Clinical trials: IIM
Muscular Dystrophies, Congenital Myopathy
Assessment of Safety and Acute Effects of a Lower-limb Powered Dermoskeleton in Patients With Neuromuscular Disorders
The aims of the current study are as follow: i) Evaluate the safety, usability, and acute efficiency of a programmable ambulation exoskeleton (KeeogoTM Dermoskeleton System, B-Temia Inc., Quebec, Canada) in patients with…
- Conditions
- Muscular Dystrophies, Congenital Myopathy, Idiopathic Inflammatory Myopathies, Mitochondrial Myopathies
- Trial name
- Exo-KGO1 (NCT05199246)
- Testing
- Lower-limb powered dermoskeleton
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Institut de Myologie, France
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
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
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
SLE (Systemic Lupus), Lupus Erythematosus, Systemic
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus…
- Conditions
- SLE (Systemic Lupus), Lupus Erythematosus, Systemic, Lupus Nephritis, Systemic Sclerosis
- Trial name
- NCT06925542
- Testing
- CTX112
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 80 people
- Sponsor
- CRISPR Therapeutics
Idiopathic Inflammatory Myopathies
Elastography in Patients With Idiopathic Inflammatory Myopathies
The aim of our study was to assess the performance of compression-strain US elastography in patients with idiopathic inflammatory myopathies over time and to study these findings with clinical and functional parameters as well as…
- Trial name
- NCT03897803
- Testing
- strain elastography
- Where
- Egypt
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Benha University
Multiple Sclerosis, NMO Spectrum Disorder
Tongji NADs Cohort
Neurological Autoimmune Diseases (NADs) are disorders caused by abnormal immune system attacks on neural tissues, affecting multiple systems including the central nervous system, peripheral nervous system, and neuromuscular…
- Conditions
- Multiple Sclerosis, NMO Spectrum Disorder, Autoimmune Encephalitis, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
- Trial name
- NCT07333196
- Testing
- No active interventions
- Where
- China
- Volunteers
- 1,550 people
- Sponsor
- Tongji Hospital
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
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System
Antibody-mediated inflammatory diseases of the nervous system (also known as autoimmune diseases of the nervous system) are autoimmune diseases in which autoimmune cells and immune molecules attack the nervous system as the main…
- Conditions
- Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Neuromyelitis Optica Spectrum Disorder, Myasthenia Gravis
- Trial name
- CARTinNS (NCT04561557)
- Testing
- CT103A cells, Cyclophosphamide and fludarabine
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Tongji Hospital
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
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
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
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
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
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
Myositis
Anti-inflammation Treatment for Idiopathic Inflammatory Myopathies
The goal of this clinical trial is to learn if the drug Maraviroc works to treat refractory idiopathic inflammatory myopathy (myositis) in patients who have not responded well to traditional therapies.
- Trial name
- NCT07668505
- Testing
- maraviroc (Selzentry, Celsentri)
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Chinese University of Hong Kong
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.
Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)
Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases
A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients…
- Conditions
- Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT07085676
- Testing
- HBI0101 CART
- Where
- Israel
- Volunteers
- 120 people
- Sponsor
- Polina Stepensky
Polymyositis, Dermatomyositis
A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis
This was a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of treatment with KZR-616 in patients…
- Trial name
- PRESIDIO (NCT04033926)
- Testing
- KZR-616
- Where
- 14 sites in United States, Czechia and 1 more
- Volunteers
- 25 people
- Sponsor
- Kezar Life Sciences, Inc.
SLE, LN
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19/BCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE/LN, AAV/AAGN, Anti-GBM, MN…
- Conditions
- SLE, LN, ANCA Associated Vasculitis, ANCA-Associated Glomerulonephritis
- Trial name
- NCT07203404
- Testing
- RD06-05 CART Cell Injection
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.