Clinical trials: Idiopathic Inflammatory Myopathy (IIM)
Giant Cell Arteritis (GCA), Polymyalgia Rheumatica (PMR)
AYLo - AutoimmunitY and Loss of y
The AYLo study (AutoimmunitY and Loss of y - Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases) aims to systematically investigate hematopoietic…
- Conditions
- Giant Cell Arteritis (GCA), Polymyalgia Rheumatica (PMR), ANCA Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathies
- Trial name
- AYLo (NCT06696027)
- Testing
- Single nucleotide polymorphisms (SNP), 3'mRNA sequencing, Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array
- Where
- Germany
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of Bonn
SLE - Systemic Lupus Erythematosus, Systemic Sclerosis
CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune…
- Conditions
- SLE - Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07596680
- Testing
- RD06-05 CAR-T Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Idiopathic Inflammatory Myopathy, Dermatomyositis
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
RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
- Conditions
- Idiopathic Inflammatory Myopathy, Dermatomyositis, Anti-Synthetase Syndrome, Immune-Mediated Necrotizing Myopathy
- Trial name
- NCT06154252
- Testing
- CABA-201 following preconditioning with fludarabine and cyclophosphamide
- Where
- 38 sites in United States, Germany and 2 more
- Volunteers
- 74 people
- Sponsor
- Cabaletta Bio
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM)
A Study of OL-108 in Relapsed/Refractory Autoimmune Diseases
This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-108 in relapsed/refractory autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), ANCA Associated Vasculitis (AAV)
- Trial name
- NCT06980597
- Testing
- OL-108
- Where
- 2 sites in China
- Volunteers
- 44 people
- Sponsor
- Beijing GoBroad Hospital
Polymyositis, Dermatomyositis
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)
The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with…
- Trial name
- JASMINE (NCT06455449)
- Testing
- Anifrolumab (blinded), Anifrolumab (unblinded, open label)
- Where
- 237 sites in United States, Argentina and 27 more
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Interstitial Lung Disease, Scleroderma
Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILD
Interstitial lung disease (ILD) is characterised by inflammation and scarring of the lung and is the leading cause of death in patients with systemic sclerosis, and contributes significantly to morbidity and mortality in many…
- Conditions
- Interstitial Lung Disease, Scleroderma, Idiopathic Inflammatory Myositis, Mixed Connective Tissue Disease
- Trial name
- RECITAL (NCT01862926)
- Testing
- Rituximab, Cyclophosphamide
- Where
- United Kingdom
- Volunteers
- 104 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
Inflammatory Myopathy
Low-dose Interleukin-2 in Combination With Standard Therapy on Idiopathic Inflammatory Myopathy
This study aims to explore the clinical and immunological efficacy of low-dose Interleukin-2 (IL-2) and cyclosporin a (CSA) on idiopathic inflammatory myopathy (IIM)
- Trial name
- NCT04237987
- Testing
- Interleukin-2, ciclosporin and corticosteroid
- Volunteers
- 20 people
- Sponsor
- Peking University People's Hospital
Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
A Study to Assess CLBR001+SWI019 in Subjects With Autoimmune Diseases
The goal of this clinical trial is to evaluate CLBR001 and SWI019 as a treatment for patients with autoimmune disorders, including systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myositis.
- Conditions
- Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)
- Trial name
- NCT06913608
- Testing
- CLBR001 + SWI019
- Sponsor
- Calibr, a division of Scripps Research
Idiopathic Inflammatory Myopathies
JAK 1/2 Inhibitor, Baricitinib, in the Treatment of Adult IIM
This study aims to investigate the clinical efficacy of baricitinib in patients with adult idiopathic inflammatory myositis (IIM).
- Trial name
- MYOJAK (NCT04208464)
- Testing
- Baricitinib
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- University of Manchester
Idiopathic Inflammatory Myositis
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)
The primary efficacy objective: To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. The secondary efficacy objectives include: 1.
- Trial name
- NCT05669014
- Testing
- Daxdilimab
- Where
- 9 sites in United States, Brazil and 4 more
- Volunteers
- 12 people
- Sponsor
- Amgen
Idiopathic Inflammatory Myopathies
Clinical Characteristics and Mechanism Research of Inhibitors of Janus Kinase in the Idiopathic Inflammatory Myopathies
This study aims to explore the clinical characteristics and mechanism of inhibitors of janus kinase in the treatment of idiopathic inflammatory myopathies
- Trial name
- NCT05400889
- Testing
- tofacitinib
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peking University People's Hospital
Autoimmune Diseases of the Nervous System, Neuromyelitis Optica Spectrum Disorder
Biomarkers in Autoimmune Disease of Nervous System
Neurological autoimmune diseases are a group of disorders characterized by the abnormal immune response attacking the nervous system, including the brain, spinal cord and peripheral nerves.
- Conditions
- Autoimmune Diseases of the Nervous System, Neuromyelitis Optica Spectrum Disorder, Multiple Sclerosis, Guillain-Barre Syndrome
- Trial name
- NCT06502015
- Testing
- biomaker levels
- Where
- China
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- Tongji Hospital
Myositis
A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
- Trial name
- SPIREA (NCT05379634)
- Testing
- Nipocalimab, Glucocorticoids
- Where
- 57 sites in United States, Canada and 11 more
- Volunteers
- 36 people
- Sponsor
- Janssen Research & Development, LLC
Sjogrens Disease, Idiopathic Inflammatory Myopathy (IIM)
OM336 in Seropositive Autoimmune Diseases
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of OM336 in adult participants with seropositive autoimmune diseases. OM336 is administered subcutaneously in ascending dose cohorts.
- Trial name
- NCT07229144
- Testing
- OM336
- Where
- New Zealand
- Volunteers
- 39 people
- Sponsor
- Lakefront Biotherapeutics West LLC
Idiopathic Inflammatory Myopathies
Adult Autoimmune Myopathies (MAIA)
This study corresponds to a monocentric prospective cohort of adult patients presenting a suspicion of idiopathic inflammatory myopathy.
- Trial name
- MAIA (NCT04792931)
- Testing
- description of adult autoimmune myopathies
- Where
- France
- Volunteers
- 60 people
- Sponsor
- University Hospital, Brest
ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
FT839 in Autoimmune Diseases
The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or…
- Conditions
- ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT07800871
- Testing
- FT839
- Where
- United States
- Volunteers
- 446 people
- Sponsor
- Fate Therapeutics
Idiopathic Inflammatory Myopathy (IIM)
GC012F Injection in Refractory Idiopathic Inflammatory Myopathy
This is a single-arm, open-label, early exploratory clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with refractory idiopathic inflammatory myopathy and to assess the pharmacokinetic and…
- Trial name
- NCT07086404
- Testing
- GC012F Injection infusion
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Daishi Tian
Polymyositis, Dermatomyositis
Anakinra in Myositis
To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients with treatment-resistant inflammatory myopathies.
- Conditions
- Polymyositis, Dermatomyositis, Inclusion Body Myositis
- Trial name
- NCT01165008
- Testing
- Anakinra
- Where
- Sweden
- Sponsor
- Karolinska Institutet
Behcet's Disease, Idiopathic Inflammatory Myopathies
Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases
Research into novel therapies for rare, immune-mediated inflammatory diseases (IMIDs) is limited due to small patient populations.
- Conditions
- Behcet's Disease, Idiopathic Inflammatory Myopathies, IgG4-related Disease
- Trial name
- DRIMID (NCT06285539)
- Testing
- Filgotinib
- Where
- 6 sites in Netherlands
- Volunteers
- 60 people
- Sponsor
- UMC Utrecht
Myositis, Idiopathic Inflammatory Myopathies
Characterizing Myositis With 68Ga-FAPI PET/CT
To evaluate the potential usefulness of 68Ga-FAPI PET/CT for the diagnosis and evaluation of systemic involvement in idiopathic inflammatory myopathies (IIM)/myositis, and compared the results with those of 18F-FDG PET/CT.
- Trial name
- NCT05952531
- Testing
- 68Ga-FAPI
- Where
- China
- Volunteers
- 50 people
- Sponsor
- The First Affiliated Hospital of Xiamen University