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NCT06118099 (Amlitelimab in Moderate to Severe Hidradenitis Suppurativa): BVCT ex-ante prediction vs. reported outcome

On 7 Dec 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 24 Apr 2025 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
NCT06118099
Drug Name
Amlitelimab
Drug MoA
anti-OX40L inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
Moderate to Severe Hidradenitis Suppurativa
Human Patients
90
Sponsor
Sanofi
Phase
Phase 2

Prediction of , index 1857

Prospective Prediction
Prediction Index
1857
Prediction Date
Commercial Prediction
FAILURE(commercially insufficient clinical benefit in HiSCR50 score non-superior to adalimumab/povorcitinib and inferior to SAR442970/sonelokimab/bimekizumab/secukinumab)
Technical Prediction
SUCCESS (statistically significant clinical benefit in HiSCR50 score against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
138 days in advance
Readout Data Interpretation
amlitelimab’s HiSCR50 is inferior to brivekimig (SAR442970)’s HiSCR50; so amlitelimab further development is discontinued
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 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Proof-of-concept Study Assessing the Efficacy and Safety of Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Phase
Phase 2
Status
Terminated
Enrollment
90
Lead sponsor
Sanofi
Conditions
Hidradenitis
Interventions
DRUG: Amlitelimab; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-11-01
Primary completion
2025-02-06
Completion
2025-10-10
Primary outcomes
  • The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16 (Week 16)

NCT06118099 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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