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A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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)

NCT07011043•Climb Bio, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (18)

Climb Bio Investigative Site #100104

Allen, Texas, United States

Climb Bio Investigative Site #100101

San Antonio, Texas, United States

Climb Bio Investigative Site# 359101

Plovdiv, Bulgaria

Climb Bio Investigative Site# 359102

Sofia, Bulgaria

Climb Bio Investigative Site #995102

Tbilisi, Georgia

Climb Bio Investigative Site #995101

Tbilisi, Georgia

Climb Bio Investigative Site# 300102

Exochi, Thessaloniki, Greece

Climb Bio Investigative Site# 300103

Thessaloniki, Thessaloniki, Greece

Climb Bio Investigative Site #100103

Caguas, Puerto Rico

Climb Bio Investigative Site# 400101

Cluj-Napoca, Romania

Key Dates

Start Date

July 10, 2025

Primary Completion Date

April 1, 2027

Completion Date

April 1, 2027

Last Updated

January 7, 2026

Enrollment

ESTIMATED participants

Conditions

Systemic Lupus Erythematosus

Interventions

Budoprutug

DRUG

Contacts

Climb Bio Study Director

CONTACT

+1 866 857 2596 clinicaltrials@climbbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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