Allergic Rhinitis
Conditions
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.
Interventions
BIOLOGICALStapokibart Injection
IL-4Rα monoclonal antibody
DRUGPlacebo
Placebo
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 4 weeks of treatment. | 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. |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed