Clinical Research Directory

IASO-782 in Systemic Lupus Erythematosus

his study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with SLE. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of SLE.

A Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE)

The goal of this clinical trial is to learn about the safety, how the body processes the drug, and its effects of a drug called cenerimod in adult Chinese participants (aged 18-75) with moderate to severe Systemic Lupus Erythematosus (SLE) who are already receiving standard background therapy. The main questions it aims to answer are: * What is the safety and tolerability of a daily 4 mg dose of cenerimod in Chinese participants with SLE? * How is cenerimod processed by the body (pharmacokinetics) in this population? * What is the effect of cenerimod on the level of lymphocytes in the blood (pharmacodynamics)? This is a single-arm study without a comparison group. Participants will: * Take one 4 mg cenerimod tablet by mouth once daily for up to 12 months. * Continue their stable, pre-existing background SLE medications throughout the study. * Attend regular clinic visits over a period of up to 22 months for tests and check-ups, including blood draws, heart monitoring (12-lead electrocardiogram), vital signs(blood pressure),and physical examinations. * Undergo a final safety follow-up 6 months after their last dose of the study drug.

CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases

CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases

Allogeneic UCB-derived CAR-T for SLE

The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the UCAR-T cell product.

CD19/BCMA CAR-T for SLE

The purpose of this clinical trial is to learn if CD19/BCMA CAR-T works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the CD19/BCMA CAR-T cell product. The main questions it aims to answer are: 1. What CAR-T-related adverse events (AEs) occur within 3 months after the CAR-T cell infusion? 2. Which dose level is the optimal biological dose (OBD)? 3. What is the the changes of disease activity status, proportion of patients achieving DORIS remission, percentage of participants achieving maintenance of drug-free DORIS remission, proportion of patients achieving SRI-4 remission, percentage of participants achieving maintenance of LLDAS? Participants will: 1. Receive CD19/BCMA CAR-T cells infusion on Day 0. 2. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. 3. Visit the clinic at Day 14, Day 28, month 3, month 6, month 9, month 12, month 18 and month 24 after CAR-T cells infusion.

MB-CART19.1 in Refractory SLE

This is a phase l/ll open-label, multicentre, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE systemic lupus erythematosus. In the phase I part, a maximum of n=12 patients will be treated in a maximum of 3 dose levels. In the phase IIa part, a maximum of n=17 will be treated (n=10 patients in a 1st stage + n=7 patients in a 2nd stage). This includes the patients from the phase I part treated on the recommended dose level.

A Study of CC312 for Relapsed/Refractory Autoimmune Diseases

This study is an open-label, multiple ascending dose investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CC312 in adult patients with relapsed or refractory autoimmune diseases.

Safety and Efficacy Study of CC312 for Moderate to Severe SLE

This study is a randomized, double-blind, placebo-controlled Phase I clinical trial featuring single and multiple ascending doses. It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of CC312 in adult patients with moderate to severe systemic lupus erythematosus (SLE).

Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study

This will be a combined retrospective and prospective cohort study, that will evaluate the incidence of de novo Systemic Lupus Erythematosus major organ manifestations (defined as BILAG A flares) in patients receiving belimumab (Arm A) and compare it to 2 standard-of-care groups (SoC) (Arm B: patients on SoC; Arm C: patients on SoC followed-up up to May 1st 2014, the first date where belimumab was available in Greece). The investigators will utilize survival analysis methods (Kaplan-Meier survival curves and Cox regression) and mixed effects longitudinal analyses. Additionally, the investigators will employ propensity score matching and/or inverse probability of treatment weighting, to create balanced cohorts and reduce bias.

Associating Gastric Infection With Autoimmune Flare Severity in an Egyptians

A cross-sectional, observational study aims to evaluate the relationship between Helicobacter pylori infection and disease activity in patients diagnosed with systemic lupus erythematosus (SLE), using a combination of structured patient interviews, standardized disease assessments, and laboratory detection of H. pylori by stool antigen testing .

OMERACT SLE Delphi

SLE is a chronic multi-systemic autoimmune disease with clinical manifestations characterized by recurrent flares in disease activity and damage in several organs. SLE affects primarily women during child bearing age and is negatively related to productivity, social role participation and health-related quality of life. The multi-systemic nature of SLE and its diverse clinical manifestations have led to many outcome measurements being utilized in SLE clinical trials and longitudinal studies. To standardize measurement in clinical trials and longitudinal studies, the OMERACT SLE Group developed the core domain set for SLE in 1998. A core domain set is a set of outcome measures, capturing all the facets/aspects of the disease, that standardizes measurement and research across clinical trials and longitudinal studies necessary for the advancement of the field. Since development in 1998, many new important domains for SLE have been identified, thus there is an unmet need to update the core domain set. A new OMERACT SLE Working Group has been established to update the SLE core domain set. This is a qualitative study that aims to prioritize domains to include in the SLE core domain set. All participants will be asked to complete a four-round online survey. During rounds 1-3 participants will be asked to rate the importance of each domain to be included; round 4 will ask participants select and rank domains. Participants will also have the option of adding other items or descriptors and to provide any other feedback. Each round of the survey will take approximately 15-20 minutes to complete. Participants will need to participate in round 1 in order to be invited to round 2, and then participate in round 2 in order to be invited to round 3, and final participate in round 3 in order to be invited to round 4.

The Relation of Albumin/Globulin Ratio and Platelet/Albumin Ratio to Lupus Nephritis

Albumin/globulin ratio and platelet/albumin ratio as a predictive non-invasive biomarker for lupus nephritis (LN) presence and severity