Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®

NCT06504966 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: MAB-22-301
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (2)

• To compare MAB-22 and Prolia® (EU-authorized) in postmenopausal women with osteoporosis to demonstrate biosimilarity and non-inferiority with respect to efficacy profile in terms of bone mineral density (BMD).

  Efficacy coprimary endpoint: percentage change from baseline (%CfB) in lumbar spine bone mineral density (BMD) (LS-BMD)

  Day 1 to Week 52

• To compare MAB-22 and Prolia® (EU-authorized) in postmenopausal women with osteoporosis to demonstrate biosimilarity and non-inferiority with respect to Pharmacodynamic (PD) profile in terms of serum cross-linked C telopeptide of type I collagen (sCTX).

  PD coprimary endpoint: area under the effect curve (AUEC) of C telopeptide of type I collagen (sCTX) over the initial 6-month period

  Day 1 to Week 26 [Predose]

Study Arms (2)

MAB-22

EXPERIMENTAL

Single subcutaneous dose at Day 1 (baseline), 6 months (Week 26) and Visit 12 (Week 52)

Drug: MAB-22

Prolia® and MAB-22

EXPERIMENTAL

Single subcutaneous dose of Prolia® at Day 1 (baseline), 6 months (Week 26) and single subcutaneous dose of MAB-22 (switching) or Prolia ® (non-switching) at Visit 12 (Week 52)

Drug: MAB-22; Drug: Prolia®

Interventions

MAB-22 DRUG

Single subcutaneous dose of 60 mg

MAB-22; Prolia® and MAB-22

Prolia® DRUG

Single subcutaneous dose of 60 mg

Prolia® and MAB-22

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained before participation in the study.
• Postmenopausal women diagnosed with osteoporosis (consistent with a lumbar spine bone mineral density (LS-BMD) \[L1-L4\] or TH-BMD T-score of ≤ -2.5 and ≥ -4.0 as measured by dual x-ray absorptiometry (DXA) at screening). Postmenopausal status is defined as at least 12 consecutive months of amenorrhea before date of screening, for which there is no other obvious pathological or physiological cause.
• Between ≥55 and ≤80 years of age at screening.
• Body weight ≥50 kg and ≤90 kg at screening.
• At least 3 vertebrae in the L1-L4 region (vertebrae to be assessed by local reading of lateral spine x-ray at screening) and at least one hip joint are evaluable by DXA.
• Adequate organ function as defined by the following criteria:
• Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN).
• Total serum bilirubin ≤1.5 × ULN.
• Absolute neutrophil count ≥1500 cells/μL (SI units: ≥1.5 × 109/L).
• Platelet count ≥100,000 cells/μL (SI units: ≥100 × 109/L) and ≤ULN.
• Hemoglobin ≥10 g/dL and ≤ULN.
• Albumin-adjusted serum calcium within the normal range for the testing laboratory.
• Estimated glomerular filtration rate \>45 mL/min.

You may not qualify if:

• Previous exposure to denosumab (Prolia®, Xgeva®, or biosimilar denosumab).
• History of hypersensitivity to any recombinant protein drugs or any of the excipients used in MAB-22 or Prolia®.
• History and/or presence of 1 severe or more than 2 moderate vertebral fractures or hip fractures (as determined by local reading of lateral spine x-ray at screening). Osteoporotic-related fracture (i.e., crush or wedge vertebral fracture or hip fracture) known or suspected to have occurred within 6 months of randomization.
• Recent long bone fracture (within 6 months) before screening. Presence of active healing fracture according to assessment of investigators.
• History and/or presence of bone metastases, bone disease, or metabolic disease, other than osteoporosis, which could interfere with the interpretation of the findings (e.g., osteogenesis imperfecta, osteopetrosis, osteomalacia, rheumatoid arthritis, Paget's disease, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, malabsorption syndrome, hypoparathyroidism or hyperparathyroidism \[irrespective of current controlled or uncontrolled status\], hypocalcemia or hypercalcemia \[based on albumin-adjusted serum calcium\]).
• Malignancy within the 5 years before screening (except cervical carcinoma in situ or basal cell carcinoma, which are acceptable).
• Ongoing use of any osteoporosis treatment (other than calcium and vitamin D supplements). The following rules for washout periods for osteoporosis treatments must be adhered to:
• Drugs being investigated for osteoporosis (e.g., romosozumab): dose received at any time.
• Strontium or fluoride (for osteoporosis): dose received at any time.
• Tibolone, oral or transdermal estrogen, selective estrogen receptor modulators, systemic hormone replacement therapy: dose received within 12 months before screening.
• Calcitonin, calcitriol, maxacalcitol, falecalcitriol, or alfacalcidol: dose received within 3 months before screening.
• Cinacalcet: dose received within 3 months before screening.
• Any oral bisphosphonate treatment. Note: those participants who have taken oral bisphosphonates for up to 3 months, or \>3 months but \<3 years cumulatively are eligible after a 12-month washout period.
• Intravenous bisphosphonates: dose received within 5 years before the first administration of study treatment.
• Parathyroid hormone (PTH), or PTH derivatives within the last 12 months before the first administration of study treatment.

Sponsors & Collaborators

• Xentria, Inc.: lead

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 11, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share