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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 - Trial NCT06413511

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.

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NCT06413511
Phase 1
Not yet recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT06413511
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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

Study Focus

Belantamab

Interventional

biological

Sponsor & Location

GlaxoSmithKline

Medley,Peachtree Corners,Memphis, United States of America

Timeline & Enrollment

Phase 1

May 29, 2024

Nov 24, 2025

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 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

NCT06413511

Non-Device Trial