Chronic Rhinosinusitis With Nasal Polyposis
Conditions
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.
Interventions
BIOLOGICALCM310
300 mg every two weeks
BIOLOGICALPlacebo
once every two weeks
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Polyps Score (NPS) | at week 24 | 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) | at week 24 | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety parameters | Baseline up to Week 60 | Incidence of treatment-emergent adverse events (TEAEs). |
| Pharmacokinetics (PK) | Baseline up to Week 60 | Concentration of CM310 in serum |
| Pharmacodynamics (PD) | Baseline up to Week 60 | Change from baseline in serum biomarker level (Thymus- and activation-regulated chemokine). |
| Anti-drug antibodies (ADA) | Baseline up to Week 60 | Incidence of ADA. |
Countries
China
Outcome results
None listed