C0251010 - A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)

Idiopathic Inflammatory Myopathy (including dermatomyositis or polymyositis)

TEAEs, SAEs, AESIs, and AEs leading to treatment discontinuation; Clinically significant abnormalities in laboratory tests, ECG measurements, and vital signs; Change from baseline in FVC/DLCO; Absolute values and change from baseline in C-SSRS at all scheduled timepoints.

Cohort 1 (DM) and Cohort 2 (PM): • Change from baseline* in MMT-8 score at all scheduled timepoints. • Change from baseline* in PhGA at all scheduled timepoints. • Change from baseline* in extramuscular activity or disease activity score at all scheduled timepoints. • Change from baseline* in results in muscle enzymes at all scheduled timepoints. • Minimal, Moderate, and Major improvement in TIS at all scheduled timepoints. • TIS (continuous) at all scheduled timepoints., Cohort 1 (DM) and Cohort 2 (PM): Change from baseline at all scheduled timepoints in: PROMIS-PF, PtGA, HAQ-DI, FACIT-F, EQ-5D-5L and EQ-VAS, HRU questionnaire; Cohort 1 (DM) only: Change from baseline at all scheduled timepoints in: 5D-Itch Scale, Change from baseline in corticosteroid dose over time; Response over time based on participants achieving: Corticosteroid dose ≤5 mg/day, Corticosteroid free; Change from baseline in non-steroid immunosuppressant/immunomodulator and antimalarial dose over time. Response over time based on participants achieving: Non-steroid immunosuppressants/immunomodulator and antimalarial free., Receive rescue therapy (yes or no) during the study; Number/cycles of rescue therapy received during the study., Auto antibodies (eg. TIF1-γ/P155, NXP2/P140, SAE, JO-1 and MDA-5)., Baseline* and post-treatment ADAs and Nabs., To be continued - secondary endpoint for secondary objective nr.1: Cohort 1 (DM) Only: Percent change from baseline and change from baseline in CDASI-A score at all scheduled timepoints; Change from baseline in CDASI-D score at all scheduled timepoints.

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