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Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Summary
The primary objective of the study was to evaluate the safety and pharmacokinetic of 611 in Chinese children and adolescents with moderate to severe atopic dermatitis.
Official title: A Phase Ib/II Study to Evaluate the Safety, Pharmacokinetic and Efficacy of Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611) in Chinese Children and Adolescents (6 Years Old ≤ Age <18 Years Old) With Moderate to Severe Atopic Dermatitis
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2024-07-10
Completion Date
2026-08
Last Updated
2025-12-16
Healthy Volunteers
No
Conditions
Interventions
Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611)
subcutaneous injection,611 450/600mg (loading dose) + 300mg once every 2 weeks/4 weeks
Locations (1)
Beijing Children's Hospital
Beijing, Beijing Municipality, China