A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Seasonal Allergic Rhinitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK139, AK139, Placebo.
- Who it may be relevant to
- Registry conditions: Seasonal Allergic Rhinitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
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
Interventions
- Drug AK139
AK139 regimen 1- subcutaneous injection. - Drug AK139
AK139 regimen 2- subcutaneous injection - Drug Placebo
Placebo-subcutaneous injection
Primary outcome measures
- Mean change from baseline in daily reflective total nasal symptom scores (rTNSS) over 2 weeks of treatment [Time frame: Up to week 2]
- Incidence of adverse events (AEs) [Time frame: Up to week 12]
Secondary outcome measures (4)
- Mean change from baseline in daily rTNSS over 2 and 4 weeks of treatment [Time frame: 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 [Time frame: Up to week 4]
- Serum AK139 concentration [Time frame: Up to week 12]
- Number of participants with detectable anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment. [Time frame: Up to week 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tong-Ren hospital — Beijing
Identifiers
NCT: NCT07436234 · AK139-203