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Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.
Official title: A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) When Used In Combination With Topical Corticosteroid Treatment (TCS) in Participants With Moderate to Severe Atopic Dermatitis.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2024-09-23
Completion Date
2026-08-16
Last Updated
2025-07-14
Healthy Volunteers
No
Conditions
Interventions
611
subcutaneous injection
Placebo
subcutaneous injection
Topical corticosteroid
Topical
Locations (3)
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China