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

Genentech, Inc.319 enrolled

Overview

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.

Type I Error Rate Control Plan Primary Outcome Measure In order to maintain an overall type I error rate of 0.05 (2-sided) across the 3 omalizumab dose levels, the testing of the primary Outcome Measure was conducted in the following hierarchical order. A p-value \< 0.05 is only considered statistically significant if statistical significance was claimed at the previous stage. * Stage 1: Omalizumab 300-mg group vs. placebo * Stage 2: Omalizumab 150-mg group vs. placebo * Stage 3: Omalizumab 75-mg group vs. placebo Secondary Outcome Measures A hierarchical analysis of the following secondary Outcome Measures was performed for each dose found to be significant in the primary Outcome Measure. A p-value \< 0.05 is only considered statistically significant if statistical significance was claimed at the previous stage. * Stage 1: Change from baseline to Week 12 in the urticaria activity score over 7 days (UAS7) * Stage 2: Change from Baseline to Week 12 in the weekly number of hives score * Stage 3: Time to minimally important difference (MID) response in the weekly itch severity score by Week 12 * Stage 4: Percentage of participants with a UAS7 score ≤ 6 at Week 12 * Stage 5: Percentage of weekly itch severity score MID responders at Week 12 * Stage 6: Change from Baseline to Week 12 in the weekly size of the largest hive score * Stage 7: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12 * Stage 8: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12 * Stage 9: Percentage of complete responders (UAS7 = 0) at Week 12

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 \< 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. * Any H2 antihistamine use within 7 days prior to screening. * Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to screening. * Any H1 antihistamines at greater than approved doses within 3 days 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. * Nursing women or women of childbearing potential, unless they meet the following definition of post-menopausal: 12 months of natural amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \> 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.

Locations (66)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Huntington Beach, California, United States

Unnamed facility

Long Beach, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Palmdale, California, United States

Unnamed facility

Outcomes

Primary 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.