A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in CSU Patients
- Conditions
- Chronic Spontaneous Urticaria
- Registration Number
- JPRN-jRCT2080223242
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 36
*Patients eligible for inclusion in this study have to fulfill all of the following criteria:
a. Written informed consent must be obtained before any assessment is performed.
b. Patients who complete the treatment epoch in study CQGE031C2201 and complete at least Visit 203 (Week 32 of the follow-up epoch,>=16 weeks after last injection) and present with active disease as defined by UAS7 >=12.
c. Patients must not have any missing eDiary entries in the 7 days prior to Visit 301 (patients are allowed to repeat until this criterion is met).
d. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
*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
*Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine
*History of anaphylaxis
*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 may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method