SAR
Conditions
Brief summary
This study is an open label, prospective study to evaluate the safety of Stapokibart Injection in subjects with SAR.
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 SAR (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 10 weeks | Number of of Adverse Reactions （ADRs） is calculated based on Adverse Events （AEs） and Serious Adverse Events （SAEs） that were assessed by the investigator as related to the study drug and categorized according to the Medical Dictionary for Regulatory Activities （MedDRA）. |
Countries
China
Contacts
CONTACTQian Jia
Outcome results
None listed