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NCT06411249

A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)

A Phase 4, Multicenter, Prospective, Open-Label Study Describing the Efficacy and Safety of Belimumab Administered Subcutaneously in Adult Participants With Early Systemic Lupus Erythematosus
GlaxoSmithKline·Phase 4·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Systemic Lupus Erythematosus
Drug/Device/Intervention
Belimumab (GSK1550188)
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GlaxoSmithKline
Timeline & enrollment
Phase
Phase 4
Start date
Jun 04, 2024
End date
May 29, 2029
Enrollment
350 participants
Primary outcome

Part A: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52

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.

ICD-10 classifications
Systemic lupus erythematosusSystemic lupus erythematosus, unspecifiedLupus erythematosusSystemic lupus erythematosus with organ or system involvementOther forms of systemic lupus erythematosus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06411249
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06411249 through Pure Global AI's free database. This Phase 4 trial is sponsored by GlaxoSmithKline and is currently Not yet recruiting. The study focuses on Systemic Lupus Erythematosus. Target enrollment is 350 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.