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NCT06413511

A Study to Investigate the Safety and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Male and Female Participants Aged 18 to 75 With Moderate to Severe Systemic Lupus Erythematosus

A Phase 1b, Dose Escalation, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Participants With Moderate to Severe Systemic Lupus Erythematosus
GlaxoSmithKline·Phase 1·ClinicalTrials.gov·biologicalNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Systemic Lupus Erythematosus
Drug/Device/Intervention
Belantamab
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
GlaxoSmithKline
Location
Medley,Peachtree Corners,Memphis, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
May 29, 2024
End date
Nov 24, 2025
Enrollment
16 participants
Primary outcome

Number of participants with adverse events (AEs) and serious adverse events (SAEs),Number of participants with clinically important findings in vital signs,Number of participants with clinically important findings in electrocardiogram,Number of participants with clinically important findings in echocardiogram,Number of participants with clinically important findings in haematology,Number of participants with clinically important findings in clinical chemistry,Number of participants with clinically important findings in urinalysis parameters,Number of participants with clinically important findings in corneal toxicity

Summary

The goal of this clinical trial is to assess the safety and tolerability profile of
 belantamab. The study will also assess how the levels of belantamab change over time and
 body's reaction to it in participants with moderate to severe systemic lupus erythematosus
 (SLE).

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
NCT06413511
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06413511 through Pure Global AI's free database. This Phase 1 trial is sponsored by GlaxoSmithKline and is currently Not yet recruiting. The study focuses on Systemic Lupus Erythematosus. Target enrollment is 16 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.