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

Официальное название

A 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

Обзор

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

Подробное описание

This is a multicenter, randomized, double-blind, placebo-controlled clinical study in adults participants aged from 18 to 65 years old (including threshold) with moderate to severe SAR. Approximately 600 participants will be randomized assigned to one of the 2 following groups in a 2:1 ratio.

PG-011 nasal spray 0.6% (1.2mg Pumecitinib) administered twice daily. PG-011 placebo nasal spray 0% (0 mg Pumecitinib) administered twice daily. Participants will receive blinded study treatment for 14 days followed by 21 days safety follow-up.

Вмешательства

• Препарат PG-011 nasal spray 0.6%(twice daily)
  2 sprays in each nostril, twice daily for 14-day treatment period.
• Препарат Placebo
  2 sprays in each nostril, twice daily for 14-day treatment period.

Первичные конечные точки

• Change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period [Срок оценки: Up to Day 14]

Вторичные конечные точки (12)

• Percent change from baseline in average retrospective Total Nasal Symptom Score (rTNSS) over the 14-day treatment period [Срок оценки: Up to Day 14]
• Change and percent change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS) over the 14-day treatment period [Срок оценки: Up to Day 14]
• Change and percentage change from baseline in average retrospective Ocular Symptom Total Score (rTOSS) over the 14-day treatment period [Срок оценки: Up to Day 14]
• Change and percent change from baseline in average instantaneous ocular symptom score (iTOSS) over 14-day treatment period [Срок оценки: Baseline and Day 14]
• rTNSS over the 14-day treatment period [Срок оценки: Up to Day 14]
• Mean change from baseline in PM participant-reported rTNSS over the 14-day treatment period [Срок оценки: Up to Day 14]
• Mean change from baseline in AM participant-reported iTNSS over the 14-day treatment period [Срок оценки: Up to Day 14]
• Mean change from baseline in PM participant-reported iTNSS over the 14-day treatment [Срок оценки: Up to Day 14]
• Mean change from baseline in AM participant-reported rTOSS over the 14-day treatment period [Срок оценки: Up to Day 14]
• Mean change from baseline in PM participant-reported rTOSS over the 14-day treatment period [Срок оценки: Up to Day 14]
• Mean change from baseline in AM participant-reported iTOSS over the 14-day treatment period [Срок оценки: Up to Day 14]
• Mean change from baseline in PM participant-reported iTOSS over the 14-day treatment period [Срок оценки: Up to Day 14]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 38 центров

• Beijing Shijitan Hospital, Capital Medical University — Пекин
• Beijing Tongren Hospital, Capital Medical University — Пекин
• Beijing Youan Hospital, Capital Medical University — Пекин
• Peking University Third Hospital — Пекин
• Gansu Provincial people's Hospital — Lanzhou
• The NO. 2 Hospital of Baoding — Baoding
• Cangzhou Central Hospital — Cangzhou
• Hebei Petro China Central Hospital — Langfang
• … и ещё 30 центров

Идентификаторы

NCT: NCT07146126 · PG-011-SAR-301(phase III)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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