Eczema drug SHR-1819 passes extended safety test in 79 patients
NCT ID NCT06012812
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at the long-term safety of the drug SHR-1819 in 79 adults with moderate to severe eczema who had already taken part in earlier studies of the same drug. Researchers tracked side effects and how well the drug controlled the disease over time. The goal was to see if the drug remains safe and effective with continued use.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
79 people
The number who actually took part.
- Started
-
Sep 2023
- Finished
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Jun 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
-
18 to 75 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The age of 18\~75 years old at the time of signing the informed consent form (including the values at both ends), gender is not limited; 2. Previous atopic dermatitis, (1) participation in a complete main study; or (2) subjects who prematurely terminate primary study therapy for reasons other than SHR-1819 injection are required to complete a last safety follow-up or withdrawal from the visit, and the investigator assesses that the influencing factor has been eliminated/no longer affects the participant's participation in the extended study. Participants were required to meet the main study inclusion criteria for the main study; 3. Be able to apply a topical emollient (moisturizer) continuously for at least 7 consecutive days before the first dose and continue to use it for the duration of the study; 4. Be able to sign informed consent forms, understand and agree to follow the requirements of the study and the trial process. Exclusion Criteria: 1. Pregnant or lactating women; 2. Female subjects of childbearing potential and male subjects whose partners are women of childbearing age have a plan to donate sperm/eggs from the signing of the informed consent form until 3 months after the last dose of the trial drug, or refuse to comply with the relevant contraceptive requirements; 3. A history of alcohol abuse or illicit drug abuse within 6 months prior to screening; 4. Hypersensitivity to the study drug or any ingredient in the study drug; 5. Diagnosed within 6 months prior to screening or judged by the investigator to have a suspected immunosuppressive disease; 6. Oral or parenteral systemic antimicrobials are used within 2 weeks before the first dose; 7. Suspected or confirmed active tuberculosis (TB); 8. Have malignancy or history of malignancy prior to screening; 9. Major surgery was performed within 3 months prior to screening, or major surgery was planned during the study; 10. There are currently significant abnormal laboratory test results, severe concomitant diseases, and other circumstances that the investigator considers inappropriate to participate in this trial; 11. There were treatment-related adverse events leading to discontinuation of treatment and study drug-related SAEs in the main study, and the investigator or sponsor medical department considered that continuing to participate in extended therapy would pose an unacceptable safety risk to participants.
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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
-
Huashan Hospital,Fudan University
Shanghai, Shanghai Municipality, 200040, China
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Other studies related to the condition(s) this trial covers.
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