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Ravulizumab Versus Placebo in...

Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis

Last Updated: 2025-07-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-19

Study Completion Date

2024-05-08

Brief Summary

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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).

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Detailed Description

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The study will be conducted in 2 parts: Part A (Phase 2) and Part B (Phase 3). There will be 3 periods in both Part A and Part B of this study: Screening Period, Randomized Controlled Period, and Open-Label Extension Period.

Conditions

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Dermatomyositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ravulizumab

Participants will receive ravulizumab in both Parts A and B.

Group Type EXPERIMENTAL

Ravulizumab

Intervention Type DRUG

Intravenous dosing will consist of a loading dose followed by maintenance doses administered every 8 weeks (q8w). The maintenance dosing will be initiated 2 weeks after the loading dose is administered.

Placebo

Participants will receive placebo in both Parts A and B.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravenous dosing will consist of a loading dose followed by maintenance doses administered q8w. The maintenance dosing will be initiated 2 weeks after the loading dose is administered.

Interventions

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Ravulizumab

Intervention Type DRUG

Placebo

Intravenous dosing will consist of a loading dose followed by maintenance doses administered q8w. The maintenance dosing will be initiated 2 weeks after the loading dose is administered.

Intervention Type DRUG

Other Intervention Names

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ALXN1210 Ultomiris

Eligibility Criteria

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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.

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 active malignant disease or malignancies diagnosed within the previous 3 years including hematological malignancies and solid tumors.
* Participants with other forms of myositis.
* 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).
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers