NCT07042126

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study was to evaluate the efficacy of 611 in Chinese Adolescents with moderate to severe atopic dermatitis.

Detailed description

The maximum study duration was 64 weeks per participants, including a screening period of up to 4 weeks, a 16-week Double blind treatment period，a 36-week maintenance treatment period ，and an 8-week follow-up period.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	611	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.）
DRUG	Matching placebo	Double blind treatment period : placebo subcutaneous injection Q2W until week 16.

Timeline

• Start date: 2025-08-05
• Primary completion: 2026-06-30
• Completion: 2027-09-30
• First posted: 2025-06-27
• Last updated: 2025-11-18

Locations

3 sites across 1 country: China