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

NCT07146126 | Not Yet Recruiting Phase 3

• 1 other identifier: PG-011-SAR-301(phase III)
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 38

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, 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

Conditions

Seasonal Allergic Rhinitis; SAR

Keywords

SAR; PG-011; Seasonal Allergic Rhinitis; Pumecitinib

Outcome Measures

Primary Outcomes (1)

• Change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period

  The reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring (AM, PM) of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate). Higher scores indicate more severe nasal symptoms, while lower scores indicate less severe nasal symptoms.

  Up to Day 14

Secondary Outcomes (33)

• Percent change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period

  Up to Day 14

• Change and percent change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS) over the 14-day treatment period

  Up to Day 14

• Change and percentage change from baseline in average retrospective Ocular Symptom Total Score (rTOSS) over the 14-day treatment period

  Up to Day 14

• Change and percent change from baseline in average instantaneous ocular symptom score (iTOSS) over 14-day treatment period

  Baseline and Day 14

• rTNSS over the 14-day treatment period

  Up to Day 14

Study Arms (2)

PG-011 nasal spray 0.6%(twice daily)

EXPERIMENTAL

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

Drug: PG-011 nasal spray 0.6%(twice daily)

Vehicle nasal spray(twice daily)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PG-011 nasal spray 0.6%(twice daily) DRUG

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

Also known as: Pumecitinib nasal spray

PG-011 nasal spray 0.6%(twice daily)

Placebo DRUG

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

Also known as: Vehicle of Pumecitinib nasal spray

Vehicle nasal spray(twice daily)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willing to sign the informed consent form and abide by the research protocol.

You may not qualify if:

• 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.
• Any nasal mucosal erosion, nasal septal ulcer or nasal septal perforation, as judged by the investigator, may affect the deposition of drugs in the intranasal, such as acute or chronic sinusitis, drug-induced rhinitis, nasal polyps, etc.
• Participants has ocular herpes simplex or other ocular infections (except seasonal allergic conjunctivitis).
• Participants with facial or systemic fungal, bacterial, viral or parasitic infections, or oral infections that had not been cured and still required continuous treatment within 4 weeks before screening.
• Participants have severe diseases such as central nervous system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system or blood system, which may affect the judgment of efficacy and safety .
• Participants who were infected with human immunodeficiency virus (HIV) at the time of screening, those in the active stage of hepatitis C virus (HCV) infection, those in the active stage of hepatitis B virus (HBV) infection (HBV - DNA \> 2000 IU/mL or 10⁴ copies/mL), or those with positive Treponema pallidum antibody indicating an active stage of infection.
• Any drug treatments before lead-in period, such as use of nasal or systemic decongestants and anticholinergic drugs within 3 days, use of antihistamines such as cetirizine, fexofenadine, and loratadine within 5 days, systemic use of glucocorticoids within 4 weeks, mast cell stabilizers, tricyclic antidepressants, and leukotriene receptor antagonists within 2 weeks, and use of anti - allergic Chinese herbal medicines within 2 weeks, use of anti-interleukin-4 receptor α subunit (IL-4Rα) monoclonal antibody such as thymic matrix lymphopoietin (TSLP) monoclonal antibody, anti-IgE monoclonal antibody, other monoclonal antibody, or other biologics within 10 weeks or 5 half-lives (whichever is longer).
• During the trial, participants who cannot stop using JAK inhibitors, tricyclic antidepressants, glucocorticoids, decongestants, antihistamines (except loratadine, which is a rescue drug required during the treatment), leukotriene receptor antagonists, mast cell stabilizers (including sodium cromoglycate, nedocromil sodium, tetrazolium chromone, nedocromil sodium, pemirolast potassium, and tranilast, etc.), anticholinergic drugs, anti - allergic Chinese herbal medicines, and those who cannot stop using nasal irrigation.
• Participants who have undergone desensitization therapy or received immunotherapy within 6 months prior to screening.
• Participants who are known or judged by the investigator to potentially have an allergic reaction to the active ingredients or excipients of the investigational drug.
• Participants who have a history of intolerance to intranasal administration.
• Participants who plan to travel outside the local area for 2 consecutive days or more during the trial.

Sponsors & Collaborators

• Prime Gene Therapeutics Co., Ltd.: lead

Study Sites (38)

Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Beijing Youan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Gansu Provincial people's Hospital

Lanzhou, Gansu, China

Location

The NO. 2 Hospital of Baoding

Baoding, Hebei, China

Location

Cangzhou Central Hospital

Cangzhou, Hebei, China

Location

Hebei Petro China Central Hospital

Langfang, Hebei, China

Location

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

Location

Hebei Provincial People's Hospital

Shijiazhuang, Hebei, China

Location

Daqing people's Hospital

Daqing, Heilongjiang, China

Location

Harbin Medical University Affiliated Fourth Hospital

Harbin, Heilongjiang, China

Location

Luo Yang First People's Hospital

Luoyang, Henan, China

Location

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China

Location

Zhengzhou Central Hospital, ,

Zhengzhou, Henan, China

Location

The Central Hospital of Wuhan

Wuhan, Hubei, China

Location

Tonghua Central Hospital

Tonghua, Jilin, China

Location

The central hospital of shenyang medical college

Shengyang, Liaoning, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

Baotou Central Hospital

Baotou, Neimenggu, China

Location

Chifeng Municipal Hospital

Chifeng, Neimenggu, China

Location

Affiliated Hospital Of Inner Mongolia Medical University

Hohhot, Neimenggu, China

Location

First People's Hospital of Yinchuan

Yinchuan, Ningxia, China

Location

People's Hospital of Ningxia Hui autonomous region

Yinchuan, Ningxia, China

Location

Shandong Second Provincial People's Hospital

Jinan, Shandong, China

Location

Liaocheng People's Hospital

Liaocheng, Shandong, China

Location

Yantai YuHuangDing Hospital

Yantai, Shandong, China

Location

Zibo Central Hospital

Zibo, Shandong, China

Location

Sinopharm Tongmei General Hospital

Datong, Shanxi, China

Location

Linfen Central Hospital

Linfen, Shanxi, China

Location

Linfen People's Hospital

Linfen, Shanxi, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Location

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Xianyang Hospital of Yan'an University

Xianyang, Shanxi, China

Location

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China

Location

Xian XD Group Hospital

Xi’an, Shanxi, China

Location

Yuncheng Central Hospital

Yuncheng, Shanxi, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Luo Zhang, Professor

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luo Zhang, Professor

CONTACT

+86 13910830399; dr.luozhang@139.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 28, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (38)