Actively Recruiting

Phase 1
Phase 2
Age: 6Years - 18Years
All Genders
NCT06713499

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

Age: 6Years - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China, 110002

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here