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A Phase III Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis
Sponsor: Prime Gene Therapeutics Co., Ltd.
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
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb/III Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2025-09-15
Completion Date
2026-07-30
Last Updated
2025-08-28
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (38)
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