A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

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

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 Overview

• Status: Completed
• Conditions: Postmenopausal Osteoporosis
• Intervention / Treatment: Drug: SB16 (Proposed Denosumab Biosimilar); Drug: Prolia® (Denosumab)

Detailed Description

Subjects will be randomised in a 1:1 ratio to receive either SB16 or Prolia®. At Month 12, subjects in Prolia® treatment group will be randomised again in a 1:1 ratio to either continue on Prolia® treatment or be transitioned to SB16 treatment. Investigational product (60 mg in 1 mL of SB16 or Prolia®) will be given subcutaneously every 6 months up to Month 12, and the last assessment will be done at Month 18.

• Study Type: Interventional
• Enrollment (Actual): 457
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Kraków, Poland
    • SB Investigative Site
  • Siedlce, Poland
    • SB Investigative Site
  • Warszawa, Poland
    • SB Investigative Site
  • Zamość, Poland
    • SB Investigative Site
  • Łódź, Poland
    • SB Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Postmenopausal women who are 55 to 80 years of age at Screening
• Ambulatory and visually unimpaired to participate in the study at Screening, in the opinion of the Investigator
• Absolute BMD consistent with T-score at the total hip or lumbar spine of -4 and -2.5 at Screening
• At least three evaluable vertebrae within L1 to L4, one evaluable femoral neck, and one evaluable hip joint for BMD measurement at Screening
• Biologic naïve at Screening
• Body weight of 50 kg and 90 kg at Screening

Exclusion Criteria:

• One severe or more than two moderate vertebral fractures on spinal X-ray according to Genant classification at Screening
• History of hip fracture or bilateral hip replacement at Screening
• Uncorrected vitamin D deficiency at Screening
• Hypercalcemia or hypocalcaemia at Screening
• Inadequate haematological function at Screening
• Inadequate renal or hepatic function at Screening
• Known allergic reactions, hypersensitivity, or intolerance to denosumab or to any ingredients of the IP, including latex allergy or hereditary problems of fructose intolerance at Screening
• May not tolerate long-term calcium or vitamin D supplementation or subject with malabsorption of calcium or vitamin D supplements, in the opinion of the Investigator, at Screening
• Use of any of the medications that can affect BMD
• Use of any non-biologic IP that is not indicated for osteoporosis from another study or use of an investigational device at Screening
• Non-osteoporosis medical conditions that can affect BMD at Screening
• Any clinically significant disease or disorder or laboratory abnormality which, in the opinion of the Investigator, would prevent the subject from completing the study or the interpretation of the study results at Screening and Randomisation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SB16 (Proposed Denosumab Biosimilar); Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months.	Drug: SB16 (Proposed Denosumab Biosimilar); 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.
Active Comparator: Prolia® (Denosumab); Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months. At Month 12, subjects in Prolia® treatment group will be re-randomised in a 1:1 ratio to either continue on Prolia® treatment or be transitioned to SB16 treatment. After re-randomisation, subjects transited to SB16 group will receive SB16, and subjects remaining in Prolia® group will continue to receive Prolia® at Month 12.	Drug: SB16 (Proposed Denosumab Biosimilar); 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.; Drug: Prolia® (Denosumab); Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change from baseline in lumbar spine BMD at Month 12	Baseline and Month 12

Collaborators and Investigators

• Sponsor: Samsung Bioepis Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2020
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): December 19, 2022

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Bone Density Conservation Agents; Denosumab
• Other Study ID Numbers: SB16-3001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No