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

Last updated: February 24, 2025
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Dermatitis, Atopic

Skin Wounds

Allergy

Treatment

SHR-1819 injection

Clinical Study ID

NCT06713499
SHR-1819-204
  • Ages 6-18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects and their parents or legal guardians have voluntarily signed the informedconsent form prior to the start of any procedures related to the study, are able tocommunicate smoothly with the investigator, understand and are willing to strictlycomply with the requirements of this clinical study protocol to complete the study;

  2. At the time of signing the informed consent, the subjects were ≥ 6 years old and < 18 years old, male or female;

  3. Have atopic dermatitis at screening.

Exclusion

Exclusion Criteria:

  1. Before enrollment, the subjects weighed < 15kg;

  2. Females who are pregnant or lactating and have a positive pregnancy test result;

  3. Have other active skin disease or skin complications due to other conditions thatmay affect the evaluation of AD;

  4. Have serious concomitant diseases and other conditions that the investigatorconsiders inappropriate to participate in this trial;

  5. Treated with biologics targeting IL-4Rα , or participated in previous clinicalstudies of biologics targeting IL-4Rα, including SHR-1819 injection;

  6. Has malignancy or has a history of malignancy;

  7. Hypersensitivity to the study drug or any ingredient in the study drug.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: SHR-1819 injection
Phase: 1/2
Study Start date:
December 18, 2024
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning 110002
    China

    Active - Recruiting

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