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Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis

NCT05419427 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2023-10-13

No results posted yet for this study

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

DRUG

Denosumab

Denosumab 60 MG/ML

DRUG

Denosumab-Ref

Denosumab 60 MG/ML

Sponsors & Collaborators

  • Intas Pharmaceutical Limited (Biopharma Division)

    collaborator UNKNOWN

  • Lambda Therapeutic Research Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-11
Primary Completion
2024-09-11
Completion
2024-11-24
FDA Drug
Yes

Countries

  • India

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05419427 on ClinicalTrials.gov