RecruitingPhase 1NCT06576271

A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants

A Phase 1, First-time-in-human, Four-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK4527363 in Healthy Participants (Part A), Participants With Active Systemic Lupus Erythematosus (Part B), Healthy Participants of Chinese and Japanese Descent (Part C) and Participants With Interstitial Lung Disease Associated With Connective Tissue Disease (Part D)


Sponsor

GlaxoSmithKline

Enrollment

142 participants

Start Date

Sep 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), healthy participants of Chinese and Japanese descent (Part C), and participants with interstitial lung disease associated with connective tissue disease (Part D)


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Belimumab, a drug called GSK4527363, and others for people with systemic lupus erythematosus. The study is currently recruiting participants at 27 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGGSK4527363

GSK4527363 will be administered to participants.

DRUGPlacebo matching GSK4527363

Placebo matching GSK4527363 will be administered to participants.

DRUGBelimumab

Belimumab will be administered to participants.


Locations(27)

GSK Investigational Site

Scottsdale, Arizona, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

San Juan Bautista, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

GSK Investigational Site

Juiz de Fora, Brazil

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

Salvador, Brazil

GSK Investigational Site

Bydgoszcz, Poland

GSK Investigational Site

Krakow, Poland

GSK Investigational Site

Poznan, Poland

GSK Investigational Site

Warsaw, Poland

GSK Investigational Site

Wroclaw, Poland

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Bilbao, Spain

GSK Investigational Site

Pamplona, Spain

GSK Investigational Site

Sabadell Barcelona, Spain

GSK Investigational Site

Valladolid, Spain

GSK Investigational Site

Cambridge, United Kingdom

GSK Investigational Site

Liverpool, United Kingdom

GSK Investigational Site

Middlesex, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06576271


Related Trials