Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
argenx
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Is at least 18 years of age and the local legal age of consent for clinical studies when signing the Informed Consent Form
Is capable of providing signed informed consent and complying with protocol requirements
Agrees to use contraceptive measures consistent with local regulations and women of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before receiving the study drug
Has a clinical diagnosis of dermatomyositis or juvenile dermatomyositis. The diagnosis date for juvenile dermatomyositis should be ≤5 years before screening
Has active muscle disease associated with classic dermatomyositis or juvenile dermatomyositis at screening and before the first study drug adminisitration and at least 1 of the following: elevated levels of creatine kinase, aldolase, lactate dehydrogenase, aspartate aminotransaminase or alanine aminotransferase at screening; or electromyography ≤18 weeks before the first study drug administration; or an MRI depicting active muscle inflammation ≤18 weeks before the first study drug administration; or muscle biopsy demonstrating signs of active inflammation ≤18 weeks before the first study drug administration
Has at least mild skin disease at screening
Complies with the permitted background dermatomyositis treatment requirements at screening
Has had immunization with the first meningococcal, pneumococcal, and the single Haemophilus influenza type B vaccine ≥14 days before the first study drug administration
You may not be if
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
