A Study of GR1802 Injection in Patients With Seasonal Allergic Rhinitis.

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07199257
• 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: 2025-09
• Study First Submitted: 2025-09-22
• Study First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Study Start: 2025-09-25
• Study First Posted: 2025-09-30
• Last Update Posted: 2025-09-30
• Primary Completion: 2027-05-15
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. Voluntarily sign the informed consent form.
2. Seasonal allergic rhinitis has been prevalent for at least 2 years.Positive for allergens associated with seasonal allergic rhinitis.
3. Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
4. Weight≥30kg.
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(Part One)	GR1802 injection	Part one
Placebo	Placebo	Part two
Interleukin-4 receptor responder(Part Two)	GR1802 injection	Part two

Primary Outcome Measures

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

Trial Locations

Locations (1)

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