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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interleukin-4 receptor responder(Part One) | Experimental | Part one |
|
| Interleukin-4 receptor responder(Part Two) | Experimental | Part two |
|
| Placebo | Placebo Comparator | Part two |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR1802 injection | Biological | Recombinant fully human anti-IL4Rα monoclonal antibody drug. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs)(Part One) | up to 12 weeks | |
| 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. | up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 2、4 weeks |
| Percentage Change from Baseline in rTNSS(Part One/Two) |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| liaison officer | Contact | 021-50805988-8039 | fangxiaoyan@genrixbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan university | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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Part one subjects received open-label treatment. Part two subjects received double-blind treatment.
| Placebo | Biological | Placebo |
|
Scores range from 0 to 12, with higher scores indicating more severe symptoms.
| up to 2、4 weeks |
| 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. | week 2、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. | week 2、4 |
| 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). | week2、4 |
| Incidence of ADAs(Part One/Two) | up to 12 weeks |
| drug concentration、Ctrough(Part One/Two) | up to 12 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |