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NCT04594369 (Brensocatib in Non-Cystic Fibrosis Bronchiectasis): BVCT ex-ante prediction vs. reported outcome

On 1 Jan 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 28 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT04594369
Acronym
ASPEN
Drug Name
Brensocatib
Drug MoA
oral reversible DDP-1 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Non-Cystic Fibrosis Bronchiectasis
Human Patients
1767
Sponsor
Insmed
Phase
Phase 3

Prediction of , index 432

Prospective Prediction
Prediction Index
432
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit with reduced efficacy from increased dosage)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
148 days in advance
Readout Data Interpretation
19.4%-21.1% reduction in APE (vs 30%-50% reduction achieved by azithromycin in similar clinical settings); clearly weak efficacy (vs azithromycin) and clearly negative dose-response relationship (in both primary and other secondary endpoints).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study
Phase
Phase 3
Status
Completed
Enrollment
1767
Lead sponsor
Insmed Incorporated
Conditions
Non-Cystic Fibrosis Bronchiectasis
Interventions
DRUG: Brensocatib 10 mg; DRUG: Brensocatib 25 mg; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2020-12-01
Primary completion
2024-10-28
Completion
2024-10-28
Results first posted
2025-12-16
Primary outcomes
  • Annualized Rate of Pulmonary Exacerbations (PEs) (Up to Week 52)

NCT04594369 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials