Not Yet RecruitingPhase 2

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

China111 participantsStarted 2026-03-02

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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;
✓. The SAR symptoms of participants remained inadequately control ledafter nasal spray corticosteroids and/or other SAR medications treatment throughout the previous same pollen season;
✓. Adequate pollen exposure during the pollen season.
✓. The SAR symptoms scores of the participants meet the requirements of the protocol at screening and baseline.
✓. During the screening/run-in period, participants must complete at least 80% of the assessments in the diary card;

Exclusion criteria

✕. 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.
✕. Other reasons the investigators believes that the participants is not suitable to enrolled in this study.

What they're measuring

Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment

Timeframe: Up to week 2

Incidence of adverse events (AEs)

Timeframe: Up to week 12

Trial details

NCT IDNCT07436234

SponsorAkeso

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Guoqin Wang

+86 (0760) 8987 3999 global.trials@akesobio.com

View on ClinicalTrials.gov More Seasonal Allergic Rhinitis trials