Status:
RECRUITING
A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis
Lead Sponsor:
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Conditions:
Allergic Rhinitis, Seasonal
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms ...
Eligibility Criteria
Inclusion
- Main
- Voluntarily sign the informed consent form.
- Seasonal allergic rhinitis has been prevalent for at least 2 years.
- Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
- Positive serum-specific IgE test results.
- Symptom severity scores for the season met the enrollment criteria.
- Main
Exclusion
- Other nasal comorbidities or co-morbidities/states that may be present at the time of screening that affect efficacy determination.
- Subjects whose allergen exposures in their home or work environments may be expected to change significantly during the trial period.
- Subjects with poorly controlled recent asthma conditions.
- Presence of current or past history of infection of special concern, e.g., active tuberculosis, helminthic infections, severe herpes virus infections, etc.
- Previous use of anti-interleukin 4 receptor alpha subunit (IL4Rα) monoclonal antibody.
- Have a serious underlying medical condition that, in the opinion of the investigator, may pose a risk to subject safety by participation in a clinical trial.
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07154342
Start Date
August 15 2025
End Date
July 31 2026
Last Update
September 4 2025
Active Locations (1)
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1
Zhongnan Hospital of Wuhan university
Wuhan, Hubei, China, 430000