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 Autoimmune Disease

NCT06413511 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: 2216152023-510340-20-00
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 stable but active autoimmune disease.

Conditions

Autoimmune Diseases

Keywords

Systemic Lupus Erythematosus; Belantamab (GSK2857914); Autoimmune Disease

Outcome Measures

Primary Outcomes (8)

• Number of participants with adverse events (AEs) and serious adverse events (SAEs)

  Up to Week 12

• Number of participants with clinically important findings in vital signs

  Up to Week 12

• Number of participants with clinically important findings in electrocardiogram

  Up to Week 12

• Number of participants with clinically important findings in echocardiogram

  Up to Week 12

• Number of participants with clinically important findings in hematology

  Up to Week 12

• Number of participants with clinically important findings in clinical chemistry

  Up to Week 12

• Number of participants with clinically important findings in urinalysis parameters

  Up to Week 12

• Number of participants with clinically important finding in corneal toxicity

  Up to Week 12

Secondary Outcomes (6)

• Change from Baseline in Immunoglobulin (Ig) M (IgM)

  Baseline (Day 1) and up to Week 12

• Area under the concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-t)] of belantamab

  Up to 12 weeks

• Area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] of belantamab

  Up to 12 weeks

• Maximum observed plasma drug concentration [Cmax] of belantamab

  Up to 12 weeks

• Number of participants with Anti-Drug Antibodies (ADAs) against belantamab

  Up to 12 weeks

Study Arms (1)

Belantamab

EXPERIMENTAL

Biological: Belantamab

Interventions

Belantamab BIOLOGICAL

Belantamab will be administered

Also known as: GSK2857914

Belantamab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) from 18 to 40 kilograms per square meter (kg/m\^2) (BMI = weight/height\^2), inclusive, and body weight of \>=40 kilogram (kg)
• IgM \>= lower limit of normal (LLN) (40 milligram per deciliter \[mg/dL\]) at initial screening visit (ISV)
• Documented clinical diagnosis of SLE according to the European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria
• Positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) autoantibody and/or positive antinuclear antibody (ANA) test results, using central lab test, at ISV.
• SLE Disease Activity Index 2000 (SLEDAI-2K) total score of \>=6 at ISV.
• Failure to adequately respond to at least two immunosuppressive therapies.
• Meets ACR/EULAR 2010 RA Classification Criteria with a duration of RA disease of \>=6 months at time of ISV
• Positive rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) test results, using central lab test, at ISV.
• Have moderate to severe active disease as defined by \>=3/68 Tender and \>=3/66 Swollen joint count at ISV and Baseline.
• Failure to adequately respond to at least two immunosuppressive therapies.
• Documented diagnosis of APS meeting the 2023 ACR/EULAR APS classification criteria
• Positive lupus anticoagulant test or moderate to high titers of positive IgG/IgM anticardiolipin (aCL) or moderate to high titers of IgG/IgM anti-beta2-glycoprotein I antibody using central lab test, at ISV
• Clinical features attributable to antiphospholipid antibodies that are resistant to warfarin and/or heparin:
• Thrombotic event within last 18 months despite adequate anti-coagulation therapy and/or
• Persistent thrombocytopenia and/or

You may not qualify if:

• 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
• RA functional status class IV according to the ACR 1991 revised criteria
• Adult Juvenile RA
• Acute thrombosis (arterial or venous acute thrombosis diagnosis) less than 30 days before study ISV
• Catastrophic APS classification within the prior 90 days of ISV

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Autoimmune Diseases; Lupus Erythematosus, Systemic

Interventions

belantamab mafodotin

Condition Hierarchy (Ancestors)

Immune System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: June 3, 2024
• Primary Completion: July 8, 2025
• Study Completion: July 8, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.