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

NCT ID: NCT00866788

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-01-31

Brief Summary

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.

Conditions

Chronic Idiopathic Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.).

Group Type: EXPERIMENTAL

omalizumab

Intervention Type: DRUG

Administered by subcutaneous injection

H1 antihistamines

Intervention Type: 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

Intervention Type: DRUG

Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

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.

Group Type: EXPERIMENTAL

omalizumab

Intervention Type: DRUG

Administered by subcutaneous injection

H1 antihistamines

Intervention Type: 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

Intervention Type: DRUG

Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

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.

Group Type: EXPERIMENTAL

omalizumab

Intervention Type: DRUG

Administered by subcutaneous injection

H1 antihistamines

Intervention Type: 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

Intervention Type: DRUG

Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

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.

Group Type: PLACEBO_COMPARATOR

omalizumab

Intervention Type: DRUG

Administered by subcutaneous injection

placebo

Intervention Type: DRUG

Participants received a single subcutaneous placebo injection on Day 0 of the study.

H1 antihistamines

Intervention Type: 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

Intervention Type: DRUG

Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

Interventions

omalizumab

Administered by subcutaneous injection

Intervention Type: DRUG

placebo

Participants received a single subcutaneous placebo injection on Day 0 of the study.

Intervention Type: DRUG

H1 antihistamines

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

Intervention Type: DRUG

Diphenhydramine

Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

Intervention Type: DRUG

Other Intervention Names

Xolair

Eligibility Criteria

Inclusion Criteria

• CIU diagnosis > 3 months (by history)
• No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria)

Exclusion Criteria

• Pregnant, breastfeeding, or women not taking contraception
• Patients < 40kg
• Treatment with any investigational agent within 30 days of screening
• Recent history of drug or alcohol abuse
• Atopic dermatitis or other skin disease associated with pruritus
• Clinically relevant major systemic disease (making interpretation of the study results difficult)
• Previously treated with omalizumab (< 12 months since last injection)
• Patients may not take during treatment period or have been taking within the past 3 months any of the following medications/treatments: regular (daily/every other day) hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, IVIG, or plasmapheresis
• Patients may not have been taking doxepin within the past 6 weeks regular (daily/every other day).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karin Rosen, M.D., Ph.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

Q4577g

Identifier Type: -

Identifier Source: org_study_id