Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis
A Multi-Center, Randomized, Double-Blind, Placebo-Ccontrolled Phase Ⅲ Clinical Trail， to Evaluate the Efficacy and Safety of 611 (Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adolescents (12 Years Old≤Age < 18 Years Old) With Moderate to Severe Atopic Dermatitis (AD)
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
180 participants
Aug 5, 2025
INTERVENTIONAL
Conditions
Summary
The primary objective of the study was to evaluate the efficacy of 611 in Chinese Adolescents with moderate to severe atopic dermatitis.
Eligibility
Plain Language Summary
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Interventions
Double blind treatment period : 611 600 mg/450 mg at day 1，then 300 mg subcutaneous injection Q2W thereafter until week 16 Maintenance treatment period : 611 300 mg subcutaneous injection Q2W/Q3W until week 52.（The subjects in the placebo group during the double-blind treatment period need to be given a loading dose at week 16.）
Double blind treatment period : placebo subcutaneous injection Q2W until week 16.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT07042126