NCT06026891

Study of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Atopic Dermatitis

Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on the Effectiveness and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 498 (estimated)
• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is to reflect the effectiveness and safety of MG-K10 humanized monoclonal antibody injection in patients with moderate to severe atopic dermatitis.administered every 4 weeks for 52 week

Detailed description

The study was a multicenter, randomized, double-blind, placebo-controlled Phase III study. Approximately 498 adults with moderate-to-severe AD who were not controlled by local therapy were scheduled to receive multiple subcutaneous injections (administered every 4 weeks for 52 weeks). The study was divided into screening period (1-5 weeks), double-blind treatment period (16 weeks), treatment maintenance period (36 weeks), and follow-up period (8 weeks).

Conditions

• Atopic Dermatitis

Interventions

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

Timeline

• Start date: 2024-01-13
• Primary completion: 2025-06-11
• Completion: 2025-12-12
• First posted: 2023-09-07
• Last updated: 2024-02-23

Locations

1 site across 1 country: China