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 Moderate to Severe Systemic Lupus Erythematosus

May 9, 2024 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 Moderate to Severe Systemic Lupus Erythematosus

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 moderate to severe systemic lupus erythematosus (SLE).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Medley, Florida, United States, 33166
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ramon Moreda
    • Georgia
      • Peachtree Corners, Georgia, United States, 30071
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Darrell Murray
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ramesh Gupta

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 32 kilograms per square meter (kg/m²) (BMI = weight/height^2), inclusive, and body weight of ≥40 kg
  • Documented clinical diagnosis of SLE according to the European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria
  • Moderate to Severe SLE disease
  • Positive anti-dsDNA autoantibody test results
  • Sex and Contraceptive/Barrier requirements for males and females

Exclusion Criteria:

  • 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
  • Major Diseases/Conditions/Morbidities including participants with any uncontrolled medical conditions (other than SLE) that in the opinion of the investigator puts the participant at unacceptable risk

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 haematology
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 corneal toxicity
Time Frame: Up to Week 12
Up to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in anti-double stranded deoxyribonucleic acid (anti-dsDNA) autoantibodies
Time Frame: Baseline (Day 1) and at Week 6
Baseline (Day 1) and at Week 6
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

Collaborators and Investigators

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

Sponsor

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 (Estimated)

May 29, 2024

Primary Completion (Estimated)

November 24, 2025

Study Completion (Estimated)

November 24, 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 (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221615

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.

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