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

Primary Purpose

Moderate to Severe Atopic Dermatitis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR-1819 injection
Sponsored by
Shanghai Hengrui Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Atopic Dermatitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SHR-1819 injection

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 22, 2023
    Last Updated
    August 22, 2023
    Sponsor
    Shanghai Hengrui Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06012812
    Brief Title
    A Study to Extend Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    May 30, 2025 (Anticipated)
    Study Completion Date
    May 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Hengrui Pharmaceutical Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Moderate to Severe Atopic Dermatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SHR-1819 injection
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-1819 injection
    Intervention Description
    SHR-1819 injection 300 mg Q2W
    Primary Outcome Measure Information:
    Title
    Treatment Emergent Adverse Events (TEAEs) (per person-year)
    Time Frame
    Up to 60 weeks
    Secondary Outcome Measure Information:
    Title
    Serious Adverse Event (SAE) during treatment (per person-year)
    Time Frame
    Up to 60 weeks
    Title
    Adverse Events of Special Interest (AESI) during treatment (per person-year)
    Time Frame
    Up to 60 weeks
    Title
    Proportion of participants with a Global Assessment (IGA) score of 0 or 1 (0-4 scale) per visit
    Time Frame
    Up to 60 weeks
    Title
    Time to first remission (remission defined as IGA = 1 or 0 after treatment) in this study (for participants visiting 2 baseline IGAs ≥2)
    Time Frame
    Up to 60 weeks
    Title
    Proportion of participants with at least 1 remission in this study
    Time Frame
    Up to 60 weeks
    Title
    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)
    Time Frame
    Up to 60 weeks
    Title
    The concentration of SHR-1819 in serum :Cmax
    Time Frame
    From the beginning of administration to the 60h week
    Title
    Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819
    Time Frame
    From the beginning of administration to the 60th week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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; 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guangchao Dong
    Phone
    0518-82342973
    Email
    guangchao.dong@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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