RecruitingPhase 1NCT07011043
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)
Sponsor
Climb Bio, Inc.
Enrollment
30 participants
Start Date
Jul 10, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria4
- Aged 18 to 65 years at the time of consent.
- Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.
- Active, seropositive disease, with SLEDAI 2K \>=8.
- Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.
Exclusion Criteria3
- Active neuropsychiatric SLE.
- 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.
- Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.
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Interventions
DRUGBudoprutug
Single IV dose of study product on Day 1 of study
Locations(18)
View Full Details on ClinicalTrials.gov
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NCT07011043
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