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NCT06576271 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline.

Recruiting
Registry status
Phase 1
Development phase
142
Enrollment target
20
Study locations

NCT06576271 is a Phase 1 study of Systemic Lupus Erythematosus that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 142 participants, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT06576271, a Phase 1 study of Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by GlaxoSmithKline.

RECRUITING
Registry status
Phase 1
Development phase
142 participants
Enrollment target
20
Study locations

Study Summary

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)

Conditions Studied

Systemic Lupus Erythematosus

Interventions

  • DRUG Belimumab
  • DRUG GSK4527363
  • DRUG Placebo matching GSK4527363

Study Locations (20)

Other

  • GSK Investigational Site - Buenos Aires
  • GSK Investigational Site - Rosario
  • GSK Investigational Site - San Juan Bautista
  • GSK Investigational Site - San Miguel de Tucumán
  • GSK Investigational Site - Juiz de Fora
  • GSK Investigational Site - Porto Alegre
  • GSK Investigational Site - Salvador
  • GSK Investigational Site - Bydgoszcz
  • GSK Investigational Site - Poznan
  • GSK Investigational Site - Warsaw
  • GSK Investigational Site - Wroclaw
  • GSK Investigational Site - Barcelona
  • GSK Investigational Site - Bilbao

Arizona

  • GSK Investigational Site - Scottsdale

Colorado

  • GSK Investigational Site - Aurora

Nevada

  • GSK Investigational Site - Las Vegas

Ohio

  • GSK Investigational Site - Columbus

Oklahoma

  • GSK Investigational Site - Oklahoma City

Texas

  • GSK Investigational Site - Dallas

Rio Grande do Sul

  • GSK Investigational Site - Porto Alegre

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2024-09-02
Est. Completion 2028-01-11
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06576271

The ClinicalTrials.gov registry entry for NCT06576271 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (63% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 3 interventions - of which Belimumab is the first listed.

NCT06576271 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Arizona, Colorado.

Frequently Asked Questions

What is clinical trial NCT06576271 about?

NCT06576271 is a clinical study titled "A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants". 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...

What is the current status of trial NCT06576271?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 142 participants. The study started on 2024-09-02. Estimated completion is 2028-01-11.

What conditions does trial NCT06576271 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus.

What interventions are being tested in trial NCT06576271?

The interventions under investigation include: Belimumab (DRUG), GSK4527363 (DRUG), Placebo matching GSK4527363 (DRUG).

Who is sponsoring clinical trial NCT06576271?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06576271 being conducted?

This trial has 20 study locations across Arizona, Colorado, Nevada, Ohio, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.