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ClinicalTrials.gov 43 recruiting now official registry

Systemic Lupus Erythematosus clinical trials

43 of 100 indexed Systemic Lupus Erythematosus trials are currently recruiting.

100 US clinical trials · 43 currently recruiting

Systemic Lupus Erythematosus is the subject of 100 registered US clinical trials on ClinicalTrials.gov, 43 of them currently open to new participants. 21 are in Phase 3-4 (later-stage) and 54 in Phase 1-2 (earlier-stage). The most active sponsor is Bristol-Myers Squibb, running 6 of these trials.

The research picture

Systemic Lupus Erythematosus has 100 registered US clinical trials, 43 of them open to new participants right now, about 43% of the total.

43
recruiting participants now
43%
of trials open to enrollment
21
in Phase 3–4 (later-stage)
6
top sponsor: Bristol-Myers Squibb
Phase 130Phase 224Phase 315Phase 46

Active & Recent Trials

100 total, page 1 of 2

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

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Phase Distribution

PhaseTrial count
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

100 indexed Systemic Lupus Erythematosus studies · 43 recruiting (43%).

Phase mix: 21 late (III/IV) vs 54 early (I/II).

Top sponsor: Bristol-Myers Squibb (6 trials), 9 others listed. 50 shown below, recruiting first.

How to read this condition's trial landscape

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.

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.

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.

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 · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

Verify with NIH →

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial for this condition, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.