A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults with Dermatomyositis
- Conditions
- DermatomyositisMyositis
- Registration Number
- NCT06284954
- Lead Sponsor
- argenx
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria:<br><br> - Is at least 18 years of age and the local legal age of consent for clinical studies<br> when signing the Informed Consent Form<br><br> - Is capable of providing signed informed consent and complying with protocol<br> requirements<br><br> - Agrees to use contraceptive measures consistent with local regulations and women of<br> child-bearing potential must have a negative serum pregnancy test at screening and a<br> negative urine pregnancy test before receiving the study drug<br><br> - Has a clinical diagnosis of dermatomyositis or juvenile dermatomyositis. The<br> diagnosis date for juvenile dermatomyositis should be =5 years before screening<br><br> - Has active muscle disease associated with classic dermatomyositis or juvenile<br> dermatomyositis at screening and before the first study drug adminisitration and at<br> least 1 of the following: elevated levels of creatine kinase, aldolase, lactate<br> dehydrogenase, aspartate aminotransaminase or alanine aminotransferase at screening;<br> or electromyography =18 weeks before the first study drug administration; or an MRI<br> depicting active muscle inflammation =18 weeks before the first study drug<br> administration; or muscle biopsy demonstrating signs of active inflammation =18<br> weeks before the first study drug administration<br><br> - Has at least mild skin disease at screening<br><br> - Complies with the permitted background dermatomyositis treatment requirements at<br> screening<br><br> - Has had immunization with the first meningococcal, pneumococcal, and the single<br> Haemophilus influenza type B vaccine =14 days before the first study drug<br> administration<br><br>Exclusion Criteria:<br><br> - Known autoimmune disease or any medical condition that would interfere with an<br> accurate assessment of clinical symptoms of dermatomyositis or puts the participant<br> at undue risk<br><br> - Naïve to standard dermatomyositis treatment according to local recommendations<br><br> - History of malignancy unless considered cured by adequate treatment with no evidence<br> of recurrence for =3 years before the first study drug administration. Adequately<br> treated participants with the following cancers can be included at any time: Basal<br> cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in<br> situ of the breast; Incidental histological findings of prostate cancer<br><br> - Clinically significant active infection that is not sufficiently resolved before the<br> first study drug administration in the investigator's opinion<br><br> - Positive serum test at screening for active infection with any of the following:<br> Hepatitis B virus, Hepatitis C virus, HIV<br><br> - Clinically significant disease, recent major surgery, or intention to have major<br> surgery during the study; or any other medical condition that, in the investigator's<br> opinion, would confound the results of the study or put the participant at undue<br> risk<br><br> - Current participation in another interventional clinical study<br><br> - Known hypersensitivity to the study drug or any of its excipients<br><br> - History (within 12 months before screening) of or current alcohol, drug, or<br> medication abuse, as assessed by the investigator<br><br> - Pregnant or lactating state or intending to become pregnant during the study<br><br> - Previous participation in an empasiprubart clinical study with at least 1 dose of<br> study drug received<br><br> - Known complement component deficiency as assessed by the investigator<br><br> - Change in dermatomyositis physical therapy or exercise program from =4 weeks before<br> screening<br><br> - Inflammatory or non-inflammatory myopathies other than dermatomyositis, such as<br> drug-induced or endocrine-induced myositis, infective myositis, polymyositis,<br> immune-mediated necrotizing myopathy, inclusion body myositis, overlap myositis,<br> metabolic myopathies, or muscle dystrophies<br><br> - Paraneoplastic dermatomyositis secondary to malignancy<br><br> - Glucocorticoid-induced myopathy<br><br> - Severe muscle damage<br><br> - Extensive or severe calcinosis<br><br> - Interstitial lung disease with at least 1 of the following: forced vital capacity<br> (FVC) =60%; supplemental oxygen therapy; rapidly progressing uncontrolled<br> interstitial lung disease; moderate or severe interstitial lung disease
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs);Percentage of participants discontinuing investigational medicinal product (IMP) due to an adverse event (AE)
- Secondary Outcome Measures
Name Time Method Mean TIS