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NCT04701983 (Itepekimab in Chronic Obstructive Pulmonary Disease): BVCT ex-ante prediction vs. reported outcome

On 18 Apr 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 30 May 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (yet weak efficacy) and commercially insufficient (slightly inferior to mepolizumab).

Clinical Trial

NCTID
NCT04701983
Acronym
AERIFY-1
Drug Name
Itepekimab
Drug MoA
IgG4P anti-IL33 inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Chronic Obstructive Pulmonary Disease (COPD)
Human Patients
1127
Sponsor
Sanofi
Phase
Phase 3

Prediction of , index 1980

Prospective Prediction
Prediction Index
1980
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit to SoC in AECOPD/FEV1/TEAE inferior to mepolizumab)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit to SoC in AECOPD/FEV1/TEAE compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
407 days in advance
Readout Data Interpretation
Itepekimab (every four weeks) + SoC achieved a statistically significant 21% placebo-adjusted reduction in AECOPD and 0% placebo-adjusted reduction in TEAE at week 52 compared with SoC alone; slightly inferior to mepolizumab’s 21% placebo-adjusted reduction in AECOPD and 3% placebo-adjusted reduction in TEAE at week 52 compared with SoC alone (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (yet weak efficacy) and commercially insufficient (slightly inferior to mepolizumab)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Phase
Phase 3
Status
Completed
Enrollment
1127
Lead sponsor
Sanofi
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG: Itepekimab SAR440340; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-12-16
Primary completion
2025-04-11
Completion
2025-08-27
Primary outcomes
  • Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) (Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants))

NCT04701983 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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