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NCT06411249 · ClinicalTrials.gov registry record · Phase 4
A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
A Phase 4 study of Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 350
- Enrollment target
- 20
- Study locations
NCT06411249: Recruiting Phase 4 study of Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline.
NCT06411249 is a Phase 4 study of Systemic Lupus Erythematosus that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 350 participants, roughly in line with the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target. The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06411249, a Phase 4 study of Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by GlaxoSmithKline.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 350 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable initial SLE therapy.
Primary Outcome
LLDAS is defined as Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than or equal to (\<=) 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no new features of lupus disease activity compared with the previous assessment, Physician Global Assessment (PGA) \<= 1, with a 7-day average oral prednisone equivalent dose for SLE reasons \<= 7.5 milligram (mg)/day and stable treatment and without discontinuing due
Conditions Studied
Interventions
- DRUG Belimumab (GSK1550188)
Study Locations (20)
California
- GSK Investigational Site - Covina
- GSK Investigational Site - Fontana
- GSK Investigational Site - Fullerton
- GSK Investigational Site - Long Beach
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Mission Hills
- GSK Investigational Site - San Diego
- GSK Investigational Site - Temecula
- GSK Investigational Site - Tujunga
- GSK Investigational Site - Van Nuys
- GSK Investigational Site - Van Nuys
- GSK Investigational Site - Whittier
Florida
- GSK Investigational Site - Aventura
- GSK Investigational Site - Clearwater
- GSK Investigational Site - Miami
- GSK Investigational Site - Tamarac
Arizona
- GSK Investigational Site - Flagstaff
- GSK Investigational Site - Mesa
- GSK Investigational Site - Tucson
Alabama
- GSK Investigational Site - Anniston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2024-06-06 |
| Est. Completion | 2029-05-29 |
| Phase | Phase 4 |
What NCT06411249 shows while recruiting
NCT06411249 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 377-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target.
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention - of which Belimumab (GSK1550188) is the first listed.
NCT06411249 names 20 study sites across 4 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06411249 about?
NCT06411249 is a clinical study titled "A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)". This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable initial SLE therapy.
What is the current status of trial NCT06411249?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 350 participants. The study started on 2024-06-06. Estimated completion is 2029-05-29.
What conditions does trial NCT06411249 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT06411249?
The interventions under investigation include: Belimumab (GSK1550188) (DRUG).
Who is sponsoring clinical trial NCT06411249?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06411249 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06411249's enrollment target sits among peer trials
350 24th of 99 higher than 76 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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