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NCT04594369 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
A Phase 3 study, sponsored by Insmed Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,767
- Enrollment target
NCT04594369: Completed Phase 3 study, sponsored by Insmed Incorporated.
NCT04594369 is a Phase 3 study that has completed, run by Insmed Incorporated. The registered enrollment target is 1,767 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (129% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04594369, a Phase 3 study, has completed, sponsored by Insmed Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,767 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.
Primary Outcome
PE was defined as having 3 or more of these symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A severe pulmonary exacerbation was that required intravenous (IV) antibacterial drug treatment and/or hospitalization. A minimum of 14 days must have
Interventions
- DRUG Placebo
- DRUG Brensocatib 10 mg
- DRUG Brensocatib 25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,767 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2024-10-28 |
| Phase | Phase 3 |
What the finished NCT04594369 record still lists
NCT04594369 is an interventional study that assigns participants to a tested intervention. Its 1,767 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (129% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04594369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04594369 about?
NCT04594369 is a clinical study titled "A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis". The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.
What is the current status of trial NCT04594369?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,767 participants. The study started on 2020-12-01. Estimated completion is 2024-10-28.
What interventions are being tested in trial NCT04594369?
The interventions under investigation include: Placebo (DRUG), Brensocatib 10 mg (DRUG), Brensocatib 25 mg (DRUG).
Who is sponsoring clinical trial NCT04594369?
This trial is sponsored by Insmed Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04594369's enrollment target sits among peer trials
1,767 127th of 2000 higher than 1,874 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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