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This study is a multicenter, open-label, Phase II, single-arm clinical trial, with a planned enrollment of 200 to 300 subjects. Its primary objective is to evaluate the safety and efficacy of TQH2722 injection in the treatment of seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQH2722 injection | Experimental | Injection combined with TQH2722, 2 weeks as a treatment cycle. |
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| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with incidence of adverse event | Adverse events occurring during treatment. | Baseline up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with incidence of serious adverse event | Serious adverse event occurring during treatment. | Baseline up to 4 weeks |
| Number of subjects with incidence of abnormality check indicators |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng Liu, Doctor | Contact | 18607110505 | zhengliuent@hotmail.com | |
| Rongfei Zhu, Doctor | Contact | 18986292602 | zrf13092@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100034 | China |
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Number of subjects with incidence of abnormality check indicators: Abnormal examination indicators occurred during treatment.
| Baseline up to 4 weeks |
| Retrospective nasal symptom score after treatment for 2 weeks | The average change in the retrospective total nasal symptom score (rTNSS) per day over 2 weeks of treatment compared to baseline. The total score is 0-12 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 weeks |
| Retrospective nasal symptom score after treatment for 4 weeks | The average change in the retrospective total nasal symptom score (rTNSS) per day over 4 weeks of treatment compared to baseline. The total score is 0-12 points, with the higher score meaning the more severe symptoms. | Baseline up to 4 weeks |
| Mean daily morning retrospective total nasal symptom score | Mean change from baseline in the morning retrospective total nasal symptom score (AM rTNSS) 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 |
| Mean daily retrospective total nasal symptom score at night | Mean change from baseline in the Post-Medication Reviewed Total Nasal Symptom Score (PMrTNSS) at night per day 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 |
| Total instantaneous nasal symptom score before medication in the morning every day | Mean change from baseline in instantaneous total nasal symptom score (iTNSS) before medication administration in the morning, for each day during the 2-week and 4-week treatment periods. The total score is 0-12 points, with the higher score meaning the more severe symptoms. | Baseline up to 2 and 4 weeks |
| Daily retrospective total nasal symptom score | Mean percentage change from baseline in daily rTNSS at 2 weeks and 4 weeks of treatment. | Baseline up to 2 and 4 weeks |
| Total instantaneous nasal symptom score before medication in the morning every day | Mean percentage change from baseline in iTNSS before medication administration in the morning, for each day during the 2-week and 4-week treatment periods. | Baseline up to 2 and 4 weeks |
| Daily retrospective scoring of individual nasal symptoms | Mean change from baseline in daily retrospective nasal single symptom scores at 2 weeks and 4 weeks of treatment. | Baseline up to 2 and 4 weeks |
| Daily retrospective nasal single symptom score during daytime | Mean change from baseline in retrospective daytime (AM) nasal individual symptom scores (rhinorrhea, nasal congestion, nasal itch, and sneezing) at 2 weeks and 4 weeks of treatment. | Baseline up to 2 and 4 weeks |
| Daily retrospective nasal single symptom score during night | Mean change from baseline in retrospective nasal individual symptom (rhinorrhea, nasal congestion, nasal itch, and sneezing) scores at night (PM) at 2 weeks and 4 weeks of treatment. | Baseline up to 2 and 4 weeks |
| Daily retrospective total score of ocular symptoms | Mean change from baseline in the retrospective Total Ocular Symptom Score (rTOSS) at 2 weeks or 4 weeks of treatment. | Baseline up to 2 and 4 weeks |
| Total score of retrospective ocular symptoms during daytime each day | Mean change from baseline in the total daytime retrospective ocular symptom score (AM rTOSS) at 2 weeks and 4 weeks of treatment. | Baseline up to 2 and 4 weeks |
| Total score of retrospective ocular symptoms each night | The average change in the retrospective total ocular symptom score (PM rTOSS) at night compared to baseline after 2 weeks and 4 weeks of treatment. | Baseline up to 2 and 4 weeks |
| Total score of instantaneous ocular symptoms before medication in the morning every day | Mean change from baseline in instantaneous total ocular symptom score (iTOSS) before medication administration in the morning, at 2 weeks and 4 weeks of treatment. | Baseline up to 2 and 4 weeks |
| Daily retrospective total score of ocular symptoms | Mean percentage change in total retrospective ocular symptom score from baseline at 2 weeks and 4 weeks of treatment, respectively. | Baseline up to 2 and 4 weeks |
| Total score of instantaneous ocular symptoms before medication each morning | Mean percentage change from baseline in total ocular symptom score immediately before medication administration in the morning, for the 2-week and 4-week treatment periods. | Baseline up to 2 and 4 weeks |
| Daily retrospective scoring of individual ocular symptoms | Mean change in individual ocular symptom scores from baseline to 2 weeks and 4 weeks after treatment, retrospectively assessed daily. | Baseline up to 2 and 4 weeks |
| Daily retrospective scoring of individual ocular symptoms during the day | Mean change from baseline in retrospective ocular symptom scores during daytime (AM) on each day at 2 weeks and 4 weeks of treatment. | Baseline up to 2 and 4 weeks |
| Nightly retrospective scoring of individual ocular symptoms | Mean change from baseline in retrospective ocular symptom scores at night (PM) at 2 weeks and 4 weeks of treatment | Baseline up to 2 and 4 weeks |
| Quality of Life Questionnaire Score for Patients with Allergic Rhinitis | The change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores from baseline for patients with allergic rhinitis after 2 weeks and 4 weeks of treatment. | Baseline up to 2 and 4 weeks |
| Daily retrospective total score of nasal symptoms | The area under the curve representing the average change in the retrospective total nasal symptom score (rTNSS) from baseline, calculated for each day during the 2-week and 4-week treatment periods. | Baseline up to 2 and 4 weeks |
| Blood eosinophil count and percentage | Changes in eosinophil count and percentage from baseline, as well as the percentage of change, at each evaluation visit point. | Baseline up 12 weeks |
| Serum total immunoglobulin E concentration | The changes in serum total immunoglobulin E concentration and the percentage of change from baseline at each evaluation visit point. | Baseline up 12 weeks |
| Forced expiratory volume in 1 second (FEV1) before bronchodilator administration (BD) in subjects with concomitant asthma | The change in forced expiratory volume in one second (FEV1) relative to baseline before the use of bronchodilator (BD) in subjects with asthma across all visit points. | Baseline up 12 week |
| Peking University People's Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100044 | China |
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| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400010 | China |
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| Hebei University Affiliated Hospital | Not yet recruiting | Baoding | Hebei | 071000 | China |
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| Cangzhou Central Hospital | Not yet recruiting | Cangzhou | Hebei | 061017 | China |
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| Hebei PetroChina Central Hospital | Not yet recruiting | Langfang | Hebei | 65000 | China |
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| Hebei Provincial People's Hospital | Not yet recruiting | Shijiazhuang | Hebei | 050051 | China |
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| Hebei Medical University Third Hospital | Not yet recruiting | Shijiazhuang | Hebei | 50000 | China |
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| The First Affiliated Hospital of Hebei North University | Not yet recruiting | Zhangjiakou | Hebei | 075000 | China |
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| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
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| The Central Hospital of Wuhan | Not yet recruiting | Wuhan | Hubei | 430014 | China |
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| Union Hospital, Tongji Medical College, Huazhong University of science and technology | Not yet recruiting | Wuhan | Hubei | 430022 | China |
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| Tongji Hospital of Tongji medical college of HUST | Not yet recruiting | Wuhan | Hubei | 430030 | China |
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| Zhongnan Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430060 | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710004 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710061 | China |
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| Yan'an University Xianyang Hospital | Not yet recruiting | Xi'an | Shaanxi | 716000 | China |
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| Shandong Second Provincial General Hospital | Not yet recruiting | Jinan | Shandong | 250000 | China |
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| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | 250012 | China |
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| Yantai Yuhuangding Hospital | Not yet recruiting | Yantai | Shandong | 264000 | China |
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| Zibo Central Hospital | Not yet recruiting | Zibo | Shandong | 255036 | China |
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| Shanxi Bethune Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
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| Hospital of Chengdu University of Traditional Chinese Medicine | Not yet recruiting | Chengdu | Sichuan | 610000 | China |
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| Second People's Hospital of Chengdu | Not yet recruiting | Chengdu | Sichuan | 610000 | China |
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| Tianjin People's Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300121 | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | China |
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| The First Affiliated Hospital of Kunming Medical University | Not yet recruiting | Kunming | Yunnan | 650032 | China |
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| Yunnan Provincial Hospital of Chinese Medicine | Not yet recruiting | Kunming | Yunnan | 650032 | China |
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| Zhejiang Provincial People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310014 | 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 |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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