Efficacy and Safety of MW031 in PMO Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

448

Participants

Timeline

Start Date

December 27, 2019

Primary Completion Date

September 27, 2021

Study Completion Date

September 27, 2021

Conditions
Osteoporosis, Postmenopausal
Interventions
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"

Trial Locations (1)

100000

Peking Union Hospital, Beijing

All Listed Sponsors
lead

Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

NCT05215977 - Efficacy and Safety of MW031 in PMO Subjects | Biotech Hunter | Biotech Hunter