Study of Stapokibart Injection in Patients With Allergic Rhinitis
ConditionAllergic Rhinitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-65
SponsorKeymed Biosciences Co.Ltd
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Stapokibart Injection
- Placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov