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ACTIVE NOT RECRUITING
NCT06837233
PHASE2

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.

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. 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

Interventions

DRUG

Pumecitinib Nasal Spray 0.3%

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

DRUG

Pumecitinib Nasal Spray 0.6%

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

DRUG

Placebo (twice daily)

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

DRUG

Pumecitinib 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, 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