Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis (NCT04999020) | Clinical Trial Compass
TerminatedPhase 2/3
Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis
Stopped: Sponsor decision
United States38 participantsStarted 2021-11-19
Plain-language summary
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 participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* 18 years of age or older at the time of signing the informed consent.
* Body weight ≥ 30 kilograms at the time of Screening.
* Male or female.
* Diagnosis: Meet 2017 American College of Rheumatology/European League Against Rheumatism classification criteria for definite or probable DM.
* 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.
* 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.
* Female participants of childbearing potential and male participants must follow specified contraception guidance as described in the protocol.
Key Exclusion Criteria:
* 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).
* Evidence of …
What they're measuring
1
Number of Participants With International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS-TIS) (TIS40) Response at Week 26 of the Randomized Controlled Period