Clinical trials: Idiopathic Inflammatory Myopathy
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 Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)
GC012F in Patients With Autoimmune Diseases
This is an open-label, early exploratory main clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with autoimmune diseases (AID), as well as to assess its pharmacokinetic (PK) and pharmacodynamic…
- Trial name
- NCT07072884
- Testing
- GC012F injection
- Volunteers
- 15 people
- Sponsor
- Qiong Fu
Autoimmune Disorders
Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
This is a multi-center, Phase 2 trial of ublituximab as first-line combination therapy in early, active autoantibody positive immune-mediated necrotizing myopathy.
- Trial name
- SUMMIT (NCT07103746)
- Testing
- Ublituximab
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID.
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjogren's Syndrome
- Trial name
- NCT06417398
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Juvenile Dermatomyositis (JDM), Polyarticular Juvenile Idiopathic Arthritis
Clinical Study of BCMA/CD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases
This is an investigator-initiated trial to evaluate the efficacy and safety of BCMA/CD70-targeted CAR-T in the treatment of refractory pediatric rheumatic diseases.
- Conditions
- Juvenile Dermatomyositis (JDM), Polyarticular Juvenile Idiopathic Arthritis, Systemic Sclerosis (SSc), Primary Sjogren's Syndrome
- Trial name
- NCT07184450
- Testing
- BCMA/CD70-targetd CAR-T
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
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
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
A Study of AZD0120 in Autoimmune Diseases
This trial is a Phase 1b/2, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc)…
- Conditions
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Rheumatoid Arthritis
- Trial name
- AURORA (NCT07295847)
- Testing
- AZD0120, SOC
- Where
- 25 sites in United States, Australia and 4 more
- Volunteers
- 27 people
- Sponsor
- AstraZeneca
Idiopathic Inflammatory Myopathies, Osteoporosis, Osteopenia
Treating Idiopathic Inflammatory Myopathies Related Reduced Bone Mineral Density With Denosumab or Zoledronic Acid
Idiopathic inflammatory myopathies (IIM) patients are at high risk of development of reduced bone mineral density due to impairment of functional status due to the disease and a relatively high dose of glucocorticoid use for the…
- Trial name
- NCT04034199
- Testing
- Denosumab, Zoledronic Acid
- Where
- Hong Kong
- Volunteers
- 40 people
- Sponsor
- Kwong Wah Hospital
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
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
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
Myositis, Dermatomyositis
High-intensity Strength Training in Myositis
This study evaluates the effects of a high-intensity strength training in patients with myositis with the primary outcome being quality of life (SF-36).
- Conditions
- Myositis, Dermatomyositis, Polymyositis, Immune-Mediated Necrotizing Myopathy
- Trial name
- HI-STIM (NCT04486261)
- Testing
- High-intensity strength training
- Where
- Denmark
- Volunteers
- 34 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
Systemic Lupus Erythematosus, Idiopahic Inflammatory Myopathies
A Study of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases
The purpose of this study is to assess the safety and efficacy of CD19 UCAR-T cell therapy in Subjects with autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Idiopahic Inflammatory Myopathies, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Sjögren's Syndrome
- Trial name
- ET-902-AID01 (NCT07212322)
- Testing
- CD19 UCAR-T cells
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Polymyositis, Dermatomyositis
Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.
This was an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM) who completed the double-blind treatment period of Study KZR-616-003, up to…
- Trial name
- NCT04628936
- Testing
- KZR-616
- Where
- 10 sites in United States, Czechia
- Volunteers
- 18 people
- Sponsor
- Kezar Life Sciences, 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.
Refractory Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myopathies (IIMs)
AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.
A Basket Trial of Refractory Rheumatoid Arthritis (RA), Sjögren's Disease (SjD), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc) subjects to evaluate the safety and efficacy of AlloNK, a non-genetically…
- Conditions
- Refractory Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myopathies (IIMs), Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA
- Trial name
- NCT06991114
- Testing
- Allogeneic NK Cells
- Where
- 52 sites in United States, Brazil and 9 more
- Volunteers
- 90 people
- Sponsor
- Artiva Biotherapeutics, Inc.
Dermatomyositis
Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")
- Trial name
- IIM (NCT02728752)
- Testing
- Octagam 10%
- Where
- 37 sites in United States, Canada and 8 more
- Volunteers
- 95 people
- Sponsor
- Octapharma
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
MYOPATHY
Stem Cell Transplantation in Idiopathic Inflammatory Myopathy Diseases
Myositis is a disease, believed to be due to immune cells, cells which normally protect the body, but are now attacking the muscles and other organ systems within body.
- Trial name
- NCT00278564
- Testing
- Hematopoietic stem cell transplantation, Cyclophosphamide, Mesna
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Northwestern University