PEGCETACOPLAN
C3 is the point of convergence between all three complement pathways and the initiation of the terminal pathway. C3 inhibition is expected to block the entire complement system, including the classical pathway and C3b opsonization. Excessive local activation and dysregulation of the alternative complement pathway in the glomeruli can cause excessive deposition of multiple complement components in the glomerulus. C3 inhibitor Pegcetacoplan regulates the cleavage of C3 and the generation of downstream effectors of complement activation.
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How is Pegecetacoplan being studied in C3GN?
A prior phase 2 DISCOVERY study showed that patients treated with Pegcetacoplan showed a greater than 65% reduction in 24-hour uPCR from baseline to Week 48 when Pegcetacoplan was administered as 360 mg daily subcutaneous infusions with transition to 1080 mg twice weekly from Week 24.
NOBLE (enrolment completed) is a phase 2 Study to evaluate the safety and efficacy of Pegcetacoplan in the treatment of post-transplant recurrence of C3GN or immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN). VALIANT (actively enrolling) is a A Phase 3, randomized, placebo-controlled, double-blinded, multicenter study to evaluate the efficacy and safety of Pegcetacoplan in patients C3GN or IC-MPGN. 90 patients will be randomized between SC infusion of 1080mg Pegcetacoplan twice weekly vs placebo comparator for 26 weeks followed by an open label treatment period for 26 weeks. Primary outcome measure studied is reduction from baseline in urine UPCR of at least 50% at Week 26.
Eligibility Criteria
01
At least 12 years of age (some countries are enrolling adults only)
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03
Significant proteinuria of at least 1g/day
05
Weight 30kg–100kg at screening
02
Have diagnosis of primary C3G or IC-MPGN, with or without prior renal transplantation
04
eGFR ≥ 30ml/min/1.73m2
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