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COMPLETED
NCT07103174
PHASE2

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

Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

View on ClinicalTrials.gov

Summary

This study is a multicenter, randomized, double-blind, parallel controlled phase II study. It is planned to include approximately 60 subjects with moderate to severe atopic dermatitis(AD) to evaluate the efficacy and safety of MG-K10 monotherapy in adult patients with moderate to severe AD, and to observe PK characteristics, PD effects and immunogenicity.

Official title: A Phase II Clinical Study on the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-06-30

Completion Date

2026-04-29

Last Updated

2026-08-03

Healthy Volunteers

No

Interventions

DRUG

MG-K10/Placebo

To ensure blinding, 4 mL of placebo will be administered subcutaneously at Weeks 4, 12 and 20., for a total of 3 doses.

DRUG

MG-K10/Placebo

To ensure blinding,an additional 2 mL of placebo will be administered subcutaneously at Weeks 4, 8, 12, 16 and 20.

Locations (2)

Tower 5,No.34,Chunxiao Road No.122 Pudong District, Shanghai, 201203.p R. china

Shanghai, Shanghai Municipality, China

Hangzhou First People's Hospital

Zhejiang, 杭州, China