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

Genentech

Status and phase: Completed; Phase 2

Conditions: Chronic Idiopathic Urticaria

Treatments: Drug: omalizumab; Drug: Diphenhydramine; Drug: H1 antihistamines; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00866788

Q4577g

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 4 patient groups, including a placebo group

Omalizumab 75 mg

Experimental group

Description:

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.).

Treatment:

Drug: H1 antihistamines

Drug: Diphenhydramine

Drug: omalizumab

Omalizumab 300 mg

Experimental group

Description:

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.

Treatment:

Drug: H1 antihistamines

Drug: Diphenhydramine

Drug: omalizumab

Omalizumab 600 mg

Experimental group

Description:

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.

Treatment:

Drug: H1 antihistamines

Drug: Diphenhydramine

Drug: omalizumab

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo

Drug: H1 antihistamines

Drug: Diphenhydramine

Drug: omalizumab