The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Participants will receive film-coated tablets of M5049 at a high dose orally, twice daily up to 24 weeks.
Participants will receive placebo matched to M5049 orally, twice daily up to 24 weeks.
DBPC Period: American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) at Week 24
Time frame: at Week 24
DBPC Period: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
Time frame: up to Week 26
DBPC Period: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements
Time frame: up to Week 26
DBPC Period: Number of Participants with American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) Greater Than or Equal to (>=) 20, >= 40 and >= 60
Time frame: Week 16 and Week 24
DBPC Period: Total Improvement Score (TIS)
Time frame: Week 4 up to Week 20
DBPC Period: Mean Score for Core Set Measures (CSM) from Week 4 up to Week 24.
Time frame: Week 4 up to Week 24
DBPC Period: Percent Change from Baseline in Most Abnormal Muscle-associated Enzyme at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
DBPC Period: Absolute Change from Baseline in the Core Set Measures (CSM) at Weeks 4, 8, 12, 16, 20 and 24'
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
DBPC Period: Percent Change from Baseline in Core Set Measures (CSM) at Weeks 4, 8, 12, 16, 20 and 24'
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Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
DBPC Period: Number of Participants with International Myositis Assessment and Clinical Studies (IMACS) Response
Time frame: Week 16 and Week 24
DBPC Period: Change from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) A and CDASI-D at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
DBPC Period: Percent Change from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) A and CDASI-D at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
DBPC Period: Change from Baseline in Investigator's Global Assessment (IGA) Skin Activity Score at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
DBPC Period: Percent Change from Baseline in Investigator's Global Assessment (IGA) Skin Activity Score at Weeks 4, 8, 12, 16, 20 and 24
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
OLE Period: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
Time frame: up to Week 50
OLE Period: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements
Time frame: up to Week 50