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A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
NCT06411249 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06411249
The ClinicalTrials.gov registry entry for NCT06411249 describes a study currently listed as recruiting. It is categorized as Phase 4, 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 350 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 1 intervention — of which Belimumab (GSK1550188) 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: NCT06411249 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06411249?
The interventions under investigation include: Belimumab (GSK1550188) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06411249?
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 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.
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