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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: Recruiting Phase 1 study of Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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 |
What NCT06576271 shows while recruiting
NCT06576271 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (63% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
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Where NCT06576271's enrollment target sits among peer trials
142 49th of 99 higher than 51 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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