Status:
RECRUITING
Study of Stapokibart Injection in Patients With Allergic Rhinitis
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06525597
Start Date
September 30 2024
End Date
October 30 2025
Last Update
November 8 2024
Active Locations (1)
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1
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China