Clinical trials: IIM- Idiopathic Inflammatory Myopathies
Autoimmune Diseases, SLE - Systemic Lupus Erythematosus
RD06-05 Universal CD19/BCMA CAR-T for Refractory Pediatric Autoimmune Diseases
This is a single-arm, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05, a universal CD19/BCMA dual-targeting chimeric antigen receptor T-cell…
- Conditions
- Autoimmune Diseases, SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies
- Trial name
- NCT07674147
- Testing
- RD06-05 CART Cell Infusion
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
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
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 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
Myositis
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
The purpose of the study is to understand how the study medicine PF-06823859 (dazukibart) works in people with idiopathic inflammatory myopathies (DM and PM).
- Trial name
- NCT05895786
- Testing
- PF-06823859
- Where
- 138 sites in United States, Argentina and 18 more
- Volunteers
- 318 people
- Sponsor
- Pfizer
Autoimmune/Connective Tissue Diseases, Idiopathic Inflammatory Myopathies
Studies of the Natural History and Pathogenesis of Autoimmune/Connective Tissue Diseases
This study will define the major genetic risk and protective factors for idiopathic inflammatory myopathies (IIM), a group of immune disorders affecting connective tissues such as muscles.
- Conditions
- Autoimmune/Connective Tissue Diseases, Idiopathic Inflammatory Myopathies, Polymyositis, Dermatomyositis
- Trial name
- NCT00341679
- Where
- United States
- Volunteers
- 719 people
- Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
Dermatomyositis, Polymyositis
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis [DM] or polymyositis [PM]).
- Trial name
- NCT06698796
- Testing
- Dazukibart
- Where
- 26 sites in United States, Argentina and 10 more
- Volunteers
- 211 people
- Sponsor
- Pfizer
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
Polymyositis, Dermatomyositis
Anakinra in Myositis
To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients with treatment-resistant inflammatory myopathies.
- Conditions
- Polymyositis, Dermatomyositis, Inclusion Body Myositis
- Trial name
- NCT01165008
- Testing
- Anakinra
- Where
- Sweden
- Sponsor
- Karolinska Institutet
Chronic Inflammatory Demyelinating Polyradiculoneuropathy, NMO Spectrum Disorder
Safety and Efficacy of BAFF-R CART for Refractory Neuroimmune Diseases
This study is a phase Ib/IIa dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of autologous T cells expressing chimeric antigen receptor (CAR)-targeted B-cell activating factor…
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy, NMO Spectrum Disorder, Myasthenia Gravis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07022197
- Testing
- BAFF-R CART
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Tianjin Medical University General Hospital
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
Behcet's Disease, Idiopathic Inflammatory Myopathies
Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases
Research into novel therapies for rare, immune-mediated inflammatory diseases (IMIDs) is limited due to small patient populations.
- Conditions
- Behcet's Disease, Idiopathic Inflammatory Myopathies, IgG4-related Disease
- Trial name
- DRIMID (NCT06285539)
- Testing
- Filgotinib
- Where
- 6 sites in Netherlands
- Volunteers
- 60 people
- Sponsor
- UMC Utrecht
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
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
Main purpose: To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID).
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, IgG4 Related Disease
- Trial name
- NCT06361745
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Where
- China
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
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
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
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
Rheumatoid Arthritis, Spondylitis, Ankylosing
Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases
Introduction: Patients with autoimmune rheumatic diseases (ARDs), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PAs), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), primary…
- Conditions
- Rheumatoid Arthritis, Spondylitis, Ankylosing, Spondyloarthritis, Systemic Lupus Erythematosus
- Trial name
- RZVRheum (NCT05879419)
- Testing
- Recombinant Herpes Zoster Vaccine (RZV), MTX Discontinuation, MMF Discontinuation
- Where
- Brazil
- Volunteers
- 2,005 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General 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.
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM)
A Study of OL-108 in Relapsed/Refractory Autoimmune Diseases
This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-108 in relapsed/refractory autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), ANCA Associated Vasculitis (AAV)
- Trial name
- NCT06980597
- Testing
- OL-108
- Where
- 2 sites in China
- Volunteers
- 44 people
- Sponsor
- Beijing GoBroad Hospital