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Seasonal Allergic RhinitisPhase 2NCT06861101

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

A Phase 2 study testing JT002 Nasal spray in people with Seasonal Allergic Rhinitis, run by Shanghai JunTop Biosciences Co., LTD at 44 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Seasonal Allergic Rhinitis
What is being tested?
JT002 Nasal spray
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
370 participants
Where
44 sitesChina
Study dates
24 Feb 2025to 14 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Male and female patients aged 18 to 75 years on screening day (inclusive of the cutoff value).
  • 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).
  • The environment of seasonal allergy exposure for the patient does not change during the 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 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.

Who cannot join

  • Pregnant or lactating women.
  • 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.
  • 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.
  • 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.
  • Patients with rhinitis who have previously demonstrated an inability to tolerate nasal drops.
  • 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.
Show all 24Show fewer
  • 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.
  • Medicamentosa, nasal polyps or abnormal nasal cavity structure, nasal trauma (such as nasal puncture), or septal deviation or nasal septum perforation.
  • Patients who have received nasal operation within 3 months prior to screening or have 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 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).
  • 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.
  • 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 or more than 3 cumulative days (not consecutive) during the study period.
  • History (at present) of immunodeficiency infection (e.g., Pneumocystis jirovecii pneumonia, Histoplasmosis, Coccidioidomycosis); or other known Immunodeficiency.
  • 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.
  • Major surgery within 8 weeks prior to screening.
  • Uncontrolled hypertension (Blood pressure systolic ≥160 mm Hg and/or Blood pressure diastolic ≥100 mm Hg, determined by two consecutive raised blood pressure readings).
  • 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.
  • 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.
  • Use of prohibited medications listed in Table 2 without meeting the washout requirements in Table 2.
  • 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.).
  • 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).
  • 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).
  • Use of traditional Chinese medicine therapy for treatment of seasonal allergic rhinitis within 4 weeks prior to the screening.

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

China44 sites

  • The Second Hospital of Baoding City

    Baoding, Hebei, 200131

  • BaogangHospital of InnerMongolia

    Baotou, InnerMongolia, 014010

  • Beijing Youan Hospital Capital Medical University

    Beijing, Beijing Municipality, 100069

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Cangzhou Central Hosptial

    Cangzhou, Hebei, 061014

  • Heping hospital affiliated to Changzhi medical college

    Changzhi, Shanxi, 046000

  • Chifeng municipal hospital

    Chifeng, Mongolia, 024099

  • The People's Hospital of daqing

    Daqing, Heilongjiang, 150081

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350004

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Hebei Retro China Central Hosptial

    Hebei, Hebei, 065000

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010030

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

    Jingzhou, Hubei, 434000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 200000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Panzhihua Hospital of Integrated Traditional Chinese and Western Medicine

    Panzhihua, Sichuan, 617000

  • Eye&Ent Hospital of fudan University

    Shanghai, Shanghai Municipality, 200031

  • Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center

    Shanghai, Shanghai Municipality, 201399

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning, 110000

  • Shenzhen Nanshan District People's Hospital

    Shenzhen, Guangdong, 518000

  • Shenzhen University General Hospital

    Shenzhen, Guangdong, 518000

  • Hebei Provincial Hospital of Traditional Chinese Medicine

    Shijiazhuang, Hebei, 050000

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

  • Second hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • First Hospital Of Shanxi Medical University

    Taiyuan, Shanxi, 030012

  • Shanxi Bethune hospital

    Taiyuan, Shanxi, 030032

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300121

  • Liaoning Provincial Health Industry Group Iron Coal General Hospital

    Tieling, Liaoning, 112700

  • The First Affiliated Hospital of Xinjiang Medical Universit

    Ürümqi, Xinjiang, 830054

  • Wuhan Central Hospital

    Wuhan, Hubei, 430014

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Wuwei People's Hospital

    Wuwei, Gansu, 733000

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi’an, Shanxi, 710000

  • The Second Affiliated Hospital of Xi 'an Jiaotong University

    Xi’an, Shanxi, 710000

  • Xi'an DaXing Hospital

    Xi’an, Shanxi, 710016

  • Xi'an High tech Hospital

    Xi’an, Shanxi, 710075

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia, 750000

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia, 750000

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 044000

  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei, 075061

  • Zhengzhou Central Hospital

    Zhengzhou, Hanan, 450000

  • Zibo central hospital

    Zibo, Shandong, 255000

Other trials in China

About this study

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

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).

Being tested
JT002 Nasal spray, Placebo
Medical subject headings
Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JT002 Nasal sprayDrug

    200 μg BID, 400 μg BID, 400 μg QD, 800 μg QD, 64 patients per cohort, total 256 patients for treatment 14 days

  • PlaceboDrug

    Total 64 patients for treatment 14 days

Study groups in NCT06861101
Study groupRoleWhat they receive
JT002Experimental200 μg BID, 400 μg BID, 400 μg QD, 800 μg QD
Receives: Drug: JT002 Nasal spray
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rTNSS

    Change from baseline in mean (AM+PM) rTNSS (reactive nasal symptom total score)

    Measured: During the 14-day treatment period

Secondary outcomes (19)

  1. iTNSS

    Change from baseline in mean (AM+PM) ITNSS

    Measured: During the 14-day treatment period

  2. rTOSS

    Change from baseline in the mean (AM+PM) rTOSS (reactive eye symptom total score)

    Measured: During the 14-day treatment period

  3. iTOSS

    Change from baseline in iTOSS mean (mean of AM and PM)

    Measured: During the 14-day treatment period

  4. AM rTNSS

    Change from baseline in AM rTNSS

    Measured: During the 14-day treatment period

  5. AM iTNSS

    Change from baseline in AM iTNSS

    Measured: During the 14-day treatment period

  6. PM rTNSS

    Change from baseline in PM rTNSS

    Measured: During the 14-day treatment period

  7. PM iTNSS

    Change from baseline in PM iTNSS

    Measured: During the 14-day treatment period

  8. AM rTOSS

    Change from baseline in AM rTOSS

    Measured: During the 14-day treatment period

  9. AM iTOSS

    Change from baseline in AM iTOSS

    Measured: During the 14-day treatment period

  10. PM rTOSS

    Change from baseline in PM rTOSS

    Measured: During the 14-day treatment period

  11. PM iTOSS

    Change from baseline in PM iTOSS

    Measured: During the 14-day treatment period

  12. 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

    Measured: During the 14-day treatment period

  13. Single-eye symptoms

    Change from baseline in mean reactive single-eye symptoms (itchy/burning eyes, red eyes, tearing)AM and PM

    Measured: During the 14-day treatment period

  14. 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

    Measured: Within 12 hours of the first dose

  15. RQLQ

    Change from baseline in scores on the RQLQ

    Measured: Day 8 and Day 15 after first dose

  16. Safety （Adverse Events）

    To evaluate the Adverse Events of JT002 in participants with seasonal allergic rhinitis

    Measured: Through study completion,Estimated 28 days

  17. PK

    According to the test of blood samples, Drug concentrations in individual subjects at different time points after dosing

    Measured: Through study completion,Estimated 22 days

  18. Immunogenicity

    According to the test of blood samples,to evaluate the incidence and titer of anti-drug antibody (ADA) of JT002

    Measured: Through study completion,Estimated 22 days

  19. Immunogenicity(Nab)

    To analyze ADA-positive blood samples for the presence of Neutralizing antibodies (Nab).

    Measured: Through study completion,Estimated 22 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2025
  2. Study start24 Feb 2025
  3. Primary completion6 May 2025
  4. Study completion14 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
370 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06861101
Sponsor's protocol ID
JT002-001-II-SAR
Status last verified
Jun 2025
First submitted
19 Feb 2025
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JT002 Nasal spray in people with Seasonal Allergic Rhinitis, run by Shanghai JunTop Biosciences Co., LTD at 44 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rTNSS (time frame: During the 14-day treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06861101.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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