Recruiting soon

PumecitinibPG-011 Nasal Spray for Seasonal Allergic Rhinitis

What is being tested

PG-011 nasal spray 0.6%(twice daily)

+ Placebo

Drug

Who is being recruted

Rhinitis, Allergic, Seasonal+7

+ Hypersensitivity

+ Hypersensitivity, Immediate

From 18 to 65 Years

+25 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: September 2025

See protocol details

Summary

Principal SponsorPrime Gene Therapeutics Co., Ltd.

Study ContactLuo Zhang, Professor

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 15, 2025

Actual date on which the first participant was enrolled.

This clinical study is focused on finding out how effective and safe a nasal spray called PG-011 is for adults suffering from moderate to severe seasonal allergic rhinitis, commonly known as hay fever. The study involves adults aged between 18 to 65 years who experience significant symptoms during allergy season. The goal is to see if PG-011 can provide better relief from allergy symptoms compared to a placebo, which is a spray with no active medication. This research is important because seasonal allergies affect many people and finding an effective treatment can greatly improve their quality of life. Participants in this study are randomly divided into two groups, with two-thirds receiving the PG-011 nasal spray and one-third receiving the placebo. Both treatments are administered as a nasal spray twice a day for 14 days. After the treatment period, participants are monitored for another 21 days to ensure safety and track any side effects. The study aims to measure how well the nasal spray reduces allergy symptoms and to observe any potential risks or side effects associated with its use. The results will help determine if PG-011 is a viable option for treating seasonal allergies.

Official TitleA 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

NCT07146126

Principal SponsorPrime Gene Therapeutics Co., Ltd.

Study ContactLuo Zhang, Professor

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Rhinitis, Allergic, SeasonalHypersensitivityHypersensitivity, ImmediateImmune System DiseasesNose DiseasesOtorhinolaryngologic DiseasesRespiratory HypersensitivityRespiratory Tract DiseasesRhinitisRhinitis, Allergic

Criteria

5 inclusion criteria required to participate

Male or female aged 18 to 65 (including threshold).

Reflective total nasal symptom score ( rTNSS) score≥ 6 and retrospective nasal obstruction ≥ 2 on the day of screening visit, D-4 and D1. Meanwhile, the baseline average rTNSS score(Calculated as the average of rTNSS score of D-3, D-2, D-1 morning, D-1 evening, and D1 morning) ≥ 6

History of SAR for at least 2 years. and positive results for any local allergen in the current season tested by either the skin prick test (SPT) (where the wheal diameter is at least 5 mm larger than that of the negative control) or the serum - specific IgE (sIgE) test (the sIgE test results obtained within ≤ 1 year before random enrollment are acceptable).

Willingness to avoid pregnancy or fathering children from the signing of the informed consent form until three month after after the end of the study.

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20 exclusion criteria prevent from participating

Participants are diagnosed of active or latent tuberculosis infection.

Participants are diagnosed of moderate to severe asthma.

Participants who had active pulmonary diseases or infections, upper respiratory tract infections or sinus infections within 2 weeks before screening, and/or those who had respiratory infections during the lead-in period.

Participants received nasal or sinus surgery within 3 months before screening or had nasal trauma that had not fully healed.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

2 sprays in each nostril, twice daily for 14-day treatment period.

Group II

Placebo

2 sprays in each nostril, twice daily for 14-day treatment period.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 38 locations

Suspended

Peking University Third Hospital

Beijing, ChinaOpen Peking University Third Hospital in Google Maps

Suspended

Sinopharm Tongmei General Hospital

Datong, China

Suspended

Xianyang Hospital of Yan'an University

Xianyang, China

Suspended

Beijing Shijitan Hospital, Capital Medical University

Beijing, China

Recruiting soon38 Study Centers