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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
GlaxoSmithKline
Study ID
NCT06576271
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • GSK4527363 — DRUG
    GSK4527363 will be administered to participants.
  • Placebo matching GSK4527363 — DRUG
    Placebo matching GSK4527363 will be administered to participants.
  • Belimumab — DRUG
    Belimumab will be administered to participants.

Study Details

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)

Key Dates

Start date
Sep 2, 2024
Status verified
Apr 2026
Primary completion
Jan 11, 2028
Completion
Jan 11, 2028

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Healthy participants receiving GSK4527363
  • Placebo Comparator: Part A: Healthy participants receiving placebo matching GSK4527363
  • Experimental: Part A: Healthy participants receiving belimumab
  • Experimental: Part B: Participants with SLE receiving GSK4527363
  • Experimental: Part B: Participants with SLE receiving belimumab
  • Experimental: Part C: Healthy Japanese participants receiving GSK4527363
  • Placebo Comparator: Part C: Healthy Japanese participants receiving placebo matching GSK4527363
  • Experimental: Part C: Healthy Chinese participants receiving GSK4527363
  • Placebo Comparator: Part C: Healthy Chinese participants receiving placebo matching GSK4527363
  • Experimental: Part D: Participants with CTD-ILD receiving GSK4527363

Primary Outcome Measure

Parts A and C: Number of Participants with Non-serious Adverse Events and Serious Adverse Events [ Time Frame: Up to Week 52 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteScottsdaleArizona85260-
GSK Investigational SiteAuroraColorado80045
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Christopher Striebich (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteLas VegasNevada89154
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Walter Chatham (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteColumbusOhio44109
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Judith Lin (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteOklahoma CityOklahoma73104
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Cristina Arriens (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteDallasTexas75390-

Find similar trials in Scottsdale, AZ

By condition
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By research site
GSK Investigational Site· Scottsdale, AZGSK Investigational Site· Aurora, COGSK Investigational Site· Las Vegas, NVGSK Investigational Site· Columbus, OHGSK Investigational Site· Oklahoma City, OKGSK Investigational Site· Dallas, TX

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