Clinical Trial

A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)

Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-08-07
Trial Details
NCT Number NCT07564596
Lead Sponsor Climb Bio, Inc.
Conditions Systemic Lupus Erthematosus
Enrollment 30 participants
Start Date 2026-06-30
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-06