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ACTIVE NOT RECRUITING
NCT06554847
PHASE3

Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis

Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

611

subcutaneous injection

DRUG

Placebo

subcutaneous injection

DRUG

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