New drug aims to tame severe eczema in kids and teens
NCT ID NCT06713499
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This study tests an experimental drug called SHR-1819 in children and adolescents aged 6 to 17 with moderate-to-severe atopic dermatitis (a type of eczema). The main goal is to check the drug's safety and how the body processes it. Researchers will also look at changes in skin-related markers and whether the body develops antibodies against the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-1819 injection
- What this could lead to
- If successful, this could provide a new treatment option for children and teens with moderate-to-severe atopic dermatitis.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply to everyone. The drug may cause side effects or not work as expected.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
51 people
The number who actually took part.
- Started
-
Dec 2024
- Finished
-
Nov 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 to 18 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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; 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 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 that may affect the evaluation of AD; 4. Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial; 5. Treated with biologics targeting IL-4Rα , or participated in previous clinical studies 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045, China
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The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110002, China