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

August 26, 2025 updated by: GlaxoSmithKline

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 Autoimmune Disease

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Noémie Gensous
  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ángel Robles Marhuenda
      • Madrid, Spain, 28040
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonio Portoles Perez
  • United States
    • Florida
      • Medley, Florida, United States, 33166
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ramon Moreda
    • Georgia
      • Peachtree Corners, Georgia, United States, 30071
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Darrell Murray

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Belantamab
Biological: Belantamab
Belantamab will be administered
Other Names:
  • GSK2857914

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-t)] of belantamab
Time Frame: Up to 12 weeks
Up to 12 weeks
Area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] of belantamab
Time Frame: Up to 12 weeks
Up to 12 weeks
Maximum observed plasma drug concentration [Cmax] of belantamab
Time Frame: Up to 12 weeks
Up to 12 weeks
Number of participants with Anti-Drug Antibodies (ADAs) against belantamab
Time Frame: Up to 12 weeks
Up to 12 weeks
Titers of ADAs against belantamab
Time Frame: Up to 12 weeks
Up to 12 weeks
Change from Baseline in Immunoglobulin (Ig) M (IgM)
Time Frame: Baseline (Day 1) and up to Week 12
Baseline (Day 1) and up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Actual)

July 8, 2025

Study Completion (Actual)

July 8, 2025

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221615
  • 2023-510340-20-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autoimmune Diseases

Clinical Trials on Belantamab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe