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Dermatomyositis clinical trials

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NCT ID: NCT06462768 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis

NETOSE
Start date: November 27, 2023
Phase:
Study type: Observational

Systemic SClerosis (SSC) is a systemic disease characterized by limited or diffuse cutaneous sclerosis, microangiopathy, overproduction of autoantibodies and variable organ damage due to vasculopathy and/or fibrosis. The loss of self-tolerance is believed to be caused by the dysregulation of both innate and adaptive immune systems and may involve Reactive Oxygen Species (ROS). Neutrophils are potent producers of ROS and may play a role in endothelial cells and fibrobasts dysfunction, as in autoantibodies generation. However, their role in SSC pathogenesis remains to be determined. Recent studies discovered abnormal regulation of Neutrophil Extracellular Traps (NETs) in other auto-immune diseases such as Systemic Lupus Erythematosus (SLE). NETs are web-like structures composed of chromatin backbones and granular molecules. They are released by activated neutrophils through a process called "NETosis". Nets were first described in 2004 as a novel host defense mechanism to trap and kill foreign pathogens. Recent evidence shows that NETs also participate in the pathogenesis of a variety of inflammatory and autoimmune diseases, including SLE. The investigators recently highlighted this phenomenon in SSc, especially in patients with vascular complications and/or at a early stage of the disease. The investigators will now explore the factors implicated in this dysregulation of NETosis in SSc.

NCT ID: NCT06455449 Not yet recruiting - Clinical trials for 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)

JASMINE
Start date: June 27, 2024
Phase: Phase 3
Study type: Interventional

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 moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment.

NCT ID: NCT06438679 Enrolling by invitation - Dermatomyositis Clinical Trials

3T Therapy in the Treatment of MDA5-positive Dermatomyositis

Start date: March 19, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to learn if a combination of tacrolimus, tafocitinib and thalidomide (3T therapy) works to treat severe MDA5 positive dermatomyositis in adults. It will also learn about the safety of 3T therapy. The main questions it aims to answer are: Does 3T therapy prolong the overall survival time of MDA5 positive dermatomyositis? What medical problems do participants have when taking 3T therapy? Participants will: Take 3T therapy every day for 12 months Visit the clinic once every 2 weeks for checkups and tests

NCT ID: NCT06433999 Not yet recruiting - Dermatomyositis Clinical Trials

A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis

Start date: June 2024
Phase: Phase 2
Study type: Interventional

This is a prospective, 12-week, open-label, single-arm study. The study population comprises individuals with refractory skin disease characteristic of dermatomyositis with no to minimal muscle involvement. After an up to 8-week Screening Period, eligible participants will receive brepocitinib 30 mg orally (PO) QD for 12 weeks.

NCT ID: NCT06371417 Not yet recruiting - Clinical trials for Immune Thrombocytopenia (ITP)

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)

Start date: May 31, 2024
Phase: Phase 1
Study type: Interventional

This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).

NCT ID: NCT06347718 Recruiting - Clinical trials for Systemic Lupus Erythematosus

CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease

CASTLE
Start date: July 17, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells.

NCT ID: NCT06339957 Recruiting - Clinical trials for Rheumatoid Arthritis

Rheumatology Diet Study

Start date: March 1, 2024
Phase:
Study type: Observational

This study aims to collect information on rheumatology patients' dietary habits, autoimmune disease activity, dietary changes, disease symptom improvements, and perceptions on their dietary habits and how it affects their autoimmune disease. The main objective is to see if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. It will also look at rheumatology patients' expectations for their rheumatologist when it comes to dietary advice and what resources they used to choose their new dietary habits. The study also seeks to measure the interest that rheumatology patients have in pursuing dietary changes as a means of controlling the symptoms of their autoimmune disease. It is expected that patients who changed their eating habits to healthier diets such as a Mediterranean diet would report less severe autoimmune disease symptoms. There are limited dietary recommendations for the management of many rheumatological diseases, so this study seeks to assess rheumatology patients' willingness to try dietary modifications, what improvements they had, and why they decide to make these changes in light of limited information.

NCT ID: NCT06298019 Not yet recruiting - Dermatomyositis Clinical Trials

Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis

Start date: April 2024
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to characterize to understand the effects of a type of cell therapy called Chimeric Antigen Receptor T lymphocyte (CAR T) therapy in adult patients with the autoimmune disease dermatomyositis. This study will utilize a technology that modifies a type of white blood cell called the cytotoxic T lymphocyte-this T cell normally functions in the immune system to kill infected or potentially harmful cells in the body. In CAR T therapy, the patients' white blood cells are harvested and the cytotoxic T cells are isolated and modified such that they are programmed to kill any cell that has a protein structure called "CD19" on its outer surface (membrane). Since the CD19 protein is only present on a type of white blood cell called the B lymphocyte, when these "re-engineered" cytotoxic T lymphocytes are then given back to the patient (by an infusion), these cells will seek out and kill essentially all of the patient's B cells. B cells are an important part of a person's immune system and have many functions, including the production of antibodies. It is thought that, in dermatomyositis and other autoimmune diseases, a tiny subset of these B cells plays a large role in making autoantibodies (antibodies directed against the patient's own tissues) and causing disease. The idea is that the therapy will "wipe out" all/most of the B cells in the patient so that they can make an entirely new set of B cells to recreate a functional immune system without the autoimmune disease. The main questions the study intends to answer are: - Understanding how well patients tolerate undergoing this therapy in terms of side effects; - Getting an early idea if this therapy can help certain aspects of the autoimmune disease, including inflammation in the skin, muscles, and lungs;

NCT ID: NCT06284954 Not yet recruiting - Dermatomyositis Clinical Trials

A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis

empacific
Start date: September 2024
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM). The study duration will be approximately 92 weeks for all participants. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either empasiprubart or placebo, respectively, during the treatment period (duration of 25 weeks). At the end of the treatment period, all the participants will enter a safety follow-up period (duration of 65 weeks).

NCT ID: NCT06203249 Recruiting - Microbiome Clinical Trials

Microecology and Immunity in Patients With Anti-MDA5 Antibody Positive Dermatomyositis and Interstitial Lung Disease

Start date: January 20, 2024
Phase:
Study type: Observational

The purpose of this study was to analyze the relationship between the microbial community, host immunity and the presence or absence of concurrent rapidly progressive interstitial lung disease patients with anti-MDA5 antibody positive dermatomyositis.