Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b/2a, open-label study will evaluate budoprutug in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time. Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts.
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Incidence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Up to week 28
Incidence of Clinical Laboratory Abnormalities
Timeframe: Up to week 28
Incidence of dose-limiting toxicities (DLTs)
Timeframe: up to 28 weeks
Change from Baseline in Systolic Blood Pressure
Timeframe: Up to week 28
Change from Baseline in Diastolic Blood Pressure
Timeframe: up to 28 weeks
Change from Baseline in Heart Rate
Timeframe: up to 28 weeks
Change from Baseline in Respiratory Rate
Timeframe: up to 28 weeks
Change from Baseline in Body Temperature
Timeframe: up to 28 weeks
Change from Baseline in PR Interval
Timeframe: up to 28 weeks
Change from Baseline in QRS Duration
Timeframe: up to 28 weeks
Change from Baseline in QT Interval
Timeframe: up to 28 weeks
Change from Baseline in QTc Interval
Timeframe: up to 28 weeks