NCT05278338

Efficacy and Safety of JMT103 in the Treatment of Postmenopausal Women With Osteoporosis

A Multicenter, Randomized, Double-blind, Placebo/Positive-controlled Phase II Study to Evaluate the Efficacy and Safety of JMT103 in Postmenopausal Women With Osteoporosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the efficacy and safety of JMT103 in the treatment of postmenopausal women with osteoporosis.

Detailed description

This study is a randomized, double-blind, placebo/positive-controlled Phase II clinical study to evaluate the efficacy, safety, immunogenicity and pharmacokinetic characteristics of JMT103 in the treatment of postmenopausal women with osteoporosis. Subjects will be screened within -28 days before treatment, and subjects who meet the inclusion/exclusion criteria will be included in the study. The enrolled postmenopausal women with osteoporosis who meet the diagnostic criteria for osteoporosis will be randomized in a 1:1:1:1:1 ratio into Test Group a (JMT103 45 mg group), Test Group b (JMT103 60 mg group), Test Group c (JMT103 90 mg group), Control Group d (denosumab 60 mg group) and Control Group e (placebo group). JMT103,denosumab and placebo will be administered as a single subcutaneous (SC) injection at the beginning of the treatment phase and at 6 months following the initial dose. Each subject will be followed up for 12 months after the first administration. Throughout the research process, subjects will be required to supplement ≥1000 mg of calcium and ≥800 IU of vitamin D every day.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	JMT103	subcutaneous injection, once every 6 months (Q6M), with a total of 2 administrations
DRUG	Denosumab	subcutaneous injection, once every 6 months (Q6M), with a total of 2 administrations
DRUG	Placebo	subcutaneous injection, once every 6 months (Q6M), with a total of 2 administrations

Timeline

• Start date: 2022-04-21
• Primary completion: 2023-12-31
• Completion: 2024-03-31
• First posted: 2022-03-14
• Last updated: 2022-07-18

Locations

1 site across 1 country: China