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

NCT07436234 | Not Yet Recruiting Phase 2

• 1 other identifier: AK139-203
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (3)

AK139 regimen 1

EXPERIMENTAL

Drug: AK139

AK139 regimen 2

EXPERIMENTAL

Drug: AK139

Placebo

EXPERIMENTAL

Drug: Placebo

Interventions

AK139 DRUG

AK139 regimen 1- subcutaneous injection.

AK139 regimen 1

Placebo DRUG

Placebo-subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Beijing Tong-Ren hospital

Beijing, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Guoqin Wang

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 27, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): May 13, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)