Trial of JYB1904 Injection in Patients With Perennial Allergic Rhinitis

Официальное название

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of JYB1904 Injection Combined With Background Therapy in Patients With Perennial Allergic Rhinitis

Обзор

This Phase II Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Patients With Perennial Allergic Rhinitis.

Подробное описание

This study is a randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of JYB1904 injection compared to placebo in patients with PAR.

Вмешательства

• Биопрепарат JYB1904
  Double-blind Induction Period: 150mg -450mg JYB1904 will be administered SC in Day1, Week 8 and Week 16. Open-label Treatment Period: 300mg JYB1904 will be administered SC every 12 weeks (Q12W) from Week 24 to Week 48.
• Биопрепарат JYB1904
  Double-blind Induction Period: 300mg JYB1904 will be administered SC in Day1 and Week 12. Open-label Treatment Period: 300mg JYB1904 will be administered SC Q12W from Week 24 to Week 48.
• Биопрепарат Placebo+JYB1904
  Double-blind Induction Period: Placebo will be administered SC in Day1, Week 8, Week 12 and Week16. Open-label Treatment Period: 300mg JYB1904 will be administered SC Q12W from Week 24 to Week 48.

Первичные конечные точки

• Change from Baseline in Reflective Total Nasal Symptom Score (rTNSS) at Week 8 (JYB1904 Q8W vs Placebo) or Week 12 (JYB1904 Q12W vs Placebo) [Срок оценки: baseline, Week 8, Week 12]

Критерии участия

Критерии включения

• Adult participants ≥18 years and ≤65 years of age at the time of signing the informed consent form (ICF).
• Physician-diagnosed PAR at screening, symptoms of allergic rhinitis present for a minimum of 2 years.
• Participants must have been on stable treatment with intranasal corticosteroids (INCS), with or without other background medications for at least four consecutive weeks before randomization, and rTNSS≥6 at screening.
• Within 1 year prior to screening or at screening, participants must have positive indoor allergen SPT and/or positive antigen-specific serum IgE to indoor allergens . Participants must have clinical symptoms associated with perennial allergen positivity (assessed by SPT) or positive serum antigen-specific IgE at study entry .
• A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum antigen-specific IgE test.
• Participants who have concomitant asthma must use permitted regular asthma treatment during the study and have been stable in the 3 months prior to screening.
• Is willing and able to comply with daily eDiary.
• Participants must complete the eDiary during the baseline evaluation period (2 weeks prior to randomization) and meet the following criteria: (1) complete the eDiary for at least 4 days per week; and (2) rTNSS score ≥6 at randomization (average of Day-7 to Day-1).

Критерии исключения

• Is currently on AIT subcutaneous immunotherapy or sublingual immunotherapy.
• Have received treatment with any rescue medication or adjustment to background therapy medications during the baseline evaluation period.
• Prior intolerance or inadequate response to omalizumab.
• Contraindications or hypersensitivity to antihistamines or intranasal corticosteroids, or history of anaphylaxis.
• Have a history of seasonal worsening of AR and if the seasonal worsening is expected during the 2-week baseline evaluation period and the 24-week double-blind induction period.
• Anticipates significant changes in their daily environmental exposure during the 2-week baseline evaluation period and the 24-week double-blind induction period.
• Has a history of nasal polyps or nasal polyps present at screening, moderate-to-severe nasal septum deviation, or rhinitis secondary to other causes.
• Has a known history of recurrent acute or chronic sinusitis.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07459452 · JYB1904-204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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