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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Belantamab will be administered
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Week 12
Number of participants with clinically important findings in vital signs
Time frame: Up to Week 12
Number of participants with clinically important findings in electrocardiogram
Time frame: Up to Week 12
Number of participants with clinically important findings in echocardiogram
Time frame: Up to Week 12
Number of participants with clinically important findings in hematology
Time frame: Up to Week 12
Number of participants with clinically important findings in clinical chemistry
Time frame: Up to Week 12
Number of participants with clinically important findings in urinalysis parameters
Time frame: Up to Week 12
Number of participants with clinically important finding in corneal toxicity
Time frame: Up to Week 12
Change from Baseline in Immunoglobulin (Ig) M (IgM)
Time frame: 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
Time frame: Up to 12 weeks
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Area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] of belantamab
Time frame: Up to 12 weeks
Maximum observed plasma drug concentration [Cmax] of belantamab
Time frame: Up to 12 weeks
Number of participants with Anti-Drug Antibodies (ADAs) against belantamab
Time frame: Up to 12 weeks
Titers of ADAs against belantamab
Time frame: Up to 12 weeks