Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis

• Status: Recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexion Pharmaceuticals
• Treatments: Ravulizumab

Criteria

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 American College of Rheumatology/European League Against Rheumatism classification criteria for definite or probable DM.

• Participants who have an inadequate response (that is, continued impairment by medical doctor report) or are intolerant to 2 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:

• Cancer-associated myositis, defined as the diagnosis of myositis within 3 years of the diagnosis of cancer (except basal or squamous cell skin cancer or carcinoma in situ of the cervix that has been excised and cured and 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.

• Participants with other forms of myositis.

• Participants with significant muscle damage (for example, severe muscle atrophy, end stage muscle disease) as per investigator opinion.

• History of Neisseria meningitidis infection.

• Human immunodeficiency virus (HIV) infection (evidenced by HIV Type 1 or Type 2 antibody titer).

• 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.

• History of hypersensitivity to murine proteins or to 1 of the excipients of ravulizumab.

• Pregnant, breastfeeding, or intending to conceive during the course of the study.

• Inability or unwillingness to adhere to the protocol requirements.