A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Patients With Allergic Rhinitis
Overview
- Phase
- Phase 2
- Intervention
- Stapokibart Injection
- Conditions
- Allergic Rhinitis
- Sponsor
- Keymed Biosciences Co.Ltd
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 4 weeks of treatment.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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.
Arms & Interventions
Stapokibart Group
Stapokibart, subcutaneous, once every two weeks
Intervention: Stapokibart Injection
Placebo Group
Placebo, subcutaneous, once every two weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 4 weeks of treatment.
Time Frame: Up to week 4
The total nasal symptom score (TNSS) is the sum of the four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.