Clinical trials: Idiopathic Inflammatory Myopathy (IIM)
Idiopathic Inflammatory Myopathies
Clinical Study Cohort of Idiopathic Inflammatory Myositis
Idiopathic inflammatory myositis (IIM), also known as myositis, are a heterogeneous group of diseases characterized by chronic inflammation of striated muscles and skin, with different clinical manifestations, treatment…
- Trial name
- NCT06306547
- Testing
- no interventions were involved
- Volunteers
- 1,000 people
- Sponsor
- RenJi Hospital
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.
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
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
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
Myositis, Active Idiopathic Inflammatory Myopathy
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007.
- Conditions
- Myositis, Active Idiopathic Inflammatory Myopathy, Dermatomyositis, Polymyositis
- Trial name
- ALKIVIA+ (NCT05979441)
- Testing
- Efgartigimod PH20 SC
- Where
- 92 sites in United States, Argentina and 27 more
- Volunteers
- 240 people
- Sponsor
- argenx
Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD)
Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
This study is an open-label, exploratory, prospective clinical trial with dose escalation(according to "3+3" design), to evaluate the safety and tolerability of QH103(Universal CD19 CAR-γδT Cell Injection)in the treatment of…
- Conditions
- Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), Autoimmune Encephalitis (AE), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Trial name
- NCT07526493
- Testing
- Universal CD19 CAR-γδT Cell Injection, Cyclophosphamide, Fludarabine
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Tongji 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
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
Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV)
IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy
This is an exploratory trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of IMPT-514, an autologous, anti-CD19/CD20 CAR T therapy, administered as an intravenous (IV)…
- Conditions
- Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathy (IIM)
- Trial name
- NCT06462144
- Testing
- IMPT-514 CART Cell Injection
- Where
- 3 sites in China
- Volunteers
- 3 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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 Sclerosis (SSc), ANCA Associated Vasculitis (AAV)
Anti-CD19 IL-10/IL15 CAR-NK Cells in Refractory/Relapsed Autoimmune Diseases
This study is a single-center, open-label, single-arm, dose-escalation trial. The aim of this study is to investigate the safety and efficacy of Anti-CD19 IL-10/IL15 CAR-NK cells in patients with refractory/relapsed autoimmune…
- Conditions
- Systemic Sclerosis (SSc), ANCA Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathy (IIM), Sjogren's Syndrome
- Trial name
- NCT06614270
- Testing
- Anti-CD19 IL-10/IL15 CAR-NK
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Systemic Lupus Erythematosus, Systemic Sclerosis
Clinical Study on Targeted CD19CAR-T Therapy for Autoimmune Diseases
This is an open-label, investigator-initiated clinical trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with active SLE, SSc, AAV, IIM, and pSS
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06549296
- Testing
- RD06-04 CART Cell Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
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
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
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
Idiopathic Inflammatory Myopathies
A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies
This study is open to adults aged 18 and older who have a condition known as active idiopathic inflammatory myopathy (IIM) or myositis. People can participate if they have a specific type of myositis.
- Trial name
- VERANDA™-IIM (NCT07789015)
- Testing
- Nerandomilast
- Where
- 150 sites in United States, Argentina and 22 more
- Volunteers
- 270 people
- Sponsor
- Boehringer Ingelheim
Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA)
A Study of BEN301 Injection in theTreatment of Autoimmune Diseases
The study aims to investigate the safety, tolerability, and preliminary clinical efficacy of BEN301 Injection in patients with autoimmune diseases.
- Conditions
- Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA), Sjogren's Syndrome (SS), Idiopathic Inflammatory Myopathies(IIM)
- Trial name
- NCT07527936
- Testing
- Single administration of 1x10^8 viable CD4+ CAR+ Foxp3+ cells., Single administration of 3x10^8 viable CD4+ CAR+ Foxp3+ cells.
- Where
- China
- Volunteers
- 24 people
- Sponsor
- RenJi Hospital