Study of Stapokibart Injection in Patients With Allergic Rhinitis

Launched by KEYMED BIOSCIENCES CO.LTD · Jul 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Stapokibart, which is given as an injection to see how well it works and how safe it is for people with allergic rhinitis, a condition that causes sneezing, runny nose, and other allergy symptoms. The trial is currently looking for participants who are between the ages of 18 and 65 and have been diagnosed with allergic rhinitis based on specific guidelines. To be eligible, participants should also have a positive skin test for allergies and their asthma, if they have it, should be stable.

Participants in this study will receive either the Stapokibart injection or a placebo (a treatment that looks the same but has no active medicine) without knowing which one they got. This helps researchers understand how effective the medication is. Before joining, individuals must not have used certain other allergy medications recently or have any infections related to the sinuses or upper respiratory tract. If you or someone you know suffers from allergic rhinitis and is interested in participating, this trial might be a valuable opportunity to help improve treatment options for this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Able to understand the study and voluntarily sign the Informed consent form.
• • Diagnosed Allergic Rhinitis according to the Criteria stated in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition).
• • Subjects with asthma must be evaluated by the researcher as having a stable condition.
• • Has a positive skin prick test (SPT) or positive antigen-specific serum immunoglobulin E (IgE).
• Exclusion Criteria:
• • Use of anti-interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody, thymic stromal lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonal antibody, other monoclonal antibodies, or other biologics within 10 weeks or 5 half-lives (whichever is longer) prior to the screening visit.
• • Use of any investigational product within 4 weeks prior to the screening visit or planning to participate in other clinical studies during this study.
• • Forced expiratory volume in 1 second (FEV1) ≤ 50% of the predicted value during the screening/run-in period.
• • Have acute sinusitis, nasal infection, or upper respiratory tract infection at screening or within 2 weeks prior to screening.
• • Have received a live-attenuated vaccine within 12 weeks prior to randomization or planning to receive one during the study.