Randomized, Double-Blind, Parallel Design, 2-arm,Multicenter Study Assessing the Biosimilarity of AVT03 and US-Prolia® in Postmenopausal Women With Osteoporosis

• Status: Not yet recruiting
• Trial end date: 2024-09-30

Summary

This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, and PK profiles of AVT03 and Prolia in postmenopausal women with osteoporosis.

After the screening activities, eligible subjects will be randomized in a 1:1 ratio to receive either AVT03 60 mg or Prolia® 60 mg, administered as a subcutaneous (s.c.) injection on Day 1 and Day 180 (Month 6). At Month 12, subjects in AVT03 treatment group will receive a third dose of AVT03 60 mg administered s.c. while subjects in Prolia® treatment group will be re-randomized in a 1:1 ratio to receive either Prolia 60 mg or AVT03 60 mg on Day 365 (Month 12), administered as a subcutaneous injection.

Afterwards, the subjects will be followed until the End of Study (EoS) Visit at Month 18 (ie, 6 months after the last dose at Month 12).

Approximately 30 clinical sites will participate in this study. The planned number of randomized patients is approximately 476.

Expected countries : Bulgaria, Czech Republic, Georgia, Poland, South Africa.

• Phase: Phase 3

Details

• Lead Sponsor: Alvotech Swiss AG
• Treatments: Denosumab