Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CS
- Conditions
- Chronic Spontaneous Urticaria
- Registration Number
- JPRN-jRCT2080222941
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 36
*Diagnosis of chronic spontaneous urticaria for at least 6 months
*Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization
*Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
*Evidence of parasitic infection
*Any other skin diseases than chronic spontaneous urticaria with chronic itching
*Previous treatment with omalizumab or QGE031
*Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine
*History of anaphylactic shock
*History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
*History of hypersensitivity to any of the study drugs or its components of similar chemical classes
*Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
Other protocol defined inclusion/exclusion may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete hives response (HSS7=0) [Time Frame: Week 12]<br>Complete hives response is defined as Hives Severity Score (HSS7) of 0
- Secondary Outcome Measures
Name Time Method Complete hives response (HSS7=0) compared with omalizumab [Time Frame: Week 12]<br>Complete hives response is defined as Hives Severity Score (HSS7=0)<br>Complete hives response (HSS7=0) of individual QGE031 doses compared with omalizumab [Time Frame: Week 20]<br>Complete hives response is defined as Hives Severity Score (HSS7) of 0