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

NCT ID: NCT04664959

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 457 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-26
• Study Completion Date: 2023-01-03

Brief 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.

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.

Conditions

Postmenopausal Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SB16 (Proposed Denosumab Biosimilar)

Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months.

Group Type: EXPERIMENTAL

SB16 (Proposed Denosumab Biosimilar)

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

SB16 (Proposed Denosumab Biosimilar)

Intervention Type: 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)

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Prolia® (Denosumab)

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Samsung Bioepis Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SB Investigative Site

Krakow, , Poland

SB Investigative Site

Lodz, , Poland

SB Investigative Site

Siedlce, , Poland

SB Investigative Site

Warsaw, , Poland

SB Investigative Site

Zamość, , Poland

Countries

Poland

References

Langdahl B, Chung YS, Plebanski R, Czerwinski E, Dokoupilova E, Supronik J, Rosa J, Mydlak A, Rowinska-Osuch A, Baek KH, Urboniene A, Mordaka R, Ahn S, Rho YH, Ban J, Eastell R. Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12. J Clin Endocrinol Metab. 2025 May 19;110(6):e1951-e1958. doi: 10.1210/clinem/dgae611.

Reference Type: DERIVED

PMID: 39243386 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SB16-3001

Identifier Type: -

Identifier Source: org_study_id