Welcome to the MIHRA CCS Listing!
This MIHRA CCS is meant to provide assistance to patients, their families and their clinicians and be an easy way to learn whether there might be an appropriate clinical study for them.
The MIHRA CCS also helps researchers understand the clinical trial landscape across the myositis diseases.
The goals are:
- to connect patients with hopeful research opportunities
- to accelerate research across the myositis diseases
- to provide an overview of current studies for investigators in order to encourage collaborations and avoid duplication of studies
Researchers: if you don’t find your studies listed contact us to submit your study for potential posting after MIHRA review.
Patients: unfortunately, we’re unable to accept queries about individual trial details but most entries have contact information for each trial’s study coordinator.
KINDLY NOTE:
At the bottom of the page will be s SOON be a 2nd listing of qualitative & patient report studies that are recruiting for patient participation. Qualitative and patient report studies require patient engagement to understand the experience of living with one or several myositis-related diseases. If you are a patient interested in learning about when studies become available, you are welcome to sign-up for the MIHRA Patient Contact Registry.
The category of myositis disease begins with a red header followed by the relevant trials
You may see the following abbreviations for different myositis-related diseases:
- aSyS = anti-Synthetase Syndrome,
- DM = Dermatomyositis,
- IBM= Inclusion Body Myositis,
- IIM= Idiopathic Inflammatory Myopathies (which is a term referring to all myositis-related diseases),
- ILD = Interstitial Lung Disease,
- IMNM = Immune-Mediated Necrotizing Myopathy,
- JM =Juvenile Myositis,
- non-IB IIMs = non-Inclusion Body Myositis,
- PM – Polymyositis, (patients, please note that PM as a diagnosis is under-reconsideration by the scientific community)
This Clinical Trials Listing is updated at least every 3 months by the MIHRA CCS Team: Drs. Myma Albayda, Pari Basharat, Karen Cheng & Jessica Day and in collaboration with our partner organization iMyoS.
| Study Number | Study Title | Study URL | Acronym | Study Status | Conditions | Sponsor | Age | Target Enrollment |
|---|---|---|---|---|---|---|---|---|
Multiple | Myositis | Diseases | ||||||
| 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 | non-IBM 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 | |
| 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 |
| 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 | |
| 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 | |||
Anti- | Synthetase | Syndrome | (aSyS) | |||||
| 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 |
| 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 | |
Dermato– | Myositis | |||||||
| 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 | (IBM) | |||||
| 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 | (IMNM) | ||||
| 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 |
If you are a patient interested in learning about when trials and other types of studies become available, you are welcome to sign-up for MIHRA’s Patient Contact Registry.