Actively Recruiting
A Phase Ib/II Study to Investigate the Safety of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-07-10
50
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial was designed to evaluate the safety of SHR-1819 in children and adolescents with moderate-to-severe atopic dermatitis.
CONDITIONS
Official Title
A Phase Ib/II Study to Investigate the Safety of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects and their parents or legal guardians have voluntarily signed the informed consent form before any study procedures and can communicate well with the investigator
- Subjects are male or female aged 6 years or older but younger than 18 years at consent
- Subjects have atopic dermatitis at screening
You will not qualify if you...
- Subjects weigh less than 15 kilograms before enrollment
- Females who are pregnant, lactating, or have a positive pregnancy test
- Subjects have other active skin diseases or skin complications that may affect atopic dermatitis evaluation
- Subjects have serious diseases or conditions deemed inappropriate for participation by the investigator
- Subjects previously treated with or participated in studies of biologics targeting IL-4R alpha, including SHR-1819 injection
- Subjects have or have had malignancy
- Subjects have hypersensitivity to the study drug or any of its ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110002
Actively Recruiting
Research Team
X
Xiaoyan Bai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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