NCT05215977

Efficacy and Safety of MW031 in PMO Subjects

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study, Evaluating the Efficacy and Safety of Recombinant Fully Human Anti-RANKL Monoclonal Antibody in Postmenopausal Osteoporosis Subjects With Increased Bone Fracture Risk

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 448 (actual)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: Female
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW031 in Chinese postmenopausal osteoporotic subjects with increased bone fracture risk .

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	MW031	The active ingredient of MW031 is a recombinant human anti-RANKL monoclonal antibody ,subcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial. Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU
DRUG	Placebo	subcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial. Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU

Timeline

• Start date: 2019-12-27
• Primary completion: 2021-09-27
• Completion: 2021-09-27
• First posted: 2022-01-31
• Last updated: 2023-10-11

Locations

1 site across 1 country: China