For Healthcare Professionals

Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis


About the study

This is a Phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants with dermatomyositis (DM).

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Key Inclusion Criteria:

  1. 18 years of age or older at the time of signing the informed consent.
  2. Body weight ≥ 30 kilograms at the time of Screening.
  3. Male or female.
  4. Diagnosis: Meet 2017 American College of Rheumatology/European League Against Rheumatism classification criteria for definite or probable DM.
  5. Participants who have an inadequate response or are intolerant to 1 or more DM treatments, including systemic corticosteroids or immunosuppressive/immunomodulatory therapies (for example, azathioprine, methotrexate, rituximab, intravenous immunoglobulin), either in combination or as monotherapy.
  6. Vaccinated against Neisseria meningitidis within 3 years prior to initiating ravulizumab as per national and local guidelines. Participants must receive the vaccination at least 2 weeks before first study intervention. The sponsor recommends that national and local guidelines for prophylactic antibiotics should also be followed.
  7. Female participants of childbearing potential and male participants must follow specified contraception guidance as described in the protocol.


Key Exclusion Criteria:

  1. Participants who have been diagnosed with cancer within the last 3 years need to have appropriate negative cancer screening as per local standard of care within 6 months before Screening (basal or squamous cell skin cancer or carcinoma in situ of the cervix needs to have been excised and without evidence of residual disease for at least 3 months before Screening).
  2. Evidence of active malignant disease or malignancies diagnosed within the previous 3 years including hematological malignancies and solid tumors.
  3. Participants with other forms of myositis.
  4. As per investigator discretion, participants with significant muscle damage (for example, severe muscle atrophy, end stage muscle disease, MRI with severe atrophy or fibrofatty replacement)
  5. History of Neisseria meningitidis infection.
  6. Human immunodeficiency virus (HIV) infection (evidenced by HIV Type 1 or Type 2 antibody titer).
  7. Active systemic bacterial, viral, or fungal infection within 14 days prior to ravulizumab administration.
  8. Presence of fever ≥ 38°Celsius (100.4°Fahrenheit) within 7 days prior to study drug administration on Day 1.
  9. History of hypersensitivity to murine proteins or to 1 of the excipients of ravulizumab.
  10. Pregnant, breastfeeding, or intending to conceive during the course of the study.
  11. Inability or unwillingness to adhere to the protocol requirements.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details



Age (in years)



Phase 2/Phase 3

Participants needed


Est. Completion Date

May 31, 2028

Treatment type



Alexion Pharmaceuticals, Inc. identifier


Study number


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