A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

Summary

This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis

Timeline

Start

2021-06-17

Primary completion

2023-05-18

Completion

2023-11-16

Outcome

Met primary endpoint

release “Results of the study showed that CT-P41 had equivalent efficacy and PD to reference denosumab” celltrion.com ↗

release “The primary efficacy endpoint was met in terms of percent change from baseline in bone mineral density (BMD)” celltrion.com ↗

release “the primary pharmacodynamics (PD) endpoint was met in terms of area under the effect curve (AUEC)” celltrion.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CT-P41	Unknown	60 mg/ml	—
Comparator	Denosumab	Monoclonal antibody	60 mg/ml	—

Indications