Phase
Condition
Connective Tissue Diseases
Lupus
Bone Diseases
Treatment
Belantamab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 initialscreening 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 AgainstRheumatism (EULAR) or American College of Rheumatology (ACR) Classification Criteria
Positive anti-double stranded deoxyribonucleic acid (anti-dsDNA) autoantibody and/orpositive 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 >=6months 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 >=3/66Swollen 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/IgManticardiolipin (aCL) or moderate to high titers of IgG/IgM anti-beta2-glycoproteinI antibody using central lab test, at ISV
Clinical features attributable to antiphospholipid antibodies that are resistant towarfarin and/or heparin:
Thrombotic event within last 18 months despite adequate anti-coagulationtherapy and/or
Persistent thrombocytopenia and/or
Persistent autoimmune hemolytic anemia
Sex and Contraceptive /Barrier requirements for females.
Exclusion
Exclusion criteria:
SLE specific exclusion:
Any acute, severe lupus related flare during the Screening Period that needsimmediate 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 daysbefore study ISV
Catastrophic APS classification within the prior 90 days of ISV
Study Design
Connect with a study center
GSK Investigational Site
Bordeaux, 33000
FranceActive - Recruiting
GSK Investigational Site
Madrid, 28040
SpainActive - Recruiting
GSK Investigational Site
Medley, Florida 33166
United StatesActive - Recruiting
GSK Investigational Site
Peachtree Corners, Georgia 30071
United StatesActive - Recruiting
GSK Investigational Site
Memphis, Tennessee 38119
United StatesSite Not Available
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