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NCT Number: NCT07436234

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tong-Ren hospital

Beijing, China

About this study

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. Participants will be randomized to receive AK139 regimen or placebo subcutaneous injection and followed up to week 12

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • The participants agree to use highly effective contraception methods from the moment of signing of the ICF to 3 months after the last dose of the investigational product.

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.

Treatment and study plan

AK139

Drug

AK139 regimen 1- subcutaneous injection.

Placebo

Drug

Placebo-subcutaneous injection

Primary outcomes

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

    Time frame: Up to week 2

  2. Incidence of adverse events (AEs)

    Time frame: Up to week 12

Secondary outcomes

  1. Mean change from baseline in daily rTNSS over 2 and 4 weeks of treatment

    Time frame: Up to week 4

  2. 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

    Time frame: Up to week 4

  3. Serum AK139 concentration

    Time frame: Up to week 12

  4. Number of participants with detectable anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.

    Time frame: Up to week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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