This study is in progress, not accepting new patients

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

a study on Dermatomyositis

Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Dermatomyositis, brepocitinib, TYK2/JAK1 inhibitor, PF-06700841, PVT-2201

Eligibility

You can join if…

Open to people ages 18-75

  • A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
  • Adult subjects (18-75 years old)
  • Active muscle and skin disease at screening and baseline
  • Prior therapy OR current therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant
  • Weight > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2.

You CAN'T join if...

  • Dermatomyositis with end-stage organ involvement
  • Dermatomyositis with irreversible muscle involvement
  • History of:
  • Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome)
  • Participants at a risk of thrombosis or cardiovascular disease
  • Participants with a high risk for herpes zoster reactivation
  • Participants with active or recent infections

Locations

  • Clinical Trial Site
    Los Angeles California 90095 United States
  • Clinical Trial Site
    Irvine California 92617 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Priovant Therapeutics, Inc.
Links
Study Website Sign up for this study
ID
NCT05437263
Phase
Phase 3 Dermatomyositis Research Study
Study Type
Interventional
Participants
About 241 people participating
Last Updated