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Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis

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ClinicalTrials.gov Identifier: NCT04999020
Recruitment Status : Recruiting
First Posted : August 10, 2021
Last Update Posted : January 20, 2023
Sponsor:
Information provided by (Responsible Party):
Alexion

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Dermatomyositis Drug: Ravulizumab Drug: Placebo Phase 2 Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 2, 2021
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Ravulizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ravulizumab
Participants will receive ravulizumab in both Parts A and B.
 Drug: Ravulizumab
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.
Other Names:
  • ALXN1210
  • Ultomiris
Placebo Comparator: Placebo
Participants will receive placebo in both Parts A and B.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Part A: IMACS-TIS (TIS40) response at Week 26 of the Randomized Controlled Period as per defined composite estimand [ Time Frame: Week 26 ]
  2. Part B: IMACS-TIS (TIS40) response at Week 26 of the Randomized Controlled Period as per defined composite estimand [ Time Frame: Week 26 ]

Secondary Outcome Measures :
  1. Part A and B: TIS At Week 26 [ Time Frame: Week 26 ]
  2. Part A and Part B: Change From Baseline In Cutaneous Dermatomyositis Disease Area And Severity Index (CDASI) Activity Score At Week 26 [ Time Frame: Baseline, Week 26 ]
  3. Part A and Part B: Change From Baseline In Five IMACS Core Set Measures (extra-muscular disease activity based on MDAAT, physician global activity assessment, patient global activity assessment, MMT-8, HAQ) At Week 26 [ Time Frame: Baseline, Week 26 ]
  4. Part A and Part B: CDASI Response (7-point improvement) at Week 26 [ Time Frame: Baseline through Week 26 ]
    Minimally clinically important differences (MCID) = 7-point improvement.

  5. Part A and Part B: Cutaneous Dermatomyositis Activity Physician's Global Assessment (CDA-IGA) Response At Week 26 [ Time Frame: Baseline, Week 26 ]
  6. Part A and Part B: TIS20 Response at Week 26 [ Time Frame: Week 26 ]
  7. Part A and Part B: TIS60 Response at Week 26 [ Time Frame: Week 26 ]
  8. Part A and Part B: Time To First Response Of TIS20, TIS40, Or TIS60 [ Time Frame: Baseline through Week 26 ]
  9. Part A and Part B: Clinical Worsening During Randomized Controlled Period At Two Consecutive Visits [ Time Frame: Baseline through Week 26 ]
  10. Part A and Part B: Response Related to Muscle Enzymes: Normalization Of Most Abnormal Baseline Enzyme At Week 26 [ Time Frame: Week 26 ]
  11. Part A and Part B: Receipt of Rescue Therapy [ Time Frame: Baseline through Week 26 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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:

  • Cancer-associated myositis, defined as the diagnosis of myositis within 2 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 wihtout evidence of residual disease 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04999020


Contacts
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Contact: Alexion Pharmaceuticals, Inc. 1-855-752-2356 clinicaltrials@alexion.com

Locations
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United States, California
Clinical Trial Site Recruiting
Los Angeles, California, United States, 90095
Clinical Trial Site Recruiting
Orange, California, United States, 92868
United States, Florida
Clinical Trial Site Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Clinical Trial Site Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Clinical Trial Site Recruiting
Chicago, Illinois, United States, 60637
United States, Kansas
Clinical Trial Site Recruiting
Kansas City, Kansas, United States, 66160
United States, Maryland
Clinical Trial Site Recruiting
Baltimore, Maryland, United States, 21224
United States, New York
Clinical Trial Site Recruiting
New York, New York, United States, 10021
United States, Ohio
Clinical Trial Site Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Clinical Trial Site Recruiting
Pittsburgh, Pennsylvania, United States, 15213
France
Clinical Trial Site Recruiting
Lille Cedex, France, 59037
Clinical Trial Site Recruiting
Paris, France, 75010
Clinical Trial Site Recruiting
Strasbourg, France, 67098
Clinical Trial Site Recruiting
Toulouse Cedex 9, France, 31059
Germany
Clinical Trial Site Recruiting
Dusseldorf, Germany, 40225
Clinical Trial Site Recruiting
Erlangen, Germany, 91054
Clinical Trial Site Recruiting
Essen, Germany, 45147
Clinical Trial Site Recruiting
Freiburg, Germany, 79106
Clinical Trial Site Recruiting
Gottingen, Germany, 37075
Italy
Clinical Trial Site Recruiting
Bari, BA, Italy, 70124
Clinical Trial Site Recruiting
Brescia, BS, Italy, 25123
Clinical Trial Site Recruiting
Pisa, PI, Italy, 56126
Clinical Trial Site Recruiting
Pavia, PV, Italy, 27100
Clinical Trial Site Recruiting
Roma, Italy, 00168
Japan
Clinical Trial Site Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8655
Clinical Trial Site Recruiting
Iruma-Gun, Japan, 350-0495
Clinical Trial Site Recruiting
Suita-Shi, Japan, 5650871
Korea, Republic of
Clinical Trial Site Recruiting
Incheon, Korea, Republic of, 22332
Clinical Trial Site Recruiting
Seoul, Korea, Republic of, 03080
Clinical Trial Site Recruiting
Seoul, Korea, Republic of, 04763
Clinical Trial Site Recruiting
Seoul, Korea, Republic of, 06591
Spain
Clinical Trial Site Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 8907
Clinical Trial Site Recruiting
Bilbao, Vizcaya, Spain, 48013
Clinical Trial Site Recruiting
Barcelona, Spain, 08035
Clinical Trial Site Recruiting
Barcelona, Spain, 08036
Clinical Trial Site Recruiting
Madrid, Spain, 28034
Clinical Trial Site Recruiting
Madrid, Spain, 28041
United Kingdom
Clinical Trial Site Recruiting
Liverpool, United Kingdom, L9 7AL
Clinical Trial Site Recruiting
Salford, United Kingdom, M55AP
Sponsors and Collaborators
Alexion
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Alexion
ClinicalTrials.gov Identifier: NCT04999020    
Other Study ID Numbers: ALXN1210-DM-310
2021-001200-15 ( EudraCT Number )
First Posted: August 10, 2021    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexion:
Ravulizumab
ALXN1210
Ultomiris
Pharmacokinetics
 Pharmacodynamics
Efficacy
DM
Additional relevant MeSH terms:
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Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
 Connective Tissue Diseases
Skin Diseases
Ravulizumab
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs