randomization (Week 0).
- In-clinic UAS ≥ 4 on at least one of the screening visit days (Day -14, Day -7, or Day 1).
- For women of childbearing potential, agreement to use an acceptable form of contraception and to continue its use for the duration of the study.
Exclusion Criteria
- Treatment with an investigational agent within 30 days prior to screening.
- Weight less than 20 kg (44 lbs).
- Clearly defined underlying etiology for chronic urticarias other than CIU.
- Evidence of parasitic infection.
- Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or other skin disease associated with itch.
- Previous treatment with omalizumab within a year prior to screening.
- Routine doses of the following medications within 30 days prior to screening: Systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide.
- Intravenous (IV) immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to screening.
- Regular (daily/every other day) doxepin (oral) use within 6 weeks prior to screening.
- Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved.
- Hypersensitivity to omalizumab or any component of the formulation.
- History of anaphylactic shock.
- Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions that could interfere with the interpretation of the study results and or compromise the safety of the patients.
- Evidence of current drug or alcohol abuse.
Data sourced from ClinicalTrials.gov (NCT01264939). 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.