A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe… (NCT06837233) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis
China160 participantsStarted 2025-03-12
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 one month after the last administration of the investigational medicinal product.
✓. 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.
What they're measuring
1
Change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period
✕. 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 .