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

Last updated: March 26, 2025
Sponsor: argenx
Overall Status: Active - Recruiting

Phase

2

Condition

Collagen Vascular Diseases

Lupus

Myositis

Treatment

Placebo IV

Empasiprubart IV

Clinical Study ID

NCT06284954
ARGX-117-2301
2023-508337-14
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is at least 18 years of age and the local legal age of consent for clinical studieswhen signing the Informed Consent Form

  • Is capable of providing signed informed consent and complying with protocolrequirements

  • Agrees to use contraceptive measures consistent with local regulations and women ofchild-bearing potential must have a negative serum pregnancy test at screening and anegative urine pregnancy test before receiving the study drug

  • Has a clinical diagnosis of dermatomyositis or juvenile dermatomyositis. Thediagnosis date for juvenile dermatomyositis should be ≤5 years before screening

  • Has active muscle disease associated with classic dermatomyositis or juveniledermatomyositis at screening and before the first study drug adminisitration and atleast 1 of the following: elevated levels of creatine kinase, aldolase, lactatedehydrogenase, aspartate aminotransaminase or alanine aminotransferase at screening;or electromyography ≤18 weeks before the first study drug administration; or an MRIdepicting active muscle inflammation ≤18 weeks before the first study drugadministration; or muscle biopsy demonstrating signs of active inflammation ≤18weeks before the first study drug administration

  • Has at least mild skin disease at screening

  • Complies with the permitted background dermatomyositis treatment requirements atscreening

  • Has had immunization with the first meningococcal, pneumococcal, and the singleHaemophilus influenza type B vaccine ≥14 days before the first study drugadministration

Exclusion

Exclusion Criteria:

  • Known autoimmune disease or any medical condition that would interfere with anaccurate assessment of clinical symptoms of dermatomyositis or puts the participantat undue risk

  • Naïve to standard dermatomyositis treatment according to local recommendations

  • History of malignancy unless considered cured by adequate treatment with no evidenceof recurrence for ≥3 years before the first study drug administration. Adequatelytreated participants with the following cancers can be included at any time: Basalcell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma insitu of the breast; Incidental histological findings of prostate cancer

  • Clinically significant active infection that is not sufficiently resolved before thefirst 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 majorsurgery during the study; or any other medical condition that, in the investigator'sopinion, would confound the results of the study or put the participant at unduerisk

  • 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, ormedication 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 ofstudy drug received

  • Known complement component deficiency as assessed by the investigator

  • Change in dermatomyositis physical therapy or exercise program from ≤4 weeks beforescreening

  • Inflammatory or non-inflammatory myopathies other than dermatomyositis, such asdrug-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 uncontrolledinterstitial lung disease; moderate or severe interstitial lung disease

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: Placebo IV
Phase: 2
Study Start date:
August 20, 2024
Estimated Completion Date:
January 20, 2028

Connect with a study center

  • Institute of Clinical Cardiology, Ltd

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • Jerarsi Clinic

    Tbilisi, 0167
    Georgia

    Active - Recruiting

  • Mtskheta street Clinic

    Tbilisi, 0179
    Georgia

    Active - Recruiting

  • The First Medical Center

    Tbilisi, 0180
    Georgia

    Active - Recruiting

  • The First University Clinic of Tbilisi State Medical University

    Tbilisi, 0141
    Georgia

    Active - Recruiting

  • V.Tsitlanadze Scientific Practical Reumatology Center

    Tbilisi, 0102
    Georgia

    Active - Recruiting

  • National and Kapodistrian University of Athens (NKUA) - University General Hospital Attikon

    Athens, 12462
    Greece

    Active - Recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Rome, 00128
    Italy

    Active - Recruiting

  • Timofei Mosneaga Republican Clinical Hospital

    Chisinau, 2025
    Moldova, Republic of

    Active - Recruiting

  • Prywatna Praktyka Lekarska Prof. UM dr Hab. Med. Pawel Hrycaj

    Poznan, 61-397
    Poland

    Active - Recruiting

  • Parc de Salut Mar - Hospital del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Quironsalud Infanta Luisa

    Sevilla, 41010
    Spain

    Active - Recruiting

  • Profound Research LLC

    Oceanside, California 92056
    United States

    Active - Recruiting

  • Omega Research Debary, LLC

    Debary, Florida 32713
    United States

    Active - Recruiting

  • Homestead Associates in Research, Inc.

    Homestead, Florida 33033
    United States

    Active - Recruiting

  • Life Clinical Trials

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Advance Medical Research Center

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Integral Rheumatology and Immunology Specialists (IRIS)

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • D and H Tamarac Research, LLC Center

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • Wright State Physicians Health Center

    Dayton, Ohio 45324
    United States

    Active - Recruiting

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