Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QBW251 in Subjects With Bronchiectasis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bronchiectasis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a randomized, subject- and investigator-blinded, placebo-controlled, parallel-group study investigating the preliminary efficacy and safety of QBW251 administered orally for 12 weeks in subjects with bronchiectasis. Approximately 72 subjects will be randomized in a 1:1 ratio to receive eithe...
This is a randomized, subject- and investigator-blinded, placebo-controlled, parallel-group study investigating the preliminary efficacy and safety of QBW251 administered orally for 12 weeks in subjects with bronchiectasis. Approximately 72 subjects will be randomized in a 1:1 ratio to receive either QBW251 or placebo in order to achieve 60 subjects who complete the treatment period based on the assumption of a 16% drop-out rate. The sample size assumptions will be reviewed in an interim analysis in a blinded manner when approximately 14 subjects complete the treatment period. The study consists of the following periods: Screening, baseline/Day 1, treatment period, and end of study assessments (EOS) visit followed by an additional post-treatment safety follow up via phone call. The total duration for each patient in the study is up to approximately 18 weeks.
Tracking Information
- NCT #
- NCT04396366
- Collaborators
- Innovative Medicines Initiative
- Investigators
- Not Provided