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Omalizumab in Anti-TPO Positive Chronic Urticaria
NCT00481676Phase 2
Key facts
- Status
- Completed
- Start
- May 2007
- Primary completion
- Apr 2009
- Countries
- 1
- Sponsor
- Novartis
- Modality
- Monoclonal Antibodies
- Drugs
- omalizumab
- Conditions
- chronic urticaria (CU)
01
Overview
Phase 2, randomised, double-blind trial in chronic urticaria (CU) comparing Omalizumab with Placebo (2 arms). Primary endpoint: Weekly Urticaria Activity Score at 24 weeks. Started May 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Omalizumab
Omalizumab 75-375 mg SC every 2 or 4 weeks + SOC
Placebo
Placebo SC every 2 or 4 weeks + SOC
03
Who it enrols
Adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase and have not responded to antihistamines.
04
Endpoints
Primary
Weekly Urticaria Activity Score
Secondary
Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas
Area Under the Curve for Urticaria Activity Score
Use of Concomitant and Rescue Medications
Dermatology Life Quality Index
Skindex Score
Chronic Urticaria Quality of Life
Patient's and Investigator's Global Assessment
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