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

RecruitingPhase 1

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)

Who can join

Ages 18 to 65 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Aged 18 to 65 years at the time of consent.
2. Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.
3. Active, seropositive disease, with SLEDAI 2K \>=8.
4. Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.

Exclusion Criteria:

1. Active neuropsychiatric SLE.
2. History of inflammatory or autoimmune diseases including, but not limited to, rheumatoid arthritis, scleroderma, myositis, vasculitis, inflammatory bowel disease, or other conditions that require immune suppressive therapy. Subjects with stable concurrent Sjogren's, asthma, or autoimmune thyroid disease may be considered for participation.
3. Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.

About the study

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.

What is being tested

Sponsor: Climb Bio, Inc. · Participants: 30 · Started: Jul 10, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07011043

Locations in the U.S.

TexasClimb Bio Investigative Site #100104, Allen
Climb Bio Investigative Site #100101, San Antonio

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.