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

Last updated: April 18, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

1

Condition

Connective Tissue Diseases

Lupus

Bone Diseases

Treatment

Belantamab

Clinical Study ID

NCT06413511
221615
2023-510340-20-00
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 initialscreening visit (ISV)

Participants with systemic lupus erythematosus (SLE) must also meet the following inclusion criteria:

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

  • Positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) autoantibody and/orpositive 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.

Participants with Rheumatoid Arthritis (RA) must also meet the following inclusion Criteria:

  • Meets ACR/EULAR 2010 RA Classification Criteria with a duration of RA disease of >=6months 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 >=3/66Swollen joint count at ISV and Baseline.

  • Failure to adequately respond to at least two immunosuppressive therapies.

Participants with antiphospholipid syndrome (APS) must also meet the following inclusion criteria:

  • Documented diagnosis of APS meeting the 2023 ACR/EULAR APS classification criteria

  • Positive lupus anticoagulant test or moderate to high titers of positive IgG/IgManticardiolipin (aCL) or moderate to high titers of IgG/IgM anti-beta2-glycoproteinI antibody using central lab test, at ISV

  • Clinical features attributable to antiphospholipid antibodies that are resistant towarfarin and/or heparin:

  • Thrombotic event within last 18 months despite adequate anti-coagulationtherapy and/or

  • Persistent thrombocytopenia and/or

  • Persistent autoimmune hemolytic anemia

  • Sex and Contraceptive /Barrier requirements for females.

Exclusion

Exclusion criteria:

SLE specific exclusion:

  • Any acute, severe lupus related flare during the Screening Period that needsimmediate 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 daysbefore study ISV

  • Catastrophic APS classification within the prior 90 days of ISV

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: Belantamab
Phase: 1
Study Start date:
June 03, 2024
Estimated Completion Date:
September 21, 2026

Connect with a study center

  • GSK Investigational Site

    Bordeaux, 33000
    France

    Active - Recruiting

  • GSK Investigational Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Medley, Florida 33166
    United States

    Active - Recruiting

  • GSK Investigational Site

    Peachtree Corners, Georgia 30071
    United States

    Active - Recruiting

  • GSK Investigational Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.