Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT06837233
Brief 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.
Study:
NCT06837233
Study Brief:
Protocol Section:
NCT06837233