A Study of Stapokibart Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

N/AActive Not RecruitingNCT07483268

Chengdu Kangnuoxing Biopharma,Inc.600 enrolled

Overview

This study is a open label, prospective study to evaluate the safety of Stapokibart Injection in subjects with CRSwNP.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

CRSWNP

Interventions

StapokibartBIOLOGICAL

subcutaneous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants aged 18 years or older at the time of informed consent and provide voluntary informed consent to participate in the study before inclusion in the study. * Physician decision to treat the participant with Stapokibart Injection for CRSwNP (according to the China-specific prescribing information) made prior to and independently of the participant's participation in the study. Exclusion Criteria: * Known history of allergic reaction to Stapokibart Injection. * Participants currently or plan participating in any interventional clinical trial. * Participants with hematologic malignancies. * Women with pregnant. * Any condition that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.

Locations (1)

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

The incidence rate of adverse reactions (ADR).

Number of adverse events and severe adverse events, categorized according to medical dictionary for regulatory activities (MedDRA)

Time frame: From enrollment to the end of treatment at 52 weeks

Data from ClinicalTrials.gov

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