A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial of JKN2403 in COPD

Официальное название

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of JKN2403 Tablets in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

Обзор

The goal of this clinical trial is to learn if drug JKN2403 works to treat moderate-to-severe COPD in adults. It will also learn about the safety and pharmacokinetic characteristics of drug JKN2403. The main questions it aims to answer are: Does drug JKN2403 reduce the incidence of AECOPD or improve the quality of life or alleviate symptoms related to COPD? Researchers will compare drug JKN2403 to a placebo (a look-alike substance that contains no drug) to see if drug JKN2403 works to treat moderate-to-severe COPD. Participants will: Take drug JKN2403 or a placebo every day for 24 weeks Visit the clinic once every four weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler

Вмешательства

• Препарат JKN2403 Tablets
  JKN2403 Tablets once daily orally, for 24 weeks
• Препарат Placebo
  Placebo

Первичные конечные точки

• The annualized incidence rate of moderate to severe AECOPD [Срок оценки: at 24 months]
• The duration from the first administration to the first occurrence of moderate to severe AECOPD [Срок оценки: at 24 months]

Вторичные конечные точки (5)

• trough (pre-bronchodilator) FEV1 [Срок оценки: at 4, 8, 12 ,16, 20 and 24 weeks]
• quality of life（SGRQ score） [Срок оценки: at 4, 8,12, 16, 20 and 24 weeks]
• quality of life (CAT score) [Срок оценки: at 4, 8,12, 16, 20 and 24 months]
• The annualized incidence rate of CID [Срок оценки: at 24 weeks]
• The duration from the first administration to the first occurrence of CID [Срок оценки: at 24 weeks]

Критерии участия

Критерии включения

• Written informed consent; able and willing to comply with study procedures.
• Adults with documented COPD diagnosis and medical history consistent with guideline criteria.
• Relevant exposure history consistent with COPD (e.g., smoking).
• On stable, guideline-based maintenance COPD therapy prior to randomization, per investigator judgment.
• Protocol-defined exacerbation history, symptom burden, and lung function at screening.

Критерии исключения

• Current or past asthma, or other clinically significant respiratory disease that may confound assessment.
• Clinically significant uncontrolled comorbidities that increase risk or interfere with participation/outcomes.
• Immunodeficiency/immune dysregulation, active autoimmune disease requiring systemic immunosuppression, or significant opportunistic infection history.
• Active clinically significant infection or recent infection requiring systemic therapy; recent protocol-defined COPD exacerbation.
• Current/recent malignancy (except low-risk, adequately treated cancers per protocol) or clinically significant abnormal screening labs.
• Prohibited recent vaccines or therapies, prior relevant biologic/targeted therapy exposure, severe hypersensitivity to biologics/IMP, - pregnancy/breastfeeding, or inability to comply (including substance abuse), per investigator judgment.

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

Китай · 1 центр

• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу

Идентификаторы

NCT: NCT07351734 · JKN2403-IIa · JKN2403-IIa

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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