NCT05437263

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Dermatomyositis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Priovant Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dermatomyositis

Interventions

Type	Name	Description
DRUG	Brepocitinib	Oral Brepocitinib
DRUG	Placebo	Oral Placebo

Timeline

• Start date: 2022-10-31
• Primary completion: 2025-07-17
• Completion: 2026-07-01
• First posted: 2022-06-29
• Last updated: 2025-09-29

Locations

109 sites across 22 countries: United States, Argentina, Belgium, Bulgaria, Canada, Chile, Czechia, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Romania, Serbia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study