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A 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. The phase IIb study, which is registered this time, is a dose-ranging component. The phase III study is a pivotal part of the overall research. The goal of this phase IIb study is to evaluate the efficacy, safety, and pharmacokinetics of PG-011 nasal spray across various dosages and administration frequencies 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 which dosage and frequency 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
160
Start Date
2025-03-12
Completion Date
2026-05
Last Updated
2025-05-25
Healthy Volunteers
No
Conditions
Interventions
Pumecitinib Nasal Spray 0.3%
2 sprays in each nostril, twice daily for 14-day treatment period.
Pumecitinib Nasal Spray 0.6%
2 sprays in each nostril, once daily for 14-day treatment period.
Placebo (twice daily)
2 sprays in each nostril, twice daily for 14-day treatment period.
Pumecitinib nasal spray 0.6%(twice daily)
2 sprays in each nostril, twice daily for 14-day treatment period.
Placebo
2 sprays in each nostril, once daily for 14-day treatment period.
Locations (20)
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
Cangzhou Central Hospital
Cangzhou, Hebei, China
Hebei Petro China Central Hospital
Langfang, Hebei, China
Luo Yang First People's Hospital
Luoyang, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Baotou Central Hospital
Baotou, Neimenggu, China
Chifeng Municipal Hospital
Chifeng, Neimenggu, 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
Linfen Central Hospital
Linfen, Shanxi, China
Linfen People's Hospital
Linfen, Shanxi, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China