GR1802 injection: Recombinant fully human anti-IL4Rα monoclonal antibody drug.
Placebo: Placebo
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 other therapeutic 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.
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.
Primary outcome measure(s)
Change from Baseline in rTNSS( reflective total nasal symptom scores) — Over 2 weeks TNSS is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3. The total score is 12, the higher the score, the worse the symptoms.
Trial sites (15)
Facility
City
Region
Status
Hebei Petro China Central Hospital
Langfang
Hebei
Central Hospital of Qinghe County
Xingtai
Hebei
Zhengzhou Central Hospital
Zhengzhou
Henan
Jingzhou Central Hospital
Jingzhou
Hubei
The Central Hospital of Wuhan
Wuhan
Hubei
Wuhan Union Hospital of China
Wuhan
Hubei
Qilu Hospital of Shandong University
Jinan
Shandong
Shandong Second Provincial General Hospital
Jinan
Shandong
Liaocheng People's Hospital
Liaocheng
Shandong
Heping Hospital Affiliated to Changzhi Medical College
Changzhi
Shanxi
First Hospital of Shanxi Medical University
Taiyuan
Shanxi
Shanxi Bethune Hospital
Taiyuan
Shanxi
Xi'an Daxing Hospital
Xi’an
Shanxi
Yuncheng Central Hospital
Yuncheng
Shanxi
Chengdu Second People's Hospital
Chengdu
Sichuan
More Genrix (Shanghai) Biopharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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