Full name

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), and Healthy Participants of Chinese and Japanese Descent (Part C)

NCT Number
NCT06576271
Primary Endpoints

Primary:

  • Parts A, B and C: Number of participants with non-serious adverse events and serious adverse events. Up to Week 52
  • Parts A, B and C: Number of participants with clinically significant changes in physical examination, laboratory parameters, vital signs, and 12 lead electrocardiogram (ECG) findings. Up to Week 52
  • Parts A, B and C: Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS). Up to Week 52

Secondary:

  • Parts A and C: Area under the concentration-time curve to the last quantifiable concentration (AUC[0-t]) of GSK4527363. Up to Week 52
  • Parts A and C: Area under the concentration-time curve to infinity (AUC[0-inf]) of GSK4527363. Up to Week 52
  • Parts A and C: Maximum plasma concentration (Cmax) of GSK4527363. Up to Week 52
  • Parts A and C: Apparent Terminal phase half-life (t1/2) of GSK4527363. Up to Week 52
  • Parts A, B and C: Number of participants with anti-drug antibodies (ADAs) against GSK4527363. Up to Week 52
  • Parts A, B and C: Titers of ADAs against GSK4527363. Up to Week 52
  • Parts A, B and C: Percentage change from Baseline in cytokine levels. Baseline (Day 1) and up to Week 52
  • Part B: Area under the concentration-time curve to the end of the dosing period (AUC[0-tau]) of GSK4527363. Up to Week 52
  • Part B: Maximum plasma concentration (Cmax) of GSK4527363. Up to Week 52
  • Part B: Concentration at the end of the dosing interval (Ctrough) of GSK4527363. Up to Week 52
Order
2
Disease
SLE
Menu title
A Study of GSK4527363 in Healthy Participants, Participants with Active Systemic Lupus Erythematosus (SLE), and Healthy Participants of Chinese and Japanese Descent
Version
ASN 2025
Phase
1
Status
Recruiting
Compound name
GSK4527363
MoA
B-cell modulator
Unmet Burden Fact
  • SLE is a heterogenous autoimmune disease that affects multiple organs, resulting in varying clinical manifestations and degrees of severity¹
  • Persistent Disease Activity remains a burden for patients with SLE²
Unmet Burden Fact Reference

1. Fasano S, et al. Nat Rev Rheumatol. 2023;19(6):331-342; 2. Pescheken 2019, see: DOI:10.3899/jrheum.171454

Study Description

This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active SLE (Part B), and healthy participants of Chinese and Japanese descent (Part C).