Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07146126
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

PG-011 nasal spray 0.6%(twice daily)

2 sprays in each nostril, twice daily for 14-day treatment period.

DRUG

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