MIHRA Current Clinical Studies Listings

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 NumberStudy TitleStudy URLAcronymStudy StatusConditionsSponsorAgeTarget Enrollment
All IIM
NCT05669014A 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/NCT05669014RECRUITINGIdiopathic Inflammatory MyositisHorizon Therapeutics Ireland DACADULT, OLDER_ADULT96
NCT05379634A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathieshttps://clinicaltrials.gov/study/NCT05379634SPIREARECRUITINGMyositisJanssen Research & Development, LLCADULT, OLDER_ADULT200
NCT05979441A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathyhttps://clinicaltrials.gov/study/NCT05979441ALKIVIA+RECRUITINGMyositisargenxADULT, OLDER_ADULT240
NCT05523167A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.https://clinicaltrials.gov/study/NCT05523167RECRUITINGActive Idiopathic Inflammatory Myopathy|Myositis|Dermatomyositis|Polymyositis|Immune-Mediated Necrotizing Myopathy|Antisynthetase SyndromeargenxADULT, OLDER_ADULT240
NCT05895786A 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/NCT05895786RECRUITINGMyositisPfizerADULT, OLDER_ADULT270
NCT05832034Add-on Intravenous Immunoglobulins in Early Myositishttps://clinicaltrials.gov/study/NCT05832034RECRUITINGInflammatory Myopathy, Idiopathic|Dermatomyositis|Antisynthetase Syndrome|Immune-Mediated Necrotizing Myopathy|Polymyositis|MyositisAcademisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)ADULT, OLDER_ADULT48
NCT05400889Clinical Characteristics and Mechanism Research of Inhibitors of Janus Kinase in the Idiopathic Inflammatory Myopathieshttps://clinicaltrials.gov/study/NCT05400889RECRUITINGIdiopathic Inflammatory MyopathiesPeking University People’s HospitalADULT, OLDER_ADULT10
NCT06154252RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathyhttps://clinicaltrials.gov/study/NCT06154252RECRUITINGIdiopathic Inflammatory Myopathy|Dermatomyositis|Anti-Synthetase Syndrome|Immune-Mediated Necrotizing MyopathyCabaletta BioADULT, OLDER_ADULT18
NCT05833711Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathyhttps://clinicaltrials.gov/study/NCT05833711RECRUITINGDermatomyositis|Polymyositis|Idiopathic Inflammatory MyopathiesImmunoforge Co. Ltd.ADULT, OLDER_ADULT39
NCT06152172CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101https://clinicaltrials.gov/study/NCT06152172CARTIMMUNENOT_YET_RECRUITINGIdiopathic Inflammatory Myopathies|Diffuse Cutaneous Systemic Sclerosis|SLE Nephritis|ANCA Associated VasculitisDavid PorterADULT, OLDER_ADULT24
NCT06154252Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathyhttps://clinicaltrials.gov/study/NCT06154252RECRUITINGIdiopathic Inflammatory Myopathy|Dermatomyositis|Anti-Synthetase Syndrome|Immune-Mediated Necrotizing MyopathyCabaletta BioADULT, OLDER_ADULT18
NCT05879419Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseaseshttps://clinicaltrials.gov/study/NCT05879419RZVRheumRECRUITINGRheumatoid Arthritis|Spondylitis, Ankylosing|Spondyloarthritis|Systemic Lupus Erythematosus|Sjogren’s Syndrome|Systemic Sclerosis|Idiopathic Inflammatory Myopathies|Vasculitis, Systemic|Juvenile Idiopathic Arthritis|Dermatomyositis, Juvenile|Beh√ßet DiseaseUniversity of Sao Paulo General HospitalADULT, OLDER_ADULT2005
NCT05859997Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseaseshttps://clinicaltrials.gov/study/NCT05859997RECRUITINGSystemic Lupus Erythematosus (SLE)|Sjogren’s Syndrome|Systemic Sclerosis|Inflammatory Myopathy|ANCA Associated Systemic Vasculitis|Antiphospholipid SyndromeBioray LaboratoriesADULT, OLDER_ADULT15
NCT05200702Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disordershttps://clinicaltrials.gov/study/NCT05200702Exo-NMD1RECRUITINGMuscular Dystrophies|Congenital Myopathy|Idiopathic Inflammatory Myopathies|Mitochondrial Myopathies|Glycogen Storage DiseaseInstitut de Myologie, FranceADULT, OLDER_ADULT52
NCT05199246Assessment of Safety and Acute Effects of a Lower-limb Powered Dermoskeleton in Patients With Neuromuscular Disordershttps://clinicaltrials.gov/study/NCT05199246Exo-KGO1RECRUITINGMuscular Dystrophies|Congenital Myopathy|Idiopathic Inflammatory Myopathies|Mitochondrial Myopathies|Glycogen Storage DiseaseInstitut de Myologie, FranceADULT, OLDER_ADULT52
NCT03912428Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositishttps://clinicaltrials.gov/study/NCT03912428RECRUITINGMyositis|Inflammatory|Rheumatoid Arthritis|Healthy VolunteersNational Institute of Mental Health (NIMH)ADULT, OLDER_ADULT111
NCT05505409Efficacy and Safety of Pirfenidone in CTD-ILDhttps://clinicaltrials.gov/study/NCT05505409RECRUITINGPirfenidone|Connective Tissue Diseases|Interstitial Lung DiseaseQilu Hospital of Shandong UniversityADULT, OLDER_ADULT120LUNG
NCT05799755Myositis Interstitial Lung Disease Nintedanib Trialhttps://clinicaltrials.gov/study/NCT05799755MINTRECRUITINGMyositis Associated Interstitial Lund Disease (MA-ILD)Rohit Aggarwal, MDADULT, OLDER_ADULT134LUNG
NCT05335278Tolerability and Safety of Nintedanib in Myositis Associated Interstitial Lung Disease: a Pilot Studyhttps://clinicaltrials.gov/study/NCT05335278RECRUITINGInterstitial Lung Disease|Myopathy, InflammatoryMcGill University Health Centre/Research Institute of the McGill University Health CentreADULT, OLDER_ADULT25LUNG
EUCTR2020-001710-37-NLIntravenous 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:2020-001710-37Authorisedidiopathic inflammatory myopathies;Therapeutic area: Diseases [C] – Immune System Diseases [C20]Academisch Medisch Centrum48
EUCTR2016-004766-26-NLEarly treatment with intravenous immunoglobulins for newly diagnosed myositis patientshttps://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004766-26Authorisedidiopathic inflammatory myopathies;Therapeutic area: Diseases [C] – Immune System Diseases [C20]Academic Medical Center20
NL9722IVIG in myositis: TIME IS MUSCLE (TIM)https://www.onderzoekmetmensen.nl/en/trial/26160RecruitingIdiopathic inflammatory myopathy, with the exception of inclusion body myositis.Prinses Beatrix spierfonds, Sanquin Plasma Products48
NCT03324152Effects of High-intensity Interval Training (HIIT) in Recent Onset Polymyositis and Dermatomyositishttps://clinicaltrials.gov/show/NCT03324152HIITmyositisRecruitingPolymyositis;DermatomyositisKarolinska University Hospital18-7030
NCT01501019Exercise in Sjogren, Myositis and Takayasu’s Arteritishttps://clinicaltrials.gov/show/NCT01501019RecruitingPrimary Sjogren¬¥s Syndrome;MyositisUniversity of Sao Paulo18-8060
NCT01184625Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammationhttp://clinicaltrials.gov/show/NCT01184625RecruitingMyositisKarolinska Institutet18-8030
NTR169Dexa-Myositis Trial.https://www.onderzoekmetmensen.nl/en/trial/25817Recruitingpolymyositis, dermatomyositis, myositis with rheumatological disorders, myositis with cancer, unspecified myositis80
Antisynthetase syndrome
NCT03770663Cyclophosphamide and Azathioprine vs Tacrolimus in Antisynthetase Syndrome-related Interstitial Lung Diseasehttps://clinicaltrials.gov/study/NCT03770663CATR-PATRECRUITINGAntisynthetase Syndrome (ASS)|Interstitial Lung DiseaseAssistance Publique РHôpitaux de ParisADULT, OLDER_ADULT76LUNG
NCT05669014A 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/NCT05669014RecruitingIdiopathic Inflammatory MyositisHorizon Therapeutics Ireland DAC18-7596
Dermatomyositis
NCT05695950A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositishttps://clinicaltrials.gov/study/NCT05695950RECRUITINGDermatomyositisGalapagos NVADULT, OLDER_ADULT62
NCT04044690A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)https://clinicaltrials.gov/study/NCT04044690RECLAIIMRECRUITINGDermatomyositisCSL BehringADULT, OLDER_ADULT126
NCT05437263A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositishttps://clinicaltrials.gov/study/NCT05437263RECRUITINGDermatomyositisPriovant Therapeutics, Inc.ADULT, OLDER_ADULT225
NCT04972760Baricitinib in Patients With Relapsing or naive Dermatomyositishttps://clinicaltrials.gov/study/NCT04972760RECRUITINGDermatomyositisAssistance Publique РHôpitaux de ParisADULT, OLDER_ADULT62
NCT03293615Exercise Capacity of Patients With Dermatomyosishttps://clinicaltrials.gov/study/NCT03293615MIDERECRUITINGDermatomyositisUniversity Hospital, Strasbourg, FranceADULT, OLDER_ADULT45
NCT05488327Lenalidomide in the Treatment of Refractory Cutaneous Dermatomyositishttps://clinicaltrials.gov/study/NCT05488327NOT_YET_RECRUITINGDermatomyositisJiangxi Provincial People’s HopitalADULT, OLDER_ADULT10
NCT05986162Safety and Preliminary Clinical Activity of Itolizumab in Dermatomyositishttps://clinicaltrials.gov/study/NCT05986162NOT_YET_RECRUITINGDermatomyositis, Adult TypeBiotech Pharmaceutical Co., Ltd.ADULT, OLDER_ADULT44
NCT05239702Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune Diseaseshttps://clinicaltrials.gov/study/NCT05239702RECRUITINGCrohn Disease|Ulcerative Colitis|Dermatomyositis|Still Disease|Autoimmune DiseasesZhejiang UniversityCHILD, ADULT, OLDER_ADULT75
NCT03816345Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancerhttps://clinicaltrials.gov/study/NCT03816345RECRUITINGAutoimmune 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 ColitisNational Cancer Institute (NCI)ADULT, OLDER_ADULT300
NCT06056921Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Diseasehttps://clinicaltrials.gov/study/NCT06056921RECRUITINGSLE (Systemic Lupus)|Sjogren’s Syndrome|Systemic Scleroderma|Dermatomyositis|Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisChongqing Precision Biotech Co., LtdADULT, OLDER_ADULT24
NCT03582800Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Studyhttps://clinicaltrials.gov/study/NCT03582800RECRUITINGSystemic Sclerosis|Dermatomyositis|iPPSD2University Hospital, LimogesCHILD, ADULT, OLDER_ADULT40
NCT05375435Efficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositishttps://clinicaltrials.gov/study/NCT05375435RECRUITINGDermatomyositis, Adult Type|Interstitial Lung DiseaseThe First Affiliated Hospital with Nanjing Medical UniversityADULT, OLDER_ADULT120
NCT05650567Study of M5049 in DM and PM Participants (NEPTUNIA)https://clinicaltrials.gov/study/NCT05650567NEPTUNIARECRUITINGDermatomyositis|PolymyositisEMD Serono Research & Development Institute, Inc.ADULT, OLDER_ADULT40
NCT05669014A 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/NCT05669014RecruitingIdiopathic Inflammatory MyositisHorizon Therapeutics Ireland DAC18-7596
Inclusion Body Myositis
NCT05721573A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositishttps://clinicaltrials.gov/study/NCT05721573Active, not recruitingInclusion Body MyositisAbcuro, Inc.ADULT, OLDER_ADULT231
NCT05032131Cell Therapy for IBM by Muscle Injection of ADSVFhttps://clinicaltrials.gov/study/NCT05032131ADSVF-in-IBMRECRUITINGInclusion Body MyositisAssistance Publique РHôpitaux de ParisADULT, OLDER_ADULT32
NCT04789070Phase III Trial of Sirolimus in IBMhttps://clinicaltrials.gov/study/NCT04789070RECRUITINGInclusion Body MyositisUniversity of Kansas Medical CenterADULT, OLDER_ADULT140
EUCTR2019-000749-11-GBAn 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 trialhttps://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-000749-11AuthorisedSporadic 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/S130
EUCTR2017-004903-33-GBStudy of Arimoclomol in patients with Inclusion Body Myositis (IBM)https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004903-33AuthorisedSporadic 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/S150
ACTRN12620001226998Sirolimus in Inclusion Body Myositis (IBM)https://anzctr.org.au/ACTRN12620001226998.aspxRecruitingInclusion Body Myositis; <br>Inclusion Body Myositis;Neurological – Other neurological disorders;Inflammatory and Immune System – Other inflammatory or immune system disordersThe Perron Institute for Neurological and Translational Science>=45140
ACTRN12614000086662Resistance 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 populationhttps://anzctr.org.au/ACTRN12614000086662.aspxRecruitingInclusion 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 disordersSir Charles Gairdner Hospital Physiotherapy Department6
Immune-mediated necrotizing myopathy
NCT04561557Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous Systemhttps://clinicaltrials.gov/study/NCT04561557CARTinNSRECRUITINGAutoimmune Diseases|Autoimmune Diseases of the Nervous System|Neuromyelitis Optica Spectrum Disorder|Myasthenia Gravis|Chronic Inflammatory Demyelinating Polyradiculoneuropathy|Immune-Mediated Necrotizing MyopathyTongji HospitalADULT, OLDER_ADULT18
Juvenile myositis
NCT05524311Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)https://clinicaltrials.gov/study/NCT05524311MYOCITRECRUITINGJuvenile DermatomyositisAssistance Publique РHôpitaux de ParisCHILD, ADULT16
NCT05545839Transition to Adulthood Through Coaching and Empowerment in Rheumatologyhttps://clinicaltrials.gov/study/NCT05545839RECRUITINGJuvenile Idiopathic Arthritis|Juvenile Rheumatoid Arthritis|Juvenile Dermatomyositis|Juvenile Psoriatic Arthritis|Autoinflammatory Disease|Autoimmune Diseases|Lupus ErythematosusMcMaster UniversityCHILD, ADULT133
NCT04286178Exercise, Creatine and Coenzyme Q10 for Childhood Myositishttps://clinicaltrials.gov/study/NCT04286178RECRUITINGMyositis, JuvenileThe Hospital for Sick ChildrenCHILD, ADULT15