Phase II Study of JT002 in the Treatment of Seasonal Allergic Rhinitis in Adults

Last updated: March 16, 2025
Sponsor: Shanghai JunTop Biosciences Co., LTD
Overall Status: Active - Recruiting

Phase

2

Condition

Common Cold

Allergy

Rhinitis, Allergic, Perennial

Treatment

Placebo

JT002 Nasal spray

Clinical Study ID

NCT06861101
JT002-001-II-SAR
  • Ages 18-75
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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.

  2. Male and female patients aged 18 to 75 years on screening day (inclusive of thecutoff value).

  3. 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).

  4. The environment of seasonal allergy exposure for the patient does not change duringthe study.

  5. Total score of reflective nasal symptoms on screening day (rTNSS) ≥ 6 points (maximal score 12 points), and nasal congestion ≥ 2 points.

  6. 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:

  1. Pregnant or lactating women.

  2. 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.

  3. 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.

  4. 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.

  5. Patients with rhinitis who have previously demonstrated an inability to toleratenasal drops.

  6. Patients with perennial allergic rhinitis, unless the investigator evaluates thatthe patient's current symptoms and signs are caused by obvious exacerbation ofseasonal allergic rhinitis.

  7. Nasal disorders that may affect drug absorption are found on nasal examination onscreening day, such as nasal mucosal erosion, nasal mucosal ulcer, sinusitis,rhinitis.

  8. Medicamentosa, nasal polyps or abnormal nasal cavity structure, nasal trauma (suchas nasal puncture), or septal deviation or nasal septum perforation.

  9. Patients who have received nasal operation within 3 months prior to screening orhave incompletely healed nasal trauma.

  10. 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).

  11. 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.

  12. Patients with eye infections, e.g., ocular herpes simplex, Conjunctivitis infective (except Conjunctivitis associated with seasonal allergic rhinitis).

  13. 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.

  14. History (at present) of immunodeficiency infection (e.g., Pneumocystis jiroveciipneumonia, Histoplasmosis, Coccidioidomycosis); or other known Immunodeficiency.

  15. 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.

  16. Major surgery within 8 weeks prior to screening.

  17. Uncontrolled hypertension (Blood pressure systolic ≥160 mm Hg and/or Blood pressurediastolic ≥100 mm Hg, determined by two consecutive raised blood pressure readings).

  18. 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.

  19. 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.

  20. Use of prohibited medications listed in Table 2 without meeting the washoutrequirements in Table 2.

  21. 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.).

  22. 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).

  23. 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).

  24. Use of traditional Chinese medicine therapy for treatment of seasonal allergicrhinitis within 4 weeks prior to the screening.

Study Design

Total Participants: 320
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 03, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Beijing Youan Hospital Capital Medical University

    Beijing, Beijing 100069
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350004
    China

    Site Not Available

  • Wuwei People's Hospital

    Wuwei, Gansu 733000
    China

    Active - Recruiting

  • Shenzhen University General Hospital

    Shenzhen, Guang Dong 518000
    China

    Active - Recruiting

  • Shenzhen Nanshan District People's Hospital

    Shenzhen, Guangdong 518000
    China

    Active - Recruiting

  • Zhengzhou Central Hospital

    Zhengzhou, Hanan 450000
    China

    Active - Recruiting

  • The Second Hospital of Baoding City

    Baoding, Hebei 200131
    China

    Active - Recruiting

  • Cangzhou Central Hosptial

    Cangzhou, Hebei 061014
    China

    Active - Recruiting

  • Hebei Retro China Central Hosptial

    Hebei, Hebei 065000
    China

    Active - Recruiting

  • Hebei Provincial Hospital of Traditional Chinese Medicine

    Shijiazhuang, Hebei 050000
    China

    Active - Recruiting

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050051
    China

    Active - Recruiting

  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei 075061
    China

    Site Not Available

  • The People's Hospital of daqing

    Daqing, Heilongjiang 150081
    China

    Site Not Available

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Active - Recruiting

  • Jingzhou Central Hospital (Jingzhou Hospital affiliated to Yangtze University)

    Jingzhou, Hubei 434000
    China

    Active - Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei 430060
    China

    Site Not Available

  • Wuhan Central Hospital

    Wuhan, Hubei 430014
    China

    Active - Recruiting

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia Autonomous Region 010030
    China

    Site Not Available

  • BaogangHospital of InnerMongolia

    Baotou, InnerMongolia 014010
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Tonghua Central Hospital

    Tonghua, Jilin 134001
    China

    Active - Recruiting

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • Liaoning Provincial Health Industry Group Iron Coal General Hospital

    Tieling, Liaoning 112700
    China

    Active - Recruiting

  • Chifeng municipal hospital

    Chifeng, Mongolia 024099
    China

    Site Not Available

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia Hui Autonomous Region 750000
    China

    Active - Recruiting

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia Hui Autonomous Region 750000
    China

    Active - Recruiting

  • Zibo central hospital

    Zibo, Shandong 255000
    China

    Active - Recruiting

  • Eye&Ent Hospital of fudan University

    Shanghai, Shanghai 200031
    China

    Active - Recruiting

  • Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center

    Shanghai, Shanghai 201399
    China

    Site Not Available

  • Heping hospital affiliated to Changzhi medical college

    Changzhi, Shanxi 046000
    China

    Active - Recruiting

  • First Hospital Of Shanxi Medical University

    Taiyuan, Shanxi 030012
    China

    Site Not Available

  • Second hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Site Not Available

  • Shanxi Bethune hospital

    Taiyuan, Shanxi 030032
    China

    Site Not Available

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, Shanxi 710000
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, Shanxi 710000
    China

    Site Not Available

  • Xi'an DaXing Hospital

    Xi'an, Shanxi 710016
    China

    Active - Recruiting

  • Xi'an High tech Hospital

    Xi'an, Shanxi 710075
    China

    Site Not Available

  • Yuncheng Central Hospital

    Yuncheng, Shanxi 044000
    China

    Active - Recruiting

  • Panzhihua Hospital of Integrated Traditional Chinese and Western Medicine

    Panzhihua, Sichuan 617000
    China

    Active - Recruiting

  • Tianjin People's Hospital

    Tianjin, Tianjin 300121
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinjiang Medical Universit

    Ürümqi, Xinjiang 830054
    China

    Site Not Available

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