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NOT YET RECRUITING
NCT07540442
PHASE3

A Phase III Study of MG-K10 in Adolescents With Moderate-to-Severe Atopic Dermatitis

Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of MG-K10 monotherapy in adolescents with moderate-to-severe atopic dermatitis (AD)

Official title: Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MG-K10 (a Humanized Monoclonal Antibody Injection) in Adolescents With Moderate-to-Severe Atopic Dermatitis

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-04-17

Completion Date

2027-11-09

Last Updated

2026-04-20

Healthy Volunteers

No

Interventions

DRUG

MG-K10 Injection (Humanized Monoclonal Antibody)

loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52

DRUG

Placebo for MG-K10

Initial loading dose (SC), then single dose Q2W through Week 52

Locations (1)

The First Hospital Of China Medical University

Shenyang, China