๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-15

A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis (NCT05437263)

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

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Priovant Therapeutics, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Clinical Trial Site โ€” Phoenix, Arizona

Age range: 18 Years to 75 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (109 Sites)

Showing the first 25 of 109 sites.

  • Clinical Trial Site โ€” Phoenix, Arizona
  • Clinical Trial Site โ€” Scottsdale, Arizona
  • Clinical Trial Site โ€” Scottsdale, Arizona
  • Clinical Trial Site โ€” Irvine, California
  • Clinical Trial Site โ€” Los Angeles, California
  • Clinical Trial Site โ€” San Francisco, California
  • Clinical Trial Site โ€” Aurora, Colorado
  • Clinical Trial Site โ€” Denver, Colorado
  • Clinical Trial Site โ€” Boynton Beach, Florida
  • Clinical Trial Site โ€” Gainesville, Florida
  • Clinical Trial Site โ€” Jacksonville, Florida
  • Clinical Trial Site โ€” Plantation, Florida
  • Clinical Trial Site โ€” Tampa, Florida
  • Clinical Trial Site โ€” Atlanta, Georgia
  • Clinical Trial Site โ€” Augusta, Georgia
  • Clinical Trial Site โ€” Marietta, Georgia
  • Clinical Trial Site โ€” Chicago, Illinois
  • Clinical Trial Site โ€” Iowa City, Iowa
  • Clinical Trial Site โ€” Kansas City, Kansas
  • Clinical Trial Site โ€” New Orleans, Louisiana
  • Clinical Trial Site โ€” New Orleans, Louisiana
  • Clinical Trial Site โ€” Baltimore, Maryland
  • Clinical Trial Site โ€” Boston, Massachusetts
  • Clinical Trial Site โ€” Ann Arbor, Michigan
  • Clinical Trial Site โ€” Minneapolis, Minnesota

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Dermatomyositis clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—