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

NCT06837233 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-05-25

No results posted yet for this study

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.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

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.

Sponsors & Collaborators

  • Prime Gene Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Luo Zhang, Professor · Beijing Tongren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-12
Primary Completion
2025-05-15
Completion
2026-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06837233 on ClinicalTrials.gov