Clinical Trial

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

Study acronym: Pumecitinib
Not Yet Recruiting Phase 3
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Record status
This record was last updated August 28, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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
Trial Details
NCT Number NCT07146126
Lead Sponsor Prime Gene Therapeutics Co., Ltd.
Conditions Seasonal Allergic Rhinitis, SAR
Enrollment 600 participants
Start Date 2025-09-15
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-28