26 completed, 7 terminated, 6 recruiting, 5 active not recruiting. 50 Phase 3, 23 Phase 2.
Follow Myositis: new trials by email Literature Review of Myositis trials Research Report on Myositis
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 |
|---|---|---|---|---|---|---|
| A Study to Investigate the Safety, Pharmacokinetics (PK), and Efficacy of Garetosmab in Children and Adolescents With Fibrodysplasia Ossificans Progressiva (FOP) garetosmab - Fibrodysplasia Ossificans Progressiva, FOP | Phase 3 | Not yet recruiting | Regeneron Pharmaceuticals | 18 | 2027-02-02 | 2026-10-20 |
| A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies Placebo, Nerandomilast - Idiopathic Inflammatory Myopathies | Phase 3 | Not yet recruiting | Boehringer Ingelheim | 270 | 2026-12-14 | 2026-10-29 |
| TELITACICEPT IN INFLAMMATORY MYOPATHIES(TELITACICEPT-IM) Telitacicept 240mg - Inflammatory Myopathy | Phase 2 / Phase 3 | Not yet recruiting | Zhongming Qiu | 30 | 2026-02-02 | 2026-01-21 |
| 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 |
| A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies Dazukibart - Dermatomyositis, Polymyositis | Phase 3 | Recruiting | Pfizer | 211 | 2025-01-22 | 2026-08-25 |
| A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP) Andecaliximab, Placebo - Fibrodysplasia Ossificans Progressiva | Phase 2 / Phase 3 | Active not recruiting | Ashibio Inc | 92 | 2024-10-25 | 2026-11-05 |
| Long-term Extension Study of Ulviprubart (ABC008) in Subjects With Inclusion Body Myositis Ulviprubart (ABC008) - Inclusion Body Myositis (IBM) | Phase 2 / Phase 3 | Active not recruiting | Abcuro, Inc. | 270 | 2024-10-21 | 2025-07-28 |
| 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) Anifrolumab (blinded), Placebo, Anifrolumab (unblinded, open label) - Polymyositis, Dermatomyositis | Phase 3 | Recruiting | AstraZeneca | 240 | 2024-06-20 | 2026-09-24 |
| 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 Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy Efgartigimod PH20 SC - Myositis, Active Idiopathic Inflammatory Myopathy | Phase 3 | Enrolling by invitation | argenx | 240 | 2023-09-12 | 2026-10-16 |
| A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)] PF-06823859, Placebo - Myositis | Phase 3 | Recruiting | Pfizer | 318 | 2023-05-20 | 2026-09-15 |
| A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis ABC008 - Inclusion Body Myositis | Phase 2 / Phase 3 | Completed | Abcuro, Inc. | 272 | 2023-02-28 | 2026-10-01 |
| Interleukin-2 on Active Dermatomyositis Interleukin-2 - Dermatomyositis | Phase 3 | Unknown | Peking University People's Hospital | 240 | 2022-12-01 | 2022-12-05 |
| A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP) Garetosmab, Placebo - Fibrodysplasia Ossificans Progressiva | Phase 3 | Active not recruiting | Regeneron Pharmaceuticals | 63 | 2022-11-21 | 2026-07-17 |
| A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis Brepocitinib, Placebo - Dermatomyositis | Phase 3 | Completed | Priovant Therapeutics, Inc. | 241 | 2022-10-31 | 2026-09-15 |
| A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy. EFG PH20 SC, PBO - Active Idiopathic Inflammatory Myopathy, Myositis | Phase 2 / Phase 3 | Completed | argenx | 265 | 2022-10-12 | 2026-09-21 |
| Baricitinib in Patients With Relapsing or naïve Dermatomyositis Baricitinib, Placebo - Dermatomyositis | Phase 3 | Recruiting | Assistance Publique - Hôpitaux de Paris | 62 | 2022-08-31 | 2026-06-02 |
| Phase III Trial of Sirolimus in IBM Sirolimus, Placebo - Inclusion Body Myositis | Phase 3 | Active not recruiting | University of Kansas Medical Center | 140 | 2022-07-01 | 2026-01-14 |
| A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies. Palovarotene - Fibrodysplasia Ossificans Progressiva (FOP) | Phase 3 | Completed | Ipsen | 61 | 2022-03-14 | 2025-06-22 |
| Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis Ravulizumab, Placebo - Dermatomyositis | Phase 2 / Phase 3 | Terminated | Alexion Pharmaceuticals, Inc. | 38 | 2021-11-19 | 2025-07-09 |
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Dermatomyositis (30) · Polymyositis (17) · Myositis, Inclusion Body (12) · Myositis Ossificans (5) · Ossification, Heterotopic (4) · Antisynthetase syndrome (3) · Arthritis, Rheumatoid (3) · Lung Diseases, Interstitial (3) · Mixed Connective Tissue Disease (3) · Scleroderma, Diffuse (3) · Autoimmune Diseases (2) · Connective Tissue Diseases (2) · Lupus Erythematosus, Systemic (2) · Muscular Atrophy (2)
Musculoskeletal Diseases (49) · Muscular Diseases (48) · Nervous System Diseases (45) · Neuromuscular Diseases (45) · Skin and Connective Tissue Diseases (33) · Skin Diseases (32) · Connective Tissue Diseases (31) · Polymyositis (14) · Pathological Conditions, Signs and Symptoms (9) · Pathologic Processes (6) · Immune System Diseases (5) · Arthritis (4) · Joint Diseases (4) · Lung Diseases (4)
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