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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: AK139; Drug: AK139; Drug: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 111
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Guoqin Wang; Phone Number: +86 (0760) 8987 3999; Email: global.trials@akesobio.com

Study Locations

• China
  • Beijing, China
    • Beijing Tong-Ren hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female aged 18-65.
2. Able to understand the study and voluntarily sign the ICF;
3. 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;
4. Have immunoglobulin E (Ig E)-mediated hypersensitivity to at least one pollen allergen in the current environment;
5. The SAR symptoms of participants remained inadequately control ledafter nasal spray corticosteroids and/or other SAR medications treatment throughout the previous same pollen season;
6. Adequate pollen exposure during the pollen season.
7. The SAR symptoms scores of the participants meet the requirements of the protocol at screening and baseline.
8. During the screening/run-in period, participants must complete at least 80% of the assessments in the diary card;
9. 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:

1. Type of rhinitis other than allergic rhinitis within 2 weeks before screening;
2. Allergic to any component of the investigational drug or intolerant to basis treatment..
3. Concomitant or associated nasal diseases/conditions that, as determined by investigators, may affect the severity of the disease and the evaluation of therapeutic effects.
4. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to.
5. Other reasons the investigators believes that the participants is not suitable to enrolled in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo	Drug: Placebo; Placebo-subcutaneous injection
Experimental: AK139 regimen 1	Drug: AK139; AK139 regimen 1- subcutaneous injection.; Drug: AK139; AK139 regimen 2- subcutaneous injection
Experimental: AK139 regimen 2	Drug: AK139; AK139 regimen 1- subcutaneous injection.; Drug: AK139; AK139 regimen 2- subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment	Up to week 2
Incidence of adverse events (AEs)	Up to week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in daily rTNSS over 2 and 4 weeks of treatment	Up to week 4
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	Up to week 4
Serum AK139 concentration	Up to week 12
Number of participants with detectable anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.	Up to week 12

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Estimated): March 2, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): May 13, 2027

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: AK139-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No