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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501351-82-00 | Other Identifier | EUCT number |
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Based on interim analyses for futility
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-blind Placebo Controlled (DBPC) Period: M5049 high dose | Experimental |
| |
| DBPC Period: Placebo | Placebo Comparator |
| |
| Open Label Extension (OLE) Period: M5049 high dose | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M5049 high dose | Drug | Participants will receive film-coated tablets of M5049 at a high dose orally, twice daily up to 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DBPC Period: American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) at Week 24 | at Week 24 | |
| DBPC Period: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) | up to Week 26 | |
| DBPC Period: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements | up to Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| DBPC Period: Number of Participants with American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Total Improvement Score (TIS) Greater Than or Equal to (>=) 20, >= 40 and >= 60 | Week 16 and Week 24 | |
| DBPC Period: Total Improvement Score (TIS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuromuscular Research Center | Phoenix | Arizona | 85028 | United States | ||
| HonorHealth Research Institute - Bob Bove Neuroscience Institute-Neuroscience Research |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
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|
| Placebo | Drug | Participants will receive placebo matched to M5049 orally, twice daily up to 24 weeks. |
|
| Week 4 up to Week 20 |
| DBPC Period: Mean Score for Core Set Measures (CSM) from Week 4 up to Week 24. | Week 4 up to Week 24 |
| DBPC Period: Percent Change from Baseline in Most Abnormal Muscle-associated Enzyme at Weeks 4, 8, 12, 16, 20 and 24 | Baseline, Weeks 4, 8, 12, 16, 20 and 24 |
| DBPC Period: Absolute Change from Baseline in the Core Set Measures (CSM) at Weeks 4, 8, 12, 16, 20 and 24' | Baseline, Weeks 4, 8, 12, 16, 20 and 24 |
| DBPC Period: Percent Change from Baseline in Core Set Measures (CSM) at Weeks 4, 8, 12, 16, 20 and 24' | Baseline, Weeks 4, 8, 12, 16, 20 and 24 |
| DBPC Period: Number of Participants with International Myositis Assessment and Clinical Studies (IMACS) Response | Week 16 and Week 24 |
| DBPC Period: Change from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) A and CDASI-D at Weeks 4, 8, 12, 16, 20 and 24 | Baseline, Weeks 4, 8, 12, 16, 20 and 24 |
| DBPC Period: Percent Change from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) A and CDASI-D at Weeks 4, 8, 12, 16, 20 and 24 | Baseline, Weeks 4, 8, 12, 16, 20 and 24 |
| DBPC Period: Change from Baseline in Investigator's Global Assessment (IGA) Skin Activity Score at Weeks 4, 8, 12, 16, 20 and 24 | Baseline, Weeks 4, 8, 12, 16, 20 and 24 |
| DBPC Period: Percent Change from Baseline in Investigator's Global Assessment (IGA) Skin Activity Score at Weeks 4, 8, 12, 16, 20 and 24 | Baseline, Weeks 4, 8, 12, 16, 20 and 24 |
| OLE Period: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) | up to Week 50 |
| OLE Period: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements | up to Week 50 |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Mayo Clinic Scottsdale (6365) | Scottsdale | Arizona | 85259 | United States |
| Barbara Davis Center | Aurora | Colorado | 80045 | United States |
| HMD Research LLC | Orlando | Florida | 32819 | United States |
| Bolanos Clinical Research | Pembroke Pines | Florida | 33026 | United States |
| Augusta University-Rheumatology | Augusta | Georgia | 30912 | United States |
| Johns Hopkins University - Department of Medicine, Division of Rheumatology | Baltimore | Maryland | 21224 | United States |
| University of Minnesota-Dermatology | Minneapolis | Minnesota | 55455 | United States |
| University of Kansas Medical Center-Neuromuscular | Kansas City | Missouri | 66103 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Austin Neuromuscular Center | Austin | Texas | 78759 | United States |
| Nerve and Muscle Center of Texas-Clinical research | Houston | Texas | 77030 | 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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 25, 2026 |
| ID | Term |
|---|---|
| D003882 | Dermatomyositis |
| D017285 | Polymyositis |
| D009220 | Myositis |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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