16 completed, 6 recruiting, 6 terminated, 1 active not recruiting. 31 Phase 3, 14 Phase 2.
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 |
|---|---|---|---|---|---|---|
| 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 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 |
| 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 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 |
| 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 |
| Add-on Intravenous Immunoglobulins in Early Myositis Immune Globulin Intravenous (Human), Placebo - Inflammatory Myopathy, Idiopathic, Dermatomyositis | Phase 2 / Phase 3 | Active not recruiting | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | 44 | 2021-09-13 | 2026-02-27 |
| A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) human immunoglobulin G, Placebo - Dermatomyositis | Phase 3 | Terminated | CSL Behring | 134 | 2019-10-21 | 2025-12-09 |
| A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments Ustekinumab 6 mg/kg, Ustekinumab 90 mg, Placebo IV - Polymyositis, Dermatomyositis | Phase 3 | Terminated | Janssen Pharmaceutical K.K. | 51 | 2019-07-26 | 2025-04-29 |
| Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis Lenabasum 20 mg, Lenabasum 5 mg, Placebo - Dermatomyositis | Phase 3 | Completed | Corbus Pharmaceuticals Inc. | 176 | 2018-12-17 | 2022-08-16 |
| Study Evaluating Efficacy and Safety of Octanorm in Patients With Dermatomyositis Octanorm, Placebo - Dermatomyositis | Phase 3 | Terminated | Octapharma | 1 | 2018-08-02 | 2021-04-23 |
| Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis Sodium Thiosulfate - Dermatomyositis, Idiopathic Inflammatory Myopathies | Phase 2 / Phase 3 | Completed | National Institute of Environmental Health Sciences (NIEHS) | 15 | 2017-10-05 | 2024-11-26 |
| Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy Abatacept subcutaneous, Placebo - Polymyositis, Dermatomyositis | Phase 3 | Completed | Bristol-Myers Squibb | 149 | 2017-05-04 | 2023-10-30 |
| Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy) Octagam 10%, Placebo - Dermatomyositis | Phase 3 | Completed | Octapharma | 95 | 2017-02-27 | 2021-12-23 |
| Belimumab in Idiopathic Inflammatory Myositis Belimumab, Placebo - Myositis | Phase 2 / Phase 3 | Completed | Northwell Health | 17 | 2015-01-01 | 2024-02-09 |
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Dermatomyositis (30) · Myositis (10) · Antisynthetase syndrome (3) · Lung Diseases, Interstitial (3) · Mixed Connective Tissue Disease (3) · Arthritis, Rheumatoid (2) · Connective Tissue Diseases (2) · Myositis, Inclusion Body (2) · Scleroderma, Diffuse (2) · Arthritis, Juvenile (1) · Autoimmune Diseases (1) · Calcinosis (1) · Crohn Disease (1) · Giant Cell Arteritis (1)
Muscular Diseases (31) · Musculoskeletal Diseases (31) · Nervous System Diseases (31) · Neuromuscular Diseases (31) · Skin Diseases (31) · Skin and Connective Tissue Diseases (31) · Connective Tissue Diseases (29) · Myositis (21) · Immune System Diseases (4) · Lung Diseases (4) · Respiratory Tract Diseases (4) · Arthritis (3) · Autoimmune Diseases (3) · Joint Diseases (3)
Cyclophosphamide (2) · Immunoglobulins, Intravenous (2) · Methotrexate (2) · Prednisone (2) · Acetylcysteine (1) · Alendronate (1) · Etanercept (1) · Hizentra (1) · Infliximab (1) · Interleukin 1 Receptor Antagonist Protein (1) · Interleukin-2 (1) · Prednisolone (1) · Rituximab (1) · Sodium Chloride (1) · Tacrolimus (1)
Karolinska Institutet (2) · Octapharma (2) · Pfizer (2) · argenx (2) · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (1) · Alexion Pharmaceuticals, Inc. (1) · Assistance Publique - Hôpitaux de Paris (1) · AstraZeneca (1) · Boston Children's Hospital (1) · Bristol-Myers Squibb (1) · CSL Behring (1) · Cabaletta Bio (1) · Children's Hospital Medical Center, Cincinnati (1) · Corbus Pharmaceuticals Inc. (1) · Institute of Rheumatology, Prague (1)
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Adam I Schiffenbauer, M.D. (1) · Alberto Martini, MD, Prof. (1) · Catherine Gordon, MD (1) · Chester V Oddis, MD (1) · Daniel J. Lovell, MD, MPH (1) · Galina Marder, MD (1) · Ingrid E Lundberg, MD, PhD (1) · Jiri Vencovsky, prof. MD. (1) · Michael Bubb, MD (1) · Nicolino Ruperto, MD, MPH (1)
PMID 16914703, PMID 17407214, PMID 17557758, PMID 26645190, PMID 27353816, PMID 27353819, PMID 28619061, PMID 31539061, PMID 33429735, PMID 36198179, PMID 36375479, PMID 37326854, PMID 37652554, PMID 37799613, PMID 38233885, PMID 39245937, PMID 39918968, PMID 40297385, PMID 40383862, PMID 40616720, PMID 41910335, PMID 42646746
2016 (1), 2018 (1), 2023 (1), P60AR047784 (1)