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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

44

Start Date

2026-02-10

Completion Date

2028-03-15

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

GSK5926371

GSK5926371 will be administered.

Locations (19)

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

GSK Investigational Site

Campinas, São Paulo, Brazil

GSK Investigational Site

São Paulo, São Paulo, Brazil

GSK Investigational Site

Bordeaux, France

GSK Investigational Site

Toulouse, France

GSK Investigational Site

Cona, Ferrara, Italy

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Hiroshima, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Panama City, Panama

GSK Investigational Site

Panama City, Panama

GSK Investigational Site

Panama City, Panama

GSK Investigational Site

Poznan, Poland

GSK Investigational Site

Warsaw, Poland

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Taipei, Taiwan