NCT03974100

Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

A Randomized, Double-blind, Multicenter Integrated Phase I/III Study in Postmenopausal Women With Osteoporosis to Compare the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety and Immunogenicity of GP2411 (Proposed Biosimilar Denosumab) and Prolia® (EU-authorized)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 527 (actual)
• Sponsor: Sandoz · Industry
• Sex: Female
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).

Detailed description

This was an international, multicenter, randomized, double-blind, parallel-group study with a total duration of up to 83 weeks. The study comprised a screening period of up to 5 weeks to assess a subject's eligibility and two treatment periods: Treatment Period 1 (TP1) from Day 1 to Week 52 and Treatment Period 2 (TP2) from Week 52 to Week 78. Women with postmenopausal osteoporosis (PMO) were randomized on Day 1 in a 1:1 ratio to receive either two 60 mg subcutaneous (s.c.) doses at 26-week intervals of GP2411 (proposed biosimilar denosumab) or EU-Prolia (EU-authorized Prolia®) during TP1. At Week 52, participants in the EU-Prolia group were re-randomized 1:1 to either continue with a third dose of EU-Prolia or switch to GP2411 for TP2. Participants in the GP2411 group continued the treatment with a third dose of GP2411 in TP2. The End of Study was achieved at Week 78.

Conditions

• Postmenopausal Women With Osteoporosis

Interventions

Type	Name	Description
BIOLOGICAL	GP2411	60 mg /mL subcutaneous injection every 6 months
BIOLOGICAL	EU-Prolia (EU-authorized Prolia®)	60 mg /mL subcutaneous injection every 6 months

Timeline

• Start date: 2019-07-02
• Primary completion: 2022-04-22
• Completion: 2022-04-22
• First posted: 2019-06-04
• Last updated: 2023-03-08
• Results posted: 2023-03-08

Locations

42 sites across 6 countries: United States, Bulgaria, Czechia, Japan, Poland, Spain

Regulatory

• FDA-regulated drug study