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A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
NCT07011043 · Climb Bio, Inc.
In plain English
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Official title
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)
About this study
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 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.
Study design
Enrollment target: 30 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-10
Estimated completion: 2027-04
Last updated: 2026-03-27
Interventions
Drug: Budoprutug
Primary outcomes
- • Incidence of Treatment-Emergent Adverse Events (TEAEs) (Up to Week 24)
- • Incidence of Clinical Laboratory Abnormalities (Up to Week 24)
- • Change from Baseline in Systolic Blood Pressure (Up to Week 24)
Sponsor
Climb Bio, Inc. · industry
Contacts & investigators
ContactClimb Bio Study Director · contact · clinicaltrials@climbbio.com · +1 866 857 2596
InvestigatorStudy Director · study_director, Climb Bio, Inc.
All locations (18)
Climb Bio Investigative Site #100104Recruiting
Allen, Texas, United States
Climb Bio Investigative Site #100101Recruiting
San Antonio, Texas, United States
Climb Bio Investigative Site# 359101Recruiting
Plovdiv, Bulgaria
Climb Bio Investigative Site# 359102Recruiting
Sofia, Bulgaria
Climb Bio Investigative Site #995102Recruiting
Tbilisi, Georgia
Climb Bio Investigative Site #995101Recruiting
Tbilisi, Georgia
Climb Bio Investigative Site# 300102Recruiting
Exochi, Thessaloniki, Greece
Climb Bio Investigative Site# 300103Recruiting
Thessaloniki, Thessaloniki, Greece
Climb Bio Investigative Site #100103Recruiting
Caguas, Puerto Rico
Climb Bio Investigative Site# 400101Recruiting
Cluj-Napoca, Romania
Climb Bio Investigative Site# 340101Recruiting
Sabadell, Barcelona, Spain
Climb Bio Investigative Site# 340102Recruiting
A Coruña, Spain
Climb Bio Investigative Site #380102Recruiting
Ivano-Frankivsk, Ukraine
Climb Bio Investigative Site #380103Recruiting
Kyiv, Ukraine
Climb Bio Investigative Site #380106Recruiting
Kyiv, Ukraine
Climb Bio Investigative Site #380101Recruiting
Ternopil, Ukraine
Climb Bio Investigative Site #380104Recruiting
Vinnytsia, Ukraine
Climb Bio Investigative Site #380105Recruiting
Vinnytsia, Ukraine