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2026 data Public-data reference. official source

Systemic Lupus Erythematosus

Open-data reference.

100 US clinical trials · 43 currently recruiting

Active & Recent Trials

RECRUITING 5,000 participants

Rheumatology Patient Registry and Biorepository

Yale University

NCT04402086

RECRUITING 2,250 participants

Study of Systemic Lupus Erythematosus

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NCT00001372

RECRUITING Phase 3 1,000 participants

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

AbbVie

NCT05843643

RECRUITING 1,000 participants

Maternal Autoimmune Disease Research Alliance (MADRA) Registry

Duke University

NCT03276923

RECRUITING 1,000 participants

Duke Lupus Registry

Duke University

NCT00512694

RECRUITING 1,000 participants

CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry

CorEvitas

NCT06804057

RECRUITING 750 participants

Systemic Lupus Erythematosus in Gullah Health

Medical University of South Carolina

NCT00756769

RECRUITING 700 participants

Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)

Hospital for Special Surgery, New York

NCT00198068

RECRUITING Phase 3 550 participants

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

Novartis Pharmaceuticals

NCT06133972

RECRUITING NA 480 participants

Intervention to Improve Communication and Medication Adherence in Lupus

Duke University

NCT06458075

RECRUITING Phase 3 450 participants

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

UCB Biopharma SRL

NCT06617325

RECRUITING 442 participants

Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

AstraZeneca

NCT06659029

RECRUITING Phase 4 350 participants

A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)

GlaxoSmithKline

NCT06411249

RECRUITING Phase 3 330 participants

Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

NYU Langone Health

NCT05799378

RECRUITING Phase 2 290 participants

Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine

State University of New York - Upstate Medical University

NCT00775476

RECRUITING Phase 1 270 participants

A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

NCT05869955

RECRUITING Phase 4 224 participants

Safety of the Herpes Zoster Subunit Vaccine in Lupus

NYU Langone Health

NCT05559671

RECRUITING Phase 2 220 participants

A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases

Amgen

NCT06570798

RECRUITING NA 200 participants

Creating Health Course Study for People With Rheumatological Conditions

Terry L. Wahls

NCT07180537

RECRUITING Phase 2 190 participants

A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

Zenas BioPharma (USA)

NCT06559163

RECRUITING Phase 1 162 participants

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)

Genentech

NCT06984341

RECRUITING Phase 1 142 participants

A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants

GlaxoSmithKline

NCT06576271

RECRUITING Phase 2 116 participants

Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus

Sanofi

NCT05039840

RECRUITING Phase 3 100 participants

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

AstraZeneca

NCT05835310

RECRUITING 90 participants

Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

Children's National Research Institute

NCT04833465

RECRUITING Phase 1 72 participants

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.

AstraZeneca

NCT06916806

RECRUITING Early Phase 1 61 participants

Safety and Efficacy of ONT01 in Lupus

Hospital for Special Surgery, New York

NCT07107659

RECRUITING Phase 1 48 participants

Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants

AstraZeneca

NCT07201558

RECRUITING Phase 1 47 participants

Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders

M.D. Anderson Cancer Center

NCT06434363

RECRUITING Phase 2 45 participants

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

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NCT05440422

RECRUITING 40 participants

Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus

Northwell Health

NCT06378736

RECRUITING Phase 1 36 participants

A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions of ABBV-319 in Adult Participants With Systemic Lupus Erythematosus (SLE) and Sjogren's Disease (SjD)

AbbVie

NCT06977724

RECRUITING Phase 1 30 participants

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

Climb Bio

NCT07011043

RECRUITING Phase 1 30 participants

Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.

IRIS Research and Development

NCT06581562

RECRUITING Phase 1 28 participants

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

Cabaletta Bio

NCT06121297

RECRUITING Phase 2 24 participants

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus

Ventus Therapeutics U.S.

NCT07260877

RECRUITING Phase 1 21 participants

Alnuctamab for Refractory SLE (LATTE Study)

Icahn School of Medicine at Mount Sinai

NCT07219563

RECRUITING Phase 2 20 participants

Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases

Stephan Grupp MD PhD

NCT05029336

RECRUITING Phase 1 18 participants

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

Luminary Therapeutics

NCT06340750

RECRUITING Phase 4 16 participants

Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users

AstraZeneca

NCT06594068

RECRUITING Phase 1 12 participants

REACT-01: Reversing Autoimmunity Through Cell Therapy

Seattle Children's Hospital

NCT06465147

RECRUITING Phase 1 10 participants

UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients

LiveKidney.Bio

NCT06737380

RECRUITING Phase 1 6 participants

A Study of NKX019, a CD19 CAR NK Cell Therapy, in Subjects With Systemic Lupus Erythematosus

Columbia University

NCT06518668

ACTIVE NOT RECRUITING Phase 3 516 participants

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

Bristol-Myers Squibb

NCT05617677

ACTIVE NOT RECRUITING Phase 3 513 participants

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

Bristol-Myers Squibb

NCT05620407

ACTIVE NOT RECRUITING Phase 3 436 participants

Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

Novartis Pharmaceuticals

NCT05639114

ACTIVE NOT RECRUITING Phase 2 379 participants

The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

NCT05540327

ACTIVE NOT RECRUITING Phase 3 367 participants

Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

AstraZeneca

NCT04877691

ACTIVE NOT RECRUITING NA 314 participants

Peer Approaches to Lupus Self-management

Medical University of South Carolina

NCT03734055

ACTIVE NOT RECRUITING Phase 3 303 participants

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

Hoffmann-La Roche

NCT04963296

ACTIVE NOT RECRUITING Phase 3 288 participants

Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

Novartis Pharmaceuticals

NCT05624749

ACTIVE NOT RECRUITING Phase 2 268 participants

A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

Bristol-Myers Squibb

NCT04895696

ACTIVE NOT RECRUITING Phase 2 186 participants

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

Galapagos

NCT05856448

ACTIVE NOT RECRUITING Phase 2 155 participants

Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

Novartis Pharmaceuticals

NCT06293365

ACTIVE NOT RECRUITING Phase 1 48 participants

A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease

Synthekine

NCT06544330

ACTIVE NOT RECRUITING Phase 1 40 participants

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

Cugene

NCT05866861

ACTIVE NOT RECRUITING NA 36 participants

REACH (Restore Energy, Activity Can Help) Lupus Study

Tufts Medical Center

NCT06479213

ACTIVE NOT RECRUITING Phase 2 36 participants

Centrally Acting ACE Inhibition in SLE

Northwell Health

NCT04486118

ACTIVE NOT RECRUITING Phase 2 25 participants

Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)

GlaxoSmithKline

NCT04179032

ACTIVE NOT RECRUITING NA 14 participants

The HOP-STEP Intervention: Improving Maternal Health in Women With Lupus sIRB

Duke University

NCT05818254

ACTIVE NOT RECRUITING Phase 1 7 participants

Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)

Sana Biotechnology

NCT06294236

ACTIVE NOT RECRUITING Phase 1 6 participants

A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases

Century Therapeutics

NCT06255028

COMPLETED 5,000 participants

Web-based Genetic Research on Lupus

23andMe

NCT02530944

COMPLETED Phase 4 4,019 participants

Belimumab Assessment of Safety in SLE

GlaxoSmithKline

NCT01705977

COMPLETED 1,056 participants

Study of Families With Twins or Siblings Discordant for Rheumatic Disorders

National Institute of Environmental Health Sciences (NIEHS)

NCT00055055

COMPLETED Phase 3 819 participants

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

Human Genome Sciences

NCT00410384

COMPLETED Phase 2 626 participants

A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

MedImmune

NCT01438489

COMPLETED Phase 2 382 participants

A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321

Anthera Pharmaceuticals

NCT01305746

COMPLETED Phase 3 321 participants

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

UCB Biopharma SRL

NCT04294667

COMPLETED Phase 2 314 participants

A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)

Eli Lilly and Company

NCT02708095

COMPLETED 300 participants

Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture

National Center for Research Resources (NCRR)

NCT00006134

COMPLETED Phase 2 264 participants

Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

Biogen

NCT02847598

COMPLETED Phase 2 227 participants

Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease

UCB Pharma

NCT00624351

COMPLETED NA 222 participants

Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions

Duke University

NCT03938324

COMPLETED NA 201 participants

Breaking Implicit Bias Habits: An Individuation Pilot Study In Rheumatology

Brigham and Women's Hospital

NCT05116163

COMPLETED Phase 4 200 participants

Lupus Atherosclerosis Prevention Study

Johns Hopkins University

NCT00120887

COMPLETED Phase 1 158 participants

Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE)

Oklahoma Medical Research Foundation

NCT00987831

COMPLETED Phase 2 154 participants

Serologically Active, Clinically Stable Systemic Lupus Erythematosus

NYU Langone Health

NCT00000421

COMPLETED NA 135 participants

Reducing Disparities in Medication Adherence in SLE

Duke University

NCT03738826

COMPLETED Phase 2 119 participants

Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis

Bristol-Myers Squibb

NCT04186871

COMPLETED Phase 3 114 participants

GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

Genelabs Technologies

NCT00082511

COMPLETED Phase 2 109 participants

JBT-101 in Systemic Lupus Erythematosus (SLE)

National Institute of Allergy and Infectious Diseases (NIAID)

NCT03093402

COMPLETED 100 participants

The Research Registry for Neonatal Lupus

NYU Langone Health

NCT00074373

COMPLETED Phase 2 93 participants

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

GlaxoSmithKline

NCT01649765

COMPLETED Phase 1 84 participants

An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects

Bristol-Myers Squibb

NCT03541564

COMPLETED Phase 2 81 participants

Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)

Medical University of South Carolina

NCT02633163

COMPLETED Phase 3 80 participants

Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients

GlaxoSmithKline

NCT02119156

COMPLETED Phase 1 80 participants

A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects

Daiichi Sankyo

NCT05203692

COMPLETED Phase 4 79 participants

A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE)

Human Genome Sciences Inc., a GSK Company

NCT01597492

COMPLETED Phase 2 75 participants

FolateScan in Autoimmune Disease

Mayo Clinic

NCT00588393

COMPLETED Phase 1 74 participants

Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis

Pfizer

NCT03334851

COMPLETED Phase 1 72 participants

A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus

Janssen Research & Development

NCT02609789

COMPLETED Phase 1 69 participants

A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis

Kezar Life Sciences

NCT03393013

COMPLETED Phase 1 49 participants

A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation

Bristol-Myers Squibb

NCT03254784

COMPLETED 40 participants

The Role of ITGAM in Systemic Lupus Erythematosus

Northwell Health

NCT01230112

COMPLETED 40 participants

CLUE Study: Connective Tissue Disease Leg Ulcer Etiology Study

George Washington University

NCT00522002

COMPLETED 32 participants

Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children

Children's Hospital of Philadelphia

NCT01330368

COMPLETED Phase 1 27 participants

Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis

Oklahoma Medical Research Foundation

NCT00594932

COMPLETED Phase 1 20 participants

Zostavax in Systemic Lupus Erythematosus

Oklahoma Medical Research Foundation

NCT01474720

COMPLETED Phase 1 13 participants

Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus

Children's Hospital Medical Center, Cincinnati

NCT03288324

Phase Distribution

PhaseTrial count
Early Phase 1 30
Phase 2 24
Phase 3 15
Phase 4 6

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Systemic Lupus Erythematosus Trial Landscape

ClinicalTrials.gov lists 100 US studies indexed under Systemic Lupus Erythematosus, and 43 of those are currently open to recruitment — roughly 43% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for Systemic Lupus Erythematosus shows 21 late-stage studies (Phase 3 and Phase 4 combined) alongside 54 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for Systemic Lupus Erythematosus is led by Bristol-Myers Squibb with 6 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 100 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Systemic Lupus Erythematosus?

PlainTrial tracks 100 US clinical trials for Systemic Lupus Erythematosus, of which 43 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Systemic Lupus Erythematosus?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2024 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

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