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Systemic Lupus Erythematosus Clinical Trials

102 recruiting trials for Systemic Lupus Erythematosus. Eligibility criteria explained in plain English.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.
102
Total Trials
102
Recruiting Now
4
Phase 3 Trials
10
Sponsors

Recruiting Trials

Clinical trial data sourced from the ClinicalTrials.gov registry, maintained by the National Library of Medicine. Always consult your doctor before considering any clinical trial.

RECRUITINGNCT04334031

Deployment o the Multidisciplinary Prospective Cohort Imminent

Immune-mediated inflammatory diseases (IMIDs) most often affect young patients and have high impact on morbidity and mortality with a significant alteration in the quality of life...

Sponsor: University Hospital, LilleEnrolling: 22001 location
RECRUITINGPhase 1 / Phase 2NCT05508009

Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant...

This is a single center, non-randomized, non-controlled open-label phase 1b/2a trial of performing sequential αβdepleted-HSCT and KT in patients requiring KT to prevent kidney...

Sponsor: Alice BertainaEnrolling: 121 location
RECRUITINGPhase 1NCT06340750

BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus

This phase 1 study seeks to examine the safety and recommended phase 2 dose (RP2D) of BAFF-ligand CAR-T cells (LMY-920) in adult patients with refractory systemic lupus...

Sponsor: Luminary TherapeuticsEnrolling: 181 location
RECRUITINGNCT05127980

Occurrence of Antibodies Cross-reacting With Autoantigens in Primary EBV Infection

The aim of this study is to assess the occurrence of antibodies cross-reacting with autoantigens that have been detected in the context of SLE in patients with primary EBV...

Sponsor: University Hospital, Basel, SwitzerlandEnrolling: 801 location
RECRUITINGPhase 1NCT07123519

A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases

This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and...

Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.Enrolling: 181 location
RECRUITINGPhase 3NCT05126277

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With...

This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination...

Sponsor: Novartis PharmaceuticalsEnrolling: 46220 locations
RECRUITINGPhase 2NCT07340463

The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis...

1. Study Design This is a single-center, prospective, randomized, controlled, exploratory clinical trial. The study is designed to evaluate and compare the efficacy and safety of...

Sponsor: Nanjing University School of MedicineEnrolling: 501 location
RECRUITINGPhase 2NCT06599658

COVID-19 Booster and IIV Schedule in Immunocompromised Hosts

The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomized controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine...

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreEnrolling: 6603 locations
RECRUITINGPhase 1NCT07276958

A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid...

The purpose of this study is to investigate the safety and tolerability of LY4298445 in healthy participants and in participants with systemic lupus erythematosus (SLE) or...

Sponsor: Eli Lilly and CompanyEnrolling: 637 locations
RECRUITINGNCT06586710

Interferon Pathway Activation in Monogenic and Nonmonogenic Forms of Pediatric SLE

Pediatric SLE includes monogenic forms, some of which involve the interferon type I (IFN-I) pathway. The IFN-I pathway is renally active in adult SLE and correlates with the...

Sponsor: Meyer Children's Hospital IRCCSEnrolling: 603 locations
RECRUITINGPhase 1NCT07104721

A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases

This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and...

Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.Enrolling: 181 location
RECRUITINGNCT05007340

ILD-SARDs Registry and Biorepository

A complex interaction between demographic, environmental and genetic mechanisms impact the onset, severity and outcome of ILD-SARDs through dysregulation of the immune system and...

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreEnrolling: 2521 location
RECRUITINGPhase 1NCT06013995

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With...

The purpose of this study is to evaluate safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via...

Sponsor: Bristol-Myers SquibbEnrolling: 4420 locations
RECRUITINGNCT03929887

KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis

Glomerulonephritis (GN) generates an enormous individual and social economic burden. However, the therapeutic options are largely based on clinical and pathological parameters and...

Sponsor: Seoul National University HospitalEnrolling: 30006 locations
RECRUITINGPhase 4NCT07225387

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus...

This is a Phase IV, open-label, randomized trial to determine whether the combination of Belimumab (BEL) and Voclosporin (VCS), plus background therapy with Mycophenolate Mofetil...

Sponsor: NephroNet, Inc.Enrolling: 307 locations
RECRUITINGNCT06527872

Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN

The purpose of the OBSErve-LN study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active LN in multiple...

Sponsor: GlaxoSmithKlineEnrolling: 3005 locations
RECRUITINGPhase 1NCT07491900

A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

This Phase 1, open label, dose escalation study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of HB2198, a tetravalent...

Sponsor: Hinge BioEnrolling: 301 location
RECRUITINGPhase 1 / Phase 2NCT06428188

Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases

This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or CD19 or both...

Sponsor: Essen BiotechEnrolling: 601 location
RECRUITINGPhase 2NCT05688696

Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus

This is a phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of orelabrutinib in adult subjects with SLE who are...

Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.Enrolling: 18620 locations
RECRUITINGPhase 2NCT03152058

IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women...

Sponsor: David Ware BranchEnrolling: 553 locations
RECRUITINGPhase 1NCT05018858

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Lupus

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Lupus

Sponsor: The Foundation for Orthopaedics and Regenerative MedicineEnrolling: 152 locations
RECRUITINGPhase 1NCT07323173

A Phase I Study to Assess LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus

A Phase I, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study of Single Subcutaneous Injections of LBL-047 in Healthy Adults and Patients with systemic lupus...

Sponsor: Nanjing Leads Biolabs Co.,LtdEnrolling: 11211 locations
RECRUITINGPhase 1 / Phase 2NCT06350110

Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)

This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002...

Sponsor: Essen BiotechEnrolling: 751 location
RECRUITINGPhase 1NCT07011043

A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)

The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be...

Sponsor: Climb Bio, Inc.Enrolling: 3018 locations
RECRUITINGPhase 1 / Phase 2NCT07041801

Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells

This study will investigate the safety and efficacy of allogeneic umbilical cord-derived stem cell therapy in treating patients with moderate to severe systemic lupus...

Sponsor: Shenzhen Beike Bio-Technology Co., Ltd.Enrolling: 581 location
RECRUITINGNCT04902807

Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation

The main objective of this study is to generate diagnosis and therapeutic-decision tools through the identification of molecular causes of PIDs with autoimmunity/inflammation and...

Sponsor: Institut National de la Santé Et de la Recherche Médicale, FranceEnrolling: 5001 location
RECRUITINGPhase 2NCT05440422

The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) -...

Background: People with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke....

Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Enrolling: 451 location
RECRUITINGPhase 1 / Phase 2NCT06106906

A Clinical Study of CD19 CAR-T in Active Systemic Lupus Erythematosus

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

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyEnrolling: 151 location
RECRUITINGEarly Phase 1NCT07507201

Allogeneic CD19/BCMA CAR-T for B Cell-Related Autoimmune Disease

This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C. QT-219C is a universal...

Sponsor: The Children's Hospital of Zhejiang University School of MedicineEnrolling: 151 location
RECRUITINGPhase 3NCT07332481

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease

The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of...

Sponsor: EMD Serono Research & Development Institute, Inc.Enrolling: 2023 locations
RECRUITINGNCT06308770

Fatigue in Lupus Intervention Programmes (FLIP)

Systemic Lupus Erythematosus (SLE) is an autoimmune rheumatic disease. Patients report that fatigue has a significant impact on their quality of life but is often not discussed in...

Sponsor: University of EdinburghEnrolling: 901 location
RECRUITINGNCT04402086

Rheumatology Patient Registry and Biorepository

To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.

Sponsor: Yale UniversityEnrolling: 50001 location
RECRUITINGNCT06339957

Rheumatology Diet Study

This study aims to collect information on rheumatology patients' dietary habits, autoimmune disease activity, dietary changes, disease symptom improvements, and perceptions on...

Sponsor: University of Central FloridaEnrolling: 5001 location
RECRUITINGNCT06659029

Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the...

Sponsor: AstraZenecaEnrolling: 4421 location
RECRUITINGPhase 2NCT07409181

A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)

This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The...

Sponsor: Boehringer IngelheimEnrolling: 40520 locations
RECRUITINGPhase 1NCT07109986

UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis

This is an open-label investigator-initiated trial (IIT) to assess the safety, efficacy, and PK(pharmacokinetic)/PD(pharmacodynamics ) of UB-VV410 in adult subjects with...

Sponsor: Nanjing IASO Biotechnology Co., Ltd.Enrolling: 211 location
RECRUITINGNCT06435468

Biocollection of Rare Pediatric-onset of Autoimmune and Autoinflammatory Diseases

Rare diseases are defined as those that affect one person in 2,000, or around three million people in France. The majority of rare diseases are caused by genetics and tend to be...

Sponsor: Hospices Civils de LyonEnrolling: 40013 locations
RECRUITINGPhase 3NCT07405970

A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus

This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.

Sponsor: Beijing Mabworks Biotech Co., Ltd.Enrolling: 3161 location
RECRUITINGPhase 1NCT06943937

A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus

This study evaluates the safety and efficacy of YTS109 cells in adults with refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus-Immune Thrombocytopenia (SLE-ITP)....

Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.Enrolling: 361 location
RECRUITINGPhase 1NCT06916806

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants...

The purpose of this study is to measure the safety, tolerability, PK, and PD of AZD5492 administered subcutaneously in adult participants with SLE or IIM or RA Study details...

Sponsor: AstraZenecaEnrolling: 7220 locations
RECRUITINGEarly Phase 1NCT07339332

A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Dynamics of Universal CD19 / 20 Car-t Cell Injection...

This study is a single arm, open, exploratory dose escalation clinical study to evaluate the safety, efficacy, and cellular metabolic dynamics of ct1195e cells in patients with...

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyEnrolling: 121 location
RECRUITINGPhase 2NCT06559163

A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).

Sponsor: Zenas BioPharma (USA), LLCEnrolling: 19020 locations
RECRUITINGNCT07302113

Complete Cognitive Intervention for cSLE

This project will work closely with patients to design and test a new program that supports brain health in children and youth with childhood-onset lupus (cSLE). The investigators...

Sponsor: Andrea KnightEnrolling: 601 location
RECRUITINGPhase 1 / Phase 2NCT07010835

Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of YK012 in participants with...

Sponsor: Excyte Biopharma LtdEnrolling: 1891 location
RECRUITINGNCT04449991

Per-protocol Repeat Kidney Biopsy in Incident Cases of Lupus Nephritis

Lupus nephritis (LN) is one of the most severe complications of systemic lupus erythematosus (SLE). Among people living with SLE, 35-60% will develop LN during the course of the...

Sponsor: Karolinska InstitutetEnrolling: 2061 location
RECRUITINGPhase 1NCT07177911

Safety and Efficacy Study of CC312 for Moderate to Severe SLE

This study is a randomized, double-blind, placebo-controlled Phase I clinical trial featuring single and multiple ascending doses. It is designed to evaluate the safety,...

Sponsor: CytoCares IncEnrolling: 321 location
RECRUITINGPhase 2NCT05680480

A Study of Telitacicept in Lupus Nephritis

The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.

Sponsor: RemeGen Co., Ltd.Enrolling: 12020 locations
RECRUITINGEarly Phase 1NCT06946485

Universal Anti-CD70 CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus

This investigator-initiated trial aims to evaluate the safety and efficacy of universal anti-CD70 CAR-T (CHT101) in patients with relapsed refractory systemic lupus erythematosus.

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolEnrolling: 151 location
RECRUITINGNCT05443516

Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus

The aim of this research project is to better understand the origin and clinical significance of two lupus-specific "genetic signatures" (IFN signature and plasma cell signature)...

Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de LouvainEnrolling: 2501 location
RECRUITINGEarly Phase 1NCT07174843

An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases

This is a single arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability and preliminary efficacy of autologous chimeric antigen receptor T...

Sponsor: Shanghai Cell Therapy Group Co.,LtdEnrolling: 201 location

Showing 50 of 102 trials.Search all Systemic Lupus Erythematosus trials

Frequently Asked Questions

There are currently 102 clinical trials for Systemic Lupus Erythematosus, with 102 actively recruiting participants. These include trials across all phases from early-stage Phase 1 to late-stage Phase 3.

To join a clinical trial for Systemic Lupus Erythematosus, review the eligibility criteria on the trial detail pages, then talk to your doctor about whether a trial is right for you. Your doctor can help you evaluate the potential benefits and risks.

Phase 3 trials are large-scale studies that test whether a treatment is effective and monitor side effects. There are 4 Phase 3 trials for Systemic Lupus Erythematosus, representing treatments closest to potential FDA approval.

Clinical trials follow strict safety protocols overseen by Institutional Review Boards (IRBs) and the FDA. Participants are monitored closely and can withdraw at any time. Always discuss risks and benefits with your healthcare provider before enrolling.

Sources: ClinicalTrials.gov, FDA
Last updated:

Trial data sourced from the ClinicalTrials.gov API. This site does not provide medical advice, always talk to your doctor about clinical trial participation.

this entity is one of the data points covered by this site’s U.S. clinical trials and research registries dataset. The detail above comes directly from the NIH ClinicalTrials.gov registry; the context that follows situates the headline numbers against the broader distribution across active and historical clinical trials.

The methodology behind every numeric value on this page is publicly documented on the the NIH ClinicalTrials.gov registry portal and described in detail on this site’s methodology page. Refresh cadence varies by underlying series; the page surfaces the as-of date for each number so readers can trace any figure back to the source release.

Practical use of this page is in combination with the comparison and ranking pages elsewhere on the site, which surface the same data for this entity’s peers within active and historical clinical trials. A single-entity reading without peer context can be misleading when an entity is an outlier on one axis but typical on another.