Status:
COMPLETED
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
Lead Sponsor:
Genentech, Inc.
Conditions:
Chronic Idiopathic Urticaria
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT01264939
Start Date
February 1 2011
End Date
November 1 2012
Last Update
November 26 2013
Active Locations (73)
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1
Scottsdale, Arizona, United States, 85251
2
Mission Viejo, California, United States, 92691
3
Napa, California, United States, 94558
4
Orange, California, United States, 92868