drugset / Trial / NCT04591275

Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .

NCT04591275

Phase 3 Completed 278 enrolled Shanghai Biomabs Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)

Timeline

Start
2021-03-31
Primary completion
2024-11-01
Completion
2024-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject CMAB807 Monoclonal antibody 60 mg Subcutaneous
Comparator Denosumab Monoclonal antibody 60 mg Subcutaneous