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A Study to Assess the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria (CIU)

2015-03-25 05:38:25 | BioPortfolio

Summary

This randomized, double-blind, placebo-controlled study will evaluate efficacy and safety of subcutaneous omalizumab as an add-on therapy through 48 weeks. After completing an initial 24-week open-label treatment period with omalizumab 300 mg every 4 weeks, participants responding to omalizumab will be randomized at a 3:2 ratio (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a further 24 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Chronic Idiopathic Urticaria

Intervention

Omalizumab

Location

Granada Hills
California
United States
91344

Status

Not yet recruiting

Source

Genentech, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-03-25T05:38:25-0400

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Medical and Biotech [MESH] Definitions

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