RecruitingPhase 3

A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis

China150 participantsStarted 2025-08-15

Plain-language 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 of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Change from Baseline in rTNSS( reflective total nasal symptom scores)

Timeframe: up to 2 weeks

Trial details

NCT IDNCT07154342

SponsorGenrix (Shanghai) Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-30

Contact for this trial

liaison officer

021-50805988-8039 fangxiaoyan@genrixbio.com

View on ClinicalTrials.gov More Allergic Rhinitis, Seasonal trials