A Prospective Study of Stapokibart Injection in Patients With Seasonal Allergic Rhinitis (SAR)

N/ANot Yet RecruitingNCT07459556

Chengdu Kangnuoxing Biopharma,Inc.400 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

SAR

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 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.

Locations (1)

Beijing Tongren Hospital, CMU

Beijing, China

Outcomes

Primary Outcomes

The incidence rate of adverse reactions (ADR).

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）.

Time frame: From enrollment to the end of treatment at 10 weeks

Central Contacts

Qian Jia

CONTACT

028-88610620 clinicaltrial@keymedbio.com

Data from ClinicalTrials.gov

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