search
Back to results

A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Primary Purpose

Eosinophilic Granulomatosis With Polyangiitis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR-1703
SHR-1703 Placebo
Sponsored by
Guangdong Hengrui Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Granulomatosis With Polyangiitis

Eligibility Criteria

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

Inclusion Criteria: Male or female subjects age 18 years or older; Diagnosed with EGPA for at least 6 months; History of relapsing or refractory EGPA; Stable dose of oral prednisone of ≥7.5 mg/day (but not >50 mg/day) for at least 4 weeks prior to randomization; If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study. Exclusion Criteria: Subjects with other eosinophilic-related diseases; Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Life-threatening EGPA within 3 months prior to randomization; Malignancy history within 5 years prior to randomization; Immunodeficiency; Uncontrolled hypertension; Uncontrolled cerebrovascular and cardiovascular disease; parasitic infection within 6 months prior to randomization; Active infectious disease requiring clinical treatment within 4 weeks prior to randomization; Subjects with a dose of oral prednisone of >50 mg/day within 4 weeks prior to randomization; Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization; Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization; Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug; Rituximab or alemtuzumab used within 12 months prior to randomization; Surgical plans that might affect the evaluation; Significant laboratory abnormalities; Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening; History of drug or substance abuse or alcohol abuse within 1 year prior to screening; Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening; Subjects is pregnant, lactating, or planning to be pregnant; Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents; Other conditions unsuitable for participation in the study per investigator judgement.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Treatment group A

    Treatment group B

    Arm Description

    SHR-1703

    SHR-1703 Placebo

    Outcomes

    Primary Outcome Measures

    Change from baseline in oral glucocorticoid dose (OCS)
    Phase 2
    The Proportion of subjects in EGPA remission
    Phase 3

    Secondary Outcome Measures

    Change from baseline in oral glucocorticoid dose
    Effectiveness Indicators (Phase 2)
    The proportion of subjects with OCS dosage ≤5 mg/d
    Effectiveness Indicators (Phase 2)
    The proportion of subjects with at least 50% reduction of OCS dosage from baseline
    Effectiveness Indicators (Phase 2)
    The Proportion of subjects with EGPA remission
    Effectiveness Indicators (Phase 2)
    The Proportion of subjects with EGPA relapse
    Effectiveness Indicators (Phase 2)
    The Proportion of subjects with Severe relapse of EGPA
    Effectiveness Indicators (Phase 2)
    The Proportion of subjects in EULAR remission
    Effectiveness Indicators (Phase 2)
    The time to the first relapse of EGPA
    Effectiveness Indicators (Phase 2)
    The time of the first Severe relapse of EGPA
    Effectiveness Indicators (Phase 2)
    Changes from baseline in Pre- and post-Bronchodilator FEV1
    Effectiveness Indicators (Phase 2)
    Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred
    Effectiveness Indicators (Phase 2)
    Changes from baseline in Pre- and post-Bronchodilator FVC
    Effectiveness Indicators (Phase 2)
    Change from baseline in OCS
    Effectiveness indicators (Phase 3)
    The proportion of subjects with OCS dosage ≤5 mg/d
    Effectiveness indicators (Phase 3)
    The proportion of subjects with at least 50% reduction of OCS dosage from baseline
    Effectiveness indicators (Phase 3)
    The total accrued duration of remission
    Effectiveness indicators (Phase 3)
    The Proportion of subjects with EGPA relapse
    Effectiveness indicators (Phase 3)
    The Proportion of subjects with Severe relapse of EGPA
    Effectiveness indicators (Phase 3)
    The time to the first relapse of EGPA
    Effectiveness indicators (Phase 3)
    The time of the first Severe relapse occurred of EGPA
    Effectiveness indicators (Phase 3)
    The Proportion of subjects in EGPA remission
    Effectiveness indicators (Phase 3)
    Changes from baseline in Pre- and post-Bronchodilator FEV1
    Effectiveness indicators (Phase 3)
    Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred
    Effectiveness indicators (Phase 3)
    Changes from baseline in Pre- and post-Bronchodilator FVC
    Effectiveness indicators (Phase 3)

    Full Information

    First Posted
    July 30, 2023
    Last Updated
    July 30, 2023
    Sponsor
    Guangdong Hengrui Pharmaceutical Co., Ltd
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05979051
    Brief Title
    A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis (EGPA)
    Official Title
    A Single-arm/Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR-1703 for Patients With EGPA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 15, 2023 (Anticipated)
    Primary Completion Date
    March 21, 2026 (Anticipated)
    Study Completion Date
    May 16, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Guangdong 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 phase 2/3 clinical trial to evaluate the efficacy and safety of SHR-1703 in patients with EGPA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eosinophilic Granulomatosis With Polyangiitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Model Description
    A single-arm/randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 clinical study.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    112 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group A
    Arm Type
    Experimental
    Arm Description
    SHR-1703
    Arm Title
    Treatment group B
    Arm Type
    Placebo Comparator
    Arm Description
    SHR-1703 Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-1703
    Intervention Description
    SHR-1703 will be administered by Subcutaneous injection in Phase 2 and Phase 3.
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-1703 Placebo
    Intervention Description
    SHR-1703 Placebo will be administered by Subcutaneous injection in Phase 3.
    Primary Outcome Measure Information:
    Title
    Change from baseline in oral glucocorticoid dose (OCS)
    Description
    Phase 2
    Time Frame
    Up to week 12
    Title
    The Proportion of subjects in EGPA remission
    Description
    Phase 3
    Time Frame
    week 36 and week 48
    Secondary Outcome Measure Information:
    Title
    Change from baseline in oral glucocorticoid dose
    Description
    Effectiveness Indicators (Phase 2)
    Time Frame
    Up to week 24
    Title
    The proportion of subjects with OCS dosage ≤5 mg/d
    Description
    Effectiveness Indicators (Phase 2)
    Time Frame
    week 12, week 24
    Title
    The proportion of subjects with at least 50% reduction of OCS dosage from baseline
    Description
    Effectiveness Indicators (Phase 2)
    Time Frame
    week 12, week 24
    Title
    The Proportion of subjects with EGPA remission
    Description
    Effectiveness Indicators (Phase 2)
    Time Frame
    week 12, week 24
    Title
    The Proportion of subjects with EGPA relapse
    Description
    Effectiveness Indicators (Phase 2)
    Time Frame
    week 12, week 24
    Title
    The Proportion of subjects with Severe relapse of EGPA
    Description
    Effectiveness Indicators (Phase 2)
    Time Frame
    week 12, week 24
    Title
    The Proportion of subjects in EULAR remission
    Description
    Effectiveness Indicators (Phase 2)
    Time Frame
    week 12 through week 24
    Title
    The time to the first relapse of EGPA
    Description
    Effectiveness Indicators (Phase 2)
    Time Frame
    Up to week 48
    Title
    The time of the first Severe relapse of EGPA
    Description
    Effectiveness Indicators (Phase 2)
    Time Frame
    Up to week 48
    Title
    Changes from baseline in Pre- and post-Bronchodilator FEV1
    Description
    Effectiveness Indicators (Phase 2)
    Time Frame
    Up to week 48
    Title
    Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred
    Description
    Effectiveness Indicators (Phase 2)
    Time Frame
    Up to week 48
    Title
    Changes from baseline in Pre- and post-Bronchodilator FVC
    Description
    Effectiveness Indicators (Phase 2)
    Time Frame
    Up to week 48
    Title
    Change from baseline in OCS
    Description
    Effectiveness indicators (Phase 3)
    Time Frame
    Week 24, Week 48
    Title
    The proportion of subjects with OCS dosage ≤5 mg/d
    Description
    Effectiveness indicators (Phase 3)
    Time Frame
    week 24, week 48
    Title
    The proportion of subjects with at least 50% reduction of OCS dosage from baseline
    Description
    Effectiveness indicators (Phase 3)
    Time Frame
    week 24, week 48
    Title
    The total accrued duration of remission
    Description
    Effectiveness indicators (Phase 3)
    Time Frame
    up to week 48
    Title
    The Proportion of subjects with EGPA relapse
    Description
    Effectiveness indicators (Phase 3)
    Time Frame
    week 24, week 48
    Title
    The Proportion of subjects with Severe relapse of EGPA
    Description
    Effectiveness indicators (Phase 3)
    Time Frame
    week 24, week 48
    Title
    The time to the first relapse of EGPA
    Description
    Effectiveness indicators (Phase 3)
    Time Frame
    Up to week 48
    Title
    The time of the first Severe relapse occurred of EGPA
    Description
    Effectiveness indicators (Phase 3)
    Time Frame
    Up to week 48
    Title
    The Proportion of subjects in EGPA remission
    Description
    Effectiveness indicators (Phase 3)
    Time Frame
    week 24 through week 48
    Title
    Changes from baseline in Pre- and post-Bronchodilator FEV1
    Description
    Effectiveness indicators (Phase 3)
    Time Frame
    Up to week 48
    Title
    Changes from baseline in Pre- and post-Bronchodilator FEV 1% pred
    Description
    Effectiveness indicators (Phase 3)
    Time Frame
    Up to week 48
    Title
    Changes from baseline in Pre- and post-Bronchodilator FVC
    Description
    Effectiveness indicators (Phase 3)
    Time Frame
    Up to week 48

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female subjects age 18 years or older; Diagnosed with EGPA for at least 6 months; History of relapsing or refractory EGPA; Stable dose of oral prednisone of ≥7.5 mg/day (but not >50 mg/day) for at least 4 weeks prior to randomization; If receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study. Exclusion Criteria: Subjects with other eosinophilic-related diseases; Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Life-threatening EGPA within 3 months prior to randomization; Malignancy history within 5 years prior to randomization; Immunodeficiency; Uncontrolled hypertension; Uncontrolled cerebrovascular and cardiovascular disease; parasitic infection within 6 months prior to randomization; Active infectious disease requiring clinical treatment within 4 weeks prior to randomization; Subjects with a dose of oral prednisone of >50 mg/day within 4 weeks prior to randomization; Oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization; Intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization; Biological agents or TH2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug; Rituximab or alemtuzumab used within 12 months prior to randomization; Surgical plans that might affect the evaluation; Significant laboratory abnormalities; Prolonged QTc interval or other electrocardiogram abnormalities with significant safety risk at screening; History of drug or substance abuse or alcohol abuse within 1 year prior to screening; Subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening; Subjects is pregnant, lactating, or planning to be pregnant; Subjects have a known history of hypersensitivity or intolerance to anti-IL-5 mabs or other biological agents; Other conditions unsuitable for participation in the study per investigator judgement.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Siai Sun
    Phone
    0518-82342973
    Email
    siai.sun@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis (EGPA)

    We'll reach out to this number within 24 hrs