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

NCT05437263 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2025-09-29

No results posted yet for this study

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

DRUG

Brepocitinib

Oral Brepocitinib

DRUG

Placebo

Oral Placebo

Sponsors & Collaborators

  • Priovant Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2025-07-17
Completion
2026-07-31
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05437263 on ClinicalTrials.gov