Clinical Research Directory

"ADEN Platform: Pilot Clinical Validation for Chronic Disease Risk Stratification in Colombia"

This protocol describes a 90-day prospective pilot study designed to validate the capacity of the ADEN clinical intelligence platform to stratify early chronic disease risk across six priority public health profiles in Colombia. A total of 120 participants will be enrolled across enriched risk groups: preventive/healthy population (n = 30), cardiometabolic (n = 40), respiratory/oncological/autoimmune (n = 30), and older adult/frailty (n = 20). ADEN's performance will be assessed using weighted Kappa agreement against a reference clinical evaluation, with sensitivity, specificity, and 95% confidence intervals as secondary measures. The study is conducted under the principles of the Declaration of Helsinki, CIOMS guidelines, Resolution 8430 of 1993 from the Colombian Ministry of Health, and personal data protection regulations (Law 1581 of 2012). All participants will sign informed consent prior to any procedure.

A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of NEUK203-215 Injection in Adult Chinese Patients With Relapsed/Refractory Autoimmune Diseases

The purpose of this study is to determine the safety, tolerability and preliminary efficacy of NEUK203-215 , a healthy donor (HD) allogeneic CD19/BCMA-targeted CAR-NK cell product, in participants with severe, refractory autoimmune diseases. This study plans to conduct an interim data analysis when the cumulative enrollment reaches 50% of the total sample size. The objectives of this analysis are: (1) to summarize the safety and tolerability profile at the current dose level; (2) to preliminarily assess trends in clinical response endpoints and explore preliminary signals of drug efficacy; and (3) to preliminarily evaluate the pharmacokinetic and pharmacodynamic characteristics of the drug in humans. This analysis is exploratory in nature and is intended to accumulate preliminary clinical evidence for the drug in the target patient population.

A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus

The main purpose of this study is to evaluate the safety and tolerability of CUG252 following multiple ascending doses in participants with Systemic Lupus Erythematosus (SLE).

Study of JANX011 in Healthy Adult Volunteers to Assess Safety and Tolerability.

This first-in-human (FIH) study aims to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JANX011 dosed subcutaneously (and potentially intravenously) in healthy adult volunteers (HVs) to gain insight into its therapeutic utility in patients with autoimmune diseases.

Taper Or Abrupt Steroid Stop: TOASSTtrial

This study is an Investigator-initiated, placebo-controlled, multicenter noninferiority trial, comparing rapid termination of systemic glucocorticoid treatment with a tapering regime over 4 weeks.

A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases

A Phase 1 dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of anito-cel in subjects with generalized myasthenia gravis (GMG). Anitocabtagene autoleucel (anito-cel) is a BCMA-directed CAR-T cell therapy.

7 Tesla MRI Brain Imaging to Decipher Filgotinib's Mode of Analgesic Action in Rheumatoid Arthritis

This is an experimental medicine, single-centre, observational test-retest study to evaluate Filgotinib's mechanism of analgesic action in RA patients. The investigators hypothesize that Filgotinib's mechanism of analgesic action is determined by at least two factors. The first is related to those CNS sensitization pathways seen in fibromyalgia, specifically DMN-insula brain functional connectivity and insular glutamate. The second is related to peripheral inflammation, specifically joint synovitis, blood cytokines/chemokines and DAN-LIPL functional brain connectivity. The CNS sensitization pain pathways related to fibromyalgia are more quickly modified compared to those related to peripheral inflammation and help explain Filgotinib's rapid onset of effect.