A Phase III Study to Assess the Efficacy and Safety of PG... | NCT07146126

Status Module

Description Module

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PG-011 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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Percent 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. Percent change is calculated as (Change from baseline / Baseline result *100).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Participants who have participated in other clinical studies of investigational drugs or medical devices within 3 months prior to screening and have used investigational products.
Participants who have a history of drug abuse or alcoholism within 1 year prior to screening
Female participants who are breastfeeding or pregnant at the time of screening
Reproductive - age participants (male or female) who plan to become pregnant, breastfeed, or donate sperm/eggs during the study or within 1 month after the study ends
Any other condition that, in the opinion of the investigator or sponsor, makes the subject unsuitable for participation in the study

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D010038	Otorhinolaryngologic Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases