CRSWNP
Conditions
Brief summary
This study is a open label, prospective study to evaluate the safety of Stapokibart Injection in subjects with CRSwNP.
Interventions
BIOLOGICALStapokibart
subcutaneous injection
Sponsors
Chengdu Kangnuoxing Biopharma,Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence rate of adverse reactions (ADR). | From enrollment to the end of treatment at 52 weeks | Number of adverse events and severe adverse events, categorized according to medical dictionary for regulatory activities (MedDRA) |
Countries
China
Contacts
CONTACTQian Jia
Outcome results
None listed