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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT05698173 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Systemic Lupus Erythematosus and Accelerated Aging

LUPAGE
Start date: September 8, 2023
Phase: N/A
Study type: Interventional

The study aims at evaluating the phenomena of immune system aging in patients with Systemic lupus erythematosus.

NCT ID: NCT05693571 Recruiting - Depression Clinical Trials

Engagement in CHildhood-Onset Systemic Lupus

ECHOS
Start date: August 2024
Phase: N/A
Study type: Interventional

The goal of this observational and pilot study is to better understand how depression symptoms may contribute to how well adolescent and young adults with lupus follow-up with their lupus clinical care. The main questions it aims to answer are: 1. Whether anhedonia (a core symptom of depression) predicts disengagement in care 2. Whether a patient-tailored mobile health application built to improve both engagement in care and depression symptoms will be feasible and acceptable to adolescents and young adults with lupus. Participants with systemic lupus, ages 15-24 from the Bronx, New York will be asked to complete questionnaires; some will be asked to participate in focus groups to help adapt the mobile health app; participants will also be invited to join a pilot study to try the mobile health app for 6 months and answer questionnaires to document the experience.

NCT ID: NCT05689580 Recruiting - Clinical trials for Systemic Lupus Erythematosus

The Influence of Ketogenic Diet on Lupus Nephritis Patients' Immunity

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The study investigates the dietary habits in relation to low doses of omega-3 fatty acids in subcutaneous adipose tissue, disease activity and atherosclerosis. The low intake of omega-3 and high intake of carbohydrate among patients with SLE appear to be associated with worse disease activity, adverse serum lipids and plaque presence.Three-month-old mice received an injection of pristane or saline solution and were fed with different experimental diets: sunflower oil diet or extra virgin olive oil (EVOO) diet. After 24 weeks, mice were sacrificed, spleens were collected and kidneys were removed for immunoinflammatory detections. The study have demonstrated that EVOO diet significantly reduced renal damage and decreased cytokine: TNF-α, IL-6, IL-10 and IL-17 production.The ketogenic diet utilizes a high fat, adequate protein, low carbohydrate diet that control type of food and exchange. The aim of the present study that ketogenic diet treated in SLE patients may decrease overactive immunity and associated inflammatory markers.

NCT ID: NCT05688696 Recruiting - Clinical trials for Systemic Lupus Erythematosus, SLE

Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus

Start date: April 29, 2023
Phase: Phase 2
Study type: Interventional

This is a phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of orelabrutinib in adult subjects with SLE who are receiving standard of care (SOC) therapy.

NCT ID: NCT05687526 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus

Start date: May 25, 2023
Phase: Phase 1
Study type: Interventional

This is a multi-center, open-label, phase 1 study.

NCT ID: NCT05672576 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus

OPUS-2
Start date: June 26, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous in adult patients with moderate to severe symptoms. The main questions it aims to answer are: - How well cenerimod works on top of the treatment already being administered. - How safe cenerimod is for adult patients with Systemic Lupus Erythematosus. Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered. In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.

NCT ID: NCT05666336 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients

Start date: December 31, 2022
Phase: Phase 4
Study type: Interventional

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with abnormal activation of B lymphocytes, which may result in many adverse consequences and even death if not treated actively. Telitacicept, approved conditionally in China in March 2021, is a biologic agent targeting B lymphocyte stimulator (BLyS)and a proliferating inducing ligand (APRIL) dually for patients with active SLE patients who have not responded to conventional treatment. The investigators hope to screen predictive biomarkers of efficacy and explore the mechanism of difference in efficacy of Telitacicept with Chinese characteristics by omics.

NCT ID: NCT05659407 Recruiting - Clinical trials for Rheumatoid Arthritis

BAFF-var as a Biomarker of Response to B-depletive Treatment in Systemic Lupus Erythematosus and Rheumatoid Arthritis

PREDICT
Start date: July 24, 2020
Phase:
Study type: Observational

A variant of the TNFSF13B gene, commonly referred to as BAFF-var has been associated with an increased risk of developing immune-mediated diseases, such as Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA). This polymorphism leads to the production of higher levels of BAFFs, that in turns are associated with more severe disease, high anti-Sm and anti-dsDNA titre, complement consumption, and increased risk of flare in SLE, and higher disease activity in RA. This is a prospective study aiming to explore the immunological basis of a potential role of BAFF-var as a prognostic biomarker for response to belimumab and rituximab, the main B-depletive treatments, in SLE and RA patients, respectively. More in detail, the study aims to evaluate if the condition of BAFF-var carrier in SLE and RA patients, treated respectively, with belimumab plus standard of care or rituximab influences immunological, molecular and clinical variables, such as: (a) soluble BAFF (BAFFs) cytokine, (b) mRNA-BAFF (c) miRNA-15a (d) B-cell subpopulations (d) disease activity, as assessed by standardized clinimetric tools.

NCT ID: NCT05648500 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

OPUS-1
Start date: December 13, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms. The main questions it aims to answer are: - How well cenerimod works on top of the treatment already being administered. - How safe cenerimod is for adult patients with Systemic Lupus Erythematosus. Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered. In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.

NCT ID: NCT05639114 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

SIRIUS-SLE 1
Start date: March 2, 2023
Phase: Phase 3
Study type: Interventional

The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).