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

NCT04664959 | Completed Phase 3 Results

• 1 other identifier: SB16-3001
• Study Type: interventional
• Target: 457
• Locations: 1 country
• Sites: 5

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.

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Lumbar Spine BMD at Month 12

  Baseline and Month 12

Study Arms (2)

SB16 (Proposed Denosumab Biosimilar)

EXPERIMENTAL

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

Drug: SB16 (Proposed Denosumab Biosimilar)

Prolia® (Denosumab)

ACTIVE COMPARATOR

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); Drug: Prolia® (Denosumab)

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); SB16 (Proposed Denosumab Biosimilar)

Prolia® (Denosumab) DRUG

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

Prolia® (Denosumab)

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (5)

SB Investigative Site

Krakow, Poland

Location

SB Investigative Site

Lodz, Poland

Location

SB Investigative Site

Siedlce, Poland

Location

SB Investigative Site

Warsaw, Poland

Location

SB Investigative Site

Zamość, Poland

Location

Related Publications (1)

• 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.

  PMID: 39243386 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Samsung Bioepis Co., Ltd

sbregistry@samsung.com

+82-32-728-0371

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 11, 2020
• Study Start: November 26, 2020
• Primary Completion: June 20, 2022
• Study Completion: January 3, 2023
• Last Updated: February 4, 2025
• Results First Posted: January 9, 2025

Record last verified: 2025-01

Locations

PL (5)