This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of participants with moderate to severe SAR
Male or female aged 18-65.
Able to understand the study and voluntarily sign the ICF;
Diagnosed SAR according to the Criteria stated in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition), with or without allergic conjunctivitis, and have SAR history at least two years;
Have immunoglobulin E (Ig E)-mediated hypersensitivity to at least one pollen allergen in the current environment;
Type of rhinitis other than allergic rhinitis within 2 weeks before screening;
Allergic to any component of the investigational drug or intolerant to basis treatment..
Concomitant or associated nasal diseases/conditions that, as determined by investigators, may affect the severity of the disease and the evaluation of therapeutic effects.
Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to.
Parallel
AK139
DrugAK139 regimen 1- subcutaneous injection.
AK139
DrugAK139 regimen 2- subcutaneous injection
Placebo
DrugPlacebo-subcutaneous injection
Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment
Incidence of adverse events (AEs)
Mean change from baseline in daily rTNSS over 2 and 4 weeks of treatment
Mean change from baseline in the daily AM and PM reflective total nasal symptom score (AM and PM rTNSS) over 2 and 4 weeks of treatment
Serum AK139 concentration
Number of participants with detectable anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.
This trial is not recruiting at the moment. You can still explore other options:
