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

Chengdu Kangnuoxing Biopharma,Inc.

Status: Not yet enrolling

Conditions: CRSWNP

Treatments: Biological: Stapokibart

Study type: Observational

Funder types: Industry

Identifiers

NCT07483268

CM310-102302

Details and patient eligibility

About

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

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 1 patient group

Group 1

Treatment:

Biological: Stapokibart