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Clinical Trials in China / NCT07146126
Starting soon Phase 3

A Phase III Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis

NCT07146126 · tracked via the Priya Life Science China tracker
Sponsor
Prime Gene Therapeutics Co., Ltd.
Phase
Phase 3
Started
2025-09-15
Last updated
2025-08-28

Condition(s) studied

Seasonal Allergic RhinitisSAR

Investigational drug(s) / intervention(s)

PG-011 nasal spray 0.6%(twice daily)Placebo

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.

Study summary

The study is a multicenter, randomized, double-blind, placebo-controlled seamless and adaptive-designed phase IIb/III study encompassing a phase IIb and a phase III component, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time.

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female aged 18 to 65 (including threshold). 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: 1. Participants are diagnosed of active or latent tuberculosis infection. 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

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
Beijing Shijitan Hospital, Capital Medical University Beijing Beijing Municipality
Beijing Tongren Hospital, Capital Medical University Beijing Beijing Municipality
Beijing Youan Hospital, Capital Medical University Beijing Beijing Municipality
Peking University Third Hospital Beijing Beijing Municipality
Gansu Provincial people's Hospital Lanzhou Gansu
The NO. 2 Hospital of Baoding Baoding Hebei
Cangzhou Central Hospital Cangzhou Hebei
Hebei Petro China Central Hospital Langfang Hebei
Hebei Provincial Hospital of Traditional Chinese Medicine Shijiazhuang Hebei
Hebei Provincial People's Hospital Shijiazhuang Hebei
Daqing people's Hospital Daqing Heilongjiang
Harbin Medical University Affiliated Fourth Hospital Harbin Heilongjiang
Luo Yang First People's Hospital Luoyang Henan
The First Affiliated Hospital of Henan University of Science & Technology Luoyang Henan
Zhengzhou Central Hospital, , Zhengzhou Henan
The Central Hospital of Wuhan Wuhan Hubei
Tonghua Central Hospital Tonghua Jilin
The central hospital of shenyang medical college Shengyang Liaoning
Shengjing Hospital of China Medical University Shenyang Liaoning
Baotou Central Hospital Baotou Neimenggu
Chifeng Municipal Hospital Chifeng Neimenggu
Affiliated Hospital Of Inner Mongolia Medical University Hohhot Neimenggu
First People's Hospital of Yinchuan Yinchuan Ningxia
People's Hospital of Ningxia Hui autonomous region Yinchuan Ningxia
Shandong Second Provincial People's Hospital Jinan Shandong
Liaocheng People's Hospital Liaocheng Shandong
Yantai YuHuangDing Hospital Yantai Shandong
Zibo Central Hospital Zibo Shandong
Sinopharm Tongmei General Hospital Datong Shanxi
Linfen Central Hospital Linfen Shanxi
Linfen People's Hospital Linfen Shanxi
First Hospital of Shanxi Medical University Taiyuan Shanxi
Shanxi Bethune Hospital Taiyuan Shanxi
The Second Hospital of Shanxi Medical University Taiyuan Shanxi
Xianyang Hospital of Yan'an University Xianyang Shanxi
The First Affiliated Hospital of Xi'an Jiao Tong University Xi’an Shanxi
Xian XD Group Hospital Xi’an Shanxi
Yuncheng Central Hospital Yuncheng Shanxi

More Prime Gene Therapeutics Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07146126 on ClinicalTrials.gov ↗ ← All trials in China