A Multicenter, Open-label, Extended Study Evaluating the Safety and Efficacy of SHR-1819 Injection in Adult Subjects With Moderate to Severe Atopic Dermatitis Who Have Previously Participated in SHR-1819 Studies for the Treatment of Atopic Dermatitis

Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country79 target enrollmentSeptember 6, 2023

ConditionsModerate to Severe Atopic Dermatitis

InterventionsSHR-1819 injection

DrugsSHR-1819 injection

Overview

Phase: Phase 2
Intervention: SHR-1819 injection
Conditions: Moderate to Severe Atopic Dermatitis
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Enrollment: 79
Locations: 1
Primary Endpoint: Treatment Emergent Adverse Events (TEAEs) (per person-year)
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

September 6, 2023

End Date

June 5, 2025

Last Updated

last month

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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；
•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；
•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;
•Be able to sign informed consent forms, understand and agree to follow the requirements of the study and the trial process.

Exclusion Criteria

•Pregnant or lactating women；
•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;
•A history of alcohol abuse or illicit drug abuse within 6 months prior to screening;
•Hypersensitivity to the study drug or any ingredient in the study drug；
•Diagnosed within 6 months prior to screening or judged by the investigator to have a suspected immunosuppressive disease;
•Oral or parenteral systemic antimicrobials are used within 2 weeks before the first dose；
•Suspected or confirmed active tuberculosis (TB);
•Have malignancy or history of malignancy prior to screening；
•Major surgery was performed within 3 months prior to screening, or major surgery was planned during the study；
•There are currently significant abnormal laboratory test results, severe concomitant diseases, and other circumstances that the investigator considers inappropriate to participate in this trial;

Arms & Interventions

SHR-1819 injection

Intervention: SHR-1819 injection

Outcomes

Primary Outcomes

Treatment Emergent Adverse Events (TEAEs) (per person-year)

Time Frame: Up to 60 weeks

Secondary Outcomes

Adverse Events of Special Interest (AESI) during treatment (per person-year)(Up to 60 weeks)
Proportion of participants with a Global Assessment (IGA) score of 0 or 1 (0-4 scale) per visit(Up to 60 weeks)
Serious Adverse Event (SAE) during treatment (per person-year)(Up to 60 weeks)
Time to first remission (remission defined as IGA = 1 or 0 after treatment) in this study (for participants visiting 2 baseline IGAs ≥2)(Up to 60 weeks)
Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819(From the beginning of administration to the 60th week)
Proportion of participants with at least 1 remission in this study(Up to 60 weeks)
Time to first relapse in this study (relapse defined as IGA = 3 or 4 points after remission) (for participants with Visit 2 baseline IGA ≥ 2)(Up to 60 weeks)
The concentration of SHR-1819 in serum :Cmax(From the beginning of administration to the 60h week)