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WithdrawnNCT06413511Updated Aug 27, 2025

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

A Phase 1 interventional study of Belantamab in Autoimmune Diseases, sponsored by GlaxoSmithKline. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Why this study was withdrawn
Sponsor decision
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Autoimmune Diseases

Keywords

  • Systemic Lupus Erythematosus
  • Belantamab (GSK2857914)
  • Autoimmune Disease
03

In context

Autoimmune Diseases

655 studies on the registry are indexed under Autoimmune Diseases; 275 are open to participants now.

Browse Autoimmune Diseases studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Belantamab

    Biological: Belantamab

Interventions

  • BiologicalBelantamab

    Belantamab will be administered

    Also known as: GSK2857914

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to Week 12

  2. Number of participants with clinically important findings in vital signs

    Time frame: Up to Week 12

  3. Number of participants with clinically important findings in electrocardiogram

    Time frame: Up to Week 12

  4. Number of participants with clinically important findings in echocardiogram

    Time frame: Up to Week 12

  5. Number of participants with clinically important findings in hematology

    Time frame: Up to Week 12

  6. Number of participants with clinically important findings in clinical chemistry

    Time frame: Up to Week 12

  7. Number of participants with clinically important findings in urinalysis parameters

    Time frame: Up to Week 12

  8. Number of participants with clinically important finding in corneal toxicity

    Time frame: Up to Week 12

Secondary outcomes

  1. Change from Baseline in Immunoglobulin (Ig) M (IgM)

    Time frame: Baseline (Day 1) and up to Week 12

  2. 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

  3. Area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] of belantamab

    Time frame: Up to 12 weeks

  4. Maximum observed plasma drug concentration [Cmax] of belantamab

    Time frame: Up to 12 weeks

  5. Number of participants with Anti-Drug Antibodies (ADAs) against belantamab

    Time frame: Up to 12 weeks

  6. Titers of ADAs against belantamab

    Time frame: Up to 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — 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/

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06413511
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
May 14, 2024
Start date
Jun 3, 2024
Primary completion
Jul 8, 2025
Completion
Jul 8, 2025
Last update
Aug 27, 2025

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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