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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT05866861 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus

Start date: April 24, 2023
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety and tolerability of CUG252 following multiple ascending doses in participants with Systemic Lupus Erythematosus (SLE).

NCT ID: NCT05863689 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

Microvascular Ocular Changes of Systemic Lupus Erythematous

VascLup
Start date: May 10, 2023
Phase:
Study type: Observational

The goal of this observational study is to to assess the ocular microvascular status of SLE patients with inactive disease and without ocular involvement. The main questions it aims to answer are: - the choroidal vascular status and thickness in SLE - the retinal macular microvascular status and structure in SLE Participants will be assessed with Spectral Domain Optical Coherence Tomography (SD-OCT). Researchers will compare SLE patients with healthy controls matched for age and sex.

NCT ID: NCT05859997 Recruiting - Systemic Sclerosis Clinical Trials

Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases

Start date: May 17, 2023
Phase: N/A
Study type: Interventional

This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.

NCT ID: NCT05859191 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Study of Neonatal IgG Fc Receptor Expression in Natural Killer T Cells Expressing an Invariant T Receptor : Implication in the Pathophysiology of Systemic Lupus

FiNKLUPUS
Start date: July 21, 2023
Phase:
Study type: Observational

This study evaluates the variation of expression of the neonatal Fc receptor (FcRn) in Natural Killer T Cells Expressing an Invariant T Receptor (iNKT) and monocytes along with the surface expression of Fc gamma type II receptor (RII) and RIII in active or newly diagnosed lupus patients compared to inactive lupus patients.

NCT ID: NCT05858684 Recruiting - CAR-T Cell Therapy Clinical Trials

Dual Target CAR-T Cell Treatment for Refractory Systemic Lupus Erythematosus (SLE) Patients

Start date: May 11, 2023
Phase: Early Phase 1
Study type: Interventional

This is an early exploratory phase, single arm, non-randomized, open label, treatment study trial to determine the maximum tolerated dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.

NCT ID: NCT05856448 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus

GALACELA
Start date: June 28, 2023
Phase: Phase 2
Study type: Interventional

A study evaluating the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG3667 administered orally once daily for 48 weeks in approximately 180 adult participants with active Systemic Lupus Erythematosus (SLE).

NCT ID: NCT05846347 Recruiting - CAR-T Clinical Trials

Phase I Clinical Study of GC012F Injection in Treatment of Refractory Systemic Lupus Erythematosus

Start date: May 15, 2023
Phase: Phase 1
Study type: Interventional

This is a phase I, single arm, non-randomized, open label, treatment study trial to determine the recommended phase II dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.

NCT ID: NCT05845593 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)

ReLATE
Start date: December 19, 2023
Phase:
Study type: Observational

This is an open label study to determine the association of the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score, Physician Global Assessment (PGA) and standard laboratory measures, including ANA, anti-DNA, anti-RNP and complement components C3 and C4, as well as Patient Reported Outcomes capturing pain, fatigue and Health-Related Quality of Life. The test will be administered on one occasion to patients with a clinical diagnosis of lupus or incomplete lupus and clinical and laboratory features evaluated contemporaneously. This trial includes a pilot study of approximately 10 subjects from 2-3 sites to assess whether the delivery times of LuGENE® laboratory results do not exceed more than 7 business days.

NCT ID: NCT05843643 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus

SELECT-SLE
Start date: July 19, 2023
Phase: Phase 3
Study type: Interventional

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 3 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib based on their disease activity and their original treatment assignment in Study 1 or 2. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world. Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

NCT ID: NCT05835986 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus

Start date: December 18, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7507062 in participants with systemic lupus erythematosus (SLE). The study will have 2 parts: Part 1 is a single ascending dose-finding (SAD) part and Part 2 is a dose escalation with fractionated dosing part.