Phase
Condition
Common Cold
Allergy
Rhinitis, Allergic, Perennial
Treatment
Placebo
JT002 Nasal spray
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The participant voluntarily signed the informed consent form before the start of anystudy-related procedures, was able to communicate smoothly with the investigator,was able to correctly use the device for the study drug, understood and was willingto strictly comply with this clinical study protocol, study procedures, visitschedule, treatment plan, Laboratory test and other study requirements specified inthe protocol.
Male and female patients aged 18 to 75 years on screening day (inclusive of thecutoff value).
Patients with seasonal allergic rhinitis, confirmed prior history for ≥ 1 year (including the main complaints) at screening, based on the diagnosis criteriareferred to the 2022 Revised Edition of the Guidelines for Diagnosis and Treatmentof Allergic Rhinitis in China published by the Chinese Medical Association Head andNeck Surgery Branch of Otolaryngology Head and Neck Surgery, confirmed positiveresults for one or more seasonal allergens in allergen tests (e.g., pollen, fungi,etc.), positive results in skin prick test or serum specific Immunoglobulins (IgE)for any allergen, positive nasal challenge test (acceptable results within the past 12 months).
The environment of seasonal allergy exposure for the patient does not change duringthe study.
Total score of reflective nasal symptoms on screening day (rTNSS) ≥ 6 points (maximal score 12 points), and nasal congestion ≥ 2 points.
Female participants of childbearing potential must be willing to use highlyeffective contraceptive methods during the study period until 1 month after the lastdose of the study drug and have a Pregnancy test negative at screening and prior torandomization. Women who are not of childbearing potential are defined as women whohave reached menopausal status (natural cessation of menstruation for ≥ 12 monthsand no other medical reasons); women who have undergone permanent sterilization (e.g., Salpingectomy, Bilateral oophorectomy, Hysterectomy); or women who haveCongenital or acquired conditions that lead to infertility (e.g., Uterinehypoplasia, Turner's syndrome, Ovarian failure, as confirmed by gynecologicalexperts). Male participants and female participants of childbearing potential mustbe willing to use highly effective contraceptive methods during the study perioduntil 1 month after the last dose of the study drug and not donate sperm/eggs duringthe study period until 1 month after the last dose of the study drug.
Exclusion
Exclusion Criteria:
Pregnant or lactating women.
History of excessive smoking, alcoholism or Drug of Abuse within 6 months prior toscreening. Alcoholism is defined as alcohol consumption of more than 14 units perweek (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcoholcontent or 150 mL of wine); excessive smoking is defined as current average dailysmoking of more than 10 cigarettes.
In the opinion of the investigator, any other situation that may interfere with theparticipant's compliance and completion of the protocol, or affect the efficacy andsafety evaluation of the study drug.
Prior use of JT002 or a history of drug allergy to any study drug component isknown. Drug allergy or hypersensitivity to immunosuppression/immunomodulators atscreening will result in an unacceptable risk to participants if they participate inthis study.
Patients with rhinitis who have previously demonstrated an inability to toleratenasal drops.
Patients with perennial allergic rhinitis, unless the investigator evaluates thatthe patient's current symptoms and signs are caused by obvious exacerbation ofseasonal allergic rhinitis.
Nasal disorders that may affect drug absorption are found on nasal examination onscreening day, such as nasal mucosal erosion, nasal mucosal ulcer, sinusitis,rhinitis.
Medicamentosa, nasal polyps or abnormal nasal cavity structure, nasal trauma (suchas nasal puncture), or septal deviation or nasal septum perforation.
Patients who have received nasal operation within 3 months prior to screening orhave incompletely healed nasal trauma.
Active respiratory tract infection (including but not limited to Bronchitis,pneumonia or influenza, upper respiratory tract infection or Sinus infection) within 14 days prior to screening, or patients who may develop upper respiratory tractinfection during the treatment run-in period. Occasional acute asthma or patientswith mild exercise-induced asthma are acceptable, provided that the treatment islimited to inhaled short-acting β-agonists (maximum 8 times per day).
Have a serious history of systemic infection or require hospitalization and/orintravenous anti-infective therapy (e.g., antibiotics, antifungal agents, antiviralagents) for ≥3 days within 12 weeks prior to screening.
Patients with eye infections, e.g., ocular herpes simplex, Conjunctivitis infective (except Conjunctivitis associated with seasonal allergic rhinitis).
Participants who plan to travel to areas outside their permanent residence (i.e.,leaving the area of seasonal allergy exposure) for more than 2 consecutive days ormore than 3 cumulative days (not consecutive) during the study period.
History (at present) of immunodeficiency infection (e.g., Pneumocystis jiroveciipneumonia, Histoplasmosis, Coccidioidomycosis); or other known Immunodeficiency.
History of lymphoid proliferative disease (current); or signs or symptoms oflymphoid proliferative disorder or any known neoplasm malignant, or history of orcurrent neoplasm malignant (except completely resected and without evidence ofrecurrence squamous cell carcinoma of skin or basal cell carcinoma or cervixcarcinoma in situ) within 5 years prior to screening.
Major surgery within 8 weeks prior to screening.
Uncontrolled hypertension (Blood pressure systolic ≥160 mm Hg and/or Blood pressurediastolic ≥100 mm Hg, determined by two consecutive raised blood pressure readings).
Other significant uncontrolled cardiovascular diseases at screening (e.g., infarctmyocardial [MI], Angina unstable, moderate to severe [New York Heart Association (NYHA) III/IV grade] cardiac failure or cerebrovascular accident [CVA]),respiratory.
Hepatic, renal, gastrointestinal, endocrine, hematological, psychological, orneurological disorders, or any of the following (including but not limited to thefollowing) as determined by the investigator are not suitable for participation inthis study.
Use of prohibited medications listed in Table 2 without meeting the washoutrequirements in Table 2.
Concomitant medications that may affect the evaluation of efficacy of theinvestigational product after long-term use (including but not limited to: tricyclicantidepressants, monoamine Coproporphyrinogen Enzyme inhibition, etc.).
Use of immunotherapeutic agent or immunosuppressive/immunomodulatory drug within 60days prior to screening (acceptable if topical use of pimecrolimus cream ortacrolimus within 30 days prior to screening and stable dose is maintained duringthe study).
Use of >1% Hydrocortisone or equivalent topical glucocorticoid within 30 days priorto screening; use of topical Hydrocortisone or equivalent at any concentrationcovering >20% of Body surface area; or presence of a condition that may requiretreatment with such preparations during the clinical study (as judged by theinvestigator).
Use of traditional Chinese medicine therapy for treatment of seasonal allergicrhinitis within 4 weeks prior to the screening.
Study Design
Connect with a study center
Beijing Youan Hospital Capital Medical University
Beijing, Beijing 100069
ChinaSite Not Available
Peking University Third Hospital
Beijing, Beijing 100191
ChinaActive - Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaActive - Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian 350004
ChinaSite Not Available
Wuwei People's Hospital
Wuwei, Gansu 733000
ChinaActive - Recruiting
Shenzhen University General Hospital
Shenzhen, Guang Dong 518000
ChinaActive - Recruiting
Shenzhen Nanshan District People's Hospital
Shenzhen, Guangdong 518000
ChinaActive - Recruiting
Zhengzhou Central Hospital
Zhengzhou, Hanan 450000
ChinaActive - Recruiting
The Second Hospital of Baoding City
Baoding, Hebei 200131
ChinaActive - Recruiting
Cangzhou Central Hosptial
Cangzhou, Hebei 061014
ChinaActive - Recruiting
Hebei Retro China Central Hosptial
Hebei, Hebei 065000
ChinaActive - Recruiting
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei 050000
ChinaActive - Recruiting
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei 050051
ChinaActive - Recruiting
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei 075061
ChinaSite Not Available
The People's Hospital of daqing
Daqing, Heilongjiang 150081
ChinaSite Not Available
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150001
ChinaActive - Recruiting
Jingzhou Central Hospital (Jingzhou Hospital affiliated to Yangtze University)
Jingzhou, Hubei 434000
ChinaActive - Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei 430060
ChinaSite Not Available
Wuhan Central Hospital
Wuhan, Hubei 430014
ChinaActive - Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia Autonomous Region 010030
ChinaSite Not Available
BaogangHospital of InnerMongolia
Baotou, InnerMongolia 014010
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006
ChinaSite Not Available
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006
ChinaSite Not Available
Tonghua Central Hospital
Tonghua, Jilin 134001
ChinaActive - Recruiting
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning 110000
ChinaSite Not Available
Liaoning Provincial Health Industry Group Iron Coal General Hospital
Tieling, Liaoning 112700
ChinaActive - Recruiting
Chifeng municipal hospital
Chifeng, Mongolia 024099
ChinaSite Not Available
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia Hui Autonomous Region 750000
ChinaActive - Recruiting
The First People's Hospital of Yinchuan
Yinchuan, Ningxia Hui Autonomous Region 750000
ChinaActive - Recruiting
Zibo central hospital
Zibo, Shandong 255000
ChinaActive - Recruiting
Eye&Ent Hospital of fudan University
Shanghai, Shanghai 200031
ChinaActive - Recruiting
Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
Shanghai, Shanghai 201399
ChinaSite Not Available
Heping hospital affiliated to Changzhi medical college
Changzhi, Shanxi 046000
ChinaActive - Recruiting
First Hospital Of Shanxi Medical University
Taiyuan, Shanxi 030012
ChinaSite Not Available
Second hospital of Shanxi Medical University
Taiyuan, Shanxi 030001
ChinaSite Not Available
Shanxi Bethune hospital
Taiyuan, Shanxi 030032
ChinaSite Not Available
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shanxi 710000
ChinaSite Not Available
The Second Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shanxi 710000
ChinaSite Not Available
Xi'an DaXing Hospital
Xi'an, Shanxi 710016
ChinaActive - Recruiting
Xi'an High tech Hospital
Xi'an, Shanxi 710075
ChinaSite Not Available
Yuncheng Central Hospital
Yuncheng, Shanxi 044000
ChinaActive - Recruiting
Panzhihua Hospital of Integrated Traditional Chinese and Western Medicine
Panzhihua, Sichuan 617000
ChinaActive - Recruiting
Tianjin People's Hospital
Tianjin, Tianjin 300121
ChinaActive - Recruiting
The First Affiliated Hospital of Xinjiang Medical Universit
Ürümqi, Xinjiang 830054
ChinaSite Not Available
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