Clinical trials: Inflammatory Myopathy, Idiopathic
SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
- Conditions
- SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies, ANCA Associated Vasculitis (AAV)
- Trial name
- NCT07315087
- Testing
- QT-019C
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Myositis, Muscular Disorders, Atrophic
Diagnostic Accuracy of MR in Myositis
A prospective observational study to determine the effectiveness of magnetic resonance (MR) imaging in the diagnosis and monitoring of idiopathic myopathy in adult humans.
- Trial name
- NCT01702870
- Testing
- Magnetic Resonance Imaging
- Where
- 3 sites in United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University of Warwick
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
Myositis, Idiopathic Inflammatory Myopathy
MYOPROSP - a Prospective Cohort Study in Myositis
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
- MYOPROSP (NCT02468895)
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- University of Manchester
Inflammatory Myopathy
Renal Manifestations During Idiopathic Inflammatory Myopathies
There are currently no recommendations regarding treatments for Idiopathic Inflammatory Myopathies (IIM) due to the difficulty in conducting high-powered randomized controlled trials.
- Trial name
- IIM (NCT06904937)
- Where
- France
- Volunteers
- 15 people
- Sponsor
- University Hospital, Strasbourg, France
Idiopathic Inflammatory Myopathies
Phase 2 Study of Rapcabtagene Autoleucel in Myositis
A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies (IIM)
- Trial name
- NCT06665256
- Testing
- Rapcabtagene autoleucel, Active Comparator Option
- Where
- 68 sites in United States, Australia and 13 more
- Volunteers
- 21 people
- Sponsor
- Novartis Pharmaceuticals
Myositis
Belimumab in Idiopathic Inflammatory Myositis
The goal of the trial is to evaluate the efficacy and safety of belimumab as a maintenance therapy in adults with refractory Idiopathic inflammatory myositis (IIM) as compared with standard of care.
- Trial name
- BIM (NCT02347891)
- Testing
- Belimumab
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Northwell Health
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
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
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
Lupus Nephritis, Autoimmune Diseases
A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease
ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease.
- Conditions
- Lupus Nephritis, Autoimmune Diseases, Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06375993
- Testing
- ADI-001, Fludarabine, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 180 people
- Sponsor
- Adicet Therapeutics
Dermatomyositis, Polymyositis
Study of M5049 in DM and PM Participants (NEPTUNIA)
The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.
- Trial name
- NCT05650567
- Testing
- M5049 dose
- Where
- 31 sites in United States, Czechia and 5 more
- Volunteers
- 20 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Relapsed/Refractory Autoimmune Diseases
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory autoimmune diseases.
- Trial name
- NCT06866080
- Testing
- LCAR-AIO T cells
- Where
- 4 sites in China
- Sponsor
- Nanjing Legend Biotech Co.
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
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)
Safety Study of CC312 in Autoimmune Disease Patients
This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune…
- Conditions
- Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA)
- Trial name
- NCT06888960
- Testing
- CC312
- Where
- China
- Volunteers
- 18 people
- Sponsor
- CytoCares Inc
Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101
The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases.
- Conditions
- Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis, SLE Nephritis, ANCA Associated Vasculitis
- Trial name
- CARTIMMUNE (NCT06152172)
- Testing
- KYV-101, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- David Porter
Systemic Lupus Erythematosus, Rheumatoid Arthritis
A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune Diseases
The purpose of this study is to learn about the safety and effects of the study medication called PF-08154225 for the potential treatment of autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Idiopathic Inflammatory Myositis, Systemic Sclerosis
- Trial name
- NCT07782450
- Testing
- PF-08154225
- Volunteers
- 54 people
- Sponsor
- Pfizer
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.
Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA)
Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases
The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune…
- Conditions
- Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Systemic Lupus Erythematosus (SLE), Juvenile Systemic Lupus Erythematosus
- Trial name
- BTNDV-ARD (NCT07087912)
- Testing
- Dengue 1,2,3,4 (attenuated) vaccine
- Where
- 2 sites in Brazil
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital