A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study)

Postmenopausal Women With Osteoporosis Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05338086
• Other study ID #: MB09-C-01-19
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 31, 2022
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: mAbxience Research S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 528
• Est. completion date: June 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Postmenopausal Women With Osteoporosis

Intervention

Drug:
• MB09 (denosumab biosimilar)
PFS 60 mg/mL solution,
• EU-Prolia
PFS 60 mg/mL solution, administered as subcutaneous injection

Dietary Supplement:
• Elemental Calcium
at least 1000 mg daily
• Vitamin D
at least 400 IU daily

Locations

Country	Name	City	State
Bulgaria	Medical Center Medconsult Pleven OOD	Pleven
Bulgaria	Medical Center Artmed OOD	Plovdiv
Bulgaria	Multiprofile Hospital for Active Treatment Plovdiv	Plovdiv
Bulgaria	Outpatient Clinic for Specialized Medical Help - Medical Center Kuchuk Paris "OOD"	Plovdiv
Bulgaria	AES - DRS - Medical Center Synexus Sofia EOOD	Sofia	Sofia-Grad
Bulgaria	Diagnostic and Consulting Center Aleksandrovska EOOD	Sofia
Bulgaria	Diagnostic- Consultative Center Convex EOOD	Sofia
Bulgaria	Medical Center Excelsior OOD - PPDS	Sofia
Bulgaria	Medical Center Hera EOOD	Sofia
Bulgaria	Specialized outpatient medical facility - Rheumatology Centre St. Irina EOOD	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD	Stara Zagora
Bulgaria	New Medical Center EOOD	Vratsa
Estonia	KLV Arstikabinet	Pärnu	Pärnu Maakon
Estonia	Center For Clinical And Basic Research	Tallinn	Harjumaa
Estonia	East Tallinn Central Hospital	Tallinn	Harjumaa
Estonia	North Estonia Medical Centre Foundation	Tallinn	Harjumaa
Estonia	Clinical Research Centre Ltd	Tartu	Tartumaa
Estonia	MediTrials OÜ	Tartu	Tartumaa
Estonia	Tartu University Hospital	Tartu	Tartumaa
Georgia	National Institute of Endocrinology	Tbilisi
Georgia	Tbilisi Heart and Vascular Clinic Ltd	Tbilisi
Georgia	Tbilisi Heart Center Ltd.	Tbilisi
Hungary	Bekes Megyei Kozponti Korhaz	Békéscsaba	Békés
Hungary	AES - DRS - Synexus Budapest - Magyarország Egészségügyi Szolgáltató Kft	Budapest
Hungary	Óbudai Egészségügyi Centrum Kft	Budapest
Hungary	QUALICLINIC Kft	Budapest
Hungary	AES - DRS - Synexus Debrecen Magyarország Egészségügyi Szolgáltató Kft	Debrecen	Hajdú-Bihar
Hungary	AES - DRS - Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft	Gyula	Békés
Hungary	Pest Megyei Flór Ferenc Kórház	Kistarcsa	Pest
Hungary	Csongrad Megyei Dr. Bugyi Istvan Korhaz	Szentes	Csongrád
Hungary	MÁV Kórház és Rendelointézet Szolnok	Szolnok	Jász-Nagykun-Szolnok
Hungary	Vital Medical Center	Veszprém
Hungary	AES - DRS - Synexus Zalaegerszeg Magyarország Egészségügyi Kft	Zalaegerszeg	Zala
Latvia	Private Practice of Laila Atike	Liepaja	Liepajas Rajon
Latvia	Outpatient Clinic Adoria	Riga	Rigas Rajons
Latvia	Outpatient Clinic Veselibas Centrs 4	Riga	Riga Rajon
Latvia	RSU Ambulance	Riga
Latvia	Sigulda Hospital, Outpatient Clinic	Sigulda	Siguldas Pilseta
Mexico	Hospital Angeles Lindavista (Consultorio de Reumatologia)	Ciudad de Mexico	Distrito Federal
Mexico	Centro de Estudios de Investigacion Basica Y Clinica SC	Guadalajara	Jalisco
Mexico	Hospital Universitario Dr. Jose Eleuterio González	Monterrey	Nuevo León
Mexico	Centro Integral Medico SJR S.C	Querétaro
Mexico	Hospital Central Dr Ignacio Morones Prieto	San Luis Potosí
Poland	Bialystok - ClinicMed Daniluk, Nowak Spólka Jawna	Bialystok	Podlaskie
Poland	NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik	Bialystok	Podlaskie
Poland	Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Centrum Medyczne Czestochowa - PRATIA - PPDS	Czestochowa	Slaskie
Poland	Centrum Medyczne Katowice - PRATIA - PPDS	Katowice
Poland	Globe Badania Kliniczne Spólka z o.o.	Klodzko	Dolnoslaskie
Poland	Krakowskie Centrum Medyczne	Krakow
Poland	Centrum Medyczne Linden	Kraków
Poland	MCM Krakow - PRATIA - PPDS	Kraków
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu	Poznan	Wielkopolskie
Poland	Lubelskie Centrum Diagnostyczne	Swidnik	Lubelskie
Poland	Lubelskie Centrum Diagnostyczne (Lotników Polskich)	Swidnik	Lubelskie
Poland	Centrum Medyczne AMED	Warsaw
Poland	Centrum Medyczne Reuma Park NZOZ	Warsaw
Poland	Rheuma Medicus Specjalistyczne Centrum Reumatologii i Osteoporozy	Warsaw
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa	Mazowieckie
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw
Serbia	Institute of Rheumatology Belgrade - PPDS	Belgrad
Serbia	Military Medical Academy	Belgrad
Serbia	University Clinical Center of Serbia - PPDS	Belgrad
Serbia	Clinical Centre of Vojvodina	Novi Sad

Sponsors (1)

Lead Sponsor	Collaborator
mAbxience Research S.L.

Countries where clinical trial is conducted

Bulgaria,  Estonia,  Georgia,  Hungary,  Latvia,  Mexico,  Poland,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from baseline in lumbar spine bone mineral density (BMD) at Month 12		Baseline and at Month 12