Recruiting
Phase 1

Belantamab

Sponsor:

GlaxoSmithKline

Code:

NCT06413511

Conditions

Autoimmune Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Belantamab

Study Details

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 ID

NCT06413511

Start date

Jun 3, 2024

Status verified date

Apr, 2025

Completion date

Sep 21, 2026

Anticipated

Primary completion date

Nov 27, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

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

  • 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.

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 >=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.

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/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

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Belantamab

Interventions

Belantamab

Belantamab will be administered

Primary outcome measure

  • Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to Week 12 ]
  • Number of participants with clinically important findings in vital signs [ Time Frame: Up to Week 12 ]
  • Number of participants with clinically important findings in electrocardiogram [ Time Frame: Up to Week 12 ]
  • Number of participants with clinically important findings in echocardiogram [ Time Frame: Up to Week 12 ]
  • Number of participants with clinically important findings in hematology [ Time Frame: Up to Week 12 ]
  • Number of participants with clinically important findings in clinical chemistry [ Time Frame: Up to Week 12 ]
  • Number of participants with clinically important findings in urinalysis parameters [ Time Frame: Up to Week 12 ]
  • Number of participants with clinically important finding in corneal toxicity [ Time Frame: Up to Week 12 ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Medley, Florida, United States, 33166

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ramon Moreda

GSK Investigational Site

Recruiting

Peachtree Corners, Georgia, United States, 30071

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Darrell Murray

More Information

Sponsor

GlaxoSmithKline

Last update posted

Apr 20, 2025

Last verified

Apr, 2025

Keywords

  • Systemic Lupus Erythematosus
  • Belantamab (GSK2857914)
  • Autoimmune Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2025-04-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.