Status:
COMPLETED
Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Spontaneous Urticaria
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 Spo...
Detailed Description
This was a randomized, multicenteric, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab as an add-on therapy for the treatment of patients of r...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2019
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT03328897
Start Date
April 26 2017
End Date
September 24 2019
Last Update
November 4 2020
Active Locations (27)
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1
Novartis Investigative Site
Beijing, Beijing Municipality, China, 100039
2
Novartis Investigative Site
Fuzhou, Fujian, China, 350025
3
Novartis Investigative Site
Guangzhou, Guangdong, China, 510630
4
Novartis Investigative Site
Nanning, Guangxi, China, 530021