IL4Rα antibody for seasonal allergic rhinitis (hay fever)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of GR1802 Injection in Combination With Background Therapy in Patients With SAR

This trial will test whether injections of an IL4Rα monoclonal antibody help people with seasonal allergic rhinitis (hay fever) who haven't been well controlled with nasal steroids.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07154342 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: People with a history of seasonal allergic rhinitis for at least two years, positive serum-specific IgE, and symptoms not well controlled by nasal glucocorticoids during pollen season are ideal candidates.

Not a fit: People with other nasal conditions that affect symptom measurement, unstable or poorly controlled asthma, ongoing or recent serious infections, or prior use of IL4Rα antibodies are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the antibody could reduce nasal and eye symptoms and improve quality of life during pollen seasons for people with difficult-to-control hay fever.

How similar studies have performed: Other IL-4Rα blocking antibodies (for example dupilumab) have shown benefits in related allergic diseases, supporting this therapeutic approach.

Eligibility criteria

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 this trial is running

Wuhan, Hubei

• Zhongnan Hospital of Wuhan university — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: liaison officer

Conditions Allergic Rhinitis, Seasonal