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

NCT07199257 — Phase 3, Not yet recruiting, 144 participants, Genrix (Shanghai) Biopharmaceutical Co., Ltd.

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A Multicenter Clinical Trial Evaluating the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1802 Injection in Combination With Background Therapy in Patients With Seasonal Allergic Rhinitis.

Registry	NCT07199257
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	144 (Estimated)
Sponsor	Genrix (Shanghai) Biopharmaceutical Co., Ltd. (Industry)
Conditions	Allergic Rhinitis, Seasonal
Interventions	GR1802 injection, Placebo (Biological)
Dates	start 2025-09-25 (estimated), primary completion 2027-05-15 (estimated), completion 2027-07-31 (estimated), first posted 2025-09-30, last updated 2025-09-30
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Interleukin-4 receptor responder(Part One)	Experimental	Biological: GR1802 injection	Part one
Interleukin-4 receptor responder(Part Two)	Experimental	Biological: GR1802 injection	Part two
Placebo	Placebo comparator	Biological: Placebo	Part two

GR1802 injection (Biological): Recombinant fully human anti-IL4Rα monoclonal antibody drug.
Placebo (Biological): Placebo

+Outcome measures

Primary outcomes

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 outcomes

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.
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.
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.
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]

+Eligibility

Sex: All, ages: 12 Years to 18 Years

Main 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.

+Locations (1)

Facility	City	Country	Status
Zhongnan Hospital of Wuhan university	Wuhan, Hubei	China