NCT05466877

A Study of MG-K10 in Subjects With Atopic Dermatitis

Phase II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Atopic Dermatitis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 163 (estimated)
• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the preliminary efficacy of MG-K10 in subjects with moderate to severe asthma, and provides a basis for the design and dosing regimen of phase III clinical trials.

Detailed description

This study is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It is planned to enroll approximately 160 adult patients with moderate-to-severe AD uncontrolled by topical therapy, who will receive multiple subcutaneous injections. The study was divided into a screening period (1-5 weeks), a treatment period (16 weeks), and a safety follow-up (8 weeks).

Conditions

• Atopic Dermatitis

Interventions

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

Timeline

• Start date: 2022-08-31
• Primary completion: 2023-09-22
• Completion: 2024-05-26
• First posted: 2022-07-20
• Last updated: 2024-02-23

Locations

2 sites across 1 country: China