Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201
- Registration Number
- NCT02075008
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.
- Detailed Description
This study planned to assess long-term safety and tolerability of QGE031 administered every 4 weeks for an additional 12 months in patients with allergic asthma who previously completed study CQGE031B2201. The study was terminated early due to the efficacy results from an interim analysis of the Phase II study CQGE031B2201.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 270
Inclusion Criteria
- forced Expiratory Volume in one second ( FEV1) >= 40% predicted
- patients who completed CQGE031B2201 study
Key
Exclusion Criteria
- life-threatening asthma attack, intubation, respiratory arrest during or after completion of CQGE031B2201 study
- new malignancy
- ongoing SAE from CQGE031B2201 that was assessed as related to study drug
- patient experienced platelets drop to < 75,000/uL
- patient experienced one unexpected grade 4 or two unexpected grade 3 hypersensitivity reactions
- patient is pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description QGE031 every 4 weeks (q4w) QGE031 QGE031 240 mg subcutaneously q4w
- Primary Outcome Measures
Name Time Method Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability 52 weeks Safety was monitored throughout the study.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Southampton, United Kingdom