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NCT Number: NCT07199257

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

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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Key information

Conditions

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

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhongnan Hospital of Wuhan university

Wuhan, Hubei, 430000, China

Location contact

Zheng Liu, PHD

PRINCIPAL_INVESTIGATOR

project manager

CONTACT

[email protected]

021-50805988-8039

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • 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.

Main Exclusion Criteria:

  • 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.

Treatment and study plan

GR1802 injection

Biological

Recombinant fully human anti-IL4Rα monoclonal antibody drug.

Placebo

Biological

Placebo

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)

    Time frame: up to 2 weeks

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

Secondary outcomes

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

    Time frame: up to 2、4 weeks

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

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

    Time frame: up to 2、4 weeks

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

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

    Time frame: week 2、4

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

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

    Time frame: week 2、4

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

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

    Time frame: week2、4

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

  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

Study contacts

Contact information is provided by the study sponsor or research team.

liaison officer

CONTACT

[email protected]

021-50805988-8039

Sponsors and collaborators

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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