A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PEGCETACOPLAN IN PATIENTS WITH C3 GLOMERULOPATHY OR IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS (A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PEGCETACOPLAN IN PATIENTS WITH C3 GLOMERULOPATHY OR IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS)

Apellis Pharmaceuticals, Inc.0 个研究点目标入组 5 人开始时间: 2023年8月18日最近更新: 2023年11月11日

试验速览

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•1.Aged at least 18 years; where approved, adolescents (aged 12-17 years) weighing at least 30 kg may also be enrolled.
•2.A diagnosis of primary C3G or IC-MPGN (with or without previous renal transplant).
•3.Evidence of active renal disease, based on one or more of the following:
•a.In adults or adolescents with a baseline renal biopsy (either one collected during screening or a historic biopsy collected within 28 weeks prior to randomization), at least 2 C3c staining on the baseline renal biopsy.
•b.In adolescents not providing a baseline renal biopsy, at least one of the following:
•Plasma sC5b-9 level above the upper limit of normal during screening
•Serum C3 below the LLN during screening
•Presence of an active urine sediment during screening, as evidenced by hematuria with at least 5 red blood cells per high-power field and/or red blood cell casts on routine local or central microscopic analysis of urine
•Presence of C3 nephritic factor within 6 months of screening, based on central laboratory results or medical history
•4.No more than 50% global glomerulosclerosis or interstitial fibrosis on the baseline biopsy for adult participants or adolescent participants providing a baseline biopsy.
•5.At least 1 g/day of proteinuria on a screening 24-hour urine collection and a uPCR of at least 1000 mg/g in at least 2 first-morning spot urine samples collected during screening.

•Previous exposure to pegcetacoplan.
•Evidence of improving renal disease in the 8 weeks prior to screening or during the screening period according to available data; improving renal disease is defined as more than 30% increase in eGFR or more than 50% decrease in proteinuria.
•From a renal transplant participant, evidence of rejection that requires treatment in the baseline renal biopsy collected during screening.
•C3G/IC-MPGN secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, a systemic autoimmune disease such as systemic lupus erythematosus, chronic antibody-mediated rejection, or a medication), in the opinion of the investigator.
•Current or prior diagnosis of HIV, hepatitis B, or hepatitis C infection or positive serology during screening that is indicative of infection with any of these viruses.
•Body weight greater than 100 kg at screening.
•Hypersensitivity to pegcetacoplan or to any of the excipients.
•History of meningococcal disease.
•Malignancy, except for the following:
•a. Cured basal or squamous cell skin cancer
•b. Curatively treated in situ disease
•c. Malignancy-free and off treatment for more than 5 years
•Severe infection (eg, requiring IV antibiotic therapy) within 14 days prior to the first dose of pegcetacoplan.
•An absolute neutrophil count less than 1000 cells/mm3 at screening.

The log-transformed ratio of uPCR at week 26 compared to baseline

The proportion of participants who meet the criteria for achieving a composite renal endpoint

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