Lupus clinical trials, in English

This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.

NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue disorders. This study will allow researchers to admit and follow patients suffering from autoimmune diseases of the kidney.

NCT00001979 · Official ClinicalTrials.gov record · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This phase II, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study is designed to measure the safety, how well it works and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \<12 with LN.

NCT05039619 · Official ClinicalTrials.gov record · Hoffmann-La Roche

This randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, non-inferiority crossover study will measure the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to dummy treatment (placebo) with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment.

NCT05559671 · Official ClinicalTrials.gov record · NYU Langone Health

Background: Systemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC).

NCT05567198 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This study wants to evaluate long-term whether it is safe and how hard side effects are to live with of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

NCT06133972 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

Patients with systemic lupus erythematosus (SLE) often experience a frustrating decline of their cognitive skills that includes considerable problems in attention, learning, and memory. This lupus-related cognitive dysfunction (termed SLE-CD) is recognized as the most prevalent of the nineteen neuropsychiatric SLE syndromes, as it affects up to 80% of patients and can significantly decrease their quality of life.

NCT06378736 · Official ClinicalTrials.gov record · Northwell Health

An exploratory clinical study of the safety and how well it works of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease

NCT06379646 · Official ClinicalTrials.gov record · China Immunotech (Beijing) Biotechnology Co., Ltd.

The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN. The goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and lymphodepleting chemotherapy that can be given to patients with the disease.

NCT06434363 · Official ClinicalTrials.gov record · M.D. Anderson Cancer Center

The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomly assigned controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC). The main questions it aims to answer are: 1.

NCT06599658 · Official ClinicalTrials.gov record · McGill University Health Centre/Research Institute of the McGill University Health Centre

This study wants to measure the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

NCT06617325 · Official ClinicalTrials.gov record · UCB Biopharma SRL

This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The purpose of the study is to identify possible optimal dose(s) by assessing the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary clinical response of SAR448501/DR-0201.

NCT06647069 · Official ClinicalTrials.gov record · Sanofi

The purpose of this up to 6-year extension study is the evaluation of the how well it works and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \[CRR\] or partial renal response \[PRR\]) on neither you nor the study doctors know who gets the real treatment treatment at the end of the SIRIUS-LN core study, and 2.

NCT06711887 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

Background: Autoimmune diseases can be caused by genes people inherit from their parents. The gene changes that cause these diseases have been well studied in people with European and Asian ancestors.

NCT06948110 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)

This study evaluates the safety and how well it works of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells/kg).

NCT06978647 · Official ClinicalTrials.gov record · China Immunotech (Beijing) Biotechnology Co., Ltd.

The goal of this watch-and-measure (no experimental treatment required) study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma subtype mycosis fungoides (MF), chronic spontaneous urticaria (CSU), and cutaneous lupus erythematosus (CLE) in daily practice. Data will be compared with data from healthy volunteers.

NCT07021495 · Official ClinicalTrials.gov record · Leiden University Medical Center

The purpose of this trial is to measure the how well it works and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).

NCT07053800 · Official ClinicalTrials.gov record · Autolus Limited

This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary how well it works of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to measure the whether it is safe and how hard side effects are to live with of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).

NCT07085104 · Official ClinicalTrials.gov record · Allogene Therapeutics

This study wants to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.

NCT07138898 · Official ClinicalTrials.gov record · NYU Langone Health

This study wants to characterize the how well it works and safety of current standard of care treatment options in participants with active systemic lupus erythematosus (SLE; including lupus nephritis) with inadequate response to glucocorticoids and at least two immunosuppressants

NCT07175285 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

This open-label, Phase I study will assess the whether it is safe and how hard side effects are to live with of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.

NCT07201558 · Official ClinicalTrials.gov record · AstraZeneca

Background: Autosomal dominant hyper-IgE syndrome (HIES), also called Job syndrome, is a genetic disorder that affects the immune system. It can cause skin and lung infections and problems with blood vessels, connective tissues, and bones.

NCT07262983 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

Lupus nephritis is a chronic and life-threatening autoimmune cause of kidney disease that predominately impacts young people and can lead to kidney failure. Sodium-glucose co-transporter-2 inhibitors, including dapagliflozin, are known to improve outcomes for people with other causes of chronic kidney disease.

NCT07323524 · Official ClinicalTrials.gov record · Brigham and Women's Hospital

The purpose of this global, multicenter, Phase 3 study is to measure the how well it works and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks.

NCT07332481 · Official ClinicalTrials.gov record · EMD Serono Research & Development Institute, Inc.

The purpose of this global, multicenter, Phase 3 study is to measure the how well it works and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks.

NCT07355218 · Official ClinicalTrials.gov record · EMD Serono Research & Development Institute, Inc.

This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at different dose levels (amounts).

NCT07363590 · Official ClinicalTrials.gov record · Merck Sharp & Dohme LLC

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

NCT07409181 · Official ClinicalTrials.gov record · Boehringer Ingelheim

The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment. Patients will be naïve to any prior conventional immunosuppressant including prior biologic therapy at enrolment.

NCT07430306 · Official ClinicalTrials.gov record · AstraZeneca

This study wants to evaluate how well nipocalimab works as compared to dummy treatment (placebo) in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).

NCT07438496 · Official ClinicalTrials.gov record · Janssen Research & Development, LLC

PREVENER is a randomly assigned, open-label, multicenter, phase IV clinical trial designed to measure the how well it works and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD). Patients with IRD, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and systemic lupus erythematosus (SLE), have a 50% higher risk of cardiovascular (CV) events compared to the general population.

NCT07611747 · Official ClinicalTrials.gov record · Instituto de Investigación Marqués de Valdecilla

The study will measure the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).

NCT07629583 · Official ClinicalTrials.gov record · Genentech, Inc.

This study wants to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while on background standard of care (SoC) therapy.

NCT07630714 · Official ClinicalTrials.gov record · AstraZeneca

This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020. The study will enroll healthy participants at low doses, followed by participants with moderate to severe autoimmune diseases with predominant B-cell involvement.

NCT07649265 · Official ClinicalTrials.gov record · Otsuka Pharmaceutical Development & Commercialization, Inc.

This study wants to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator, while monitoring whether it is safe and how hard side effects are to live with. Study details include: * Participants can transition in ROSY-S once they complete their participation in the parent study and should have received at least one dose of anifrolumab in the parent study.

NCT07691970 · Official ClinicalTrials.gov record · AstraZeneca

To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus

NCT07713940 · Official ClinicalTrials.gov record · University of California, San Diego

This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.

NCT07732309 · Official ClinicalTrials.gov record · Antengene Biologics Limited

Background: Rheumatic diseases can affect the joints, ligaments, tendons, bones, muscles, and skin. They can also cause inflammation, damage body tissues, and change nerve signals in the brain.

NCT07829497 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This study wants to measure the long-term safety and how well it works of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908\_0001) (NCT07332481) and Elowen-2 (MS504908\_0008) (NCT07355218) study treatment and to provide participants an opportunity to receive active treatment with enpatoran for up to 108 weeks in this open-label study. Study details include: Study Duration: 120 weeks.

NCT07840287 · Official ClinicalTrials.gov record · EMD Serono Research & Development Institute, Inc.

This study is evaluating whether afimetoran, an investigational oral medicine that blocks toll-like receptors 7 and 8 (TLR7/TLR8), can improve skin disease in adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus, whose disease has not responded to or who cannot tolerate antimalarial therapy. Participants are assigned by chance to receive afimetoran or a matching dummy treatment (placebo) capsule once daily for 24 weeks, in addition to their existing standard lupus care.

NCT07881120 · Official ClinicalTrials.gov record · Beeline Medicines Corporation

Systemic lupus erythematosus (SLE) is a complex autoimmune disorder that affects individuals globally, yet there is a significant lack of data regarding its prevalence and management, particularly in Asian populations like Pakistan. To address this gap, we are initiating a groundbreaking project to establish a Lupus Registry in Pakistan.

NCT07902622 · Official ClinicalTrials.gov record · Foundation University Islamabad

People with systemic lupus erythematous (SLE) have an increased risk of premature atherosclerotic cardiovascular disease, which is believed to be caused by arterial inflammation. The aim of this study is to investigate the effects an interferon-targeting drug (anifrolumab) used for the treatment of active SLE on arterial inflammation.

NCT07913919 · Official ClinicalTrials.gov record · University of Cambridge