A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR).

Last updated: April 23, 2025
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Common Cold

Allergy

Acute Rhinitis

Treatment

GR1802 injection

Placebo

Clinical Study ID

NCT06315426
GR1802-011
  • Ages 18-75
  • All Genders

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. Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a comorbid feature of allergic disease.

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  1. Voluntarily sign the informed consent form.

  2. Seasonal allergic rhinitis has been prevalent for at least 2 years.

  3. Poor control of seasonal allergic rhinitis with nasal glucocorticoids or othertherapeutic agents during the same pollen season in the past.

  4. Positive SPT or serum-specific IgE test results.

  5. Symptom severity scores for the season met the enrollment criteria.

Exclusion

Main Exclusion Criteria:

  1. Other nasal comorbidities or co-morbidities/states that may be present at the timeof screening that affect efficacy determination.

  2. Subjects whose allergen exposures in their home or work environments may be expectedto 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., activetuberculosis, helminthic infections, severe herpes virus infections, etc.

  5. Previous use of anti-interleukin 4 receptor alpha subunit (IL4Rα) monoclonalantibody.

  6. Have a serious underlying medical condition that, in the opinion of theinvestigator, may pose a risk to subject safety by participation in a clinicaltrial.

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: GR1802 injection
Phase: 2
Study Start date:
March 24, 2024
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Hebei Petro China Central Hospital

    Langfang, Hebei 065000
    China

    Site Not Available

  • Central Hospital of Qinghe County

    Xingtai, Hebei 054800
    China

    Site Not Available

  • Zhengzhou Central Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Jingzhou Central Hospital

    Jingzhou, Hubei 434000
    China

    Site Not Available

  • The Central Hospital of Wuhan

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Wuhan Union Hospital of China

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250000
    China

    Site Not Available

  • Shandong Second Provincial General Hospital

    Jinan, Shandong 250000
    China

    Site Not Available

  • Liaocheng People's Hospital

    Liaocheng, Shandong 252000
    China

    Site Not Available

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi 046000
    China

    Site Not Available

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030000
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030000
    China

    Site Not Available

  • Xi'an Daxing Hospital

    Xi'an, Shanxi 710000
    China

    Site Not Available

  • Yuncheng Central Hospital

    Yuncheng, Shanxi 044000
    China

    Site Not Available

  • Chengdu Second People's Hospital

    Chendu, Sichuan 610000
    China

    Site Not Available

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