Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 37 trials
NCT07575347
This study aims to evaluate the burden and phenotypic spectrum of periodontal disease in patients with rare kidney disorders (such as Alport syndrome, Fabry disease, and tuberous sclerosis complex) and systemic lupus erythematosus (SLE), compared with chronic kidney disease (CKD) controls and population controls. This is a cross-sectional, case-control observational study. Participants will undergo a single structured evaluation including a full-mouth periodontal examination, a clinical questionnaire, and collection of relevant clinical and nephrological data. The primary objective is to compare the prevalence of periodontitis across study groups. Secondary objectives include characterization of periodontal disease severity, prevalence of gingivitis and xerostomia, and identification of disease-specific oral phenotypes. Exploratory analyses will assess associations between periodontal disease and clinical variables such as kidney function, proteinuria, and immunosuppressive exposure.
NCT06875960
The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) who have completed study IM011074 or Study IM011132
NCT06647069
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. The study duration per participant will be a minimum of approximately 13 months, including a screening period of up to 28 days, a treatment period of 71 days, and a follow-up period of 42 weeks. If necessary, participants will continue to have visits after End of Study (EOS) every 4 weeks until peripheral blood B cells return to at least 80% of either the lower limit of normal (LLN) or the participant's baseline value.
NCT06375993
ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease. The study will consist of different periods including screening, lymphodepletion, treatment, and follow-up
NCT06144710
This is a randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single dose in healthy volunteers and multiple doses of SG301 SC injection in participants with systemic lupus erythematosus (SLE).
NCT04461158
To address the health disparities in SLE outcomes for minorities, targeted intervention will be used to address the common barriers to care among patients; a comprehensive patient navigator approach will be utilized based on evidence from prior studies is the purpose of this research. The navigator services most commonly provided include facilitation and coordination of care, practical support, including scheduling transportation and referrals to financial assistance programs, appointment scheduling and reminders, education and psycho-social support. The most effective patient navigators address both health system and patient barriers.
NCT06839976
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.
NCT07413341
This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular RNA encoding the CD19 chimeric antigen receptor (CAR), which is a therapeutic biological product. It is clinically intended for the treatment of various relapsed and refractory B cell-related autoimmune diseases, such as systemic lupus erythematosus, sjögren's syndrome, systemic sclerosis, idiopathic inflammatory myositis, and antiphospholipid syndrome.
NCT07331272
This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.
NCT06462144
This is an exploratory trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of IMPT-514, an autologous, anti-CD19/CD20 CAR T therapy, administered as an intravenous (IV) infusion, in participants with B cell driven autoimmune diseases, including active, refractory Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV), and Idiopathic Inflammatory Myopathy (IIM).
NCT06927219
Summary The Lupus Foundation of America (LFA) Research Accelerated by You (RAY) Registry is a fully remote, longitudinal registry designed to collect data from adults and children living with lupus. The primary goal is to better understand the diagnosis, treatment, care, and quality of life for those affected by the disease. Remote Participation This is a decentralized, online-only registry. Participation is conducted entirely through a secure web-based portal. There are no physical site visits or travel requirements; participants can contribute from any location with internet access. Participation Details Consent: Informed consent is completed electronically. Surveys: Participants complete electronic surveys upon enrollment and every six months thereafter. Data Types: Collected data is self-reported and includes demographics, diagnosis history, treatment information, and patient-reported outcomes (PROs), such as quality of life. Purpose and Data Use The LFA uses registry data to: Address Constituent Needs: Inform programs and resources for the lupus community. Advance Research: Share patient insights with to ensure therapies are developed with the consideration of what matters and what matters most to people living with lupus. Patient Engagement and Clinical Research Matching: Participants may be contacted to assess eligibility for patient engagement or clinical research opportunities or to complete specific sub-surveys regarding trial participation.
NCT07339332
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 SLE.
NCT07281105
Neuropsychiatric systemic lupus erythematosus with cognitive impairment (NPSLE-CI) is a serious, disabling, and potentially life-threatening manifestation of SLE, affecting up to 80% of patients with cognitive impairments ("brain fog"), leading to substantial disability, approximately 2 times higher unemployment risk, reduced health-related quality of life (HRQoL), and mortality 2-14 times higher than the general population (standardized mortality ratio, SMR). No approved therapies exist for NPSLE cognitive dysfunction, representing a high-priority unmet need for this FDA-recognized serious condition with major functional and psychosocial burden. The objective of this study is to evaluate the safety, tolerability and efficacy of EG-501 in a precise patient subset with NPSLE. Participants will complete a full 14-week clinical trial, receiving either EG-501 or a placebo.
NCT07185269
This study will evaluate the effect and safety of 626 in patients with SLE
NCT07031713
A clinical study to explore the safety, efficacy and cell metabolic kinetics of universal CD19/20 car-t cell injection in moderate to severe refractory systemic lupus erythematosus. This study is a single arm, open, exploratory dose increasing clinical study, which aims to evaluate the safety, efficacy and cell metabolic dynamics of ct1192 cells in patients with SLE.
NCT07209540
The goal of this observational study is to learn more about how systemic lupus erythematosus (SLE or lupus) develops in the first years after diagnosis, and how patients respond to different treatments. The main questions the study aims to answer are: How many patients with newly diagnosed lupus reach remission or low disease activity in the first years after starting treatment? Which biological markers (in blood or urine) can help predict treatment response, disease complications, or symptoms such as pain and fatigue? Adults recently diagnosed with lupus (within the past 6 months) will be invited to participate. They will continue with their normal medical care, but in addition, they will take part in study visits over a 5-year period. At these visits, doctors will collect information about symptoms, treatment, and quality of life. Blood and urine samples will also be stored in a biobank for later analysis. Around 720 patients from several European countries are expected to join the study. Because participants are included very soon after diagnosis, researchers can follow the course of lupus from the beginning, before long-term treatment or damage occurs. By combining clinical information and biological samples, researchers hope to identify new ways to understand lupus, improve treatment strategies, and eventually develop personalized medicine approaches. This could help future patients achieve better disease control, fewer complications, and improved quality of life.
NCT03656562
This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 (ianalumab) or CFZ533 (iscalimab) in patients with systemic lupus erythematosus (SLE) to enable further development of these compounds as treatment in this disease population
NCT05411016
Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males. Part 2 : To evaluate the safety and tolerability of repeated IV or SC administration of KK4277 in patients with Systemic lupus erythematosus (SLE) or Cutaneous lupus erythematosus (CLE).
NCT06888960
This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune diseases. The trial also assesses pharmacokinetics (PK) and preliminary efficacy. CC312 is a trispecific T cell engager (TriTE) that targets the B cell surface antigen CD19, the T cell antigen CD3, and the T cell co-stimulatory molecule CD28. Given its mechanism of action, which is similar to the "biopharmaceutical version" of CAR-T, there is a higher risk of cytokine release syndrome (CRS) at the onset of infusion administration. Therefore, a lower priming dose will be administered before the therapeutic dosing phase to mitigate this risk and ensure safety, followed by a therapeutic dose to achieve and maintain efficacy. The study is divided into three dose groups, with 3-6 subjects enrolled in each group, resulting in a total of 9-18 subjects in the study. A "3+3" dose escalation design is employed to systematically evaluate the safety and determine the optimal dose of CC312.
NCT05934149
The purpose of the registry and biorepository is to provide a mechanism to store clinical data, linked biospecimens and molecular data to support the conduct of future research on Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).