NCT05405725

A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 504 (actual)
• Sponsor: Enzene Biosciences Ltd. · Industry
• Sex: Female
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
BIOLOGICAL	ENZ215	Enrolled women with postmenopausal osteoporosis receive ENZ215 (60mg)
BIOLOGICAL	Prolia	Enrolled women with postmenopausal osteoporosis receive Prolia

Timeline

• Start date: 2022-07-04
• Primary completion: 2024-07-18
• Completion: 2024-07-18
• First posted: 2022-06-06
• Last updated: 2026-02-10
• Results posted: 2026-02-10

Locations

48 sites across 7 countries: Bulgaria, Czechia, Denmark, Lithuania, Poland, Serbia, Spain