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

Dermatomyositis

TIS at Week 52 TIS is a composite endpoint based on the following six Disease Activity CSM scores and ranges from 0 to 100 (2016 ACR /EULAR Myositis Response Criteria): PhGA-VAS; PtGA-VAS; MMT8 ;HAQ Disability Index; Muscle Enzyme Assessment, EMGA-VAS

Change from baseline in CDASI Activity Score at Week 52, DMOMS at Week 52 DMOMS is a composite endpoint based on the following four component measures and ranges from 0 to 100 [Pandya, 2024]: MMT-8; CDASI; PhGA-VAS; PtGA-VAS, The proportion of participants achieving TIS ≥ 40 points (moderate improvement) at Week 52, Time to achievement of consecutive (≥ 2 visits) TIS ≥ 40 points (moderate improvement) by Week 52, 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, The proportion of participants achieving ≥ 40% improvement with a ≥ 4-point improvement from baseline in CDASI Activity Score at Week 52, The proportion of participants achieving TIS ≥ 60 points (major improvement) at Week 52, Change from baseline in HAQ-DI at Week 52, Change from baseline in CDASI Activity score at Week 4

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