Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 600
Summary
- Conditions
- Asthma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This study is a phase IIb, multicenter, multi-national, double-blind, randomized, parallel-arm, placebo-controlled study to evaluate the effect of 5 dose levels of CSJ117 (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard of care asthma therapy in adult subjects...
This study is a phase IIb, multicenter, multi-national, double-blind, randomized, parallel-arm, placebo-controlled study to evaluate the effect of 5 dose levels of CSJ117 (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard of care asthma therapy in adult subjects with inadequately controlled asthma despite medium to high dose ICS plus LABA. Approximately 625 patients will be randomized into this study.
Tracking Information
- NCT #
- NCT04410523
- Collaborators
- Not Provided
- Investigators
- Not Provided