Clinical Trial

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

Study acronym: Pumecitinib
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-02-19; most recent amendment 2025-05-23.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-05-23
Trial Details
NCT Number NCT06837233
Lead Sponsor Prime Gene Therapeutics Co., Ltd.
Conditions Seasonal Allergic Rhinitis
Enrollment 160 participants
Start Date 2025-03-12
Primary Completion 2025-05-15 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-05-25