A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Seasonal Allergic Rhinitis

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAkeso

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • AK139
  • AK139
  • Placebo

Treatment groups

111 Participants
are divided into 3 treatment groups

Sponsors and collaborators