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Systemic Lupus Erythematosus clinical trials

View clinical trials related to Systemic Lupus Erythematosus.

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NCT ID: NCT06255028 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of CNTY-101 in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)

CALiPSO-1
Start date: August 2024
Phase: Phase 1
Study type: Interventional

CALiPSO-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety and efficacy of CNTY-101 in participants with moderate to severe systemic lupus erythematosus.

NCT ID: NCT06238531 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

A Clinical Trial to Evaluate Safety of Gusacitinib in Patients With Systemic Lupus Erythematosus (SLE) or Lupus

Start date: June 5, 2024
Phase: Phase 1
Study type: Interventional

Background: Systemic lupus erythematosus (SLE), also called lupus, is a disease that causes the body s immune system to attack healthy tissue. Lupus causes swelling and inflammation in the skin, skin, joints, kidneys, brain, blood vessels, and other organs. There is no cure for lupus. Current treatments do not help everyone and may have adverse effects. Better treatments are needed. Objective: To test a study drug (Gusacitinib) in people with lupus. Eligibility: People aged 18 years and older with lupus. Design: Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function. They will have a chest X-ray. They will have tests that use blood pressure cuffs to measure blood flow and pressure throughout the body. Participants will have 9 clinic visits and 6 phone visits over about 7 months. The study has 3 parts. Part 1: Gusacitinib is a tablet taken by mouth. Participants will be divided into 3 groups. One group will receive the study drug, and a second group will get a placebo. The placebo looks like the study drug but does not contain any medicine. Both of these groups will take their tablets once a day for 12 weeks. The third group will continue to take their usual medications for lupus throughout the study. Part 2: All participants who took the study drug or placebo in part 1 will take the study drug once a day for 12 weeks. Part 3: All participants who took the study drug will stop taking it for 4 weeks.

NCT ID: NCT06228222 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Predictors of Remission and Renal Outcomes in Lupus Nephritis in Assuit University Hospitals.

Start date: January 25, 2024
Phase:
Study type: Observational

the goal of this opservetional study is to identify predictors of remission and renal outcomes in SLE patients affected with Lupus nephritis. the main question it aims to answer is: *What are the clinical, histological and chemical parameters that connected to undesirable renal prognosis in LN? All patients will be subjected to the following: Complete through history taking, clinical examination disease activity will be assessed by SLEDAI. The Laboratory investigations and renal biopsy.

NCT ID: NCT06227559 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

The Role of Some Hematological Parameters in Juvenile Systemic Lupue Erythematosus

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

Juvenile systemic lupus erythematosus is an autoimmune disorder with multisystem involvement, leading to inflammatory damage to the joints, kidney, central nervous system, and hematopoietic system. Although the prevalence rate of juvenile systemic lupus erythematosus in a developing country is not known, as per literature the female-to-male ratio rises from 4.5 : 1 in adolescence to 8--12 : 1 in adult-onset patients. - The full mechanism of SLE is still unknown however, production of autoantibodies and immune complex deposition with subsequent infiltration of neutrophils, hyper-activation of B and T cells, reduced ability of immune complexes and apoptotic cell clearance, and defects in multiple immune regulatory networks, are central to organ inflammation and subsequent damage in SLE. Systemic lupus erythematosus goes on with organ involvements by remission and relapses.

NCT ID: NCT06188507 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

A First Time in Human Study to Evaluate the Safety and Tolerability of GSK3996401 Following Dosing With GSK4347859 in Healthy Participants

Start date: January 11, 2024
Phase: Phase 1
Study type: Interventional

This is a first time in human (FTiH) study which means that this is the first time that GSK4347859 is given to humans. The study is designed to investigate the safety, tolerability, and concentration of GSK3996401 (the activated form of GSK4347859) in the blood following single ascending doses (Part 1) and multiple ascending doses (Part 2) of GSK4347859 in healthy participants. Part 1 consists of 2 planned cohorts with up to 4 treatment periods in each and is expected to have up to 8 dose levels. Part 2 will investigate 14 days of repeat dosing in 3 cohorts with 3 dose levels.

NCT ID: NCT06106906 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

A Clinical Study of CD19 CAR-T in Refractory/Moderate-to-severe Systemic Lupus Erythematosus

Start date: December 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to explore the safety and efficacy of CD19 CAR-T in refractory/moderately severe systemic lupus erythematosus.

NCT ID: NCT05929248 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Exploring the Therapeutic Effect of Telitacicept on Lupus Erythematosus Complicated With Thrombocytopenia

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

The purpose of this study is to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus and refractory thrombocytopenia

NCT ID: NCT05917288 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus

Start date: June 29, 2023
Phase: Phase 1
Study type: Interventional

This study will evaluate the pharmacokinetic characteristics and safety of belimumab subcutaneous (SC) in Chinese pediatric participants with SLE who have completed 48 weeks belimumab Intravenous (IV) treatment in 213560 study (NCT04908865)

NCT ID: NCT05818254 Not yet recruiting - Contraception Clinical Trials

The HOP-STEP Intervention: Improving Maternal Health in Women With Lupus sIRB

HOP-STEPsIRB
Start date: May 31, 2024
Phase: N/A
Study type: Interventional

While the HOP-STEP (Healthy Outcomes in Pregnancy with SLE Through Education of Providers) program has been demonstrated to be effective in improving provider confidence, increasing contraception documentation, and facilitating equitable pregnancy planning care in a single sub-specialty clinic here at Duke, the delivery of HOP-STEP may need to be changed to increase its fit with the local context at the University of Chicago Medical Center (UCMC) and subsequent locations. Thus, the investigators will now fit the intervention into a high-minority, high-poverty academic rheumatology center, and later pilot it through a randomized trial to identify and overcome existing barriers to equitable pregnancy prevention and planning at another institution (The University of Chicago Medical Center). The objective of this study is to prepare for a multi-center trial of the HOP-STEP intervention by fitting and then piloting its implementation and measuring its potential impact on maternal outcomes.

NCT ID: NCT05799378 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

SHIELD
Start date: April 2024
Phase: Phase 3
Study type: Interventional

Hydroxychloroquine (HCQ) is a systemic lupus erythematosus (SLE) medication that has been very effective in reducing lupus disease activity and keeping patients stable with reduced symptoms. Despite a track record of safety with regard to infection compared to traditional immunosuppressive agents, the risk of HCQ retinal toxicity escalates with continued use. Evaluation using sensitive standard of care approaches suggests nearly a third of patients accrue retinal damage. Data are needed to accurately weigh the balance between accumulating ocular exposure of HCQ versus the risk of disease flare in a population that may have more inactive disease than younger patients. The purpose of this trial is to address the safety of withdrawal of HCQ in SLE patients =60 years old. The central hypothesis is that HCQ can be safely discontinued in stable/quiescent patients assessed by validated disease activity and flare instruments in the context of serologic, cytokine and transcriptomic profiling. Patients will be randomized to either the placebo or active arm and followed every 2 months for one year to assess disease activity and flares.