AT-1501
(Tegoprubart)
Tegoprubart is a next generation monoclonal antibody directed against CD40 ligand (CD40L; CD154),a target in cell and antibody mediated immunity. Inhibiting CD40L is expected to disrupt the pathophysiology of IgAN by blocking antibody and immune complex formation and by interfering with the cell based inflammatory response in the glomeruli.
Enroll in this clinical study
How is it being studied in IgA nephropathy?
42 adults with biopsy proven IgAN and proteinuria ≧0.75g/24h will be enrolled in a phase 2 trial consisting of 2 sequential open-label cohorts. The 2 cohorts will be 10mg/kg and 5mg/kg of tegoprubart administered IV every 3 weeks. The primary endpoint is change from baseline of urine protein to creatinine ratio after 24 weeks of therapy. The study will continue through Week 96 to assess change in eGFR.
Eligibility Criteria
01
Biopsy proven IgAN
03
eGFR ≥ 45 mL/min per 1.73 m2 or eGFR < 45 mL/min per 1.73 m2 and ≥ 30 mL/min per 1.73 m2 with a kidney biopsy within 2 years of Screening showing < 50% tubulointerstitial fibrosis
02
Urine protein ≥ 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB)
04
Agree to comply with contraception requirements during and for 90 days after study completion.
