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NCT06280391 (Itepekimab in Bronchiectasis): BVCT ex-ante prediction vs. reported outcome

On 18 Apr 2025, BioinvestGPT's BVCT predicted technical partial failure and commercial failure for this trial. The 29 Jan 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT06280391
Drug Name
Itepekimab (SAR440340)
Drug MoA
IgG4P anti-IL33 inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Bronchiectasis
Human Patients
312
Sponsor
Sanofi
Phase
Phase 2

Prediction of , index 1982

Prospective Prediction
Prediction Index
1982
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in PEs)
Technical Prediction
partial FAILURE (statistically insignificant clinical benefit in PEs compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
286 days in advance
Readout Data Interpretation
itepekimab's further development on bronchiectasis has been deprioritised
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of Itepekimab, in Participants With Non-cystic Fibrosis Bronchiectasis
Phase
Phase 2
Status
Completed
Enrollment
312
Lead sponsor
Sanofi
Conditions
Bronchiectasis
Interventions
DRUG: Itepekimab (SAR440340); DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2024-02-20
Primary completion
2025-09-16
Completion
2026-02-02
Primary outcomes
  • Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period (Baseline up to End of Treatment (EOT) (24-52 weeks))

NCT06280391 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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