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

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ClinicalTrials.gov Identifier: NCT04664959
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: SB16 (Proposed Denosumab Biosimilar) Drug: Prolia® (Denosumab) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 26, 2020
Estimated Primary Completion Date : September 25, 2022
Estimated Study Completion Date : March 26, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Denosumab

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.




Primary Outcome Measures :
  1. Percent change from baseline in lumbar spine BMD at Month 12 [ Time Frame: Baseline and Month 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664959


Contacts
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Contact: Samsung Bioepis +82 31 8061 1096 sbregistry@samsung.com

Locations
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Poland
SB Investigative Site Recruiting
Kraków, Poland
SB Investigative Site Recruiting
Siedlce, Poland
SB Investigative Site Recruiting
Warszawa, Poland
SB Investigative Site Recruiting
Zamość, Poland
SB Investigative Site Recruiting
Łódź, Poland
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
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Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT04664959    
Other Study ID Numbers: SB16-3001
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs