Overview

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