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The study included three phases: the treatment introduction period (4-7 days before randomization), the treatment period (14 days after randomization) and the follow-up period (7 days after the last dose). Eligible participants in this study entered the 4-7 day treatment introduction period. After completing the treatment introduction period, patients who did not meet the random exclusion criteria of this study were randomly assigned to one of the 4 dose cohorts in a 1:1:1:1 ratio, with 80 patients planned to be enrolled in each cohort, and then randomly assigned to receive the investigational product or placebo in the cohort at a 4:1 ratio, for a total of 320 patients. Participants were stratified by prior Drug therapy for Rhinitis allergic. Ultimately, the proportion of patients receiving 200 μg BID, 400 μg BID, 400 μg QD, 800 μg QD and placebo was 1:1:1:1:1 (64 patients in each group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JT002 | Experimental | 200 μg BID, 400 μg BID, 400 μg QD, 800 μg QD |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JT002 Nasal spray | Drug | 200 μg BID, 400 μg BID, 400 μg QD, 800 μg QD, 64 patients per cohort, total 256 patients for treatment 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| rTNSS | Change from baseline in mean (AM+PM) rTNSS (reactive nasal symptom total score) | During the 14-day treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| iTNSS | Change from baseline in mean (AM+PM) ITNSS | During the 14-day treatment period |
| rTOSS | Change from baseline in the mean (AM+PM) rTOSS (reactive eye symptom total score) |
| Measure | Description | Time Frame |
|---|---|---|
| PD(IgE) | To evaluate the change in peripheral blood IgE level after treatment with JT002 in patients with Seasonal allergic rhinitis | Through study completion,Estimated 22 days |
| PD(IFN-α) | To evaluate the changes in IFN-α in the lavage fluid of subjects with seasonal allergic rhinitis after JT002 treatment and the cellular classification |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Youan Hospital Capital Medical University | Beijing | Beijing Municipality | 100069 | China | ||
| Peking University Third Hospital |
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the proportion of patients receiving 200 μg BID, 400 μg BID, 400 μg QD, 800 μg QD and placebo was 1:1:1:1:1
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| Placebo | Drug | Total 64 patients for treatment 14 days |
|
| During the 14-day treatment period |
| iTOSS | Change from baseline in iTOSS mean (mean of AM and PM) | During the 14-day treatment period |
| AM rTNSS | Change from baseline in AM rTNSS | During the 14-day treatment period |
| AM iTNSS | Change from baseline in AM iTNSS | During the 14-day treatment period |
| PM rTNSS | Change from baseline in PM rTNSS | During the 14-day treatment period |
| PM iTNSS | Change from baseline in PM iTNSS | During the 14-day treatment period |
| AM rTOSS | Change from baseline in AM rTOSS | During the 14-day treatment period |
| AM iTOSS | Change from baseline in AM iTOSS | During the 14-day treatment period |
| PM rTOSS | Change from baseline in PM rTOSS | During the 14-day treatment period |
| PM iTOSS | Change from baseline in PM iTOSS | During the 14-day treatment period |
| Single nasal symptom | Change from baseline in mean value of responsive single nasal symptom (sneezing, Runny nose, nasal itching and nasal congestion) AM and PM | During the 14-day treatment period |
| Single-eye symptoms | Change from baseline in mean reactive single-eye symptoms (itchy/burning eyes, red eyes, tearing)AM and PM | During the 14-day treatment period |
| iTNSS | Evaluation 15 ± 5 min, 30 ± 5 min, 45 ± 5 min, 60 ± 5 min, 90 ± 10 min, 2 h ± 10 min, 4 h ± 0.5 h after the first dose, Change from baseline at 8 ± 0.5 h and 12 ± 0.5 h | Within 12 hours of the first dose |
| RQLQ | Change from baseline in scores on the RQLQ | Day 8 and Day 15 after first dose |
| Safety (Adverse Events) | To evaluate the Adverse Events of JT002 in participants with seasonal allergic rhinitis | Through study completion,Estimated 28 days |
| PK | According to the test of blood samples, Drug concentrations in individual subjects at different time points after dosing | Through study completion,Estimated 22 days |
| Immunogenicity | According to the test of blood samples,to evaluate the incidence and titer of anti-drug antibody (ADA) of JT002 | Through study completion,Estimated 22 days |
| Immunogenicity(Nab) | To analyze ADA-positive blood samples for the presence of Neutralizing antibodies (Nab). | Through study completion,Estimated 22 days |
| Through study completion,Estimated 22 days |
| PD( CXCL10) | To evaluate the changes in CXCL10 in the lavage fluid of subjects with seasonal allergic rhinitis after JT002 treatment and the cellular classification | Through study completion,Estimated 22 days |
| Beijing |
| Beijing Municipality |
| 100191 |
| China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350004 | China |
| Wuwei People's Hospital | Wuwei | Gansu | 733000 | China |
| Shenzhen Nanshan District People's Hospital | Shenzhen | Guangdong | 518000 | China |
| Shenzhen University General Hospital | Shenzhen | Guangdong | 518000 | China |
| Zhengzhou Central Hospital | Zhengzhou | Hanan | 450000 | China |
| The Second Hospital of Baoding City | Baoding | Hebei | 200131 | China |
| Cangzhou Central Hosptial | Cangzhou | Hebei | 061014 | China |
| Hebei Retro China Central Hosptial | Hebei | Hebei | 065000 | China |
| Hebei Provincial Hospital of Traditional Chinese Medicine | Shijiazhuang | Hebei | 050000 | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050051 | China |
| The First Affiliated Hospital of Hebei North University | Zhangjiakou | Hebei | 075061 | China |
| The People's Hospital of daqing | Daqing | Heilongjiang | 150081 | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| Jingzhou Central Hospital (Jingzhou Hospital affiliated to Yangtze University) | Jingzhou | Hubei | 434000 | China |
| Wuhan Central Hospital | Wuhan | Hubei | 430014 | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | 010030 | China |
| BaogangHospital of InnerMongolia | Baotou | InnerMongolia | 014010 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 200000 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| Shengjing Hospital Affiliated to China Medical University | Shenyang | Liaoning | 110000 | China |
| Liaoning Provincial Health Industry Group Iron Coal General Hospital | Tieling | Liaoning | 112700 | China |
| Chifeng municipal hospital | Chifeng | Mongolia | 024099 | China |
| People's Hospital of Ningxia Hui Autonomous Region | Yinchuan | Ningxia | 750000 | China |
| The First People's Hospital of Yinchuan | Yinchuan | Ningxia | 750000 | China |
| Zibo central hospital | Zibo | Shandong | 255000 | China |
| Eye&Ent Hospital of fudan University | Shanghai | Shanghai Municipality | 200031 | China |
| Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center | Shanghai | Shanghai Municipality | 201399 | China |
| Heping hospital affiliated to Changzhi medical college | Changzhi | Shanxi | 046000 | China |
| Second hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| First Hospital Of Shanxi Medical University | Taiyuan | Shanxi | 030012 | China |
| Shanxi Bethune hospital | Taiyuan | Shanxi | 030032 | China |
| The First Affiliated Hospital of Xi 'an Jiaotong University | Xi’an | Shanxi | 710000 | China |
| The Second Affiliated Hospital of Xi 'an Jiaotong University | Xi’an | Shanxi | 710000 | China |
| Xi'an DaXing Hospital | Xi’an | Shanxi | 710016 | China |
| Xi'an High tech Hospital | Xi’an | Shanxi | 710075 | China |
| Yuncheng Central Hospital | Yuncheng | Shanxi | 044000 | China |
| Panzhihua Hospital of Integrated Traditional Chinese and Western Medicine | Panzhihua | Sichuan | 617000 | China |
| Tianjin People's Hospital | Tianjin | Tianjin Municipality | 300121 | China |
| The First Affiliated Hospital of Xinjiang Medical Universit | Ürümqi | Xinjiang | 830054 | 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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