RecruitingPhase 2NCT06525597

Study of Stapokibart Injection in Patients With Allergic Rhinitis

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Patients With Allergic Rhinitis

Sponsor

Keymed Biosciences Co.Ltd

Enrollment

120 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

Allergic Rhinitis

Summary

This study is a Randomized, Double-blind, Placebo-controlled phase II clinical study evaluating the efficacy and safety of Stapokibart injection in patients with allergic rhinitis.

Eligibility

Min Age: 12 YearsMax Age: 65 Years

Inclusion Criteria4

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 Criteria5

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.

Interested in this trial?

Get notified about updates and connect with the research team.