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A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE) - Trial NCT06411249

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.

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NCT06411249
Phase 4
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06411249
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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

Study Focus

Belimumab (GSK1550188)

Interventional

drug

Sponsor & Location

GlaxoSmithKline

Timeline & Enrollment

Phase 4

Jun 04, 2024

May 29, 2029

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 erythematosus
Systemic lupus erythematosus, unspecified
Lupus erythematosus
Systemic lupus erythematosus with organ or system involvement
Other forms of systemic lupus erythematosus

Data Source

ClinicalTrials.gov

NCT06411249

Non-Device Trial