Autoimmune Diseases
Conditions
Keywords
Systemic Lupus Erythematosus, Belantamab (GSK2857914), Autoimmune Disease
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.
Interventions
BIOLOGICALBelantamab
Belantamab will be administered
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with clinically important finding in corneal toxicity | Up to Week 12 |
| Number of participants with clinically important findings in vital signs | Up to Week 12 |
| Number of participants with clinically important findings in electrocardiogram | Up to Week 12 |
| Number of participants with clinically important findings in echocardiogram | Up to Week 12 |
| Number of participants with clinically important findings in hematology | Up to Week 12 |
| Number of participants with clinically important findings in clinical chemistry | Up to Week 12 |
| Number of participants with clinically important findings in urinalysis parameters | Up to Week 12 |
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Up to Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with Anti-Drug Antibodies (ADAs) against belantamab | Up to 12 weeks |
| Titers of ADAs against belantamab | Up to 12 weeks |
| Change from Baseline in Immunoglobulin (Ig) M (IgM) | Baseline (Day 1) and up to Week 12 |
| Area under the concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-t)] of belantamab | Up to 12 weeks |
| Area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] of belantamab | Up to 12 weeks |
| Maximum observed plasma drug concentration [Cmax] of belantamab | Up to 12 weeks |
Outcome results
None listed