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RECRUITING
NCT07371468
PHASE1

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 1, Open-label, Dose-escalation Study (ELEVATE-1) to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a CD19/CD20 T-cell Engager in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2026-02-10

Completion Date

2028-03-15

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

BIOLOGICAL

GSK5926371

GSK5926371 will be administered.

Locations (3)

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Hiroshima, Japan

GSK Investigational Site

Hokkaido, Japan