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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interleukin-4 receptor responder 1 | Experimental |
| |
| Interleukin-4 receptor responder 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR1802 injection | Biological | Recombinant fully human anti-IL4Rα monoclonal antibody drug. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in rTNSS( reflective total nasal symptom scores) | 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. | Over 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in rTOSS( reflective total ocular symptom scores) | TOSS is the sum of symptom scores of eye itching/foreign body sensation/redness and tearing, with each symptom scoring from 0 to 3. The total score is 6, the higher the score, the worse the symptoms. | Over 2、4 weeks |
| Change from Baseline in rTNSS |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zheng Liu, PHD | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Petro China Central Hospital | Langfang | Hebei | 065000 | China | ||
| Central Hospital of Qinghe County |
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| Placebo | Biological | Placebo |
|
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. |
| Over 4 weeks |
| Mean change from baseline in iTNSS(instantaneous total nasal symptom scores) | 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. | week 2、4 |
| Mean change from baseline in iTOSS(instantaneous total ocular symptom scores) | TOSS is the sum of symptom scores of eye itching/foreign body sensation/redness and tearing, with each symptom scoring from 0 to 3. The total score is 6, the higher the score, the worse the symptoms. | week 2、4 |
| Change from baseline in VAS(Visual Analog Scale) score | Patients marked the score corresponding to the severity of the current overall AR symptoms by drawing a line on a 0-10 cm scale,the higher the score, the worse the symptoms. | week2、4 |
| Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores | The RQLQ is used to measure the problems that adults with rhinoconjunctivitis experience in their daily lives. It has 28 questions in 7 domains. The total score is the sum of the 7 domain scores, with higher scores being associated with poorer quality of life. | week2、4 |
| Adverse events (AEs) | Incidence of AEs. | up to 12 weeks |
| Immunogenicity characteristics | Positive rate of ADA(anti-drug antibody) testing | up to 12 weeks |
| Xingtai |
| Hebei |
| 054800 |
| China |
| Zhengzhou Central Hospital | Zhengzhou | Henan | 450000 | China |
| Jingzhou Central Hospital | Jingzhou | Hubei | 434000 | China |
| The Central Hospital of Wuhan | Wuhan | Hubei | 430000 | China |
| Wuhan Union Hospital of China | Wuhan | Hubei | 430000 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250000 | China |
| Shandong Second Provincial General Hospital | Jinan | Shandong | 250000 | China |
| Liaocheng People's Hospital | Liaocheng | Shandong | 252000 | China |
| Heping Hospital Affiliated to Changzhi Medical College | Changzhi | Shanxi | 046000 | China |
| First Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030000 | China |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | 030000 | China |
| Xi'an Daxing Hospital | Xi’an | Shanxi | 710000 | China |
| Yuncheng Central Hospital | Yuncheng | Shanxi | 044000 | China |
| Chengdu Second People's Hospital | Chengdu | Sichuan | 610000 | China |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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