Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT06837233
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-25
First Post:
2025-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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.
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pumecitinib
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CTR20250489 | OTHER | China's National Medical Products Administration (NMPA)，http://www.chinadrugtrials.org.cn/index.html | View |