NCT04591275

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

Randomized, Doubel-blinded, Parallel, Active-controlled Phase III Study, to Evaluate the Efficacy and Safety of CMAB807 Treatment Compared with Prolia® in Chinese Postmenopausal Women with Osteoporosis At High Risk of Fracture.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Shanghai Biomabs Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

this is a randomized, double-blinded, parallel, active-controlled clinical phase III study. the primary objective is to evaluate the efficacy and safety of CMAB807 treatment compared with Prolia in Chinese postmenopausal women with osteoporosis at high risk of fracture. Subjects should sequentially enrolled according to the protocol in one of two arms. Subjects who entered in test arm would receive 60mg of CMAB807 subcutaneously every 6 months for one year, while those who entered in control arm should receive 60mg of Prolia subcutaneously every 6 months for one year. Meanwhile, every subject should taking 600mg calcium and 400IU vitamin D daily from successfully screening to the end of study.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	CMAB807 Injection	mAb targeting RANKL, human monoclonal antibody targeting RANKL
DRUG	Prolia®	mAb targeting RANKL, human monoclonal antibody targeting RANKL

Timeline

• Start date: 2021-03-31
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2020-10-19
• Last updated: 2025-02-20

Locations

1 site across 1 country: China