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

NCT05436275 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-11-08

No results posted yet for this study

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).

Conditions

  • Chronic Rhinosinusitis With Nasal Polyposis

Interventions

BIOLOGICAL

CM310

300 mg every two weeks

BIOLOGICAL

Placebo

once every two weeks

Sponsors & Collaborators

  • Keymed Biosciences Co.Ltd

    lead INDUSTRY

Principal Investigators

  • Luo Zhang · Beijing Tong-Ren hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-09
Primary Completion
2024-06-25
Completion
2024-06-25

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05436275 on ClinicalTrials.gov