NCT06576271

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, 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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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)

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-02
• Primary completion: 2028-01-11
• Completion: 2028-01-11
• First posted: 2024-08-28
• Last updated: 2026-03-12

Locations

26 sites across 6 countries: United States, Argentina, Brazil, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study