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

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: mAbxience S.A
• Treatments: Calcium; Denosumab; Vitamin D

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.