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Lupus Erythematosus, Systemic clinical trials

View clinical trials related to Lupus Erythematosus, Systemic.

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NCT ID: NCT04895241 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

TOPAZ-1
Start date: May 25, 2021
Phase: Phase 3
Study type: Interventional

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: - After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. - All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. - Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - There will be a follow-up safety period that lasts up to 24 weeks. - In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.

NCT ID: NCT04893161 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

A Model About the Response of Belimumab in SLE

MRBS
Start date: June 1, 2024
Phase: Phase 4
Study type: Interventional

A prospective, single-center cohort study aims to determine a predictive model of the response of belimumab at Week 48.

NCT ID: NCT04882878 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

Start date: August 20, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).

NCT ID: NCT04877691 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

Tulip SC
Start date: June 8, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy

NCT ID: NCT04873739 Completed - Clinical trials for Systemic Lupus Erythematosus

AS-OCT Study of Cornea and Tear Film Parameters in SLE Patients

Start date: July 1, 2020
Phase:
Study type: Observational

The aim of thie study to assess tear film parameters such as tear meniscus height (TMH), tear meniscus area (TMA), and tear meniscus depth (TMD). In addition, corneal pachymetry and epithelial thickness maps in SLE patients and compared to healthy subjects of similar age and gender.

NCT ID: NCT04857151 Completed - Inflammation Clinical Trials

Stress, Inflammation and Immune Response Pilot Study- Aim 3

Start date: February 2, 2022
Phase: Early Phase 1
Study type: Interventional

The overall goal of this study is to investigate the effects of stress and glucose intake at the molecular level including gene expression, protein and functional analysis of immune cells in real time. Aim 1- Characterizing the immune response after acute stress and glucose consumption Aim 2- Temporal mapping of the modulation of immune cell function via meditation Aim 3-Influence of meditative practice on lupus patients Aim 4-Influence of meditative practice on healthy subjects Current Clinicaltrials.gov record, will be focused on Aim-3 only. Aim-3 will test whether meditation alters neutrophil function and inflammation in patients with lupus. Study team will investigate whether patient neutrophils have altered NET formation, phagocytosis, ROS signaling and migration after ABMP. Innate immune function via analysis of monocytes by flow cytometry will also be analyzed. Other immune cell responses including CD8 T cells will also be investigated.

NCT ID: NCT04857034 Active, not recruiting - Clinical trials for Lupus Erythematosus, Discoid

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

Start date: July 12, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.

NCT ID: NCT04839315 Terminated - Osteoarthritis Clinical Trials

COVID-19 Vaccination in Rheumatic Disease Patients

Start date: February 15, 2021
Phase: Early Phase 1
Study type: Interventional

The research is being done to study the immune responses to COVID-19 vaccination in patients with rheumatic diseases.

NCT ID: NCT04835883 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients

Start date: September 26, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label, one-arm single-center phase Ⅱa study exploring the efficacy and safety of CS20AT04 (HLA-haplo Matched Allogenic Bone Marrow-Derived Stem Cells) in two subpopulation group of systemic lupus erythematosus patients - lupus nephritis and lupus cytopenia.

NCT ID: NCT04835441 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus

Synergy
Start date: June 22, 2021
Phase: Phase 2
Study type: Interventional

This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of ALPN-101 (acazicolcept) in adults with moderate to severe active systemic lupus erythematosus (SLE)