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To evaluate TQH2722 injection in all patients receiving background treatment with mometasone furoate nasal spray (MFNS) and loratadine. The efficacy, safety and immunogenicity of the solution in patients with seasonal allergic rhinitis compared with placebo are expected to include 168 patients with confirmed seasonal allergic rhinitis (SAR) who have failed to respond to standard treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQH2722 injection | Experimental |
| |
| TQH2722 Placebo | Placebo Comparator | TQH2722 placebo, 1 weeks as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQH2722 injection | Drug | TQH2722 injection is a humanized monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retrospective nasal symptom score after treatment for 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 treatment for 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 |
| Mean daily changes in retrospective nasal symptom total score |
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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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| TQH2722 Placebo | Drug | Placebo without drug substance. |
|
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 |
| Mean daily nightly retrospective nasal symptom total score | 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 | 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 |
| Instantaneous nasal symptom score: Mean daily rTNSS change from baseline | Mean daily rTNSSchange 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 |
| Instantaneous nasal symptom score: Mean change rate of iTNSS from baseline | 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 | 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 single 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: Mean changes from baseline in scores of individual nasal symptoms during the day | 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 single 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: Mean changes from baseline in scores of individual nasal symptoms at night | 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 single 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: Mean changes in daily retrospective ocular symptom score | 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: Mean changes in retrospective ocular symptom score during the day | 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: Mean retrospective ocular symptom score at night | 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 |
| Retrospective ocular symptom score: Mean change of instantaneous ocular symptom total score | 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: Mean rate of change in daily 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 |
| Retrospective nasal symptom score: Average daily retrospective nasal symptom score | Average daily retrospective nasal symptom score (rTNSS) changed from baseline after 4 weeks of treatment. The total score is 0-12points, with the higher score meaning the more severe symptoms. | Baseline up to 4 weeks |
| Retrospective ocular symptom score: Mean change rate of iTOSS each morning | 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 2 and 4 weeks |
| Instantaneous ocular single symptom score: Average changes in scores of individual ocular symptoms | Average changes in scores of individual ocular symptoms (itchy, tearing, red eyes) at 2 and 4 weeks of treatment compared with baseline. The single score is 0-3 points, with the higher score meaning the more severe symptoms | Baseline up to 2 and 4 weeks |
| Instantaneous ocular single symptom score: Average changes of individual ocular symptom scores during the day | 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 single score is 0-3 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Instantaneous ocular single symptom score: Average changes of individual ocular symptoms at night | 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 single 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 after treatment. | Baseline up to 4 weeks |
| Time to Reach Maximum Plasma Concentration (Tmax) | Time to reach maximum plasma concentration after administration. | 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 | Baseline up to 2 and 4 weeks |
| Number of days with no or mild symptoms of Allergic rhinitis symptoms | Number of days with no or mild symptoms during 2 weeks and 4 weeks of treatment | Baseline up to 2 and 4 weeks |
| Adverse event rate | Incidence and severity of adverse events (AE) and serious adverse events (SAE), physical examination, vital signs, 12-lead electrocardiogram (ECG), and abnormal laboratory indicators. | Baseline up to 12 weeks |
| Beijing |
| Beijing Municipality |
| 100044 |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| Gansu Provincial Hospital | Lanzhou | Gansu | 730000 | China |
| Cangzhou Central Hospital | Cangzhou | Hebei | 061017 | China |
| Hebei Medical University Third Hospital | Shijiazhuang | Hebei | 50000 | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450000 | China |
| The Central Hospital of Wuhan | Wuhan | Hubei | 430014 | China |
| Union Hospital, Tongji Medical College, Huazhong University of science and technology | Wuhan | Hubei | 430022 | China |
| Tongji Hospital of Tongji medical college of HUST | Wuhan | Hubei | 430030 | China |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430071 | China |
| Baotou Central Hospital | Baotou | Inner Mongolia | 014000 | China |
| Chifeng Municipal Hospital | Chifeng | Inner Mongolia | 024005 | China |
| The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | 015000 | China |
| Ansteel Group General hospital | Anshan | Liaoning | 114000 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
| Liaoning Health Industry Group Iron Coal General Hospital | Tieling | Liaoning | 112700 | China |
| The First People's Hospital of Yinchuan | Yinchuan | Ningxia | 750000 | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710004 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| Shandong Second Provincial General Hospital | Jinan | Shandong | 250000 | China |
| Qilu Hospital of Shandong University | Qilu | Shandong | 250012 | China |
| Yantai Yuhuangding Hospital | Yantai | Shandong | 264000 | China |
| Zibo Central Hospital | Zibo | Shandong | 255036 | China |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | 030000 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300041 | China |
| Tianjin People's Hospital | Tianjin | Tianjin Municipality | 300121 | China |
| Tianjin First Central Hospital | Tianjin | Tianjin Municipality | 300192 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830054 | 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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