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

NCT ID: NCT06413511

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2025-07-08

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Belantamab

Group Type: EXPERIMENTAL

Belantamab

Intervention Type: BIOLOGICAL

Belantamab will be administered

Interventions

Belantamab

Belantamab will be administered

Intervention Type: BIOLOGICAL

Other Intervention Names

GSK2857914

Eligibility Criteria

Inclusion Criteria

• 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
• Persistent autoimmune hemolytic anemia
• Sex and Contraceptive /Barrier requirements for females.

Exclusion Criteria

SLE specific exclusion:

• 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 specific exclusions:

• RA functional status class IV according to the ACR 1991 revised criteria
• Adult Juvenile RA

APS specific exclusions:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

2023-510340-20-00

Identifier Type: OTHER

Identifier Source: secondary_id

221615

Identifier Type: -

Identifier Source: org_study_id