Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
40 participants
INTERVENTIONAL
2023-01-19
2025-06-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
NCT05895786
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
NCT06698796
A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
NCT06455449
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
NCT06284954
Allogeneic Mitochondria (PN-101) Transplantation for Refractory Polymyositis or Dermatomyositis
NCT04976140
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Double-blind Placebo Controlled (DBPC) Period: M5049 high dose
M5049 high dose
Participants will receive film-coated tablets of M5049 at a high dose orally, twice daily up to 24 weeks.
DBPC Period: Placebo
Placebo
Participants will receive placebo matched to M5049 orally, twice daily up to 24 weeks.
Open Label Extension (OLE) Period: M5049 high dose
M5049 high dose
Participants will receive film-coated tablets of M5049 at a high dose orally, twice daily up to 24 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
M5049 high dose
Participants will receive film-coated tablets of M5049 at a high dose orally, twice daily up to 24 weeks.
Placebo
Participants will receive placebo matched to M5049 orally, twice daily up to 24 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Active disease on standard of care (SoC), must meet 1 of the criteria within 6 months prior to Screening: Pathological evidence of active myositis in muscle biopsy; Evidence of active myositis by Electromyography (EMG); Magnetic resonance imaging (MRI) with evidence of active myositis; or any muscle enzyme greater than or equal to (\>=) 4 × upper limit of normal (ULN) at time of Screening; Active PM/DM skin rash as per cutaneous dermatomyositis area and severity index-A (CDASI-A) \>= 7 at time of Screening
* Minimum disease severity defined by: moderate to severe myopathy with manual muscle testing-8 (MMT-8) \>= 80 and less than or equal to (\<=) 142 AND at least 2 of the following core set measures (CSM) abnormalities: Patient Global Activity (PtGA) \>= 2 centimeters (cm); Physician Global Activity (PGA) derived from myositis disease activity assessment tool (MDAAT) \>= 2 cm; Extramuscular Activity Assessment derived from MDAAT \>2 cm; At least 1 muscle enzyme \> 1.5 times ULN; health assessment questionnaire-disability index (HAQ-DI) \>= 0.25
* Stable doses of oral corticosteroids (CS) and/or maximum of 1 non-corticosteroid immunosuppressive/immunomodulatory medications (methotrexate, 6 mercaptopurine, sulfasalazine, mycophenolate mofetil or sodium, azathioprine, leflunomide, cyclosporine, oral tacrolimus) for DM or PM
* Participants have a body mass index (BMI) lower or Equal to 40.0 kilograms per square meter (kg/m\^2)
Exclusion Criteria
* Primary diagnosis of juvenile DM, or adult participants previously diagnosed with juvenile DM
* Any other active concurrent connective tissue disease associated with inflammatory myopathy in the Investigator's opinion. Eligibility of participants with diagnosis of concurrent connective tissue disease(s) will be reviewed and approved by an idiopathic inflammatory myopathies (IIM) expert committee
* Severe interstitial lung disease defined as supplemental oxygen required at rest, or forced vital capacity (FVC) of \<60 percent (%) predicted. Participants within 1 year of PM/DM diagnosis and anti-MDA5 antibody, should have been evaluated for interstitial lung disease (ILD) with high resolution computed tomography (HRCT) Chest
* Any uncontrolled disease (for example \[e.g.\], severe respiratory, cardiovascular, gastrointestinal, neurological, psychiatric, hematological, metabolic \[including thyroiditis with increased/decreased thyroid stimulating hormone (TSH)\], renal \[Estimated glomerular filtration rate \< 40 milliliter per minute/1.73 m\^2 as calculated by the Modification of Diet in Renal Disease equation by the central laboratory\], hepatic, endocrine/reproductive organ disease) other than DM/PM, that in the Investigator's or Sponsor/designee's opinion constitutes an inappropriate risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neuromuscular Research Center
Phoenix, Arizona, United States
HonorHealth Research Institute - Bob Bove Neuroscience Institute-Neuroscience Research
Scottsdale, Arizona, United States
Mayo Clinic Scottsdale (6365)
Scottsdale, Arizona, United States
Barbara Davis Center
Aurora, Colorado, United States
HMD Research LLC
Orlando, Florida, United States
Bolanos Clinical Research
Pembroke Pines, Florida, United States
Augusta University-Rheumatology
Augusta, Georgia, United States
Johns Hopkins University - Department of Medicine, Division of Rheumatology
Baltimore, Maryland, United States
University of Minnesota-Dermatology
Minneapolis, Minnesota, United States
University of Kansas Medical Center-Neuromuscular
Kansas City, Missouri, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Austin Neuromuscular Center
Austin, Texas, United States
Nerve and Muscle Center of Texas-Clinical research
Houston, Texas, United States
Institute of Rheumatology - Rheumatology
Prague, , Czechia
Hippokration Hospital - 2nd Department of Medicine and Laboratory
Athens, , Greece
National and Kapodistrian University of Athens (Egnitio Hospital)
Athens, , Greece
University General Hospital of Larissa
Larissa, , Greece
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco Di Catania (Vittorio Emanuele) - Reumatologia
Catania, , Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, , Italy
Azienda Usl Toscana Centro
Florence, , Italy
Arcispedale S. Maria Nuova
Reggio Emilia, , Italy
Fondazione Policlinico Universitario A. Gemelli-IRCCS, UCSC - Scienze Mediche e Chirurgiche
Rome, , Italy
Instytut Reumatologii im. Eleonory Reicher - Department of Connective Tissue Diseases
Warsaw, , Poland
CHUAC - Complexo Hospitalario Universitario A Coruña - Rheumatology
A Coruña, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Ramon y Cajal, Madrid - Rheumatology Department
Madrid, , Spain
Doncaster Royal Infirmary (3466)
Doncaster, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
University College London Hospitals NHS Foundation Trust- Neuromuscular Diseases
London, , United Kingdom
Salford Royal Hospital, Barnes Clinical Research Facility
Salford, , United Kingdom
Royal Wolverhampton Hospitals (6493)
Wolverhampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-501351-82-00
Identifier Type: OTHER
Identifier Source: secondary_id
MS200569_0041
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.