A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®
brief summary
The Study will be conducted to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women with Osteoporosis. The primary goal for the study is 1. To evaluate the efficacy of ENZ215 when compared to Prolia® in patients with postmenopausal osteoporosis, in terms of change in BMD at the lumbar spine from baseline to Month 12 and 2. To compare the AUEC of sCTX levels from baseline to Month 6
detailed description
The study will be divided into three periods: Screening period: up to 35 days; Double-blind treatment period of 12 months; and Open-label, switch-over period of six months.
Five hundred four (504) patients (252 patients in each treatment arm) will be enrolled in this study. All eligible patients will be randomized in the double blind treatment period in a 1:1 ratio to receive either ENZ215 or Prolia® (60 mg) subcutaneously (SC) on Day 1 and Month 6. These participants will complete study at 12 months. A PK sub-study will be conducted in a subset of 120 participants with 60 participants in each arm.
A subset of 120 participants randomised to Prolia arm and who completed 12 months of the double-blind treatment period without any significant safety concerns per the Investigator's discretion will be offered to enroll in the open-label, switch-over extension period. After re-consenting for the open-label, switch-over study, the participants will be re-randomised in a 1:1 ratio to receive either ENZ215 or Prolia® (60 mg) SC at Month 12. These participants will complete the study at Month 18.
official title
A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women With Osteoporosis