Not yet recruiting NCT07459556
A Prospective Study of Stapokibart Injection in Patients With Seasonal Allergic Rhinitis (SAR)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stapokibart.
- Who it may be relevant to
- Registry conditions: SAR. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study of Stapokibart Injection in Patients With SAR
Overview
This study is an open label, prospective study to evaluate the safety of Stapokibart Injection in subjects with SAR.
Interventions
- Biological Stapokibart
subcutaneous injection
Primary outcome measures
- The incidence rate of adverse reactions (ADR). [Time frame: From enrollment to the end of treatment at 10 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Beijing Tongren Hospital, CMU — Beijing
Identifiers
NCT: NCT07459556 · CM310-107301