Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria

• Status: Completed
• Trial end date: 2019-09-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Omalizumab

Criteria

Main Inclusion Criteria:

• Symptomatic CSU patients with CSU diagnosis for at least 6 months.

• Patients must have been on an approved dose of an H1AH for CSU for at least the 3 consecutive days immediately prior to the Day -14 screening visit

• Patients must have documented current use on the day of the initial screening visit

Main Exclusion Criteria

• Clearly defined underlying etiology for chronic urticarias other than CSU (main manifestation being physical urticaria)

• Other skin disease associated with itch Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer