Back to resultsA Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study)
Primary Purpose
Postmenopausal Women With Osteoporosis
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MB09 (denosumab biosimilar)
EU-Prolia
Elemental Calcium
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Postmenopausal Women With Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal women, diagnosed with osteoporosis.
- Aged ≥ 55 and ≤ 80 years at screening.
- Body weight ≥ 50 kg and ≤ 99.9 kg, and a body mass index of ≤30 kg/m2 at screening.
- Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar spine or total hip as measured by DXA.
- At least two intact, nonfractured vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA.
- Adequate organ function.
Exclusion Criteria:
- Previous exposure to denosumab (Prolia®, Xgeva®, or denosumab biosimilar) or other monoclonal anti-body.
- History and/or presence of one severe or more than two moderate vertebral fractures or hip fracture.
- Recent long bone fracture (6 months).
- History and/or presence of bone metastases, bone disease or other metabolic disease.
- Ongoing use of any osteoporosis treatment or use of prohibited treatment.
- Other bone active drugs.
- History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or hypercalcemia.
- Other Inclusion/exclusion criteria may apply.
Sites / Locations
- AES - DRS - Medical Center Synexus Sofia EOOD
- Medical Center Medconsult Pleven OOD
- Medical Center Artmed OOD
- Multiprofile Hospital for Active Treatment Plovdiv
- Outpatient Clinic for Specialized Medical Help - Medical Center Kuchuk Paris "OOD"
- Diagnostic and Consulting Center Aleksandrovska EOOD
- Diagnostic- Consultative Center Convex EOOD
- Medical Center Excelsior OOD - PPDS
- Medical Center Hera EOOD
- Specialized outpatient medical facility - Rheumatology Centre St. Irina EOOD
- University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
- New Medical Center EOOD
- Center For Clinical And Basic Research
- East Tallinn Central Hospital
- North Estonia Medical Centre Foundation
- KLV Arstikabinet
- Clinical Research Centre Ltd
- MediTrials OÜ
- Tartu University Hospital
- National Institute of Endocrinology
- Tbilisi Heart and Vascular Clinic Ltd
- Tbilisi Heart Center Ltd.
- Bekes Megyei Kozponti Korhaz
- AES - DRS - Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft
- Csongrad Megyei Dr. Bugyi Istvan Korhaz
- AES - DRS - Synexus Debrecen Magyarország Egészségügyi Szolgáltató Kft
- MÁV Kórház és Rendelointézet Szolnok
- Pest Megyei Flór Ferenc Kórház
- AES - DRS - Synexus Zalaegerszeg Magyarország Egészségügyi Kft
- AES - DRS - Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft
- QUALICLINIC Kft
- Óbudai Egészségügyi Centrum Kft
- Vital Medical Center
- Private Practice of Laila Atike
- Outpatient Clinic Veselibas Centrs 4
- Outpatient Clinic Adoria
- Sigulda Hospital, Outpatient Clinic
- RSU Ambulance
- Hospital Angeles Lindavista (Consultorio de Reumatologia)
- Centro de Estudios de Investigacion Basica Y Clinica SC
- Hospital Universitario Dr. Jose Eleuterio González
- Centro Integral Medico SJR S.C
- Hospital Central Dr Ignacio Morones Prieto
- Globe Badania Kliniczne Spólka z o.o.
- Lubelskie Centrum Diagnostyczne (Lotników Polskich)
- Lubelskie Centrum Diagnostyczne
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
- Bialystok - ClinicMed Daniluk, Nowak Spólka Jawna
- NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik
- Centrum Medyczne Czestochowa - PRATIA - PPDS
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
- Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
- Centrum Medyczne Katowice - PRATIA - PPDS
- Krakowskie Centrum Medyczne
- Centrum Medyczne Linden
- MCM Krakow - PRATIA - PPDS
- Centrum Medyczne AMED
- Centrum Medyczne Reuma Park NZOZ
- Rheuma Medicus Specjalistyczne Centrum Reumatologii i Osteoporozy
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
- Institute of Rheumatology Belgrade - PPDS
- Military Medical Academy
- University Clinical Center of Serbia - PPDS
- Clinical Centre of Vojvodina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
MB09-MB09
Prolia-MB09
Prolia-Prolia
Arm Description
Subjects randomised into MB09-MB09 group will receive MB09 (60 mg in 1 mL) SC injection every 6 months.
Subjects randomised into Prolia- MB09 group will receive Prolia® (60 mg in 1 mL) SC injection every 6 months.
Subjects randomised into Prolia-Prolia group will receive Prolia® (60 mg in 1 mL) SC injection every 6 months.
Outcomes
Primary Outcome Measures
Percentage change from baseline in lumbar spine bone mineral density (BMD) at Month 12
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05338086
Brief Title
A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study)
Official Title
A Randomised, Double-blind, Parallel, Multicentre, Multinational Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 (Proposed Denosumab Biosimilar) Versus Prolia® (EU-sourced) in Postmenopausal Women With Osteoporosis (SIMBA Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
mAbxience Research S.L.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with osteoporosis
Detailed Description
The study will randomise approximately 528 postmenopausal women with osteoporosis aged ≥55 and ≤80 years old with a Bone Mineral Density (BMD) consistent with T-score of ≤ -2.5 and ≥ -4 at the lumbar spine or hip as measured by DXA during the Screening Period. Screening evaluations will be completed within 28 days prior to randomisation.
On Day 1, 528 eligible postmenopausal women with osteoporosis will be randomised in a 2:1:1 ratio to re-ceive MB09-MB09 (Arm 1), Prolia-MB09 (Arm 2), or Prolia-Prolia (Arm 3) using an Interactive Response Sys-tem (IRT).
During the Main Treatment Period, subjects will receive one subcutaneous injection (60 mg/mL) of study drug on Day 1 and at Month 6. At Month 12, after all efficacy and safety assessments have been performed, the subject will enter the Transition/Safety Follow Up Period and will receive the third dose of study drug. Subjects assigned to the MB09 MB09 arm (Arm 1) will receive MB09 on Day 1, at Month 6 and at Month 12. Subjects assigned to the Prolia MB09 arm (Arm 2) will receive EU-Prolia on Day 1 and at Month 6, and MB09 at Month 12. Subjects assigned to the Prolia-Prolia arm (Arm 3) will receive EU-Prolia on Day 1, at Month 6, and at Month 12. All subjects will be followed up to Transition Period Month 6.
All subjects will receive daily supplementation of calcium and vitamin D.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Women With Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
528 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MB09-MB09
Arm Type
Experimental
Arm Description
Subjects randomised into MB09-MB09 group will receive MB09 (60 mg in 1 mL) SC injection every 6 months.
Arm Title
Prolia-MB09
Arm Type
Active Comparator
Arm Description
Subjects randomised into Prolia- MB09 group will receive Prolia® (60 mg in 1 mL) SC injection every 6 months.
Arm Title
Prolia-Prolia
Arm Type
Active Comparator
Arm Description
Subjects randomised into Prolia-Prolia group will receive Prolia® (60 mg in 1 mL) SC injection every 6 months.
Intervention Type
Drug
Intervention Name(s)
MB09 (denosumab biosimilar)
Intervention Description
PFS 60 mg/mL solution,
Intervention Type
Drug
Intervention Name(s)
EU-Prolia
Intervention Description
PFS 60 mg/mL solution, administered as subcutaneous injection
Intervention Type
Dietary Supplement
Intervention Name(s)
Elemental Calcium
Intervention Description
at least 1000 mg daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
at least 400 IU daily
Primary Outcome Measure Information:
Title
Percentage change from baseline in lumbar spine bone mineral density (BMD) at Month 12
Time Frame
Baseline and at Month 12
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Postmenopausal women, diagnosed with osteoporosis.
Aged ≥ 55 and ≤ 80 years at screening.
Body weight ≥ 50 kg and ≤ 99.9 kg, and a body mass index of ≤30 kg/m2 at screening.
Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar spine or total hip as measured by DXA.
At least two intact, nonfractured vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA.
Adequate organ function.
Exclusion Criteria:
Previous exposure to denosumab (Prolia®, Xgeva®, or denosumab biosimilar) or other monoclonal anti-body.
History and/or presence of one severe or more than two moderate vertebral fractures or hip fracture.
Recent long bone fracture (6 months).
History and/or presence of bone metastases, bone disease or other metabolic disease.
Ongoing use of any osteoporosis treatment or use of prohibited treatment.
Other bone active drugs.
History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or hypercalcemia.
Other Inclusion/exclusion criteria may apply.
Facility Information:
Facility Name
AES - DRS - Medical Center Synexus Sofia EOOD
City
Sofia
State/Province
Sofia-Grad
Country
Bulgaria
Facility Name
Medical Center Medconsult Pleven OOD
City
Pleven
Country
Bulgaria
Facility Name
Medical Center Artmed OOD
City
Plovdiv
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Plovdiv
City
Plovdiv
Country
Bulgaria
Facility Name
Outpatient Clinic for Specialized Medical Help - Medical Center Kuchuk Paris "OOD"
City
Plovdiv
Country
Bulgaria
Facility Name
Diagnostic and Consulting Center Aleksandrovska EOOD
City
Sofia
Country
Bulgaria
Facility Name
Diagnostic- Consultative Center Convex EOOD
City
Sofia
Country
Bulgaria
Facility Name
Medical Center Excelsior OOD - PPDS
City
Sofia
Country
Bulgaria
Facility Name
Medical Center Hera EOOD
City
Sofia
Country
Bulgaria
Facility Name
Specialized outpatient medical facility - Rheumatology Centre St. Irina EOOD
City
Sofia
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
City
Stara Zagora
Country
Bulgaria
Facility Name
New Medical Center EOOD
City
Vratsa
Country
Bulgaria
Facility Name
Center For Clinical And Basic Research
City
Tallinn
State/Province
Harjumaa
Country
Estonia
Facility Name
East Tallinn Central Hospital
City
Tallinn
State/Province
Harjumaa
Country
Estonia
Facility Name
North Estonia Medical Centre Foundation
City
Tallinn
State/Province
Harjumaa
Country
Estonia
Facility Name
KLV Arstikabinet
City
Pärnu
State/Province
Pärnu Maakon
Country
Estonia
Facility Name
Clinical Research Centre Ltd
City
Tartu
State/Province
Tartumaa
Country
Estonia
Facility Name
MediTrials OÜ
City
Tartu
State/Province
Tartumaa
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
State/Province
Tartumaa
Country
Estonia
Facility Name
National Institute of Endocrinology
City
Tbilisi
Country
Georgia
Facility Name
Tbilisi Heart and Vascular Clinic Ltd
City
Tbilisi
Country
Georgia
Facility Name
Tbilisi Heart Center Ltd.
City
Tbilisi
Country
Georgia
Facility Name
Bekes Megyei Kozponti Korhaz
City
Békéscsaba
State/Province
Békés
Country
Hungary
Facility Name
AES - DRS - Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft
City
Gyula
State/Province
Békés
Country
Hungary
Facility Name
Csongrad Megyei Dr. Bugyi Istvan Korhaz
City
Szentes
State/Province
Csongrád
Country
Hungary
Facility Name
AES - DRS - Synexus Debrecen Magyarország Egészségügyi Szolgáltató Kft
City
Debrecen
State/Province
Hajdú-Bihar
Country
Hungary
Facility Name
MÁV Kórház és Rendelointézet Szolnok
City
Szolnok
State/Province
Jász-Nagykun-Szolnok
Country
Hungary
Facility Name
Pest Megyei Flór Ferenc Kórház
City
Kistarcsa
State/Province
Pest
Country
Hungary
Facility Name
AES - DRS - Synexus Zalaegerszeg Magyarország Egészségügyi Kft
City
Zalaegerszeg
State/Province
Zala
Country
Hungary
Facility Name
AES - DRS - Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft
City
Budapest
Country
Hungary
Facility Name
QUALICLINIC Kft
City
Budapest
Country
Hungary
Facility Name
Óbudai Egészségügyi Centrum Kft
City
Budapest
Country
Hungary
Facility Name
Vital Medical Center
City
Veszprém
Country
Hungary
Facility Name
Private Practice of Laila Atike
City
Liepāja
State/Province
Liepājas Rajon
Country
Latvia
Facility Name
Outpatient Clinic Veselibas Centrs 4
City
Riga
State/Province
Riga Rajon
Country
Latvia
Facility Name
Outpatient Clinic Adoria
City
Riga
State/Province
Rigas Rajons
Country
Latvia
Facility Name
Sigulda Hospital, Outpatient Clinic
City
Sigulda
State/Province
Siguldas Pilsēta
Country
Latvia
Facility Name
RSU Ambulance
City
Riga
Country
Latvia
Facility Name
Hospital Angeles Lindavista (Consultorio de Reumatologia)
City
Ciudad de Mexico
State/Province
Distrito Federal
Country
Mexico
Facility Name
Centro de Estudios de Investigacion Basica Y Clinica SC
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio González
City
Monterrey
State/Province
Nuevo León
Country
Mexico
Facility Name
Centro Integral Medico SJR S.C
City
Querétaro
Country
Mexico
Facility Name
Hospital Central Dr Ignacio Morones Prieto
City
San Luis Potosí
Country
Mexico
Facility Name
Globe Badania Kliniczne Spólka z o.o.
City
Kłodzko
State/Province
Dolnoslaskie
Country
Poland
Facility Name
Lubelskie Centrum Diagnostyczne (Lotników Polskich)
City
Świdnik
State/Province
Lubelskie
Country
Poland
Facility Name
Lubelskie Centrum Diagnostyczne
City
Świdnik
State/Province
Lubelskie
Country
Poland
Facility Name
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Bialystok - ClinicMed Daniluk, Nowak Spólka Jawna
City
Bialystok
State/Province
Podlaskie
Country
Poland
Facility Name
NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik
City
Bialystok
State/Province
Podlaskie
Country
Poland
Facility Name
Centrum Medyczne Czestochowa - PRATIA - PPDS
City
Częstochowa
State/Province
Slaskie
Country
Poland
Facility Name
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
City
Poznań
State/Province
Wielkopolskie
Country
Poland
Facility Name
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
City
Bydgoszcz
Country
Poland
Facility Name
Centrum Medyczne Katowice - PRATIA - PPDS
City
Katowice
Country
Poland
Facility Name
Krakowskie Centrum Medyczne
City
Krakow
Country
Poland
Facility Name
Centrum Medyczne Linden
City
Kraków
Country
Poland
Facility Name
MCM Krakow - PRATIA - PPDS
City
Kraków
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warsaw
Country
Poland
Facility Name
Centrum Medyczne Reuma Park NZOZ
City
Warsaw
Country
Poland
Facility Name
Rheuma Medicus Specjalistyczne Centrum Reumatologii i Osteoporozy
City
Warsaw
Country
Poland
Facility Name
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
City
Wrocław
Country
Poland
Facility Name
Institute of Rheumatology Belgrade - PPDS
City
Belgrad
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrad
Country
Serbia
Facility Name
University Clinical Center of Serbia - PPDS
City
Belgrad
Country
Serbia
Facility Name
Clinical Centre of Vojvodina
City
Novi Sad
Country
Serbia
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study)
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