Welcome to the MIHRA CCS Listing!
This MIHRA CCS is meant to provide assistance patients, their families and their clinicians and an easy way to learn whether there might be a clinical study for them.
The MIHRA CCS also helps researchers easily get a snapshot of the study landscape across the myositis diseases. The goal is to create an impetus for build strong collaborations, and accelerate research across the myositis diseases.
Researchers: if you don’t find your studies listed contact usto submit your study for review.
Patients: unfortunately, we do not accept queries about the studies but most entries have contact information for the study coordinator.
The page is divided into to two main areas:
Below one can find studies organized according to:
- Which myositis diseases for clinical trials
- At the bottom of the page are a list of qualitative studies which require patient engagement to understand the experience of living with one or several myositis-related diseases
- Category of myositis disease
| Study Number | Study Title | Study URL | Acronym | Study Status | Conditions | Sponsor | Age | Target Enrollment | |
|---|---|---|---|---|---|---|---|---|---|
| All IIM | |||||||||
| NCT05669014 | 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) | https://clinicaltrials.gov/study/NCT05669014 | RECRUITING | Idiopathic Inflammatory Myositis | Horizon Therapeutics Ireland DAC | ADULT, OLDER_ADULT | 96 | ||
| NCT05379634 | A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies | https://clinicaltrials.gov/study/NCT05379634 | SPIREA | RECRUITING | Myositis | Janssen Research & Development, LLC | ADULT, OLDER_ADULT | 200 | |
| NCT05979441 | A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy | https://clinicaltrials.gov/study/NCT05979441 | ALKIVIA+ | RECRUITING | Myositis | argenx | ADULT, OLDER_ADULT | 240 | |
| NCT05523167 | A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy. | https://clinicaltrials.gov/study/NCT05523167 | RECRUITING | Active Idiopathic Inflammatory Myopathy|Myositis|Dermatomyositis|Polymyositis|Immune-Mediated Necrotizing Myopathy|Antisynthetase Syndrome | argenx | ADULT, OLDER_ADULT | 240 | ||
| NCT05895786 | A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)] | https://clinicaltrials.gov/study/NCT05895786 | RECRUITING | Myositis | Pfizer | ADULT, OLDER_ADULT | 270 | ||
| NCT05832034 | Add-on Intravenous Immunoglobulins in Early Myositis | https://clinicaltrials.gov/study/NCT05832034 | RECRUITING | Inflammatory Myopathy, Idiopathic|Dermatomyositis|Antisynthetase Syndrome|Immune-Mediated Necrotizing Myopathy|Polymyositis|Myositis | Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA) | ADULT, OLDER_ADULT | 48 | ||
| NCT05400889 | Clinical Characteristics and Mechanism Research of Inhibitors of Janus Kinase in the Idiopathic Inflammatory Myopathies | https://clinicaltrials.gov/study/NCT05400889 | RECRUITING | Idiopathic Inflammatory Myopathies | Peking University People’s Hospital | ADULT, OLDER_ADULT | 10 | ||
| NCT06154252 | RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy | https://clinicaltrials.gov/study/NCT06154252 | RECRUITING | Idiopathic Inflammatory Myopathy|Dermatomyositis|Anti-Synthetase Syndrome|Immune-Mediated Necrotizing Myopathy | Cabaletta Bio | ADULT, OLDER_ADULT | 18 | ||
| NCT05833711 | Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy | https://clinicaltrials.gov/study/NCT05833711 | RECRUITING | Dermatomyositis|Polymyositis|Idiopathic Inflammatory Myopathies | Immunoforge Co. Ltd. | ADULT, OLDER_ADULT | 39 | ||
| NCT06152172 | CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 | https://clinicaltrials.gov/study/NCT06152172 | CARTIMMUNE | NOT_YET_RECRUITING | Idiopathic Inflammatory Myopathies|Diffuse Cutaneous Systemic Sclerosis|SLE Nephritis|ANCA Associated Vasculitis | David Porter | ADULT, OLDER_ADULT | 24 | |
| NCT06154252 | Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy | https://clinicaltrials.gov/study/NCT06154252 | RECRUITING | Idiopathic Inflammatory Myopathy|Dermatomyositis|Anti-Synthetase Syndrome|Immune-Mediated Necrotizing Myopathy | Cabaletta Bio | ADULT, OLDER_ADULT | 18 | ||
| NCT05879419 | Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases | https://clinicaltrials.gov/study/NCT05879419 | RZVRheum | RECRUITING | Rheumatoid Arthritis|Spondylitis, Ankylosing|Spondyloarthritis|Systemic Lupus Erythematosus|Sjogren’s Syndrome|Systemic Sclerosis|Idiopathic Inflammatory Myopathies|Vasculitis, Systemic|Juvenile Idiopathic Arthritis|Dermatomyositis, Juvenile|Beh√ßet Disease | University of Sao Paulo General Hospital | ADULT, OLDER_ADULT | 2005 | |
| NCT05859997 | Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases | https://clinicaltrials.gov/study/NCT05859997 | RECRUITING | Systemic Lupus Erythematosus (SLE)|Sjogren’s Syndrome|Systemic Sclerosis|Inflammatory Myopathy|ANCA Associated Systemic Vasculitis|Antiphospholipid Syndrome | Bioray Laboratories | ADULT, OLDER_ADULT | 15 | ||
| NCT05200702 | Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disorders | https://clinicaltrials.gov/study/NCT05200702 | Exo-NMD1 | RECRUITING | Muscular Dystrophies|Congenital Myopathy|Idiopathic Inflammatory Myopathies|Mitochondrial Myopathies|Glycogen Storage Disease | Institut de Myologie, France | ADULT, OLDER_ADULT | 52 | |
| NCT05199246 | Assessment of Safety and Acute Effects of a Lower-limb Powered Dermoskeleton in Patients With Neuromuscular Disorders | https://clinicaltrials.gov/study/NCT05199246 | Exo-KGO1 | RECRUITING | Muscular Dystrophies|Congenital Myopathy|Idiopathic Inflammatory Myopathies|Mitochondrial Myopathies|Glycogen Storage Disease | Institut de Myologie, France | ADULT, OLDER_ADULT | 52 | |
| NCT03912428 | Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis | https://clinicaltrials.gov/study/NCT03912428 | RECRUITING | Myositis|Inflammatory|Rheumatoid Arthritis|Healthy Volunteers | National Institute of Mental Health (NIMH) | ADULT, OLDER_ADULT | 111 | ||
| NCT05505409 | Efficacy and Safety of Pirfenidone in CTD-ILD | https://clinicaltrials.gov/study/NCT05505409 | RECRUITING | Pirfenidone|Connective Tissue Diseases|Interstitial Lung Disease | Qilu Hospital of Shandong University | ADULT, OLDER_ADULT | 120 | LUNG | |
| NCT05799755 | Myositis Interstitial Lung Disease Nintedanib Trial | https://clinicaltrials.gov/study/NCT05799755 | MINT | RECRUITING | Myositis Associated Interstitial Lund Disease (MA-ILD) | Rohit Aggarwal, MD | ADULT, OLDER_ADULT | 134 | LUNG |
| NCT05335278 | Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease: a Pilot Study | https://clinicaltrials.gov/study/NCT05335278 | RECRUITING | Interstitial Lung Disease|Myopathy, Inflammatory | McGill University Health Centre/Research Institute of the McGill University Health Centre | ADULT, OLDER_ADULT | 25 | LUNG | |
| EUCTR2020-001710-37-NL | Intravenous immunoglobulin and prednisone vs. prednisone in newly diagnosed myositis: a double blind randomized clinical trial. | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001710-37 | Authorised | idiopathic inflammatory myopathies;Therapeutic area: Diseases [C] – Immune System Diseases [C20] | Academisch Medisch Centrum | 48 | |||
| EUCTR2016-004766-26-NL | Early treatment with intravenous immunoglobulins for newly diagnosed myositis patients | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004766-26 | Authorised | idiopathic inflammatory myopathies;Therapeutic area: Diseases [C] – Immune System Diseases [C20] | Academic Medical Center | 20 | |||
| NL9722 | IVIG in myositis: TIME IS MUSCLE (TIM) | https://www.onderzoekmetmensen.nl/en/trial/26160 | Recruiting | Idiopathic inflammatory myopathy, with the exception of inclusion body myositis. | Prinses Beatrix spierfonds, Sanquin Plasma Products | 48 | |||
| NCT03324152 | Effects of High-intensity Interval Training (HIIT) in Recent Onset Polymyositis and Dermatomyositis | https://clinicaltrials.gov/show/NCT03324152 | HIITmyositis | Recruiting | Polymyositis;Dermatomyositis | Karolinska University Hospital | 18-70 | 30 | |
| NCT01501019 | Exercise in Sjogren, Myositis and Takayasu’s Arteritis | https://clinicaltrials.gov/show/NCT01501019 | Recruiting | Primary Sjogren¬¥s Syndrome;Myositis | University of Sao Paulo | 18-80 | 60 | ||
| NCT01184625 | Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation | http://clinicaltrials.gov/show/NCT01184625 | Recruiting | Myositis | Karolinska Institutet | 18-80 | 30 | ||
| NTR169 | Dexa-Myositis Trial. | https://www.onderzoekmetmensen.nl/en/trial/25817 | Recruiting | polymyositis, dermatomyositis, myositis with rheumatological disorders, myositis with cancer, unspecified myositis | 80 | ||||
| Antisynthetase syndrome | |||||||||
| NCT03770663 | Cyclophosphamide and Azathioprine vs Tacrolimus in Antisynthetase Syndrome-related Interstitial Lung Disease | https://clinicaltrials.gov/study/NCT03770663 | CATR-PAT | RECRUITING | Antisynthetase Syndrome (ASS)|Interstitial Lung Disease | Assistance Publique РHôpitaux de Paris | ADULT, OLDER_ADULT | 76 | LUNG |
| NCT05669014 | 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) | https://clinicaltrials.gov/ct2/show/NCT05669014 | Recruiting | Idiopathic Inflammatory Myositis | Horizon Therapeutics Ireland DAC | 18-75 | 96 | ||
| Dermatomyositis | |||||||||
| NCT05695950 | A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis | https://clinicaltrials.gov/study/NCT05695950 | RECRUITING | Dermatomyositis | Galapagos NV | ADULT, OLDER_ADULT | 62 | ||
| NCT04044690 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) | https://clinicaltrials.gov/study/NCT04044690 | RECLAIIM | RECRUITING | Dermatomyositis | CSL Behring | ADULT, OLDER_ADULT | 126 | |
| NCT05437263 | A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis | https://clinicaltrials.gov/study/NCT05437263 | RECRUITING | Dermatomyositis | Priovant Therapeutics, Inc. | ADULT, OLDER_ADULT | 225 | ||
| NCT04972760 | Baricitinib in Patients With Relapsing or naive Dermatomyositis | https://clinicaltrials.gov/study/NCT04972760 | RECRUITING | Dermatomyositis | Assistance Publique РHôpitaux de Paris | ADULT, OLDER_ADULT | 62 | ||
| NCT03293615 | Exercise Capacity of Patients With Dermatomyosis | https://clinicaltrials.gov/study/NCT03293615 | MIDE | RECRUITING | Dermatomyositis | University Hospital, Strasbourg, France | ADULT, OLDER_ADULT | 45 | |
| NCT05488327 | Lenalidomide in the Treatment of Refractory Cutaneous Dermatomyositis | https://clinicaltrials.gov/study/NCT05488327 | NOT_YET_RECRUITING | Dermatomyositis | Jiangxi Provincial People’s Hopital | ADULT, OLDER_ADULT | 10 | ||
| NCT05986162 | Safety and Preliminary Clinical Activity of Itolizumab in Dermatomyositis | https://clinicaltrials.gov/study/NCT05986162 | NOT_YET_RECRUITING | Dermatomyositis, Adult Type | Biotech Pharmaceutical Co., Ltd. | ADULT, OLDER_ADULT | 44 | ||
| NCT05239702 | Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune Diseases | https://clinicaltrials.gov/study/NCT05239702 | RECRUITING | Crohn Disease|Ulcerative Colitis|Dermatomyositis|Still Disease|Autoimmune Diseases | Zhejiang University | CHILD, ADULT, OLDER_ADULT | 75 | ||
| NCT03816345 | Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer | https://clinicaltrials.gov/study/NCT03816345 | RECRUITING | Autoimmune Disease|Crohn Disease|Dermatomyositis|Hematopoietic and Lymphoid Cell Neoplasm|Inflammatory Bowel Disease|Malignant Solid Neoplasm|Multiple Sclerosis|Psoriasis|Psoriatic Arthritis|Rheumatoid Arthritis|Sjogren Syndrome|Systemic Lupus Erythematosus|Systemic Scleroderma|Ulcerative Colitis | National Cancer Institute (NCI) | ADULT, OLDER_ADULT | 300 | ||
| NCT06056921 | Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease | https://clinicaltrials.gov/study/NCT06056921 | RECRUITING | SLE (Systemic Lupus)|Sjogren’s Syndrome|Systemic Scleroderma|Dermatomyositis|Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis | Chongqing Precision Biotech Co., Ltd | ADULT, OLDER_ADULT | 24 | ||
| NCT03582800 | Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study | https://clinicaltrials.gov/study/NCT03582800 | RECRUITING | Systemic Sclerosis|Dermatomyositis|iPPSD2 | University Hospital, Limoges | CHILD, ADULT, OLDER_ADULT | 40 | ||
| NCT05375435 | Efficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositis | https://clinicaltrials.gov/study/NCT05375435 | RECRUITING | Dermatomyositis, Adult Type|Interstitial Lung Disease | The First Affiliated Hospital with Nanjing Medical University | ADULT, OLDER_ADULT | 120 | ||
| NCT05650567 | Study of M5049 in DM and PM Participants (NEPTUNIA) | https://clinicaltrials.gov/study/NCT05650567 | NEPTUNIA | RECRUITING | Dermatomyositis|Polymyositis | EMD Serono Research & Development Institute, Inc. | ADULT, OLDER_ADULT | 40 | |
| NCT05669014 | 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) | https://clinicaltrials.gov/ct2/show/NCT05669014 | Recruiting | Idiopathic Inflammatory Myositis | Horizon Therapeutics Ireland DAC | 18-75 | 96 | ||
| Inclusion Body Myositis | |||||||||
| NCT05721573 | A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis | https://clinicaltrials.gov/study/NCT05721573 | Active, not recruiting | Inclusion Body Myositis | Abcuro, Inc. | ADULT, OLDER_ADULT | 231 | ||
| NCT05032131 | Cell Therapy for IBM by Muscle Injection of ADSVF | https://clinicaltrials.gov/study/NCT05032131 | ADSVF-in-IBM | RECRUITING | Inclusion Body Myositis | Assistance Publique РHôpitaux de Paris | ADULT, OLDER_ADULT | 32 | |
| NCT04789070 | Phase III Trial of Sirolimus in IBM | https://clinicaltrials.gov/study/NCT04789070 | RECRUITING | Inclusion Body Myositis | University of Kansas Medical Center | ADULT, OLDER_ADULT | 140 | ||
| EUCTR2019-000749-11-GB | An open-label, non-randomized trial to investigate the efficacy and safety of early versus delayed start of arimoclomol in patients with sporadic inclusion body myositis who have completed the IBM4809 trial | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-000749-11 | Authorised | Sporadic Inclusion Body Myositis (sIBM) <br>MedDRA version: 21.1 Level: LLT Classification code 10075052 Term: Sporadic inclusion body myositis System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] – Metabolic Phenomena [G03] | Orphazyme A/S | 130 | |||
| EUCTR2017-004903-33-GB | Study of Arimoclomol in patients with Inclusion Body Myositis (IBM) | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004903-33 | Authorised | Sporadic Inclusion Body Myositis (sIBM) <br>MedDRA version: 21.1 Level: LLT Classification code 10075052 Term: Sporadic inclusion body myositis System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] – Metabolic Phenomena [G03] | Orphazyme A/S | 150 | |||
| ACTRN12620001226998 | Sirolimus in Inclusion Body Myositis (IBM) | https://anzctr.org.au/ACTRN12620001226998.aspx | Recruiting | Inclusion Body Myositis; <br>Inclusion Body Myositis;Neurological – Other neurological disorders;Inflammatory and Immune System – Other inflammatory or immune system disorders | The Perron Institute for Neurological and Translational Science | >=45 | 140 | ||
| ACTRN12614000086662 | Resistance training with Partial Vascular Occlusion (VOT) in Inclusion Body Myositis (IBM). A single group interventional study: a pilot study to corroborate prior findings of VOT in the IBM population | https://anzctr.org.au/ACTRN12614000086662.aspx | Recruiting | Inclusion Body Myositis; <br>Inclusion Body Myositis;Physical Medicine / Rehabilitation – Physiotherapy;Inflammatory and Immune System – Other inflammatory or immune system disorders;Musculoskeletal – Other muscular and skeletal disorders | Sir Charles Gairdner Hospital Physiotherapy Department | 6 | |||
| Immune-mediated necrotizing myopathy | |||||||||
| NCT04561557 | Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous System | https://clinicaltrials.gov/study/NCT04561557 | CARTinNS | RECRUITING | Autoimmune Diseases|Autoimmune Diseases of the Nervous System|Neuromyelitis Optica Spectrum Disorder|Myasthenia Gravis|Chronic Inflammatory Demyelinating Polyradiculoneuropathy|Immune-Mediated Necrotizing Myopathy | Tongji Hospital | ADULT, OLDER_ADULT | 18 | |
| Juvenile myositis | |||||||||
| NCT05524311 | Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT) | https://clinicaltrials.gov/study/NCT05524311 | MYOCIT | RECRUITING | Juvenile Dermatomyositis | Assistance Publique РHôpitaux de Paris | CHILD, ADULT | 16 | |
| NCT05545839 | Transition to Adulthood Through Coaching and Empowerment in Rheumatology | https://clinicaltrials.gov/study/NCT05545839 | RECRUITING | Juvenile Idiopathic Arthritis|Juvenile Rheumatoid Arthritis|Juvenile Dermatomyositis|Juvenile Psoriatic Arthritis|Autoinflammatory Disease|Autoimmune Diseases|Lupus Erythematosus | McMaster University | CHILD, ADULT | 133 | ||
| NCT04286178 | Exercise, Creatine and Coenzyme Q10 for Childhood Myositis | https://clinicaltrials.gov/study/NCT04286178 | RECRUITING | Myositis, Juvenile | The Hospital for Sick Children | CHILD, ADULT | 15 |