CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 457 enrolled
Drug / intervention
SB16 (Proposed Denosumab Biosimilar) +1 moredrug
Likely dose
SB16 (Proposed Denosumab Biosimilar) 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04664959
NCT04664959Phase 3Completed
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A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia® in Postmenopausal Women With Osteoporosis

Samsung Bioepis Co., Ltd.·interventional·Posted Dec 11, 2020·Updated Feb 4, 2025

In Brief

A Phase 3 clinical trial evaluating SB16 (Proposed Denosumab Biosimilar) and Prolia® (Denosumab) for Postmenopausal Osteoporosis. Completed, enrolled 457 participants across 5 sites.

Detailed Summary

This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesPoland
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedDec 11, 2020
Enrollment StartNov 26, 2020
Primary CompletionJun 20, 2022
Study CompletionJan 3, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.6 years ago

Interventions

SB16 (Proposed Denosumab Biosimilar)drug

Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months. At Month 12, subjects transited from Prolia® group to SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously.

Prolia® (Denosumab)drug

Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months.