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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
241
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
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Clinical Trial Site
Phoenix, Arizona, United States
Clinical Trial Site
Scottsdale, Arizona, United States
Clinical Trial Site
Scottsdale, Arizona, United States
Clinical Trial Site
Irvine, California, United States
Clinical Trial Site
Los Angeles, California, United States
Clinical Trial Site
San Francisco, California, United States
Clinical Trial Site
Aurora, Colorado, United States
Clinical Trial Site
Denver, Colorado, United States
Clinical Trial Site
Boynton Beach, Florida, United States
Clinical Trial Site
Gainesville, Florida, United States
...and 99 more locations
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