A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis (NEZHA-3)

Phase 3Not Yet RecruitingNCT07807826

Beijing Keymed Biosciences Co., Ltd.240 enrolled

Overview

This is a multi-center, randomized, double blind, placebo-controlled Phase III study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immunogenicity of CM512 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP)

This study consists of a screening/run-in period (up to 4 weeks), a treatment period (24-week double-blind treatment period + 24-week maintenance treatment period), and a 12-week safety follow-up period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

240

Conditions

Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

Interventions

CM512BIOLOGICAL

subcutaneous injection

PlaceboDRUG

subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 * Nasal Congestion Score of 2 or 3 at screening period, and at least 2 at baseline * Contraception Exclusion Criteria: * Not enough washing out period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for Interleukin (IL)-4 receptor alpha subunit antagonists, less than 8 weeks or 5 half-lives for systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity

Locations (1)

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Change from baseline in the Nasal Congestion Score (NCS) at week 24

Congestion Score is scored on a scale of 0 to 3.higher score means a worse outcome.

Time frame: At week 24

Central Contacts

Qian Jia

CONTACT

028-88610620 clinicaltrial@keymedbio.com

Data from ClinicalTrials.gov

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