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NCT05437263 (Brepocitinib in Dermatomyositis): BVCT ex-ante prediction vs. reported outcome

On 14 May 2025, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 17 Sep 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05437263
Acronym
VALOR
Drug Name
Brepocitinib
Drug MoA
JAK1/TYK2 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
Dermatomyositis
Human Patients
241
Sponsor
Roivant Sciences
Phase
Phase 3

Prediction of , index 1132

Prospective Prediction
Prediction Index
1132
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient additive clinical benefit in TIS score compared with placebo for previously untreated patients) partial FAILURE (commercially insufficient clinical benefit in TIS score compared with placebo for previously treated patients)
Technical Prediction
partial SUCCESS (statistically significant additive clinical benefit in TIS score compared with placebo for previously untreated patients) partial FAILURE (statistically insignificant clinical benefit in TIS score compared with placebo for previously treated patients)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
126 days in advance
Readout Data Interpretation
brepocitinib 30mg achieved 15.3 placebo-adjusted improvement in TIS at week 52 (p=0.0006)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Dermatomyositis
Phase
Phase 3
Status
Completed
Enrollment
241
Lead sponsor
Priovant Therapeutics, Inc.
Conditions
Dermatomyositis
Interventions
DRUG: Brepocitinib; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-10-31
Primary completion
2025-07-17
Completion
2026-09-09
Primary outcomes
  • Total Improvement Score (TIS) at Week 52 (52 weeks)

NCT05437263 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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