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NCT05421598 (Amlitelimab in Moderate-to-severe Asthma): BVCT ex-ante prediction vs. reported outcome

On 19 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 14 Apr 2025 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05421598
Acronym
TIDE-asthma
Drug Name
Amlitelimab
Drug MoA
anti-OX40L inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Moderate-to-severe Asthma
Human Patients
446
Sponsor
Sanofi
Phase
Phase 2

Prediction of , index 1757

Prospective Prediction
Prediction Index
1757
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in FEV1/ACQ5)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in annualized rate of severe exacerbation)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
238 days in advance
Readout Data Interpretation
amlitelimab failed to meet the primary endpoint of annualized exacerbation rate at week 48
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal disease modelling of asthma not uncontrollable by background therapies that have been permanently improved
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma
Phase
Phase 2
Status
Completed
Enrollment
437
Lead sponsor
Sanofi
Conditions
Asthma
Interventions
DRUG: Amlitelimab; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-06-30
Primary completion
2024-10-11
Completion
2025-03-20
Results first posted
2026-03-30
Primary outcomes
  • Annualized Rate of Severe Asthma Exacerbation Events Over 48 Weeks (Baseline (Day 1) to Week 48)

NCT05421598 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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