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RECRUITING
NCT06576271
PHASE1

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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)

Official title: A Phase 1, First-time-in-human, Three-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)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2024-09-02

Completion Date

2028-01-11

Last Updated

2026-03-12

Healthy Volunteers

Yes

Interventions

DRUG

GSK4527363

GSK4527363 will be administered to participants.

DRUG

Placebo matching GSK4527363

Placebo matching GSK4527363 will be administered to participants.

DRUG

Belimumab

Belimumab will be administered to participants.

Locations (26)

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

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