Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis
Reason given: Sponsor decision
Key facts
- Where
- Atlanta, Baltimore, Chapel Hill, Charleston, Chicago, Cleveland, Durham, Fairway, Irvine, Las Vegas, Manhasset, Memphis, New York, North Richland Hills, Phoenix, Pittsburgh, Santa Monica, Seattle, Tampa, and Washington D.C., United StatesSee the 20 sites
- Phase
- Phase 2/3
Where in United States
- Atlanta, GeorgiaHospital not named in the registryNo longer taking part
- Baltimore, MarylandHospital not named in the registryNo longer taking part
- Chapel Hill, North CarolinaHospital not named in the registryNo longer taking part
- Charleston, West VirginiaHospital not named in the registryNo longer taking part
- Chicago, IllinoisHospital not named in the registryNo longer taking part
- Cleveland, OhioHospital not named in the registryNo longer taking part
- Durham, North CarolinaHospital not named in the registryNo longer taking part
- Fairway, KansasHospital not named in the registryNo longer taking part
- Irvine, CaliforniaHospital not named in the registryNo longer taking part
- Las Vegas, NevadaHospital not named in the registryNo longer taking part
- Manhasset, New YorkHospital not named in the registryNo longer taking part
- Memphis, TennesseeHospital not named in the registryNo longer taking part
- New YorkHospital not named in the registryNo longer taking part
- North Richland Hills, TexasHospital not named in the registryNo longer taking part
- Phoenix, ArizonaHospital not named in the registryNo longer taking part
- Pittsburgh, PennsylvaniaHospital not named in the registryNo longer taking part
- Santa Monica, CaliforniaHospital not named in the registryNo longer taking part
- Seattle, WashingtonHospital not named in the registryNo longer taking part
- Tampa, FloridaHospital not named in the registryNo longer taking part
- Washington D.C., District of ColumbiaHospital not named in the registryNo longer taking part
Trial details
- Who runs it
- Alexion Pharmaceuticals, Inc.
- Trial code
- NCT04999020
- Record updated
- 9 July 2025
- Original description
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).Read full original descriptionShow less
A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Dermatomyositis
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).
Inclusion: 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.
Exclusion: 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 active malignant disease or malignancies diagnosed within the previous 3 years including hematological malignancies and solid tumors; Active systemic bacterial, viral, or fungal infection within 14 days prior to ravulizumab administration; Presence of fever ≥ 38°Celsius (100.4°Fahrenheit) within 7 days prior to study drug administration on Day 1; 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); History of Neisseria meningitidis infection; Human immunodeficiency virus (HIV) infection (evidenced by HIV Type 1 or Type 2 antibody titer); History of hypersensitivity to murine proteins or to 1 of the excipients of ravulizumab; Participants with other forms of myositis; Pregnant, breastfeeding, or intending to conceive during the course of the study; Inability or unwillingness to adhere to the protocol requirements.