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

K

Keymed Biosciences

Status and phase

Not yet enrolling
Phase 3

Conditions

Chronic Rhinosinusitis With Nasal Polyposis

Treatments

Biological: CM310
Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05436275
CM310-102208

Details and patient eligibility

About

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).

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

180 participants in 2 patient groups, including a placebo group

CM310
Experimental group
Description:
CM310 300mg is given subcutaneously (SC) every two weeks
Treatment:
Biological: Placebo
Placebo
Placebo Comparator group
Description:
Placebo is given subcutaneously (SC) every two weeks
Treatment:
Biological: CM310

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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