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

NCT06837233 | Active Not Recruiting Phase 2

• 2 other identifiers: PG-011-SAR-301CTR20250489
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 20

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.

Conditions

Seasonal Allergic Rhinitis

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.

  Baseline and Day 14

Secondary Outcomes (5)

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

  Baseline and Day 14

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

  Baseline and Day 14

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

  Baseline and Day 14

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

  Baseline and Day 14

• Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score of general activities on day 15

  Baseline and Day 15

Study Arms (4)

PG-011 nasal spray 0.3% (twice daily)

EXPERIMENTAL

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

Drug: Pumecitinib Nasal Spray 0.3%

PG-011 nasal spray 0.6%(once daily)

EXPERIMENTAL

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

Drug: Pumecitinib Nasal Spray 0.6%; Drug: Placebo

PG-011 nasal spray 0.6%(twice daily)

EXPERIMENTAL

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

Drug: Pumecitinib 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 (twice daily)

Interventions

Pumecitinib Nasal Spray 0.3% DRUG

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

PG-011 nasal spray 0.3% (twice daily)

Pumecitinib Nasal Spray 0.6% DRUG

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

PG-011 nasal spray 0.6%(once daily)

Placebo (twice daily) DRUG

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

Vehicle nasal spray(twice daily)

Pumecitinib nasal spray 0.6%(twice daily) DRUG

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

PG-011 nasal spray 0.6%(twice daily)

Placebo DRUG

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

PG-011 nasal spray 0.6%(once 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 one month after the last administration of the investigational medicinal product.
• 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 (including but not limited to bronchitis, pneumonia), upper respiratory tract infections or sinus infections within 4 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, nasal septal perforation or other nasal diseases that, 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 (anti - HCV positive), 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, or local use of glucocorticoids, mast cell stabilizers, tricyclic antidepressants, and leukotriene receptor antagonists within 2 weeks, and use of anti - allergic Chinese herbal medicines within 2 weeks.
• 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 (20)

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

Cangzhou Central Hospital

Cangzhou, Hebei, China

Location

Hebei Petro China Central Hospital

Langfang, Hebei, China

Location

Luo Yang First People's Hospital

Luoyang, Henan, China

Location

Zhengzhou Central Hospital

Zhengzhou, Henan, China

Location

The Central Hospital of Wuhan

Wuhan, Hubei, 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

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

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

The First Affiliated Hospital of Xi'an Jiao Tong University

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: February 14, 2025
• First Posted: February 20, 2025
• Study Start: March 12, 2025
• Primary Completion: May 15, 2025
• Study Completion: May 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (20)