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

Not Applicable

Recruiting

• Conditions: Allergic Rhinitis, Seasonal
• Interventions: Biological: GR1802 injection; Biological: Placebo

• Registration Number: NCT07154342
• Lead Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-13
• Study Start: 2025-08-15
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2026-04-30
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interleukin-4 receptor responder	GR1802 injection	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in rTNSS( reflective total nasal symptom scores)	up to 2 weeks	Scores range from 0 to 12, with higher scores indicating more severe symptoms.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in rTOSS( reflective total ocular symptom scores)	up to 2、4 weeks	Scores range from 0 to 9, with higher scores indicating more severe symptoms.
Change from Baseline in rTNSS	up to 4 weeks	Scores range from 0 to 12, with higher scores indicating more severe symptoms.
Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)	week 2、4	Scores range from 0 to 12, with higher scores indicating more severe symptoms.
Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)	week 2、4	Scores range from 0 to 9, with higher scores indicating more severe symptoms.
Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores	week2、4	There are 28 questions in 7 fields，Each question is answered on a 7-point scale (0 to 6).
Adverse events (AEs)	up to 12 weeks
Incidence of ADAs	up to 12 weeks
Ctrough	up to 12 weeks

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan university; 🇨🇳 Wuhan, Hubei, China