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NCT05397470 (Losmapimod in Facioscapulohumeral Muscular Dystrophy): BVCT ex-ante prediction vs. reported outcome

On 25 Jul 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 12 Sep 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
NCT05397470
Acronym
REACH
Drug Name
Losmapimod
Drug MoA
p38α/β-MAPK small molecule inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Musculoskeletal Diseases
Indication
Facioscapulohumeral Muscular Dystrophy (FSHD)
Human Patients
260
Sponsor
Fulcrum Therapeutics
Phase
Phase 3

Prediction of , index 1629

Prospective Prediction
Prediction Index
1629
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in RWS for patients that are not stratified by p38MAPK expression levels)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in RWS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
49 days in advance
Readout Data Interpretation
losmapimod failed to meet RWS primary endpoint.
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 3 Global, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Patients With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)
Phase
Phase 3
Status
Terminated
Enrollment
260
Lead sponsor
Fulcrum Therapeutics
Conditions
Facioscapulohumeral Muscular Dystrophy (FSHD)
Interventions
DRUG: Losmapimod; DRUG: Placebo oral tablet
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-06-16
Primary completion
2024-11-19
Completion
2024-11-19
Results first posted
2025-11-10
Primary outcomes
  • Part A: Change From Baseline in Total Relative Surface Area (RSA) Quadrants 1 to 5 (Q1-Q5) With 500 Grams (g) Wrist Weight Averaged Over Both Arms as Assessed by Reachable Workspace (RWS) at Week 48 (Baseline (Day 1) and at Week 48)
  • Part B: Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and Non-serious TEAEs > 5% (Week 48 to Week 127)
  • Part B: Number of Participants With Clinically Significant Changes in Chemistry Parameters (Week 48 to Week 127)
  • Part B: Number of Participants With Clinically Significant Changes in Hematology Parameters (Week 48 to Week 127)
  • Part B: Number of Participants With Clinically Significant Changes in Urinalysis (Week 48 to Week 127)

NCT05397470 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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