A Phase 2, randomized, double-blind, placebo-controlled, efficacy and safety study of daxdilimab subcutaneous injection in adult participants with inadequately controlled dermatomyositis or anti-synthetase inflammatory myositis
Details
The study will enroll 96 participants with 2 idiopathic inflammatory myositis populations:
- Population 1 or dermatomyositis (DM): participants with DM with definite or probable myositis according to the American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria and a DM rash.
- Population 2 or anti-synthetase inflammatory myositis (ASIM): participants with ASIM with definite or probable myositis according to ACR/EULAR 2017 criteria and a positive ASIM associated antibody.
Participants will be randomized by population in a 1:1 ratio and receive investigational product (IP) daxdilimab or placebo by subcutaneous injection.
The estimated total study duration will be up to 60 weeks.
Eligibility
You can join if...
Key Inclusion Criteria:
Adult men or women 18 and less than or equal to 75 years of age at the time of signing the informed consent (ICF).
A diagnosis of definite or probable myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria:
Population 1: DM (Diagnosis of DM with DM rash current or historical), or
Population 2: ASIM
Currently active myositis with all the following (a, b, and c) during screening:
Manual Muscle Testing (MMT 8) score < 142
At least 2 other abnormal core set measures (CSM) from the following list: a) Patient global disease activity (PtGDA) greater than or less than 2 cm in a 10 cm visual analog scale (VAS); b) Physician's Global Disease Activity (PhGDA) greater than or equal to 2 cm in a 10 cm VAS; c) Extramuscular activity greater than or equal to 2cm in a 10 cm VAS; d) At least one muscle enzyme 1.5 times upper limit of normal (ULN); and e)Health assessment questionnaire-disability index (HAQ-DI) greater than or equal to 0.5
Global muscle damage score less than or equal to 5 on a 10 cm VAS on the myositis damage index (MDI).
Participants should be on stable standard of care therapy if tolerated; if they are not able to tolerate it or have failed standard of care, medications should have a washed out period.
Participants should be willing to taper corticosteroid dose per protocol when stable or improving.
Other protocol-defined Inclusion/ Exclusion Criteria apply