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