A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
Recruiting
Phase 1
Phase 2
Interventional Study
Systemic Lupus Erthematosus
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About This Trial
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/2a, open-label study will evaluate budoprutug in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study…
Trial Locations
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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 \>=6 at screening
4. Inadequate re…
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