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

Information source: Genentech, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Idiopathic Urticaria

Intervention: omalizumab (Drug); placebo (Drug); H1 antihistamines (Drug); Diphenhydramine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Genentech, Inc.

Official(s) and/or principal investigator(s):
Karin Rosen, M.D., Ph.D., Study Director, Affiliation: Genentech, Inc.

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.

Clinical Details

Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4

Secondary outcome:

Change in the Weekly Pruritus Score From Baseline to Week 4

Change in the Weekly Score for Number of Hives From Baseline to Week 4

Change in the Weekly Score for Sleep Interference From Baseline to Week 4

Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4

Number of Patients With Adverse Events by Severity

Number of Participants With Immunogenicity

Eligibility

Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.

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).

Locations and Contacts

Additional Information

Starting date: March 2009
Last updated: September 16, 2011

Page last updated: August 23, 2015

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