Clinical trials: Idiopathic Inflammatory Myopathies
Autoimmune Diseases, Lupus Erythematosus, Systemic
Comparative Autoantibody and Immunologic Cell Marker Study
The purpose of this study is to compare immune phenotype, function, and specificity of B lymphocytes from different developmental stages in autoimmune patients to B cells from infectious disease patients and healthy controls.
- Conditions
- Autoimmune Diseases, Lupus Erythematosus, Systemic, Communicable Diseases
- Trial name
- NCT02422875
- Where
- 3 sites in United States
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Emory University
Systemic Lupus Erythematosus
A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)
This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose.
- Trial name
- ELEVATE-1 (NCT07371468)
- Testing
- GSK5926371
- Where
- 19 sites in Argentina, Brazil and 7 more
- Volunteers
- 44 people
- Sponsor
- GlaxoSmithKline
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases
This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced…
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes, Systemic Sclerosis (SSc)
- Trial name
- CELL-ATTACK 1 (NCT07544225)
- Testing
- anti-CD19 CAR-T cells
- Where
- France
- Volunteers
- 6 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Systemic Lupus Erythematosus, Sjögren's Disease
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases
The purpose of this study is to evaluate the safety and tolerability of BMS-986553, CD19 in vivo Chimeric Antigen Receptor (CAR) T cells, in participants with refractory autoimmune diseases including systemic lupus erythematosus…
- Conditions
- Systemic Lupus Erythematosus, Sjögren's Disease, Rheumatoid Arthritis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07873931
- Testing
- BMS-986553
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
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
Juvenile Dermatomyositis, Rheumatic Diseases
Comparison Of The Effects Of Two Different Exercise Training Based On Internal And External Focus In Children and Adolescents With Rheumatic Diseases
The study aims to compare the effects of two different exercise programs, based on distinct focus strategies, on physical fitness and fatigue in children and adolescents with rheumatic diseases.
- Conditions
- Juvenile Dermatomyositis, Rheumatic Diseases, Juvenile Idiopathic Arthritis (JIA), Familial Mediterranean Fever (FMF)
- Trial name
- NCT07138157
- Testing
- External Focus Exercises, Internal Focus Exercises
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people
- Sponsor
- Istanbul University - Cerrahpasa
Relapsed/Refractory Systemic Lupus Erythematosus, Relapsed/Refractory Systemic Sclerosis
Autologous CD19/BCMA Dual-Target CAR-T for Relapsed/Refractory Autoimmune Diseases
Autoimmune diseases occur when the immune system mistakenly attacks the body's own tissues, leading to chronic inflammation and damage to organs such as the kidneys, lungs, muscles, nerves, or blood cells.
- Conditions
- Relapsed/Refractory Systemic Lupus Erythematosus, Relapsed/Refractory Systemic Sclerosis, Relapsed/Refractory Idiopathic Inflammatory Myopathies, Relapsed/Refractory sjögren's Syndrome
- Trial name
- NCT07361094
- Testing
- Autologous CD19-BCMA Dual-Target CAR T-Cell Therapy
- Where
- China
- Sponsor
- Beijing Boren Hospital
Pericarditis, Tako-TSUBO Cardiomyopathy
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
INFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with…
- Conditions
- Pericarditis, Tako-TSUBO Cardiomyopathy, Myocarditis, Inflammatory Cardiomyopathies
- Trial name
- INFLAME-BANK (NCT07737470)
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Idiopathic Inflammatory Myopathy, Dermatomyositis
Muscle Function and Effects of Repetitive Task Training in Patients With Inflammatory Myopaties
Idiopathic inflammatory myopathies lead to important functional limitations resulting from the loss of muscle strength and endurance, especially in the hip and shoulder, which leads to a significant loss of quality of life for…
- Conditions
- Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis
- Trial name
- NCT05027152
- Testing
- Repetitive task training
- Where
- Brazil
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Federal University of Espirito Santo
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
Active Idiopathic Inflammatory Myopathy, Myositis
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM).
- Conditions
- Active Idiopathic Inflammatory Myopathy, Myositis, Dermatomyositis, Polymyositis
- Trial name
- ALKIVIA (NCT05523167)
- Testing
- EFG PH20 SC, PBO
- Where
- 202 sites in United States, Argentina and 34 more
- Volunteers
- 265 people
- Sponsor
- argenx
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, Rheumatoid Arthritis
- Trial name
- NCT05869955
- Testing
- CC-97540, Fludarabine, Cyclophosphamide
- Where
- 46 sites in United States, Belgium and 4 more
- Volunteers
- 270 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Inflammatory Myopathy, Cardiac Disease
Adult Idiopathic Inflammatory Myopathy With Cardiac Injury
Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be recruited. Patients will be approached, consented, have baseline demographics, diagnostics and disease activity measures recorded, and…
- Trial name
- NCT05982041
- Volunteers
- 300 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics
Inflammatory Myopathy
Low-dose Interleukin-2 Treatment on Idiopathic Inflammatory Myopathy
This study aims to explore the clinical and immunological efficacy of low-dose Interleukin-2 (IL-2) on idiopathic inflammatory myopathy (IIM).
- Trial name
- NCT04062019
- Testing
- Interleukin-2
- Volunteers
- 15 people
- Sponsor
- Peking University People's Hospital
Idiopathic Inflammatory Myopathies
Optimizing Treatment on Idiopathic Inflammatory Myopathies
As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies with methyprednisolone and/or human intravenous immunoglobulin, or only methyprednisolone at disease onset.
- Trial name
- NCT03092180
- Testing
- Intravenous Infusion
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- University of Sao Paulo
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathies(IIM)
A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.
- Trial name
- NCT07331272
- Testing
- LUCAR-G79D T cells
- Where
- 5 sites in China
- Volunteers
- 38 people
- Sponsor
- Nanjing Legend Biotech Co.
Myocarditis, ANCA Associated Vasculitis
EACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases
Inflammatory Cardiovascular Diseases and Autoimmune Rheumatic Diseases (ICARDs) encompass cardiovascular involvement in connective tissue diseases, vasculitis, and primary inflammatory cardiac processes affecting all layers of…
- Conditions
- Myocarditis, ANCA Associated Vasculitis, Pericarditis, Systemic Sclerosis
- Trial name
- EACVI-INFLAME (NCT07077304)
- Testing
- observational study
- Where
- France
- Volunteers
- 5,000 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS)
- Trial name
- NCT05000216
- Testing
- Moderna mRNA-1273, BNT162b2, Ad26.COV2.S
- Where
- 29 sites in United States
- Volunteers
- 258 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)