Conditions: Asthma
Keywords: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: no

Brief summary:
This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).

Detailed description:

Arms:
arm 1: QGE031 240 mg subcutaneous injection every 4 weeks arm 2: QGE031 72 mg subcutaneous injection every 4 weeks arm 3: QGE031 24 mg subcutaneous injection every 4 weeks arm 4: Placebo subcutaneous injection every 4 weeks

Interventions: intervention 1: QGE031 intervention 2: Placebo
Intervention descriptions: intervention 1: QGE031 120 mg per 1 mL liquid in vial intervention 2: Placebo to QGE031 0 mg per 1 mL liquid in vial

Protocol document: