Clinical Research Directory

Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus

The purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple dose levels of ESK-001 compared with placebo in adult patients with SLE.

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

The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE). Another goal is to learn about the safety of VENT-03 and how it is processed by the body. The main questions it aims to answer are: * Does VENT-03 affect the activity and severity of CLE? * What side effects do participants have when taking VENT-03? Researchers will compare VENT-03 to a placebo (a look-alike substance that contains no drug) to see if VENT-03 works to treat patients with CLE. Participants will: * Take VENT-03 or a placebo for 4 weeks, then all participants will switch to VENT-03 for another 8 weeks; * Visit the clinic once a month for checkups and tests.

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus

Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).

CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus

This is a single-center, single-arm, open-label phase 1/2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE). Phase 1 will evaluate the safety of CART19 in 6-12 patients with Systemic lupus erythematosus (SLE). There is no planned dose escalation, but a dose de-escalation will be made based on the incidence of Dose Limiting Toxicities. Phase 2 will evaluate the efficacy and further evaluate the safety of CART19 in this population.

Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases

This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS, MG

Efficacy and Safety of CRC01 in Participants With Severe, Refractory Systemic Lupus Erythematosus

The purpose of this clinical trial is to evaluate the safety and efficacy of CRC01, an investigational autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, in people with lupus nephritis (LN), a serious kidney complication of systemic lupus erythematosus (SLE). The main objectives of the study are: 1. To determine whether CRC01 infusion can improve kidney outcomes and reduce disease activity in participants with lupus nephritis. 2. To assess the safety profile, including potential risks such as cytokine release syndrome (CRS) and neurotoxicity. Study Design This is a single-arm, open-label, multi-center, Phase 1/2 study. All enrolled participants will receive CRC01 after screening and baseline assessments. Study Procedures Participants will: * Undergo eligibility screening, including blood tests, urine tests, and disease activity assessments. * Provide autologous T lymphocytes through a procedure called leukapheresis. * Receive a lymphodepleting pre-conditioning regimen (short course of chemotherapy). * Receive a single intravenous infusion of CRC01 cells. * Be hospitalized for close monitoring to detect and manage early adverse events such as CRS or neurotoxicity. * Return for scheduled follow-up assessments through Week 52 (12 months) post-infusion to evaluate safety and treatment response. Key Outcomes Researchers will measure: * Changes in proteinuria and kidney function. * Changes in disease activity scores. * Incidence and severity of adverse events.

Pregnancies Before the Diagnosis of Systemic Lupus Erythematosus

This is an observational, monocentric, retrospective cohort study. Its primary objective is to examine maternal and foetal outcomes in pregnancies that occurred before the diagnosis of systemic lupus erythematosus (SLE) in a group of female participants who were subsequently diagnosed with the condition.

Myocardial Inflammation in Systemic Lupus Erythematosus

The goal is to assess for myocardial edema on cardiac MRI during SLE flare to assess for myocardial inflammation.

A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.

To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).

AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus

AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies. This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches, or other forms of refractory systemic lupus erythematosus. The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus a B-cell depleting mAb (e.g., rituximab, obinutuzumab) after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V, or other forms of refractory systemic lupus erythematosus. Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with a B-cell depleting mAb (e.g., rituximab, obinutuzumab). All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status. Patients may receive up to 2 cycles of treatment spaced 24 weeks apart.

Safety and Efficacy of ONT01 in Lupus

ONT01 is a drug that is being studied for the treatment of Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) and is not approved by the FDA. The purpose of this study is to better determine whether ONT01 is safe and tolerated by people with lupus nephritis or SLE. The study also looks at how the administration of ONT01 in combination with widely used treatments given for lupus, including the medication mycophenolate mofetil and others, can improve symptoms of lupus. A total of 61 participants will be enrolled in this study.

A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.

An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19/BCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE/LN, AAV/AAGN, Anti-GBM, MN, SSc, and IIM).

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

The goal of this clinical trial is to evaluate the safety and effectiveness of UC-MSCs in adults with systemic lupus erythematosus (SLE). The main questions this study aims to answer are: 1. Can UC-MSCs improve kidney function and reduce SLE disease activity? 2. Are UC-MSCs safe and well-tolerated in this patient population? Participants in this study will: * Receive UC-MSCs in a single dose in addition to standard of care treatment. * Provide blood and urine samples for laboratory assessments, including biomarkers and immune profiling (e.g., cytokines, complement proteins, and autoantibodies). * Attend regular clinic visits for physical exams, disease activity scoring, and imaging tests to monitor kidney health. * Complete assessments for safety, such as monitoring for adverse events and changes in laboratory values. This study aims to provide new insights into treatment options for SLE and lupus nephritis, addressing an unmet medical need in this population.

Association of Serum Interleukin-33 Levels With Clinical Manifestations in Systemic Lupus Erythematosus

This is a case-control study investigating serum IL-33 levels and their association with clinical manifestations in systemic lupus erythematosus (SLE). The study compares IL-33 levels in three groups: SLE patients with lupus nephritis, SLE patients without nephritis, and healthy controls. The goal is to clarify IL-33's role as a biomarker reflecting disease activity and organ involvement, especially renal pathology.

Vaccine Hesitancy in Black/African Americans With Rheumatic Diseases

To establish the efficacy of a community-based POL (Popular Opinion Leader) intervention with two different trainings designed to increase COVID-19 vaccine and booster uptake and reduce hesitancy among social networks of Black individuals with rheumatic conditions. The investigators will also determine the structure and composition of the personal and outreach social networks of POLs.

Assessment of Blood Indices in Systemic Lupus Erythematosus

This case-control study aims to explore the relationship between specific blood indices (lymphocyte-monocyte ratio, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and systemic immune-inflammatory index) and disease activity in patients with systemic lupus erythematosus (SLE). The study includes 70 SLE patients and 70 healthy controls, matched for age and gender, recruited from Assiut University Hospital. Disease activity is assessed using the SLEDAI-2K score, and blood indices are analyzed to determine correlations with disease activity.

Evaluating Mental Health Challenges in Juvenile Lupus Erythematosus and Their Caregivers

assessment of psychiatric problems in pediatric SLE and their caregivers. evaluate the possible risk factors of psychiatric problems such as peer victimization, academic performance, fatigue, self-esteem and quality of life.

Vaccination Against Herpes Zoster in Patients With Inflammatory Rheumatic Diseases

The purpose of HZ-REUMA study is explore vaccine response and protection against shingles (herpes zoster, HZ) after vaccination with two doses of Shingrix in immunosuppressed patients with inflammatory rheumatic diseases (IRD) compared to immunocompetent patients with IRD (controls). Hypothesis: The immunological disturbance as part of the rheumatic disease in combination with different immunomodulating treatments may impair vaccine response to non-live HZ vaccine (Shingrix) and thereby lead to an insufficient protection against infection. Primary objective (outcome) 1. The impact of modern anti-rheumatic treatments including synthetic disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate and different biological treatments (anti-TNF, anti IL6r, anti-IL12/23/17, anti-CD20, anti-BlyS, anti-INFERON treatment, or targeted DMARDs (JAK-inhibitors) on antibody response elicited by two doses of subunit vaccine against herpes zoster (HZ) administrated 1-2 months apart in patients with IRD. Secondary outcomes 2. The numbers and frequency of antigen specific CD4 2+ T cells expressing ≥2 or more activation markers (TNFalpha, INF-gama, interleukin-2 or CD40ligand) 3. Long-term immunogenicity of two doses of Shingrix in immunosuppressed patients with IRD measured 3 and 5 after vaccination 4. the tolerability of the vaccine, the impact on existing rheumatic disease, and possible association with onset of new autoimmune diseases 5. if vaccination against herpes zoster protects against infections in patients with inflammatory rheumatic diseases Study Population Adult patients (18 years and older) with a clinically diagnosed inflammatory rheumatic disease and regularly followed at Skåne University Hospital, section for rheumatology in Lund/Malmö, Sweden are eligible for the study and will be offered vaccination free of charge. Control group comprises adult individuals with known inflammatory rheumatic disease without immunosuppressive treatment except for low dose prednisone (max 5 mg daily) . Inclusion criteria: * age ≥18 years (patients) * regular follow up at Skåne University Hospital, section for rheumatology Lund/Malmö due to an inflammatory rheumatic disease (patients) * receive active treatment with disease modifying anti-rheumatic drugs (DMARDs) such conventional synthetic (cs), biologic (b) or targeted synthetic (ts) DMARDs or patients without active immunosuppressive treatment (controls) Exclusions criteria * age \<18 years (patients) * pregnancy (women of childbearing potential, WOCBP, are not excluded since all patients using DMARDs are advised to use a safe and effective contraceptive method) * allergy/intolerability of any component in the vaccine * active infection inclusive herpes zoster (shingles) * received Shingrix vaccine previously * ongoing treatment with any immunosuppressive drug for the other diseases Target enrolment/sample size: 240. Study start date: December, 17 2024- June 30, 2029

Fetal-Hope Study: Home Monitoring of Fetal Heart Rate in SSA+ Pregnant Women

Serological positivity for anti Ro-SSA antibodies is frequently found in pathologies such as Sjogren's Syndrome and SLE. Worldwide, approximately 0.5-1% of women of reproductive age are positive for Ro-SSA antibodies, and in 1-2% of these women, pregnancy will be complicated by cardiac abnormalities of the fetus, particularly varying degrees of atrioventricular block. It is essential to promptly identify patients with fetal heart rhythm abnormalities to prevent both intrauterine deaths and the birth of newborns with third-degree atrioventricular block, requiring lifelong cardiac pacing. At the moment, the only means to identify these alterations is represented by fetal cardiac ultrasound. Fetal atrioventricular block can develop within a few hours in these patients and fetal ultrasound, normally performed no more frequently than once every two weeks, does not allow for the timely identification of these conditions and therefore for pharmacological intervention. Using home fetal heart rate monitoring, carried out directly by patients three times a day with the aid of a special device that allows easy identification of the fetal heart rhythm, would allow rapid recognition of rhythm alterations and early access to confirmation tests and possible therapies. Fetal heart rhythm surveillance could detect a medically reversible disease that, if untreated, would progress to lifelong cardiac pacing, with its many associated comorbidities. Applying such protocol in pregnant women anti-Ro/SSA positive could become standard practice. The main objectives of this study are: * Estimation of the incidence of the development of fetal AV conduction abnormalities in patients with positivity for Ro/SSA autoantibodies; * Estimation of the reliability of home monitoring of fetal heart rate with fetal Doppler device in detecting fetal atrioventricular conduction disturbances; * Evaluation of the results of the therapy administered early, immediately after the diagnosis of fetal atrioventricular conduction disorders.

Argentinian Prospective Registry of Patients With Lupus

In Latin America, information about patients with systemic lupus erythematosus (SLE) is limited. Multicenter studies are needed to obtain "real world data '' and to carry out longer follow-ups. The purpose of this project is to design a cohort of Argentinian patients with SLE to describe "our real setting" and to identify possible limitations in access to specialized consultations and treatments.