30 completed, 12 recruiting, 9 terminated, 4 withdrawn. 63 Phase 2, 14 Phase 3, 7 Phase 1.
Follow Polymyositis: new trials by email Literature Review of Polymyositis trials Research Report on Polymyositis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM) FISH OIL 500MG OMEGA-3 SOFT GEL MINIS, Placebo - Dermatomyositis (DM), Juvenile Dermatomyositis (JDM) | Phase 2 | Recruiting | National Institute of Environmental Health Sciences (NIEHS) | 3000 | 2026-11-04 | 2026-10-30 |
| FT839 in Autoimmune Diseases FT839 - ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM) | Phase 1 / Phase 2 | Recruiting | Fate Therapeutics | 446 | 2026-10-01 | 2026-09-02 |
| Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study Emapalumab - Dermatomyositis, Dermatomyositis Sine Myositis | Phase 2 | Recruiting | University of Miami | 5 | 2026-07-23 | 2026-08-25 |
| Study of NM8074 in Patients with Dermatomyositis (DM) NM8074 - Dermatomyositis | Phase 2 | Not yet recruiting | NovelMed Therapeutics | 8 | 2026-06-01 | 2025-03-25 |
| Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders Descartes-08 - Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV) | Phase 1 / Phase 2 | Recruiting | Cartesian Therapeutics | 50 | 2026-01-14 | 2026-07-27 |
| Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM) ULSC (1.5 x 10^8 cells/dose), Placebo (no cells) - Idiopathic Inflammatory Myositis (IIM), DERMATOMYOSITIS OR POLYMYOSITIS | Phase 2 / Phase 3 | Recruiting | Restem, LLC. | 40 | 2026-01-06 | 2026-04-27 |
| Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty Methotrexate, Sulfasalazine, Hydroxychloroquine - Rheumatic Disease | Phase 2 | Recruiting | NYU Langone Health | 80 | 2025-12-12 | 2026-07-09 |
| Phase 2 Trial to Evaluate the Efficacy, Safety of Allogeneic Mitochondria (PN-101) in Patients With Refractory Polymyositis or Dermatomyositis placebo, PN-101 - Polymyositis, Dermatomyositis | Phase 2 | Not yet recruiting | Paean Biotechnology Inc. | 36 | 2025-12-01 | 2025-08-14 |
| Study of Deucravacitinib for Refractory Adults With Dermatomyositis/Juvenile Dermatomyositis Deucravacitinb - Myositis, Dermatomyositis | Phase 2 | Withdrawn | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | 2025-11-21 | 2025-11-24 | |
| Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis Ruxolitinib Topical Cream - Dermatomyositis | Phase 2 | Recruiting | The Cleveland Clinic | 15 | 2025-06-01 | 2026-10-28 |
| Intralesional Injection of STS in Treatment of Calcinosis Sodium Thiosulfate (STS) - Systemic Sclerosis (SSc), Dermatomyositis | Phase 2 | Recruiting | Robyn T. Domsic, MD, MPH | 20 | 2025-03-17 | 2026-05-05 |
| Mesenchymal Stem Cells Infusion in Patients With Autoimmune Diseases Mesenchymal Stem Cells, Placebo - Rheumatoid Arthritis, Systemic Lupus Erythematosus (SLE) | Phase 1 / Phase 2 | Enrolling by invitation | National Institute of Blood and Marrow Transplant (NIBMT), Pakistan | 200 | 2025-02-01 | 2025-03-21 |
| Phase 2 Study of Rapcabtagene Autoleucel in Myositis Rapcabtagene autoleucel, Active Comparator Option - Idiopathic Inflammatory Myopathies | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 21 | 2024-12-17 | 2026-06-23 |
| Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases CAR T cell - Lupus Erythematosus, Systemic, System; Sclerosis | Phase 1 / Phase 2 | Recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | 8 | 2024-11-29 | 2025-04-11 |
| A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis Brepocitinib - Dermatomyositis, Dermatomyositis, Adult Type | Phase 2 | Completed | Priovant Therapeutics, Inc. | 5 | 2024-08-28 | 2025-05-20 |
| A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis Empasiprubart IV, Placebo IV - Dermatomyositis, Myositis | Phase 2 | Active not recruiting | argenx | 3 | 2024-08-20 | 2025-09-25 |
| RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy CABA-201 following preconditioning with fludarabine and cyclophosphamide - Idiopathic Inflammatory Myopathy, Dermatomyositis | Phase 2 / Phase 3 | Recruiting | Cabaletta Bio | 74 | 2023-12-20 | 2026-10-15 |
| A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM) Daxdilimab, Placebo - Idiopathic Inflammatory Myositis | Phase 2 | Completed | Amgen | 12 | 2023-12-04 | 2026-08-25 |
| Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy Froniglutide, Placebo - Dermatomyositis, Polymyositis | Phase 2 | Unknown | Immunoforge Co. Ltd. | 39 | 2023-09-05 | 2023-09-13 |
| CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease anti-CD19 CAR T cell therapy - Systemic Lupus Erythematosus, Systemic Sclerosis | Phase 1 / Phase 2 | Recruiting | Miltenyi Biomedicine GmbH | 24 | 2023-07-17 | 2025-09-30 |
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Dermatomyositis (61) · Myositis (22) · Lupus Erythematosus, Systemic (7) · Scleroderma, Systemic (6) · Arthritis, Juvenile (5) · Arthritis, Rheumatoid (5) · Lung Diseases, Interstitial (5) · Myositis, Inclusion Body (5) · Mixed Connective Tissue Disease (4) · Vasculitis (4) · Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (3) · Autoimmune Diseases (3) · Calcinosis (3) · Connective Tissue Diseases (3)
Nervous System Diseases (63) · Neuromuscular Diseases (63) · Muscular Diseases (61) · Musculoskeletal Diseases (61) · Skin Diseases (61) · Skin and Connective Tissue Diseases (61) · Connective Tissue Diseases (58) · Myositis (41) · Immune System Diseases (12) · Autoimmune Diseases (8) · Respiratory Tract Diseases (8) · Joint Diseases (7) · Lung Diseases (7) · Pathological Conditions, Signs and Symptoms (7)
Infliximab (3) · Methotrexate (3) · Rituximab (3) · siponimod (3) · sodium thiosulfate (3) · Abatacept (2) · Cyclophosphamide (2) · Etanercept (2) · Interleukin 1 Receptor Antagonist Protein (2) · KZR-616 (2) · Mycophenolic Acid (2) · Tacrolimus (2) · baricitinib (2) · belimumab (2) · tocilizumab (2)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (4) · Novartis Pharmaceuticals (4) · Karolinska Institutet (3) · Kezar Life Sciences, Inc. (2) · National Institute of Environmental Health Sciences (NIEHS) (2) · Paean Biotechnology Inc. (2) · Pfizer (2) · argenx (2) · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (1) · Alexion Pharmaceuticals, Inc. (1) · Alison Ehrlich (1) · Amgen (1) · Assistance Publique - Hôpitaux de Paris (1) · Boston Children's Hospital (1) · Cabaletta Bio (1)
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Adam I Schiffenbauer, M.D. (2) · Chester V. Oddis, MD (2) · Ingrid E Lundberg, MD, PhD (2) · Alison Ehrlich, MD (1) · Amit Bar-Or, MD, FRCP (1) · Andre Thevenon, Professor (1) · Andrea Morris, MD (1) · Andrew L Mammen, M.D. (1) · Ann M. Reed, MD (1) · Anthony Fernandez, MD (1) · Carole Bitar, MD (1) · Catherine Gordon, MD (1)
PMID 42542380, PMID 15942915, PMID 22227955, PMID 23124935, PMID 27789240, PMID 28619061, PMID 29174792, PMID 29237618, PMID 31539061, PMID 35490744, PMID 36197661, PMID 36375479, PMID 37326854, PMID 37941470, PMID 38172601, PMID 38805213, PMID 39245937, PMID 39403556, PMID 39798982, PMID 41289027, PMID 41501497, PMID 41874840, PMID 42177178, PMID 42273013
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