A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis (NEZHA-1)

NCT ID: NCT06930612

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2026-09-16

Brief Summary

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This is a multi-center, randomized, double blind, placebo-controlled Phase II 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).

Detailed Description

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The study consists of a Screening Period (up to 4 weeks), Treatment Period (24 weeks for double-blind treatment period) and Safety Follow-up Period (12 weeks).

Conditions

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Chronic Rhinosinusitis With Nasal Polyposis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CM512 Dose 1

Group Type EXPERIMENTAL

CM512

Intervention Type BIOLOGICAL

Administered subcutaneous injection

CM512 Dose 2

Group Type EXPERIMENTAL

CM512

Intervention Type BIOLOGICAL

Administered subcutaneous injection

CM512 Dose 3

Group Type EXPERIMENTAL

CM512

Intervention Type BIOLOGICAL

Administered subcutaneous injection

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered subcutaneous injection

Interventions

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CM512

Administered subcutaneous injection

Intervention Type BIOLOGICAL

Placebo

Administered subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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 biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity.
* Vaccination with live attenuated vaccine within 30 days before randomization or during the planned study period.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luo Zhang

Role: PRINCIPAL_INVESTIGATOR

Beijing Tong-Ren hospital

Locations

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Beijing Tong-Ren hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Qian Jia

Role: CONTACT

028-88610620

Other Identifiers

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CM512-102101

Identifier Type: -

Identifier Source: org_study_id

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