NCT06188507 is a Phase 1 clinical trial of GSK4347859 in Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline.

Who is sponsoring NCT06188507?

NCT06188507 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT06188507?

Interventions in NCT06188507: GSK4347859, Placebo.

What condition does NCT06188507 study?

NCT06188507 studies Systemic Lupus Erythematosus.

Is NCT06188507 still recruiting?

NCT06188507 is currently suspended. Last updated 3 October 2025.

Last reviewed 2025-10-03 · How we verify

NCT06188507

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A First Time in Human Study to Evaluate the Safety and Tolerability of GSK3996401 Following Dosing With GSK4347859 in Healthy Participants

Suspended Phase 1 Last updated 3 October 2025

What this trial tests

Phase 1 trial testing GSK4347859 in Systemic Lupus Erythematosus in 65 participants. Suspended.

Timeline

12 January 2024

Primary endpoint
14 July 2026

14 July 2026

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Suspended
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	65
Start date	12 January 2024
Primary completion	14 July 2026
Estimated completion	14 July 2026
Sites	2 locations across United Kingdom

Drugs / interventions tested

GSK4347859 — full drug profile →
Placebo

Conditions studied

Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 55, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a first time in human (FTiH) study which means that this is the first time that GSK4347859 is given to humans. The study is designed to investigate the safety, tolerability, and concentration of GSK3996401 (the activated form of GSK4347859) in the blood following single ascending doses (Part 1) and multiple ascending doses (Part 2) of GSK4347859 in healthy participants. Part 1 consists of 2 planned cohorts with up to 4 treatment periods in each and is expected to have up to 8 dose levels. Part 2 will investigate 14 days of repeat dosing in 3 cohorts with 3 dose levels.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Systemic Lupus Erythematosus

Currently open trials in the same condition.

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NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06188507 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 3 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06188507.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing