This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM). The study duration will be approximately 92 weeks for all participants. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either empasiprubart or placebo, respectively, during the treatment period (duration of 25 weeks). At the end of the treatment period, all the participants will enter a safety follow-up period (duration of 65 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3
Intravenous infusion with Empasiprubart IV
Intravenous infusion with Placebo IV
Incidence of adverse events (AEs)
Time frame: Up to 90 weeks
Percentage of participants discontinuing investigational medicinal product (IMP) due to an adverse event (AE)
Time frame: Up to 25 weeks
Mean TIS
The Total Improvement Score (TIS) assesses minimal, moderate, and major clinical response categorically or continuously using American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) criteria.
Time frame: Up to 25 weeks
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