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A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
NCT06576271 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2024-09-02 |
| Est. Completion | 2028-01-11 |
| Phase | Phase 1 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06576271 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06576271?
The interventions under investigation include: Belimumab (DRUG), GSK4527363 (DRUG), Placebo matching GSK4527363 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06576271?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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