NCT06837922

Clinical Trial of MG-K10 in Stage III of Moderate to Severe Asthma

A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Adolescent and Adult Patients With Moderate-to-Severe Asthma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 504 (estimated)
• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, placebo-controlled Phase III clinical trial on the efficacy and safety of MG-K10 humanized monoclonal antibody injection in adolescent and adult patients with moderate to severe asthma.

Detailed description

A randomized, double-blind, placebo-controlled Phase III clinical trial on the efficacy and safety of MG-K10 humanized monoclonal antibody injection in adolescent and adult patients with moderate to severe asthma is planned to enroll 504 subjects. These patients will receive multiple subcutaneous injection treatments. This study is divided into: a screening period of 1 week, a lead-in period of 4 weeks, a treatment period of 52 weeks, and a follow-up period of 8 weeks.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	MG-K10/Placebo	MG-K10 Humanized Monoclonal Antibody Injection

Timeline

• Start date: 2025-03-25
• Primary completion: 2027-11-15
• Completion: 2028-01-15
• First posted: 2025-02-20
• Last updated: 2025-04-17

Locations

1 site across 1 country: China