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

Keymed Biosciences

Status and phase: Not yet enrolling; Phase 2

Conditions: Chronic Rhinosinusitis With Nasal Polyposis

Treatments: Biological: CM512; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06930612

CM512-102101

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 120 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

CM512 Dose 1

Experimental group

Treatment:

Biological: CM512

CM512 Dose 2

Experimental group

Treatment:

Biological: CM512

CM512 Dose 3

Experimental group

Treatment:

Biological: CM512

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo