A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis (ATMOS)
UCB Biopharma SRL
Summary
The purpose of the study is to investigate the efficacy of galvokimig versus placebo on the time to the first pulmonary exacerbation in study participants with non-cystic fibrosis bronchiectasis (NCFB)
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must be 18 to ≤80 years of age, inclusive, at the time of signing the informed consent form (ICF) * Participant with a documented history of Non-Cystic Fibrosis Bronchiectasis (NCFB) (cough, chronic sputum production, and/or recurrent respiratory infections) confirmed by high resolution computed tomography (HRCT) demonstrating bronchiectasis in 1 or more lobes. Confirmation of diagnosis via HRCT will be performed as close as possible to, and within 7 calendar days of the Baseline visit, in all participants who meet all inclusion criteria and no exclusion crit…
Interventions
- BiologicalGalvokimig
Drug: Galvokimig Pharmaceutical form: Solution for injection
- BiologicalPlacebo
Drug: Placebo Pharmaceutical form: Solution for injection
Locations (3)
- Ncfb01 50005Plantation, Florida
- Ncfb01 50004DuBois, Pennsylvania
- Ncfb01 50001McKinney, Texas