A Phase 3 interventional study of Brepocitinib and Placebo in Dermatomyositis, sponsored by Priovant Therapeutics, Inc.. Completed at 109 sites in 22 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Priovant Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
History of:
Drug: Brepocitinib
Drug: Brepocitinib
Drug: Placebo
Oral Brepocitinib
Oral Placebo
Total Improvement Score (TIS) at Week 52
TIS is a composite endpoint based on improvement in the 6 Disease Activity Core Set Measure (CSM) scores and ranges from 0 to 100 (2016 American College of Rheumatology \[ACR\] Myositis Response Criteria/European League Against Rheumatism \[EULAR\]) where a higher score indicates more improvement
Time frame: 52 weeks
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52
CDASI Activity Score 0 to 100 with higher scores indicating a worse outcome.
Time frame: 52 weeks
Dermatomyositis Outcomes for Muscle and Skin (DMOMS) at Week 52
DMOMS is a composite endpoint based on 4 component measures and ranges from 0 to 100 (Pandya, 2024) where a higher score indicates more improvement.
Time frame: 52 weeks
The proportion of participants achieving TIS ≥ 40 points (moderate improvement) at Week 52
Time frame: 52 weeks
Time to achievement of consecutive (≥ 2 visits) TIS ≥ 40 points (moderate improvement) by Week 52
Time frame: 52 weeks
The proportion of participants, regardless of baseline corticosteroid use, achieving TIS ≥ 40 points (moderate improvement) at Week 52 with 0 to ≤ 2.5 mg/day of oral prednisone (or equivalent) at both Week 48 and Week 52
Time frame: 52 weeks
The proportion of participants achieving ≥ 40% improvement with a ≥ 4-point improvement from baseline in CDASI Activity Score at Week 52
Time frame: 52 weeks
The proportion of participants achieving TIS ≥ 60 points (major improvement) at Week 52
Time frame: 52 weeks
Change from baseline in HAQ Disability Index score at Week 52
Change from baseline in HAQ Disability Index score at Week 52. Health Assessment Questionnaire (HAQ) Disability Index: Score for function and disability from 0 \[without any difficulty\] to 3 \[unable to do\]. Higher score associated with worse outcome.
Time frame: 52 weeks
Change from baseline in CDASI Activity Score at Week 4
Time frame: 4 weeks
Showing the first 100 of 109 sites across 22 countries.
Plan to share: Yes — Priovant Therapeutics will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) from eligible studies upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Data requests will be reviewed and approved on the basis of scientific merit.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Priovant Therapeutics, Inc.