NCT05419427

Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis

A Randomized,Double Blind,Active Controlled Parallel Arm Multicenter Study Comparing Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Denosumab of Intas Pharmaceutical Limited (60 mg/mL) With Prolia® in Postmenopausal Women With Osteoporosis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 552 (estimated)
• Sponsor: Lambda Therapeutic Research Ltd. · Industry
• Sex: Female
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Denosumab of Intas is biosimilar denosumab candidate under development by Intas Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian drug licensing authority- Drug Controller General (India) for marketing in Indian population since 2018.As per regulatory requirement, a comparative clinical study to establish Pharmacokinetic, Pharmacodynamic and Immunogenicity equivalence is required to conclude therapeutic equivalence to obtain marketing authorization of a biosimilar investigational product. This is a multicenter, randomized, double-blind, active controlled study in approximately 552postmenopausal women with osteoporosis. An extension of the study is planned after completion of the initial 1 year of treatment. This extension is with the objective of submitting data on safety, and Immunogenicity, after switching of Prolia treatment arm to either Prolia or Intas denosumab for 6 months. This switching data is applicable only for FDA submission. Only patients who have undergone PK assessment will be eligible for the extension phase.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	Denosumab	Denosumab 60 MG/ML
DRUG	Denosumab-Ref	Denosumab 60 MG/ML

Timeline

• Start date: 2021-11-11
• Primary completion: 2024-09-11
• Completion: 2024-11-24
• First posted: 2022-06-15
• Last updated: 2023-10-13

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study