A Phase 1b Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)

What this Trial Is About

Researchers are studying budoprutug, an investigational humanized antibody that targets CD19 cells, in adults aged 18 to 65 with active and seropositive systemic lupus erythematosus (SLE) who have not responded adequately to standard treatments. This Phase 1b open-label study focuses on assessing the safety and tolerability of budoprutug, as well as its behavior in the body and early signs of effectiveness. Participants will receive a single intravenous infusion of budoprutug at one of several ascending dose levels. The study will monitor how the drug affects B cell counts and antibody levels in the blood over time following the infusion. Multiple dose groups will be evaluated to understand safety and the drug’s movement and action in the body. Throughout the study, participants will be closely observed for treatment-emergent adverse events and changes in vital signs and laboratory tests up to 24 weeks after dosing. Researchers will also measure budoprutug’s concentration in the blood and immune responses, including the presence of anti-drug antibodies. The total monitoring period helps ensure comprehensive safety and pharmacological data collection.

A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)