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

NCT07199257 | Not Yet Recruiting Phase 3

• 1 other identifier: GR1802-015
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis, Seasonal

Outcome Measures

Primary Outcomes (2)

• Adverse events (AEs)(Part One)

  up to 12 weeks

• Change from Baseline in rTNSS( reflective total nasal symptom scores)(Part Two)

  Scores range from 0 to 12, with higher scores indicating more severe symptoms.

  up to 2 weeks

Secondary Outcomes (7)

• Change from Baseline in rTOSS( reflective total ocular symptom scores)(Part One/Two)

  up to 2、4 weeks

• Percentage Change from Baseline in rTNSS(Part One/Two)

  up to 2、4 weeks

• Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)(Part One/Two)

  week 2、4

• Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)(Part One/Two)

  week 2、4

• Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores(Part One/Two)

  week2、4

Study Arms (3)

Interleukin-4 receptor responder(Part One)

EXPERIMENTAL

Part one

Biological: GR1802 injection

Interleukin-4 receptor responder(Part Two)

EXPERIMENTAL

Part two

Biological: GR1802 injection

Placebo

PLACEBO COMPARATOR

Part two

Biological: Placebo

Interventions

GR1802 injection BIOLOGICAL

Recombinant fully human anti-IL4Rα monoclonal antibody drug.

Interleukin-4 receptor responder(Part One); Interleukin-4 receptor responder(Part Two)

Placebo BIOLOGICAL

Placebo

Placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Voluntarily sign the informed consent form.
• Seasonal allergic rhinitis has been prevalent for at least 2 years.Positive for allergens associated with seasonal allergic rhinitis.
• Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.
• Weight≥30kg.
• Symptom severity scores for the season met the enrollment criteria.

You may not qualify if:

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

Sponsors & Collaborators

• Genrix (Shanghai) Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhongnan Hospital of Wuhan university

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

liaison officer

CONTACT

021-50805988-8039; fangxiaoyan@genrixbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part one subjects received open-label treatment. Part two subjects received double-blind treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

CN (1)