This is a phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening.
Phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of Screening. Up to 42 eligible patients will receive one of 2 doses of AT-1501. All patients are scheduled to receive AT-1501 by intravenous infusion every 3 weeks for approximately 2 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Liverpool Hospital
Liverpool, South Wales, Australia
Efficacy - change in participants UPCR
The change in 24-hour urine protein to creatinine ratio (UPCR) from baseline to 24 weeks
Time frame: Up to 24 weeks
Safety- Number of participants with treatment related adverse events
Incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs of special interest (AEoSI)
Time frame: Through study completion, an average of 100 weeks
Change in eGFR slope
The change in eGFR slope from baseline to 96 weeks
Time frame: Baseline- 96 weeks
Change in urine protein excretion (mg/mg)
The change in urine protein excretion over time
Time frame: Up to 96 weeks
Development of Anti drug Antibodies (ADAs)
The percentage of participants who develop ADAs
Time frame: Up to 96 weeks
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