IL4Rα antibody for seasonal allergic rhinitis (hay fever)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional trial compares repeated injections of GR1802, an IL4Rα-targeting monoclonal antibody, with placebo in patients who have had seasonal allergic rhinitis for at least two years and have positive specific IgE. Eligible participants have had poor symptom control with nasal glucocorticoids or other therapies during the same pollen season; those with certain nasal comorbidities, unstable asthma, specific infections, or prior IL4Rα antibody use are excluded. Symptom severity scores and other clinical measures will be collected during the pollen season to determine treatment effect. The trial is conducted at Zhongnan Hospital of Wuhan University and follows phase 3 interventional procedures.

Why it matters

Who can join: the full rules

Main Inclusion Criteria:

1. Voluntarily sign the informed consent form.
2. Seasonal allergic rhinitis has been prevalent for at least 2 years.
3. Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
4. Positive serum-specific IgE test results.
5. Symptom severity scores for the season met the enrollment criteria.

Main Exclusion Criteria:

1. Other nasal comorbidities or co-morbidities/states that may be present at the time of screening that affect efficacy determination.
2. Subjects whose allergen exposures in their home or work environments may be expected to change significantly during the trial period.
3. Subjects with poorly controlled recent asthma conditions.
4. Presence of current or past history of infection of special concern, e.g., active tuberculosis, helminthic infections, severe herpes virus infections, etc.
5. Previous use of anti-interleukin 4 receptor alpha subunit (IL4Rα) monoclonal antibody.
6. 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.

Where it's running

• Zhongnan Hospital of Wuhan university
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: liaison officer
• Email: fangxiaoyan@genrixbio.com
• Phone: 021-50805988-8039

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.