Study to Evaluate the Efficacy and Safety of DW1807 in Perennial Allergic Rhinitis Patients With Asthma

Официальное название

A Randomized, Double-blind, Active-controlled, Parallel, Multi-center, Phase 3 Trial to Compare and Evaluate the Efficacy and Safety of DW1807 and DW1807-R2 in Perennial Allergic Rhinitis Patients With Asthma

Обзор

This study aims to compare the efficacy and safety of DW1807 and DW1807-R2 in patients with perennial allergic rhinitis and comorbid asthma. The primary objective is to demonstrate the superiority of DW1807 over DW1807-R2 in improving the reflective total nasal symptom score (rTNSS) after 4 weeks of treatment.

Вмешательства

• Препарат Experimental
  1. DW1807 Once daily with water regardless of meals without chewing or crushing for up to 4 weeks 2. DW1807-R2 placebo Once daily with water regardless of meals without chewing or crushing for up to 4 weeks
• Препарат Comparator
  1. DW1807 placebo Once daily with water regardless of meals without chewing or crushing for up to 4 weeks 2. DW1807-R2 Once daily with water regardless of meals without chewing or crushing for up to 4 weeks

Первичные конечные точки

• The mean change in reflective Total Nasal Symptom Score (rTNSS) [Срок оценки: During the last 2 weeks of the treatment period (i.e., Weeks 3 to 4 of investigational product administration]

Вторичные конечные точки (7)

• The mean change from baseline in reflective Total Nasal Symptom Score (rTNSS) [Срок оценки: During the first two weeks of the treatment period (Weeks 1 through 2 of investigational product administration).]
• The mean change from baseline in instantaneous Total Nasal Symptom Score (iTNSS) [Срок оценки: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.]
• The mean change from baseline in Daytime Nasal Symptom Score (DNSS) [Срок оценки: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.]
• The mean change from baseline in Nighttime Nasal Symptom Score (NNSS) [Срок оценки: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.]
• The mean change from baseline in Nighttime Symptom Score (NSS) [Срок оценки: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.]
• The mean change from baseline in [Insert Specific Symptom or Score] [Срок оценки: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.]
• The Global Evaluation of Allergic Rhinitis (GEAR) assessed independently by both the investigator and the subject [Срок оценки: At Week 4 of investigational product administration.]

Критерии участия

Критерии включения

<Screening Visit>

• Male or female adults aged 19 years or older.
• Individuals with a confirmed history or treatment record of perennial allergic rhinitis for at least 2 years at the time of screening.
• Individuals who have a positive result on an allergy skin prick test or serum allergen-specific IgE antibody test (e.g., MAST or ImmunoCAP) conducted within 1 year prior to screening, and have a documented history of allergy to at least one perennial allergen (e.g., house dust mites, cats, dogs, molds, etc.).
• Individuals diagnosed with asthma classified as Step 2 to Step 4.
• Individuals who voluntarily provide written informed consent to participate in this clinical trial.

<Randomization Visit>

• Subjects who meet all of the following criteria based on self-assessed nasal symptom scores recorded in the subject diary during the 7-day run-in period.

① Performed nasal symptom evaluations twice daily (morning and evening) on at least 4 days during the run-in period.

② Had an average daily Reflective Total Nasal Symptom Score (rTNSS) of ≥6 (maximum score: 12).

• Subjects with medication compliance of ≥80% during the 7-day run-in period.

Критерии исключения

<A. Disease and Medical History-Related Exclusion Criteria>

• Individuals diagnosed with non-allergic rhinitis of other causes.
• Individuals with a documented acute exacerbation of asthma within 12 weeks prior to screening.
• Individuals diagnosed with pulmonary diseases other than asthma.
• Individuals diagnosed with the following types of sinusitis:

① Acute sinusitis within 4 weeks prior to screening.

② Clinically significant chronic sinusitis, as determined by the investigator.

• Individuals with nasal polyps or other clinically significant nasal structural abnormalities.
• Individuals who have undergone nasal or perinasal surgery within 12 weeks prior to screening.
• Individuals with a documented upper respiratory tract infection (including the common cold) or systemic infection within 3 weeks prior to screening.

<B. Concomitant Medication Use>

• Subjects who have initiated immunotherapy or changed the dosage within 4 weeks prior to the screening visit.
• Subjects who are on chronic use of medications that, in the opinion of the investigator, may interfere with the assessment of the investigational product's efficacy (e.g., tricyclic antidepressants).
• Subjects who are currently taking, or are expected to require during the study, any medications that are prohibited as per the protocol.

<C. Laboratory Criteria>

• Subjects with serum AST (GOT) or ALT (GPT) levels > 2 × the upper limit of normal (ULN) based on screening test results.
• Subjects with an estimated glomerular filtration rate (eGFR, calculated by CKD-EPI) < 30 mL/min/1.73 m² based on screening test results.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Konkuk University Medical Center — Seoul

Идентификаторы

NCT: NCT07168473 · DW1807-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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