Clinical trials: Myositis
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.
Post-COVID-19 Condition, Ulcerative Colitis
Emerging Indications for Hyperbaric Oxygen Treatment
This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric…
- Conditions
- Post-COVID-19 Condition, Ulcerative Colitis, Crohn Disease, Calciphylaxis
- Trial name
- NCT07240649
- Testing
- Hyperbaric oxygen treatment (HBOT), 100% Oxygen
- Volunteers
- 100 people
- Sponsor
- Jay C. Buckey Jr.
Fibrodysplasia Ossificans Progressiva
Saracatinib Trial TO Prevent FOP
This is a phase 2 study, designed as a European multicentre 6-month double blind random-ized controlled trial (RCT) of AZD0530 versus matched placebo, followed by a 12 month trial comparing open-label extended AZD0530 treatment…
- Trial name
- STOPFOP (NCT04307953)
- Testing
- AZD0530 Difumarate
- Where
- 3 sites in Germany, Netherlands and 1 more
- Volunteers
- 20 people
- Sponsor
- Amsterdam UMC, location VUmc
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases
This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced…
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes, Systemic Sclerosis (SSc)
- Trial name
- CELL-ATTACK 1 (NCT07544225)
- Testing
- anti-CD19 CAR-T cells
- Where
- France
- Volunteers
- 6 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
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
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)
Inclusion Body Myositis (IBM), Motor Neuron Disease, Amyotrophic Lateral Sclerosis
The Aim of the Study is to Characterize Patients Exhibiting Muscular Atrophy and Weakness Who Require a Muscle Biopsy for Diagnosis (IBM vs Atypical MND), Through an Innovative Technique Which Enables the Evaluation of the Neuromuscular Junction Involvement in Each Condition
The aim of the study is to characterize 30 patients exhibiting muscular atrophy and weakness who require a muscle biopsy for diagnosis (suspected inclusion body myopathy vs atypical motor neuron disease), through an innovative…
- Trial name
- TDP-signatures (NCT07796776)
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- IRCCS San Raffaele
Systemic Lupus Erthematosus, Sjogren's Syndrome
Mass Spectrometry-based Immune Profiling in Autoimmune Diseases
Based on mass spectrometry flow method, this study analyzed the typing of new T, B, NK and DC cell subsets in peripheral blood of common autoimmune diseases and their correlation with disease activity, aiming at establishing an…
- Conditions
- Systemic Lupus Erthematosus, Sjogren's Syndrome, Inflammatory Myopathies, Systemic Sclerosis (SSc)
- Trial name
- NCT07188285
- Where
- China
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Peking University People's Hospital
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
Dermatomyositis, Dermatomyositis Sine Myositis
Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study
This is a proof of concept study to determine if Emapalumab appears effective for the treatment of anti-MDA5 antibody positive rapidly progressive interstitial lung disease (MDA5 RP-ILD).
- Conditions
- Dermatomyositis, Dermatomyositis Sine Myositis, Dermatomyositis With Myopathy, Dermatomyositis With Respiratory Involvement
- Trial name
- NCT07486869
- Testing
- Emapalumab
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Miami
Interstitial Lung Disease, Myositis
Treatment Response in Immune-mediated Myositis Associated Rapidly-progressing Interstitial Lung Disease
Idiopathic inflammatory myopathies (IIM) are a group of autoimmune conditions characterized by inflammation of muscles with possible extra-muscular manifestations which can include skin and interstitial lung disease (ILD).
- Trial name
- NCT07775235
- Testing
- Immunosuppressant Regimen
- Where
- Singapore
- Volunteers
- 80 people
- Sponsor
- Singapore General Hospital
Antisynthetase Syndrome
Descartes-08 in Autoantibody Myositis
This is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy, safety and tolerability of an autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen…
- Trial name
- NCT07391605
- Testing
- Descartes-08
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cartesian Therapeutics
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
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in…
- Conditions
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Antineutrophil Cytoplasmic Antibody-Associated Vasculitis, Rheumatoid Arthritis
- Trial name
- NCT06733935
- Testing
- NKX019, Fludarabine, Cyclophosphamide
- Where
- 18 sites in United States, Australia and 1 more
- Volunteers
- 240 people
- Sponsor
- Nkarta, Inc.
Fibrodysplasia Ossificans Progressiva (FOP)
IL1 Inhibition in FOP
This is an observational pre-post study to observe if the off label use of anti-IL1 therapies, such as anakinra or canakinumab, can block ACVR1-induced flare activity and heterotopic ossification in FOP.
- Trial name
- NCT06724562
- Testing
- Anti-IL1 Therapy
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of California, San Francisco
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, Rheumatoid Arthritis
- Trial name
- NCT05869955
- Testing
- CC-97540, Fludarabine, Cyclophosphamide
- Where
- 46 sites in United States, Belgium and 4 more
- Volunteers
- 270 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Healthy, Idiopathic Inflammatory Myopathies
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases.
- Conditions
- Healthy, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjögren's Disease
- Trial name
- NCT07284797
- Testing
- XmAb657
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Xencor, Inc.
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.
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
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
A Study of AZD0120 in Autoimmune Diseases
This trial is a Phase 1b, 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
- Where
- 22 sites in United States, Australia and 4 more
- Volunteers
- 27 people
- Sponsor
- AstraZeneca