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To evaluate TQC2938 injection in all patients receiving background treatment with azelastine fluticasone nasal spray. The efficacy, safety and immunogenicity of the injection in patients with seasonal allergic rhinitis compared with placebo are expected to include 136 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQC2938 injection | Experimental | TQC2938 injection, 4 weeks as a treatment cycle. |
|
| TQC2938 Placebo | Placebo Comparator | TQC2938 placebo, 4 weeks as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQC2938 injection | Drug | TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retrospective nasal symptom score after 2 weeks | Average daily retrospective nasal symptom score (rTNSS) changed from baseline after 2 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Retrospective nasal symptom score after 4 weeks | Mean daily retrospective nasal symptom total score (rTNSS) changes from baseline at 4 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms. | Baseline up to 4 weeks |
| Retrospective nasal symptom score at 2-week and 4-week at day time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
| Peking University People's Hospital |
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| TQC2938 Placebo | Drug | TQC2938 placebo, 4 weeks as a treatment cycle. |
|
Mean daily changes in retrospective nasal symptom total score (AM rTNSS) from baseline at 2 weeks and 4 weeks after treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms. |
| Baseline up to 2 and 4 weeks |
| Retrospective nasal symptom score at 2-week and 4-week at night time | Mean daily nightly retrospective nasal symptom total score (PM rTNSS) changes from baseline at 2 weeks and 4 weeks after treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Instantaneous nasal symptom score | Mean change of instantaneous nasal symptom total score (iTNSS) from baseline every morning before treatment for 2 weeks and 4 weeks. The total score is 0-12 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Retrospective nasal symptom score-Mean daily rTNSS change | Mean daily rTNSS change from baseline at 2 weeks and 4 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Peak Inspiratory Flow | Mean daily changes in peak inspiratory flow from baseline at 2 weeks and 4 weeks after treatment. | Baseline up to 2 and 4 weeks |
| Instantaneous nasal symptom score | Mean change rate of iTNSS from baseline before treatment at 2 weeks and 4 weeks each morning. The total score is 0-12 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Instantaneous nasal single symptom score | Mean changes from baseline in daily retrospective nasal symptom scores (runny nose, nasal congestion, nasal itchy, and sneezing) at 2 and 4 weeks of treatment. The total score is 0-3 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Instantaneous nasal single symptom score at day time | Mean changes from baseline in scores of individual nasal symptoms (runny nose, nasal congestion, itchy nose, and sneezing) were reviewed daily (AM) at 2 weeks and 4 weeks of treatment. The total score is 0-3 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Instantaneous nasal single symptom score at night time | Mean changes from baseline in scores of individual nasal symptoms (runny nose, nasal congestion, nasal itchy and sneezing) at night (PM) after 2 and 4 weeks of treatment. The total score is 0-3 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Retrospective ocular symptom score (rTOSS) | Mean changes in daily retrospective ocular symptom score (rTOSS) from baseline at 2 and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Retrospective ocular symptom score (AM rTOSS) | Mean daily changes in retrospective ocular symptom score (AM rTOSS) from baseline at 2 weeks and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Retrospective ocular symptom score (PM rTOSS) | Mean nightly retrospective ocular symptom score (PM rTOSS) changes from baseline at 2 weeks and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Instantaneous ocular symptom score (iTOSS) | Mean change of instantaneous ocular symptom total score (iTOSS) from baseline every morning at 2 weeks and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Retrospective ocular symptom score ( rTOSS) | Mean rate of change in daily rTOSS from baseline at 2 and 4 weeks of treatment. The total score is 0-9 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Instantaneous ocular symptom score | Mean change rate of iTOSS from baseline before treatment at 2 weeks and 4 weeks each morning. The total score is 0-9 points, with the higher score meaning the more severe symptoms. | Baseline up to 4 weeks |
| Retrospective ocular single symptom score | Average changes in scores of individual ocular symptoms (itchy, tearing, red eyes) at 2 and 4 weeks of treatment compared with baseline. The total score is 0-3 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Retrospective ocular single symptom score | Average changes of individual ocular symptom scores (itchy, watery eyes, red eyes) compared with baseline were reviewed daily (AM) at 2 weeks and 4 weeks of treatment. The total score is 0-3 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Retrospective ocular single symptom score | Average changes of individual ocular symptoms (itchy, watery eyes, red eyes) scores at night (PM) after 2 weeks of treatment and 4 weeks of treatment compared with baseline. The total score is 0-3 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Quality of life questionnaire | Changes in quality of life questionnaire (RQLQ) scores from baseline for patients with allergic rhinitis after 2 weeks and 4 weeks of treatment. The total score is 0-168 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Time of onset | Time of onset | Baseline up to 4 weeks |
| Time to Reach Maximum Plasma Concentration (Tmax) | Curative effect peak time; | Baseline up to 4 weeks |
| Area under the curve | Area under the curve of mean daily rTNSS change from baseline at 2 and 4 weeks of treatment. The total score is 0-12 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Severity of nasal symptoms (e.g., Runny nose, nasal congestion, nasal itching, and sneezing.) | 2 weeks of treatment and 4 weeks of asymptomatic or mild symptoms (e.g., Runny nose, nasal congestion, nasal itching, and sneezing.). | Baseline up to 2 and 4 weeks |
| Adverse events and serious adverse events | Incidence and severity of adverse events (AE) and serious adverse events(SAE), and abnormal laboratory test indicators | Baseline up to 12 weeks |
| Blood drug concentration | Blood drug concentration. | Week 0,2, 4, 8, 12 before administration |
| Blood eosinophil (EOS) count at each evaluation visit | Blood eosinophil (EOS) count and percentage at each evaluation visit. | Week 0,2, 4, 8, 12 before administration |
| Change from baseline in serum total immunoglobulin E (IgE) concentration | Change and percentage change from baseline in serum total immunoglobulin E (IgE) concentration. | Week 0,2, 4, 8, 12 before administration |
| The incidence of antidrug antibodies (ADA) | The incidence and titers of antidrug antibodies (ADA) in the test subjects. If a positive result is detected for ADA in the test subjects, then the neutralizing antibody will be tested as well. | Week 0,2, 4, 8, 12 before administration |
| the incidence of neutralizing antibodies (Nab) | The incidence of neutralizing antibodies (Nab). If a positive result is detected for ADA in the test subjects, then the neutralizing antibody will be tested as well. | Week 0,2, 4, 8, 12 before administration |
| Beijing |
| Beijing Municipality |
| 100044 |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| Beijing TongRen Hospital, Capital Medical University | Beijing | Beijing Municipality | 100730 | China |
| Ganzu Province People's Hospital | Lanzhou | Ganzu | 730000 | China |
| Cangzhou central hosipital | Cangzhou | Hebei | 061000 | China |
| Hebei Medical University Third Hospital | Shijiazhuang | Hebei | 050000 | China |
| First Affiliated Hospital, Heilongjang University of Chinese Medigine | Harbin | Heilongjang | 150040 | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450002 | China |
| People'S Hospital of Zhengzhou | Zhengzhou | Henan | 450002 | China |
| Zhengzhou Central Hospital | Zhengzhou | Henan | 450007 | China |
| Tongji Hospital of Tongji medical college of HUST | Wuhan | Hubei | 430030 | China |
| Baotou Central Hospital | Baotou | Inner Mongolia | 14000 | China |
| Northern Jiangsu People'S Hospital | Yangzhou | Jiangsu | 225000 | China |
| The first hospital of Jilin University | Changchun | Jilin | 130031 | China |
| China-japan Friendship Hospital, Jilin University | Changchun | Jilin | 130033 | China |
| Affiliated Zhongshan Hospital Of Dalian university | Dalian | Liaoning | 116001 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
| Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710004 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine | Xi'an | Shaanxi | 710089 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250021 | China |
| The Second People's Hospital of Shandong Province | Jinan | Shandong | 250021 | China |
| Yantai Yuhuangding Hospital | Yantai | Shandong | 264000 | China |
| Zibo Central Hospital | Zibo | Shandong | 255020 | China |
| First Hospital of Shangxi Medical University | Taiyuan | Shangxi | 30001 | China |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | 030000 | China |
| Tianjin First Central Hospital | Tianjin | Tianjin Municipality | 300192 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830013 | China |
| The First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650032 | China |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| 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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