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RecruitingPhase 1Phase 2NCT06713499

A Phase Ib/II Study to Investigate the Safety of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis

A Phase Ib/II Study to Investigate the Safety、PK and PD of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Enrollment

50 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

Children and Adolescents With Moderate-to-severe Atopic Dermatitis

Summary

This trial was designed to evaluate the safety of SHR-1819 in children and adolescents with moderate-to-severe atopic dermatitis.

Eligibility

Min Age: 6 YearsMax Age: 18 Years

Inclusion Criteria3

  • Subjects and their parents or legal guardians have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol to complete the study;
  • At the time of signing the informed consent, the subjects were ≥ 6 years old and < 18 years old, male or female;
  • Have atopic dermatitis at screening.

Exclusion Criteria7

  • Before enrollment, the subjects weighed < 15kg;
  • Females who are pregnant or lactating and have a positive pregnancy test result;
  • Have other active skin disease or skin complications due to other conditions that may affect the evaluation of AD;
  • Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial;
  • Treated with biologics targeting IL-4Rα , or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection;
  • Has malignancy or has a history of malignancy;
  • Hypersensitivity to the study drug or any ingredient in the study drug.

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Interventions

DRUGSHR-1819 injection

SHR-1819 injection.

Locations(1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

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NCT06713499