A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.

mAbxience

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Women With Osteoporosis

Treatments: Drug: MB09 (denosumab biosimilar); Dietary Supplement: Elemental Calcium; Dietary Supplement: Vitamin D; Drug: EU-Prolia

Study type: Interventional

Funder types: Industry

Identifiers

NCT05338086

MB09-C-01-19

Details and patient eligibility

About

This was 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

Full description

The study was planning to 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 total hip as measured by DXA during the Screening Period. Screening evaluations were to be completed within 28 days prior to randomisation.

On Day 1, 528 eligible postmenopausal women with osteoporosis were to be randomised in a 2:1:1 ratio to receive 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 received 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 were to be enter the Transition/Safety Follow Up Period and were to receive the third dose of study drug. Subjects assigned to the MB09 MB09 arm (Arm 1) received MB09 on Day 1, at Month 6 and at Month 12. Subjects assigned to the Prolia MB09 arm (Arm 2) received EU-Prolia on Day 1 and at Month 6, and MB09 at Month 12. Subjects assigned to the Prolia-Prolia arm (Arm 3) received EU-Prolia on Day 1, at Month 6, and at Month 12. All subjects were to be followed up to Transition Period Month 6.

All subjects received daily supplementation of calcium and vitamin D.

Enrollment: 558 patients

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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 Dual-energy X-ray Absorptiometry (DXA).
• At least two intact, nonfractured vertebrae in the L1-L4 region and at least one hip joint evaluable by DXA.
• Adequate organ function.

Exclusion criteria

• Previous exposure to denosumab (Prolia®, Xgeva®, or denosumab biosimilar) or other monoclonal antibody.
• History and/or presence of one severe or more than two moderate vertebral fractures or hip fracture.
• Recent long bone fracture (within 6 months).
• History and/or presence of bone metastases, bone disease or other metabolic disease.
• Intravenous bisphosphonate administered within 5 years of screening.
• Oral bisphosphonates ≥12 months cumulative use prior to screening. If used <12 months cumulatively and the last dose was ≥12 months before screening, the subject could be enrolled.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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558 participants in 3 patient groups

MB09-MB09

Experimental group

Description:

Subjects randomised into MB09-MB09 group were administered MB09 (60 mg in 1 mL) SC injection every 6 months.

Treatment:

Dietary Supplement: Vitamin D

Dietary Supplement: Elemental Calcium

Drug: MB09 (denosumab biosimilar)

Prolia-MB09

Active Comparator group

Description:

Subjects randomised into Prolia- MB09 group were administered Prolia® (60 mg in 1 mL) SC injection every 6 months.

Treatment:

Drug: EU-Prolia

Dietary Supplement: Vitamin D

Dietary Supplement: Elemental Calcium

Drug: MB09 (denosumab biosimilar)

Prolia-Prolia

Active Comparator group

Description:

Subjects randomised into Prolia-Prolia group were administered Prolia® (60 mg in 1 mL) SC injection every 6 months.

Treatment:

Drug: EU-Prolia

Dietary Supplement: Vitamin D

Dietary Supplement: Elemental Calcium