The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of budoprutug in participants with SLE
This is a Phase 1b/2a, multicenter, open-label study designed to evaluate the safety, tolerability, PK, and PD of budoprutug in adult participants with SLE. In Phase 1b, participants who fulfill the 2012 Systemic Lupus International Collaborating Clinics(SLICC) classification criteria for SLE, and who have active SLE (as defined by a SLEDAI ≥ 4 at Screening and Day 1),have failed at least 1 line of treatment, and who are assessed as appropriate for the study by the Eligibility Adjudicator, will be enrolled in sequential escalating dose cohorts. Three dose cohorts are planned. The Phase 2a expansion cohort will include approximately 16 to 20 participants with active SLE, at least one-half of whom will have renal involvement. Participants will continue to be followed through Week 52 for safety, PK, and PD assessmentsParticipants will also be monitored during this time for ongoing clinical response, safety parameters, and kinetics of re-population of B-cell subsets after the return of B cells to baseline values.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
monoclonal antibody
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Safety assessments of budoprutug include changes in vital signs, clinical findings on physicial exam, electrocardiogram and clinical laboratory findings
Time frame: Day 1 through Week 24
PK parameters
Area under the maximum observed concentration (AUC)
Time frame: Day 1 through Week 24
PK parameters
Peak concentration (Cmax)
Time frame: Day 1 through Week 24
PK parameters
Time to maximum observed concentration(T-max)
Time frame: Day 1 through Week 24
PK parameters
Terminal half-life
Time frame: Day 1 through Week 24
PK parameters
Apparent clearance
Time frame: Day 1 through Week 24
PK parameters
Volume of distribution
Time frame: Day 1 through Week 24
Immunogenicity
Incidence of anti-drug antibodies (ADA)
Time frame: Day 1 through Week 24
Immunogenicity
Time-course of anti-drug antibodies (ADA)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 through Week 24
Immunogenicity
Titers of anti-drug antibodies (ADA)
Time frame: Day 1 through Week 24