NCT06713499CompletedPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
This trial was designed to evaluate the safety of SHR-1819 in children and adolescents with moderate-to-severe atopic dermatitis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 24 Nov 2024
- Start date
- 18 Dec 2024
- Primary completion date
- 22 Nov 2025
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06713499
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 51
- From 18 Dec 2024 to the primary completion date, 22 Nov 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Have other active skin disease or skin complications due to other conditions that may affect the evaluation of AD;
- Has malignancy or has a history of malignancy;
- Hypersensitivity to the study drug or any ingredient in the study drug.
Other
- Before enrollment, the subjects weighed \< 15kg;
- Females who are pregnant or lactating and have a positive pregnancy test result;
Who the study is looking for
- 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.
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.