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Eczema drug SHR-1819 passes extended safety test in 79 patients

NCT ID NCT06012812

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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 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

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

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

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.