NCT06837233

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Prime Gene Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled clinical study in adults participants aged from 18 to 65 years old (including threshold) with moderate to severe SAR. Approximately 160 participants will be randomized assigned to one of the 4 following groups in a 1:1:1:1 ratio. PG-011 nasal spray 0.3% ( 0.6mg Pumecitinib) administered twice daily, PG-011 nasal spray 0.6% (1.2mg Pumecitinib) administered once daily, PG-011 nasal spray 0.6% (1.2mg Pumecitinib) administered twice daily, PG-011 placebo nasal spray 0% (0 mg Pumecitinib) administered once or twice daily. Participants will receive blinded study treatment for 14 days followed by 21 days safety follow-up.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-12
• Primary completion: 2025-05-15
• Completion: 2026-05-01
• First posted: 2025-02-20
• Last updated: 2025-05-25

Locations

20 sites across 1 country: China