A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis

Exclusion Criteria

• •Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of dermatomyositis or puts the participant at undue risk
• •Naïve to standard dermatomyositis treatment according to local recommendations
• •History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first study drug administration. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological findings of prostate cancer
• •Clinically significant active infection that is not sufficiently resolved before the first study drug administration in the investigator's opinion
• •Positive serum test at screening for active infection with any of the following: Hepatitis B virus, Hepatitis C virus, HIV
• •Clinically significant disease, recent major surgery, or intention to have major surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
• •Current participation in another interventional clinical study
• •Known hypersensitivity to the study drug or any of its excipients
• •History (within 12 months before screening) of or current alcohol, drug, or medication abuse, as assessed by the investigator
• •Pregnant or lactating state or intending to become pregnant during the study
• •Previous participation in an empasiprubart clinical study with at least 1 dose of study drug received
• •Known complement component deficiency as assessed by the investigator
• •Change in dermatomyositis physical therapy or exercise program from ≤4 weeks before screening
• •Inflammatory or non-inflammatory myopathies other than dermatomyositis, such as drug-induced or endocrine-induced myositis, infective myositis, polymyositis, immune-mediated necrotizing myopathy, inclusion body myositis, overlap myositis, metabolic myopathies, or muscle dystrophies
• •Paraneoplastic dermatomyositis secondary to malignancy
• •Glucocorticoid-induced myopathy
• •Severe muscle damage
• •Extensive or severe calcinosis
• •Interstitial lung disease with at least 1 of the following: forced vital capacity (FVC) ≤60%; supplemental oxygen therapy; rapidly progressing uncontrolled interstitial lung disease; moderate or severe interstitial lung disease