A Phase III Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis
NCT ID: NCT07146126
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2025-09-15
2026-07-30
Brief Summary
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The goal of this phase III study is to evaluate the efficacy, safety, and pharmacokinetics of PG-011 nasal spray for treating adults with moderate to severe seasonal allergic rhinitis (SAR). Investigators will compare PG-011 nasal spray to a placebo (a look-alike substance that contains no drug) to see if PG-011 nasal spray works to treat moderate to severe seasonal allergic rhinitis
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Detailed Description
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PG-011 nasal spray 0.6% (1.2mg Pumecitinib) administered twice daily. PG-011 placebo nasal spray 0% (0 mg Pumecitinib) administered twice daily. Participants will receive blinded study treatment for 14 days followed by 21 days safety follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PG-011 nasal spray 0.6%(twice daily)
2 sprays in each nostril, twice daily for 14-day treatment period.
PG-011 nasal spray 0.6%(twice daily)
2 sprays in each nostril, twice daily for 14-day treatment period.
Vehicle nasal spray(twice daily)
2 sprays in each nostril, twice daily for 14-day treatment period.
Placebo
2 sprays in each nostril, twice daily for 14-day treatment period.
Interventions
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PG-011 nasal spray 0.6%(twice daily)
2 sprays in each nostril, twice daily for 14-day treatment period.
Placebo
2 sprays in each nostril, twice daily for 14-day treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Reflective total nasal symptom score ( rTNSS) score≥ 6 and retrospective nasal obstruction ≥ 2 on the day of screening visit, D-4 and D1. Meanwhile, the baseline average rTNSS score(Calculated as the average of rTNSS score of D-3, D-2, D-1 morning, D-1 evening, and D1 morning) ≥ 6
3. History of SAR for at least 2 years. and positive results for any local allergen in the current season tested by either the skin prick test (SPT) (where the wheal diameter is at least 5 mm larger than that of the negative control) or the serum - specific IgE (sIgE) test (the sIgE test results obtained within ≤ 1 year before random enrollment are acceptable).
4. Willingness to avoid pregnancy or fathering children from the signing of the informed consent form until three month after after the end of the study.
5. Willing to sign the informed consent form and abide by the research protocol.
Exclusion Criteria
2. Participants are diagnosed of moderate to severe asthma.
3. Participants who had active pulmonary diseases or infections, upper respiratory tract infections or sinus infections within 2 weeks before screening, and/or those who had respiratory infections during the lead-in period.
4. Participants received nasal or sinus surgery within 3 months before screening or had nasal trauma that had not fully healed.
5. Any nasal mucosal erosion, nasal septal ulcer or nasal septal perforation, as judged by the investigator, may affect the deposition of drugs in the intranasal, such as acute or chronic sinusitis, drug-induced rhinitis, nasal polyps, etc.
6. Participants has ocular herpes simplex or other ocular infections (except seasonal allergic conjunctivitis).
7. Participants with facial or systemic fungal, bacterial, viral or parasitic infections, or oral infections that had not been cured and still required continuous treatment within 4 weeks before screening.
8. Participants have severe diseases such as central nervous system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system or blood system, which may affect the judgment of efficacy and safety .
9. Participants who were infected with human immunodeficiency virus (HIV) at the time of screening, those in the active stage of hepatitis C virus (HCV) infection, those in the active stage of hepatitis B virus (HBV) infection (HBV - DNA \> 2000 IU/mL or 10⁴ copies/mL), or those with positive Treponema pallidum antibody indicating an active stage of infection.
10. Any drug treatments before lead-in period, such as use of nasal or systemic decongestants and anticholinergic drugs within 3 days, use of antihistamines such as cetirizine, fexofenadine, and loratadine within 5 days, systemic use of glucocorticoids within 4 weeks, mast cell stabilizers, tricyclic antidepressants, and leukotriene receptor antagonists within 2 weeks, and use of anti - allergic Chinese herbal medicines within 2 weeks, use of anti-interleukin-4 receptor α subunit (IL-4Rα) monoclonal antibody such as thymic matrix lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonal antibody, other monoclonal antibody, or other biologics within 10 weeks or 5 half-lives (whichever is longer).
11. During the trial, participants who cannot stop using JAK inhibitors, tricyclic antidepressants, glucocorticoids, decongestants, antihistamines (except loratadine, which is a rescue drug required during the treatment), leukotriene receptor antagonists, mast cell stabilizers (including sodium cromoglycate, nedocromil sodium, tetrazolium chromone, nedocromil sodium, pemirolast potassium, and tranilast, etc.), anticholinergic drugs, anti - allergic Chinese herbal medicines, and those who cannot stop using nasal irrigation.
12. Participants who have undergone desensitization therapy or received immunotherapy within 6 months prior to screening.
13. Participants who are known or judged by the investigator to potentially have an allergic reaction to the active ingredients or excipients of the investigational drug.
14. Participants who have a history of intolerance to intranasal administration.
15. Participants who plan to travel outside the local area for 2 consecutive days or more during the trial.
16. Participants who have participated in other clinical studies of investigational drugs or medical devices within 3 months prior to screening and have used investigational products.
17. Participants who have a history of drug abuse or alcoholism within 1 year prior to screening
18. Female participants who are breastfeeding or pregnant at the time of screening
19. Reproductive - age participants (male or female) who plan to become pregnant, breastfeed, or donate sperm/eggs during the study or within 1 month after the study ends
20. Any other condition that, in the opinion of the investigator or sponsor, makes the subject unsuitable for participation in the study
18 Years
65 Years
ALL
No
Sponsors
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Prime Gene Therapeutics Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Luo Zhang, Professor
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital
Locations
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Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Gansu Provincial people's Hospital
Lanzhou, Gansu, China
The NO. 2 Hospital of Baoding
Baoding, Hebei, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Hebei Petro China Central Hospital
Langfang, Hebei, China
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
Hebei Provincial People's Hospital
Shijiazhuang, Hebei, China
Daqing people's Hospital
Daqing, Heilongjiang, China
Harbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang, China
Luo Yang First People's Hospital
Luoyang, Henan, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Zhengzhou Central Hospital, ,
Zhengzhou, Henan, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
Tonghua Central Hospital
Tonghua, Jilin, China
The central hospital of shenyang medical college
Shengyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Baotou Central Hospital
Baotou, Neimenggu, China
Chifeng Municipal Hospital
Chifeng, Neimenggu, China
Affiliated Hospital Of Inner Mongolia Medical University
Hohhot, Neimenggu, China
First People's Hospital of Yinchuan
Yinchuan, Ningxia, China
People's Hospital of Ningxia Hui autonomous region
Yinchuan, Ningxia, China
Shandong Second Provincial People's Hospital
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Yantai YuHuangDing Hospital
Yantai, Shandong, China
Zibo Central Hospital
Zibo, Shandong, China
Sinopharm Tongmei General Hospital
Datong, Shanxi, China
Linfen Central Hospital
Linfen, Shanxi, China
Linfen People's Hospital
Linfen, Shanxi, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Xianyang Hospital of Yan'an University
Xianyang, Shanxi, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China
Xian XD Group Hospital
Xi’an, Shanxi, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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PG-011-SAR-301(phase III)
Identifier Type: -
Identifier Source: org_study_id
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