Clinical Trial

A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis

Study acronym: VALOR
Active, Not Recruiting Phase 3
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Summary
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.
Protocol Amendment History 28 amendments
This ClinicalTrials.gov record has been amended 28 times since 2022-06-24; most recent amendment 2026-07-15.
Status change: Recruiting → Active, Not Recruiting 2024-08-04
Trial Details
NCT Number NCT05437263
Lead Sponsor Priovant Therapeutics, Inc.
Conditions Dermatomyositis
Enrollment 241 participants
Start Date 2022-10-31
Primary Completion 2025-07-17 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-17