Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis
Study Identifier:
ALXN1210-DM-310
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other
Available Documents
Study Details
Medical Condition
- Dermatomyositis
Study Drug
- Drug: Ravulizumab
- Drug: Placebo
Date
Nov 2021 - Oct 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
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.
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Dermatomyositis
Study Drug
- Drug: Ravulizumab
- Drug: Placebo
Date
Nov 2021 - Oct 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
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.
Protocol 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).
Trial Locations
Location
Status
Location
Research Site
Phoenix, Arizona, United States, 85032
Status
N/A
Location
Research Site
Irvine, California, United States, 92617
Status
N/A
Location
Research Site
Santa Monica, California, United States, 90404
Status
N/A
Location
Research Site
Washington D.C., District of Columbia, United States, 20037
Status
N/A
Location
Research Site
Tampa, Florida, United States, 33612
Status
N/A
Location
Research Site
Atlanta, Georgia, United States, 30322
Status
N/A
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