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

Genentech, Inc.336 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

336

Conditions

Chronic Idiopathic Urticaria

Interventions

Omalizumab

H1 antihistamine, H2 antihistamine, leukotriene receptor antagonistDRUG

Participants were required to maintain stable doses of their pre-randomization combination therapy with an H1 antihistamine and either an H2 blocker or leukotriene receptor antagonist, or all 3 drugs in combination, throughout the 24-week treatment period and 16-week follow-up period of the 40-week study.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (73)

Unnamed facility

Scottsdale, Arizona, United States

Unnamed facility

Mission Viejo, California, United States

Unnamed facility

Napa, California, United States

Unnamed facility

Orange, California, United States

Unnamed facility

Sacramento, California, United States

Unnamed facility

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Events

The percentage of participants with serious adverse events and other adverse events is summarized by MedDRA preferred terms and organ classes in the Reported Adverse Events section below.

Time frame: Baseline to the end of study (up to 40 weeks)

Secondary Outcomes

Change From Baseline to Week 12 in the Weekly Itch Severity Score

The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.