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NCT05237284 (SAR443820 in Amyotrophic Lateral Sclerosis): BVCT ex-ante prediction vs. reported outcome

On 21 Nov 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 16 Feb 2024 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
NCT05237284
Acronym
HIMALAYA
Drug Name
SAR443820
Drug MoA
RIPK1 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Amyotrophic Lateral Sclerosis
Human Patients
305
Sponsor
Denali Therapeutics / Sanofi
Phase
Phase 2

Prediction of , index 1341

Prospective Prediction
Prediction Index
1341
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
87 days in advance
Readout Data Interpretation
primary endpoint not met.
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 Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR443820 in Adult Participants With Amyotrophic Lateral Sclerosis, Followed by an Open-label Extension
Phase
Phase 2
Status
Terminated
Enrollment
305
Lead sponsor
Sanofi
Conditions
Amyotrophic Lateral Sclerosis
Interventions
DRUG: SAR443820; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-04-13
Primary completion
2024-03-07
Completion
2024-03-07
Results first posted
2025-03-21
Primary outcomes
  • Part A: Change From Baseline to Week 24 in the Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) Total Score (Baseline (Day 1, pre-dose) and Week 24)
  • Part B: Combined Assessment of the Function and Survival (CAFS) Score at Week 52 (Week 52)

NCT05237284 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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