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Not yet recruitingNCT07199257Updated Sep 30, 2025

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

A Phase 3 interventional study of GR1802 injection and Placebo in Allergic Rhinitis, Seasonal, sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
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Study 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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Conditions studied

  • Allergic Rhinitis, Seasonal
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In context

Rhinitis, Allergic, Seasonal

392 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 25 are open to participants now.

This study's planned enrollment of 144 is close to the median of 136 across 356 interventional studies indexed under Rhinitis, Allergic, Seasonal.

Browse Rhinitis, Allergic, Seasonal studies →

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd. is the lead sponsor of 27 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    Interleukin-4 receptor responder(Part One)

    Part one

    Biological: GR1802 injection

  • Experimental
    Interleukin-4 receptor responder(Part Two)

    Part two

    Biological: GR1802 injection

  • Placebo comparator
    Placebo

    Part two

    Biological: Placebo

Interventions

  • BiologicalGR1802 injection

    Recombinant fully human anti-IL4Rα monoclonal antibody drug.

  • BiologicalPlacebo

    Placebo

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What researchers measure

Primary outcomes

  1. Adverse events (AEs)(Part One)

    Time frame: up to 12 weeks

  2. 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.

    Time frame: up to 2 weeks

Secondary outcomes

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

    Scores range from 0 to 9, with higher scores indicating more severe symptoms.

    Time frame: up to 2、4 weeks

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

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

    Time frame: up to 2、4 weeks

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

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

    Time frame: week 2、4

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

    Scores range from 0 to 9, with higher scores indicating more severe symptoms.

    Time frame: week 2、4

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

    There are 28 questions in 7 fields，Each question is answered on a 7-point scale (0 to 6).

    Time frame: week2、4

  6. Incidence of ADAs(Part One/Two)

    Time frame: up to 12 weeks

  7. drug concentration、Ctrough(Part One/Two)

    Time frame: up to 12 weeks

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Study locations

1 site
  • Zhongnan Hospital of Wuhan university
    Wuhan, Hubei 430000, China
    • project manager · Contact · dongjie@genrixbio.com · 021-50805988-8039
    • Zheng Liu, PHD · Principal investigator
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07199257
Lead sponsor
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 30, 2025
Start date
Sep 25, 2025 (estimated)
Primary completion
May 15, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Sep 30, 2025

Study contacts

liaison officer
Contact
fangxiaoyan@genrixbio.com
021-50805988-8039

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Other studies in this condition

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Genrix (Shanghai) Biopharmaceutical Co., Ltd.

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