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The Study of Long-term Outcomes of GR1802 in Patients With Chronic Rhinosinusitis With Nasal Polyps

Primary Purpose

Chronic Rhinosinusitis With Nasal Polyps

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
GR1802 injection
Sponsored by
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

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

Inclusion Criteria: Participation in a clinical study of GR1802 injection for the treatment of chronic rhinosinusitis with nasal polyps (Protocol No. GR1802-005) and fulfillment of the following: completion of prescribed treatment as required by the protocol and completion of the W16 visit. the investigator judges that the subject may benefit from continued use of the test drug. Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign the informed consent form Exclusion Criteria: Poor compliance in the GR1802-005 trial and in the judgment of the investigator is unable to complete this continuation trial; Use of any protocol-specified prohibited medication/treatment during the GR1802-005 trial and prior to the first dose of this study that, in the judgment of the investigator, makes continued participation in the continuation trial unsuitable. The time to first dosing in the extension trial program was greater than 4 weeks from the GR1802-005 study W16 visit; Nasal polyp scoring is not available for nasal polyp scores for nasal or sinus surgery (e.g., nasal polypectomy, balloon dilatation, or intranasal stent placement) that was performed prior to the first administration of the drug in the extension trial that alters the structure of the nasal sidewall; Individuals who have received live/attenuated vaccination within 8 weeks prior to the first dose of the extension trial or who plan to receive live/attenuated vaccination during the trial; Any serious progressive or poorly controlled concomitant disease (e.g., asthma exacerbation requiring adjustment of background medication) identified during the GR1802-005 study period for which, in the judgment of the Principal Investigator, the subject is considered unsuitable for participation in the trial; Other.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental: GR1802

    Arm Description

    GR1802 injection 300mg every two weeks for 16-week treatment

    Outcomes

    Primary Outcome Measures

    Adverse events
    to characterise the safety and tolerability of GR1802 injection, including abnormal vital signs, laboratory tests, electrocardiogram.

    Secondary Outcome Measures

    Change From Baseline at each evaluation time point in Nasal Polyp Score
    NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
    Change From Baseline at each evaluation time in Nasal Congestion/Obstruction Symptom(NCS) Severity Score
    Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom.
    Total Nasal Symptom Score(TNSS) score
    Change from baseline in TNSS score. TNSS score (0-9). Higher score means worse nasal symptom.
    University of Pennsylvania Smell Identification Test (UPSIT)
    Change from baseline in UPSIT. UPSIT score (0-40). Higher score means better sense of smell.
    Visual Analogue Scale (VAS) for Rhinosinusitis
    Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom.
    Proportion of subjects receiving rescue therapy for nasal polyps
    Rescue therapy includes Systemic Corticosteroids and endoscopic surgery
    Ctrough
    PK parameter: trough concentration of GR1802 injection. and exposure(CL/F, Vz/F etc.)
    Vz/F
    PK parameter: The volume of distribution based on the terminal elimination phase adjusted by bioavailability.
    CL/F
    PK parameter: The apparent volume of the central compartment cleared of drug per unit time adjusted by bioavailability.
    Anti-drug antibodies(ADA)
    Incidence of ADA

    Full Information

    First Posted
    August 15, 2023
    Last Updated
    August 22, 2023
    Sponsor
    Genrix (Shanghai) Biopharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06015243
    Brief Title
    The Study of Long-term Outcomes of GR1802 in Patients With Chronic Rhinosinusitis With Nasal Polyps
    Official Title
    An Open-label, Single-arm, Multicenter, Extension Study to Evaluate the Long-term Safety and Efficacy of GR1802 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 18, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    March 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genrix (Shanghai) Biopharmaceutical 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 is an open-label, single-arm, multicenter, extension study to evaluate the long-term safety and efficacy of GR1802 injection in patients with Chronic Rhinosinusitis With Nasal Polyps
    Detailed Description
    This trial was designed as an open, extension trial with the primary objective of evaluating the safety of long-term administration of GR1802 injection in patients with chronic rhinosinusitis with nasal polyps, and to a lesser extent, also evaluating the efficacy, immunogenicity, etc.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Rhinosinusitis With Nasal Polyps

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental: GR1802
    Arm Type
    Experimental
    Arm Description
    GR1802 injection 300mg every two weeks for 16-week treatment
    Intervention Type
    Drug
    Intervention Name(s)
    GR1802 injection
    Intervention Description
    150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
    Primary Outcome Measure Information:
    Title
    Adverse events
    Description
    to characterise the safety and tolerability of GR1802 injection, including abnormal vital signs, laboratory tests, electrocardiogram.
    Time Frame
    Baseline up to Week 24
    Secondary Outcome Measure Information:
    Title
    Change From Baseline at each evaluation time point in Nasal Polyp Score
    Description
    NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
    Time Frame
    Baseline up to Week 24
    Title
    Change From Baseline at each evaluation time in Nasal Congestion/Obstruction Symptom(NCS) Severity Score
    Description
    Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom.
    Time Frame
    Baseline up to Week 24
    Title
    Total Nasal Symptom Score(TNSS) score
    Description
    Change from baseline in TNSS score. TNSS score (0-9). Higher score means worse nasal symptom.
    Time Frame
    Baseline up to Week 24
    Title
    University of Pennsylvania Smell Identification Test (UPSIT)
    Description
    Change from baseline in UPSIT. UPSIT score (0-40). Higher score means better sense of smell.
    Time Frame
    Baseline up to Week 24
    Title
    Visual Analogue Scale (VAS) for Rhinosinusitis
    Description
    Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom.
    Time Frame
    Baseline up to Week 24
    Title
    Proportion of subjects receiving rescue therapy for nasal polyps
    Description
    Rescue therapy includes Systemic Corticosteroids and endoscopic surgery
    Time Frame
    Baseline up to Week 24
    Title
    Ctrough
    Description
    PK parameter: trough concentration of GR1802 injection. and exposure(CL/F, Vz/F etc.)
    Time Frame
    Baseline up to Week 24
    Title
    Vz/F
    Description
    PK parameter: The volume of distribution based on the terminal elimination phase adjusted by bioavailability.
    Time Frame
    Baseline up to Week 24
    Title
    CL/F
    Description
    PK parameter: The apparent volume of the central compartment cleared of drug per unit time adjusted by bioavailability.
    Time Frame
    Baseline up to Week 24
    Title
    Anti-drug antibodies(ADA)
    Description
    Incidence of ADA
    Time Frame
    Baseline up to Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participation in a clinical study of GR1802 injection for the treatment of chronic rhinosinusitis with nasal polyps (Protocol No. GR1802-005) and fulfillment of the following: completion of prescribed treatment as required by the protocol and completion of the W16 visit. the investigator judges that the subject may benefit from continued use of the test drug. Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign the informed consent form Exclusion Criteria: Poor compliance in the GR1802-005 trial and in the judgment of the investigator is unable to complete this continuation trial; Use of any protocol-specified prohibited medication/treatment during the GR1802-005 trial and prior to the first dose of this study that, in the judgment of the investigator, makes continued participation in the continuation trial unsuitable. The time to first dosing in the extension trial program was greater than 4 weeks from the GR1802-005 study W16 visit; Nasal polyp scoring is not available for nasal polyp scores for nasal or sinus surgery (e.g., nasal polypectomy, balloon dilatation, or intranasal stent placement) that was performed prior to the first administration of the drug in the extension trial that alters the structure of the nasal sidewall; Individuals who have received live/attenuated vaccination within 8 weeks prior to the first dose of the extension trial or who plan to receive live/attenuated vaccination during the trial; Any serious progressive or poorly controlled concomitant disease (e.g., asthma exacerbation requiring adjustment of background medication) identified during the GR1802-005 study period for which, in the judgment of the Principal Investigator, the subject is considered unsuitable for participation in the trial; Other.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Study of Long-term Outcomes of GR1802 in Patients With Chronic Rhinosinusitis With Nasal Polyps

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