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Completed

NCT Number: NCT06713499

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

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

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Key information

Conditions

Children and Adolescents With Moderate-to-severe Atopic Dermatitis

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Children's Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

SHR-1819 Injection

Drug

SHR-1819 injection.

Primary outcomes

  1. Adverse events

    Time frame: Up to 14 weeks.

  2. Heart rate

    Time frame: Up to 14 weeks.

  3. PR interval

    Time frame: Up to 14 weeks.

  4. QT interval

    Time frame: Up to 14 weeks.

  5. QRS duration

    Time frame: Up to 14 weeks.

Secondary outcomes

  1. The concentration of SHR-1819 in serum

    Time frame: From the beginning of administration to the 14th week.

  2. Changes in the level of TARC/CCL17 in the serum

    Time frame: From the beginning of administration to the 14th week.

    Changes in the level of biomarkers in serum.

  3. Evaluate the incidence and timing of ADA positivity for SHR-1819

    Time frame: From the beginning of administration to the 14th week.

    Changes in the level of immunogenicity in the body.

Sponsors and collaborators

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.