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Lupus Erythematosus, Systemic clinical trials

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NCT ID: NCT05835310 Recruiting - Clinical trials for Systemic Lupus Erythematosus

An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants

SLE
Start date: March 14, 2024
Phase: Phase 3
Study type: Interventional

A Study to evaluate the PK, PD, efficacy, and safety of Anifrolumab in children with moderate to severe active SLE

NCT ID: NCT05828147 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Anti-CD20 Antibodies for Treatment of SLE-PAH

Start date: May 25, 2023
Phase: Phase 4
Study type: Interventional

This is a prospective, single-arm, single-center, explorative clinical trial to evaluate the effect of Rituximab on disease progression in subjects with SLE-PAH receiving concurrent stable-dose standard medical therapy. The study will focus on assessment of clinical response and safety measures longitudinally. In addition, the biomarker of treatment efficacy with Rituximab and pathogenic autoantibody response in this disease will be investigated.

NCT ID: NCT05798117 Recruiting - Clinical trials for Systemic Lupus Erythematosus

An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus

Start date: February 28, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The study is intended to assess safety, efficacy and cellular kinetics of YTB323 treatment in participants with severe refractory systemic lupus erythematosus.

NCT ID: NCT05796206 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Clinical Study of MIL62 in Systemic Lupus Erythematosus

Start date: May 26, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, pharmacokinetics(PK) 、pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.

NCT ID: NCT05765006 Recruiting - Clinical trials for Systemic Lupus Erythematosus

CD19-CART(Relma-cel) for Moderate to Severe Active Systemic Lupus Erythematosus

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

This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.

NCT ID: NCT05763225 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

Validation of Patient E-tool to Measure Systemic Lupus Activity

OPTIMISE
Start date: February 9, 2023
Phase:
Study type: Observational

Validation of a self-questionnaire (SLEDAI-P/LUPIN) completed by the patient to measure the activity of the systemic lupus, in order to improve the patient's empowerment.

NCT ID: NCT05748899 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Effect of Applying Ujjayi Pranayama on Cortisol in Lupus Patients

Start date: December 15, 2022
Phase: N/A
Study type: Interventional

stress vulnerability is very common in lupus patients, specifically women, hence the rates of depression , insomnia, easy fatigue perception, anxiety are high in those women. pranayama is a yogic intervention that may treat the above problems

NCT ID: NCT05747651 Recruiting - Clinical trials for Systemic Lupus Erythematosus (SLE)

3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2

3TR-SLE2
Start date: March 27, 2023
Phase:
Study type: Observational

The natural history of Systemic lupus erythematosus (SLE) is characterized by relapses or flares alternated with periods of remission. Flares are associated with accrual of organ damage independently of other risk factors, both contributing to a considerable morbidity. No useful biomarker is currently available to predict which patients with a quiescent disease are at risk of flare. The 3TR project (funded by the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 831434, and supported by European Union's Horizon 2020 research and innovation programme and EFPIA) is a transdisciplinary consortium that primary aims at identifying biosignatures as predictors of response and non-response to therapy in seven different autoimmune, allergic and inflammatory diseases, including SLE. 3TR will perform a longitudinal multi-dimensional molecular analysis in patients with these diseases. A molecular profiling approach is a modern and innovative way to investigate and stratify heterogeneous diseases on the basis of their common biomolecular pathways. The main hypothesis of the 3TR project is that data obtained from multiomic analysis across the seven different diseases will identify shared biological pathways that better predict the response or non-response to therapy despite their differences in terms of clinical phenotypes and pathogenetic mechanisms. Therefore patients from multiple European centers participating in 3TR will be recruited for a longitudinal clinical follow-up and collections of several samples that will be used to perform multi-omic analysis.

NCT ID: NCT05714930 Recruiting - Clinical trials for Systemic Lupus Erythematosus

LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus

Lupus-Best
Start date: December 12, 2023
Phase: N/A
Study type: Interventional

Multicenter, national, two-armed cluster-randomized controlled trial to evaluate the effect of a treat-to-target (T2T) strategy in in systemic lupus erythematosus (SLE). 14 centers will be randomized 1:1 to T2T or standard of care. Per arm 303 patients with SLE who are not in remission will be included and receive either tight control with 6-weekly visits with the aim to reach remission or SoC with control visits and treatment adjustment according to the physicians discretion. Study duration is 120 weeks using damage accrual and Health related Quality of Life as major outcomes.

NCT ID: NCT05704153 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)

VaNeSA
Start date: September 30, 2022
Phase: N/A
Study type: Interventional

The overall goal of this clinical trial is to evaluate the causality relationship between the non vagus nerve stimulation waveform parameters and the therapeutic effect. Thus, unlocking a pathway to optimize parameters that maximize the benefits of therapy and minimize unwanted side effects. The experimental design includes the analysis of physiological signals, clinical biomarkers of disease, and clinical outcomes to determine the most effective measures for the monitoring, optimization, and personalization of non vagus nerve stimulation in systemic lupus erythematosus disease.