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A study to evaluate safety and efficacy of Empasiprubart in adults with Dermatomyositis
EU CTIS ID: 2023-508337-14-00
What this study is testing
To evaluate the safety and tolerability of empasiprubart compared with placebo in adult participants with dermatomyositis (DM).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 administration 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.
You likely can't join 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.
- 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.
See the full eligibility criteria
Who can join
- 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 administration 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.
What rules you out
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- United States
- Korea, Republic of
- Moldova, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; United States; Korea, Republic of; Moldova, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.