NCT07011043

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

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Climb Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.

Detailed description

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, open-label study will evaluate budoprutug administered as a single intravenous infusion 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 following a single infusion.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Budoprutug	Single IV dose of study product on Day 1 of study

Timeline

• Start date: 2025-07-10
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-06-08
• Last updated: 2026-03-27

Locations

18 sites across 8 countries: United States, Bulgaria, Georgia, Greece, Puerto Rico, Romania, Spain, Ukraine

Regulatory

• FDA-regulated drug study