A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)

Conditions

• Chronic Idiopathic Urticaria

Eligibility Criteria

Sex

ALL

Age

12 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• omalizumab — DRUG
  Administered by subcutaneous injection
• placebo — DRUG
  Participants received a single subcutaneous placebo injection on Day 0 of the study.
• H1 antihistamines — DRUG
  Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10 mg QD or Desloratadine 5 mg QD
• Diphenhydramine — DRUG
  Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

Study Details

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.

Key Dates

Start date

Mar 31, 2009

Status verified

Jun 2017

Primary completion

Jan 31, 2010

Completion

Jan 31, 2010

Study Design

Enrollment

90 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Omalizumab 75 mg
  Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.).
• Experimental: Omalizumab 300 mg
  Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
• Experimental: Omalizumab 600 mg
  Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
• Placebo Comparator: Placebo
  Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.

Primary Outcome Measure

Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 [ Time Frame: Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) ]