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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT06153095 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of IMPT-514 in Active Refractory Systemic Lupus Erythematosus (SLE)

Start date: February 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-514, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with active, refractory lupus nephritis and systemic lupus erythematosus. IMPT-514 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Individual participants will remain in the active post-treatment period for approximately 1 year. Participants will continue in long-term follow-up for 15 years from treatment.

NCT ID: NCT06151990 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Assessment of Lipid Profile in Juvenile Systemic Lupus Erythematosus

Start date: December 2023
Phase:
Study type: Observational

. To determine pattern and frequency of dyslipoproteinemia in patients with newly diagnosed juvenile SLE and to assess effect of disease activity on lipid profile of patients with juvenile SLE.

NCT ID: NCT06144710 Recruiting - Clinical trials for Systemic Lupus Erythematosus (SLE)

SG301-SC Injection Safety Study in Subjects With Systemic Lupus Erythematosus

Start date: November 10, 2023
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single dose in healthy volunteers and multiple doses of SG301 SC injection in participants with systemic lupus erythematosus (SLE).

NCT ID: NCT06137053 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Effect of Telitacicept on Transitional Regulatory B Cells in Patients With Systemic Lupus Erythematosus

Start date: November 1, 2022
Phase:
Study type: Observational

The effect of Telitacicept treatment on the changes of transitional regulatory B lymphocyte T1, T2B cell subsets and plasma blasts and the expression levels of cytokines IL-10, IL-35, April and BAFF in SLE.

NCT ID: NCT06133972 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

SIRIUS-SLE LTE
Start date: May 21, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

NCT ID: NCT06121297 Recruiting - Clinical trials for Systemic Lupus Erythematosus

RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus

Start date: February 16, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus

NCT ID: NCT06119763 Recruiting - Clinical trials for Systemic Lupus Erythematosus

AntiDFS70 Lupus Nephritis

Start date: October 15, 2023
Phase:
Study type: Observational

Systemic lupus erythematous (SLE) is a heterogeneous autoimmune disease that involve many different organs and display a variable clinical course. The prevalence of SLE varies across gender, race/ethnicity, and geographic regions. SLE demonstrates a striking female predominance with a peak incidence of disease during the Reproductive years. In adults, the female to male ratio is 10- 15:1(1)( 2) Clinical features in individual patients can be quite variable and range from mild joint and skin involvement to severe, life-threatening internal organ disease. Constitutional symptoms, rash, mucosal ulcers, inflammatory polyarthritis, photosensitivity, and serositis are the most common clinical features of the disease. (3) (4) Anti-DFS70 antibodie) and their clinical associations remain an immunological paradox. Unlike other antinuclear antibodies , there is a growing body of evidence that anti-DFS70 antibodies, when present in high titers and in isolation (without accompanying other antibodies), are useful to aid in the exclusion of antinuclear antibodies associated rheumatic diseases. (8) Anti-DFS70 antibodies were not associated with lupus nephritis development in Systemic lupus erythematosus patients but were associated with anti-dsDNA antibodies , proliferative lupus nephritis, and renal activity index . This suggests their potential to serve as a non-histological biomarker for lupus nephritis subclass and activity status. (8)

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: NCT06106893 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Clinical Study of CD19 Universal CAR-γδT Cells in Active Systemic Lupus Erythematosus

Start date: January 12, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to explore the safety and efficacy of CD19 Universal CAR-γδT cells in active severe systemic lupus erythematosus.

NCT ID: NCT06087523 Enrolling by invitation - Pulmonary Disease Clinical Trials

Pulmonary Disease Among Patients With Systemic Lupus Erythematosus

Start date: August 15, 2023
Phase:
Study type: Observational

Pulmonary diseases are common among patients with Systemic Lupus Erythematosus (SLE) and associated with a significantly increased morbidity, mortality, and lower self-reported health related quality of life. The investigators aim to diagnose and categorise SLE patients in regards of pulmonary disease and introduce alternative diagnostic tools. The investigators will perform a cross-sectional study of a population-based study population of SLE patients. The participants will undergo review of medical record, a clinical assessment, body plethysmography, six-minute walk test, high-resolution computed tomography of the thorax (HRCT), thoracic and diaphragmatic ultrasound, blood sampling with analysis of autoantibodies, and three questionnaires. After the investigations, pulmonary diseases among the participants will be diagnosed at a multidisciplinary discussion by a specialised pulmonologist with contribution from a rheumatologist and a radiologist. The investigators believe that the study will increase the understanding of pulmonary diseases among SLE patients, which could improve overall disease management. The investigators will introduce new alternative diagnostic tools, that could ease diagnosing pulmonary disease among SLE.