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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06413511
• Other study ID #: 221615
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 29, 2024
• Est. completion date: November 24, 2025

Study information

• Verified date: May 2024
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: November 24, 2025
• Est. primary completion date: November 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) from 18 to 32 kilograms per square meter (kg/m²) (BMI = weight/height^2), inclusive, and body weight of =40 kg

• Documented clinical diagnosis of SLE according to the European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria

• Moderate to Severe SLE disease

• Positive anti-dsDNA autoantibody test results

• Sex and Contraceptive/Barrier requirements for males and females

Exclusion Criteria:

• Any acute, severe lupus related flare during the Screening Period that needs immediate treatment

• Has any unstable or progressive manifestation of SLE

• Significant, likely irreversible organ damage related to SLE

• Major Diseases/Conditions/Morbidities including participants with any uncontrolled medical conditions (other than SLE) that in the opinion of the investigator puts the participant at unacceptable risk

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• Belantamab
Belantamab will be administered.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Medley	Florida
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Peachtree Corners	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs) and serious adverse events (SAEs)		Up to Week 12
Primary	Number of participants with clinically important findings in vital signs		Up to Week 12
Primary	Number of participants with clinically important findings in electrocardiogram		Up to Week 12
Primary	Number of participants with clinically important findings in echocardiogram		Up to Week 12
Primary	Number of participants with clinically important findings in haematology		Up to Week 12
Primary	Number of participants with clinically important findings in clinical chemistry		Up to Week 12
Primary	Number of participants with clinically important findings in urinalysis parameters		Up to Week 12
Primary	Number of participants with clinically important findings in corneal toxicity		Up to Week 12
Secondary	Change from baseline in anti-double stranded deoxyribonucleic acid (anti-dsDNA) autoantibodies		Baseline (Day 1) and at Week 6
Secondary	Area under the concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-t)] of belantamab		Up to 12 weeks
Secondary	Area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] of belantamab		Up to 12 weeks
Secondary	Maximum observed plasma drug concentration [Cmax] of belantamab		Up to 12 weeks
Secondary	Number of participants with Anti-Drug Antibodies (ADAs) against belantamab		Up to 12 weeks
Secondary	Titers of ADAs against belantamab		Up to 12 weeks