A Study to Extend Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis

Last updated: March 3, 2026
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

2

Condition

Rash

Atopic Dermatitis

Allergy

Treatment

SHR-1819 injection

Clinical Study ID

NCT06012812
SHR-1819-203
  • Ages 18-75
  • All Genders

Study Summary

This study is a multicenter, open-label, extended study to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of SHR-1819 injection in adult subjects with moderate to severe atopic dermatitis who have previously participated in the SHR-1819 injection study for atopic dermatitis (defined as the main study, referred to as the main study hereinafter).

Eligibility Criteria

Inclusion

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 thanSHR-1819 injection are required to complete a last safety follow-up or withdrawalfrom the visit, and the investigator assesses that the influencing factor has beeneliminated/no longer affects the participant's participation in the extended study.Participants were required to meet the main study inclusion criteria for the mainstudy;

  3. Be able to apply a topical emollient (moisturizer) continuously for at least 7consecutive days before the first dose and continue to use it for the duration ofthe study;

  4. Be able to sign informed consent forms, understand and agree to follow therequirements of the study and the trial process.

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women;

  2. Female subjects of childbearing potential and male subjects whose partners are womenof childbearing age have a plan to donate sperm/eggs from the signing of theinformed consent form until 3 months after the last dose of the trial drug, orrefuse 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 asuspected immunosuppressive disease;

  6. Oral or parenteral systemic antimicrobials are used within 2 weeks before the firstdose;

  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 wasplanned during the study;

  10. There are currently significant abnormal laboratory test results, severe concomitantdiseases, and other circumstances that the investigator considers inappropriate toparticipate in this trial;

  11. There were treatment-related adverse events leading to discontinuation of treatmentand study drug-related SAEs in the main study, and the investigator or sponsormedical department considered that continuing to participate in extended therapywould pose an unacceptable safety risk to participants.

Study Design

Total Participants: 79
Treatment Group(s): 1
Primary Treatment: SHR-1819 injection
Phase: 2
Study Start date:
September 06, 2023
Estimated Completion Date:
June 05, 2025

Connect with a study center

  • Huashan Hospital,Fudan University

    Shanghai, Shanghai Municipality 200040
    China

    Site Not Available

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