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A Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （CROWNS-2）

Primary Purpose

Chronic Rhinosinusitis With Nasal Polyposis

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
CM310
Placebo
Sponsored by
Keymed Biosciences Co.Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • with chronic rhinosinusitis with nasal polyposis (CRSwNP).
  • Nasal Polyp Score (NPS) of ≥5 with a minimum score of 2 in each nasal cavity.
  • NCS score of 2 or 3 at screening period, and at least 2 at baseline.
  • Contraception.

Exclusion Criteria:

  • Not enough washingout period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for IL-4Rα antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).
  • Participated and any studies of CM310.
  • With malignant or benign tumor of nasal cavity.
  • Vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    CM310

    Placebo

    Arm Description

    CM310 300mg is given subcutaneously (SC) every two weeks

    Placebo is given subcutaneously (SC) every two weeks

    Outcomes

    Primary Outcome Measures

    Nasal Polyps Score (NPS)
    Change from baseline in the Nasal Polyps Score (NPS) at week 24. NPS score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
    Nasal Congestion Score (NCS)
    Change from baseline in the Nasal Congestion Score (NCS) at week 24. NCS score range from 0 to 3, with higher score means worse nasal symptom.

    Secondary Outcome Measures

    Safety parameters
    Incidence of treatment-emergent adverse events (TEAEs).
    Pharmacokinetics (PK)
    Concentration of CM310 in serum
    Pharmacodynamics (PD)
    Change from baseline in serum biomarker level (Thymus- and activation-regulated chemokine).
    Anti-drug antibodies (ADA)
    Incidence of ADA.

    Full Information

    First Posted
    June 20, 2022
    Last Updated
    June 30, 2022
    Sponsor
    Keymed Biosciences Co.Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05436275
    Brief Title
    A Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （CROWNS-2）
    Official Title
    A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 30, 2022 (Anticipated)
    Primary Completion Date
    August 30, 2024 (Anticipated)
    Study Completion Date
    August 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Keymed Biosciences 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 a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM310, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM310 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
    Detailed Description
    The study consists of a Screening Period (up to 4 weeks), Treatment Period (24 weeks for double-blind treatment period and 28 weeks for open-label maintenance treatment) and Safety Follow-up Period (8 weeks). 180 patients who meet eligibility criteria will be randomized 1:1 to receive either CM310 300 mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 12 times at the double-blind treatment period and 14 times at the open-label treatment period. All patients will receive MFNS on a daily basis as a background treatment throughout the study. Central reading will be implemented to nasal endoscopic nasal polyp score (NPS) , CT scans to Lund-Mackay score and volume of the involved area of nasosinusitis on 3D-construction images, and nasal polyp biopsy tissue analysis to eosinophil counts & percentage.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CM310
    Arm Type
    Experimental
    Arm Description
    CM310 300mg is given subcutaneously (SC) every two weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo is given subcutaneously (SC) every two weeks
    Intervention Type
    Biological
    Intervention Name(s)
    CM310
    Intervention Description
    300 mg every two weeks
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Intervention Description
    once every two weeks
    Primary Outcome Measure Information:
    Title
    Nasal Polyps Score (NPS)
    Description
    Change from baseline in the Nasal Polyps Score (NPS) at week 24. NPS score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
    Time Frame
    at week 24
    Title
    Nasal Congestion Score (NCS)
    Description
    Change from baseline in the Nasal Congestion Score (NCS) at week 24. NCS score range from 0 to 3, with higher score means worse nasal symptom.
    Time Frame
    at week 24
    Secondary Outcome Measure Information:
    Title
    Safety parameters
    Description
    Incidence of treatment-emergent adverse events (TEAEs).
    Time Frame
    Baseline up to Week 60
    Title
    Pharmacokinetics (PK)
    Description
    Concentration of CM310 in serum
    Time Frame
    Baseline up to Week 60
    Title
    Pharmacodynamics (PD)
    Description
    Change from baseline in serum biomarker level (Thymus- and activation-regulated chemokine).
    Time Frame
    Baseline up to Week 60
    Title
    Anti-drug antibodies (ADA)
    Description
    Incidence of ADA.
    Time Frame
    Baseline up to Week 60

    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: with chronic rhinosinusitis with nasal polyposis (CRSwNP). Nasal Polyp Score (NPS) of ≥5 with a minimum score of 2 in each nasal cavity. NCS score of 2 or 3 at screening period, and at least 2 at baseline. Contraception. Exclusion Criteria: Not enough washingout period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for IL-4Rα antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy). Participated and any studies of CM310. With malignant or benign tumor of nasal cavity. Vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （CROWNS-2）

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