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

ConditionSAR
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChengdu Kangnuoxing Biopharma,Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Participants who are treated with Stapokibart Injection for SAR at the physician's discretion (according to the China-specific prescribing information).

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Stapokibart

    Biological/Vaccine

    subcutaneous injection

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Group of Stapokibart Injection1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: