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

GlaxoSmithKline (GSK)

Status and phase

Enrolling

Phase 1

Conditions

Autoimmune Diseases

Treatments

Biological: Belantamab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06413511

2023-510340-20-00 (Other Identifier)

221615

Details and patient eligibility

About

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.

Enrollment

16 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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