A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
NCT06576271 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 142
Last updated 2026-04-29
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
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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-09-02
- Primary Completion
- 2028-01-11
- Completion
- 2028-01-11
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Brazil
- Poland
- Spain
- United Kingdom
Study Locations
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