Clinical trial NCT06861101: Phase II Study of JT002 in the Treatment of Seasonal Allergic Rhinitis in Adults
Official title: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JT002 in Adult Patients With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Shanghai JunTop Biosciences Co., LTD
Sponsor class: INDUSTRY
First posted: 2025-03-06
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

Brief 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 Criteria:

1. The participant voluntarily signed the informed consent form before the start of any study-related procedures, was able to communicate smoothly with the investigator, was able to correctly use the device for the study drug, understood and was willing to strictly comply with this clinical study protocol, study procedures, visit schedule, treatment plan, Laboratory test and other study requirements specified in the protocol.
2. Male and female patients aged 18 to 75 years on screening day (inclusive of the cutoff value).
3. Patients with seasonal allergic rhinitis, confirmed prior history for ≥ 1 year (including the main complaints) at screening, based on the diagnosis criteria referred to the 2022 Revised Edition of the Guidelines for Diagnosis and Treatment of Allergic Rhinitis in China published by the Chinese Medical Association Head and Neck Surgery Branch of Otolaryngology Head and Neck Surgery, confirmed positive results 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 during the 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 highly effective contraceptive methods during the study period until 1 month after the last dose of the study drug and have a Pregnancy test negative at screening and prior to randomization. Women who are not of childbearing potential are defined as women who have reached menopausal status (natural cessation of menstruation for ≥ 12 months and no other medical reasons); women who have undergone permanent sterilization (e.g., Salpingectomy, Bilateral oophorectomy, Hysterectomy); or women who have Congenital or acquired conditions that lead to infertility (e.g., Uterine hypoplasia, Turner's syndrome, Ovarian failure, as confirmed by gynecological experts). Male participants and female participants of childbearing potential must be willing to use highly effective contraceptive methods during the study period until 1 month after the last dose of the study drug and not donate sperm/eggs during the study period until 1 month after the last dose of the study drug.

Exclusion Criteria:

1. Pregnant or lactating women.
2. History of excessive smoking, alcoholism or Drug of Abuse within 6 months prior to screening. Alcoholism is defined as alcohol consumption of more than 14 units per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine); excessive smoking is defined as current average daily smoking of more than 10 cigarettes.
3. In the opinion of the investigator, any other situation that may interfere with the participant's compliance and completion of the protocol, or affect the efficacy and safety evaluation of the study drug.
4. Prior use of JT002 or a history of drug allergy to any study drug component is known. Drug allergy or hypersensitivity to immunosuppression/immunomodulators at screening will result in an unacceptable risk to participants if they participate in this study.
5. Patients with rhinitis who have previously demonstrated an inability to tolerate nasal drops.
6. Patients with perennial allergic rhinitis, unless the investigator evaluates that the patient's current symptoms and signs are caused by obvious exacerbation of seasonal allergic rhinitis.
7. Nasal disorders that may affect drug absorption are found on nasal examination on screening day, such as nasal mucosal erosion, nasal mucosal ulcer, sinusitis, rhinitis.
8. Medicamentosa, nasal polyps or abnormal nasal cavity structure, nasal trauma (such as nasal puncture), or septal deviation or nasal septum perforation.
9. Patients who have received nasal operation within 3 months prior to screening or have 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 tract infection during the treatment run-in period. Occasional acute asthma or patients with mild exercise-induced asthma are acceptable, provided that the treatment is limited to inhaled short-acting β-agonists (maximum 8 times per day).
11. Have a serious history of systemic infection or require hospitalization and/or intravenous anti-infective therapy (e.g., antibiotics, antifungal agents, antiviral agents) 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 or more than 3 cumulative days (not consecutive) during the study period.
14. History (at present) of immunodeficiency infection (e.g., Pneumocystis jirovecii pneumonia, Histoplasmosis, Coccidioidomycosis); or other known Immunodeficiency.
15. History of lymphoid proliferative disease (current); or signs or symptoms of lymphoid proliferative disorder or any known neoplasm malignant, or history of or current neoplasm malignant (except completely resected and without evidence of recurrence squamous cell carcinoma of skin or basal cell carcinoma or cervix carcinoma 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 pressure diastolic ≥100 mm Hg, determined by two consecutive raised blood pressure readings).
18. Other significant uncontrolled cardiovascular diseases at screening (e.g., infarct myocardial \[MI\], 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, or neurological disorders, or any of the following (including but not limited to the following) as determined by the investigator are not suitable for participation in this study.
20. Use of prohibited medications listed in Table 2 without meeting the washout requirements in Table 2.
21. Concomitant medications that may affect the evaluation of efficacy of the investigational product after long-term use (including but not limited to: tricyclic antidepressants, monoamine Coproporphyrinogen Enzyme inhibition, etc.).
22. Use of immunotherapeutic agent or immunosuppressive/immunomodulatory drug within 60 days prior to screening (acceptable if topical use of pimecrolimus cream or tacrolimus within 30 days prior to screening and stable dose is maintained during the study).
23. Use of \>1% Hydrocortisone or equivalent topical glucocorticoid within 30 days prior to screening; use of topical Hydrocortisone or equivalent at any concentration covering \>20% of Body surface area; or presence of a condition that may require treatment with such preparations during the clinical study (as judged by the investigator).
24. Use of traditional Chinese medicine therapy for treatment of seasonal allergic rhinitis within 4 weeks prior to the screening.

Primary outcomes:
measure: rTNSS
timeFrame: During the 14-day treatment period
Secondary outcomes:
measure: iTNSS
timeFrame: During the 14-day treatment period
measure: rTOSS
timeFrame: During the 14-day treatment period
measure: iTOSS
timeFrame: During the 14-day treatment period
measure: AM rTNSS
timeFrame: During the 14-day treatment period
measure: AM iTNSS
timeFrame: During the 14-day treatment period
measure: PM rTNSS
timeFrame: During the 14-day treatment period
measure: PM iTNSS
timeFrame: During the 14-day treatment period
measure: AM rTOSS
timeFrame: During the 14-day treatment period
measure: AM iTOSS
timeFrame: During the 14-day treatment period
measure: PM rTOSS
timeFrame: During the 14-day treatment period
measure: PM iTOSS
timeFrame: During the 14-day treatment period
measure: Single nasal symptom
timeFrame: During the 14-day treatment period
measure: Single-eye symptoms
timeFrame: During the 14-day treatment period
measure: iTNSS
timeFrame: Within 12 hours of the first dose
measure: RQLQ
timeFrame: Day 8 and Day 15 after first dose
measure: Safety （Adverse Events）
timeFrame: Through study completion,Estimated 28 days
measure: PK
timeFrame: Through study completion,Estimated 22 days
measure: Immunogenicity
timeFrame: Through study completion,Estimated 22 days
measure: Immunogenicity(Nab)
timeFrame: Through study completion,Estimated 22 days
Other outcomes:
measure: PD(IgE)
timeFrame: Through study completion,Estimated 22 days
measure: PD(IFN-α)
timeFrame: Through study completion,Estimated 22 days
measure: PD( CXCL10)
timeFrame: Through study completion,Estimated 22 days
Locations:
city: Beijing
country: China
facility: Beijing Youan Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Wuwei
country: China
facility: Wuwei People's Hospital
state: Gansu
city: Shenzhen
country: China
facility: Shenzhen University General Hospital
state: Guang Dong
city: Shenzhen
country: China
facility: Shenzhen Nanshan District People's Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: Zhengzhou Central Hospital
state: Hanan
city: Baoding
country: China
facility: The Second Hospital of Baoding City
state: Hebei
city: Cangzhou
country: China
facility: Cangzhou Central Hosptial
state: Hebei
city: Hebei
country: China
facility: Hebei Retro China Central Hosptial
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei Provincial Hospital of Traditional Chinese Medicine
state: Hebei
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Zhangjiakou
country: China
facility: The First Affiliated Hospital of Hebei North University
state: Hebei
city: Daqing
country: China
facility: The People's Hospital of daqing
state: Heilongjiang
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Jingzhou
country: China
facility: Jingzhou Central Hospital (Jingzhou Hospital affiliated to Yangtze University)
state: Hubei
city: Wuhan
country: China
facility: Wuhan Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia Autonomous Region
city: Baotou
country: China
facility: BaogangHospital of InnerMongolia
state: InnerMongolia
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: Shengjing Hospital Affiliated to China Medical University
state: Liaoning
city: Tieling
country: China
facility: Liaoning Provincial Health Industry Group Iron Coal General Hospital
state: Liaoning
city: Chifeng
country: China
facility: Chifeng municipal hospital
state: Mongolia
city: Yinchuan
country: China
facility: People's Hospital of Ningxia Hui Autonomous Region
state: Ningxia Hui Autonomous Region
city: Yinchuan
country: China
facility: The First People's Hospital of Yinchuan
state: Ningxia Hui Autonomous Region
city: Zibo
country: China
facility: Zibo central hospital
state: Shandong
city: Shanghai
country: China
facility: Eye&Ent Hospital of fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
state: Shanghai
city: Changzhi
country: China
facility: Heping hospital affiliated to Changzhi medical college
state: Shanxi
city: Taiyuan
country: China
facility: Second hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: First Hospital Of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi 'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi 'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: Xi'an DaXing Hospital
state: Shanxi
city: Xi'an
country: China
facility: Xi'an High tech Hospital
state: Shanxi
city: Yuncheng
country: China
facility: Yuncheng Central Hospital
state: Shanxi
city: Panzhihua
country: China
facility: Panzhihua Hospital of Integrated Traditional Chinese and Western Medicine
state: Sichuan
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical Universit
state: Xinjiang
Study officials:
References: