A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

Sponsor
GlaxoSmithKline
Study ID
NCT07371468
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • GSK5926371 — BIOLOGICAL
    GSK5926371 will be administered.

Study Details

This is a 2-part study of GSK5926371 in participants with autoimmune rheumatic diseases (ARD). In part 1, participants will receive different doses of GSK5926371 to find a suitable priming dose. In part 2, participants will receive GSK5926371 at doses based on data from part 1. The study is aimed at testing if GSK5926371 is safe, well-tolerated, how the body processes the study drug, how it works in the body, and whether it triggers any immune responses.

Key Dates

First listed
Jan 28, 2026
Start date
Feb 10, 2026
Status verified
Jun 2026
Primary completion
Mar 15, 2028
Completion
Mar 15, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation of GSK5926371
  • Experimental: Part 2: Dose Division of GSK5926371

Primary Outcome Measure

Part 1 and Part 2: Number of Participants with Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Up to 196 days ]

Central Contacts

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