Phase II Study of RC1416 Injection in COPD

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of RC1416 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of RC1416 injection in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Подробное описание

Each participant will receive the study treatment once every two weeks for a total treatment duration of 52 weeks. The study aims to evaluate the annualized rate of moderate or severe COPD exacerbations (AECOPD) and the change in FEV1 from baseline over the 52-week treatment period. The changes in FeNO, total IgE, eosinophil count, and TARC levels from baseline will be evaluated.

Вмешательства

• Препарат RC1416
  There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
• Препарат RC1416 Placebo
  Each subjects will receive the placebo by subcutaneous injection.

Первичные конечные точки

• moderate or severe COPD exacerbations (AECOPD) and forced expiratory volume in 1 Second (FEV1) [Срок оценки: During 52 weeks]

Вторичные конечные точки (4)

• The safety and tolerability [Срок оценки: During 52 weeks]
• pharmacokinetic [Срок оценки: During 52 weeks]
• immunogenicity [Срок оценки: During 52 weeks]
• biomarkers predictive of the efficacy [Срок оценки: During 52 weeks]

Критерии участия

Критерии включения

• Aged 40 to 85 years (inclusive) at the time of signing the informed consent form, regardless of gender.
• Body Mass Index (BMI) ≥ 16 kg/m².
• Meets the diagnostic criteria for chronic obstructive pulmonary disease (COPD), and has medical records or relevant documentation indicating a history of COPD for ≥ 12 months at screening.
• Post-bronchodilator ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) < 0.7, and post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted value at screening.
• A current smoker or former smoker with a smoking history of ≥ 10 pack-years, or a history of exposure to other risk factors.
• A score of ≥ 2 on the modified Medical Research Council (mMRC) dyspnea scale at screening.
• Medical records or relevant documentation showing ≥ 2 moderate COPD. exacerbations (AECOPD) or ≥ 1 severe AECOPD within the 12 months prior to screening.
• Medical records or relevant documentation showing receipt of background triple therapy (ICS + LABA + LAMA) for ≥ 3 months prior to randomization.
• A blood eosinophil count ≥ 150/mm³ (0.15×10⁹/L) at screening.

Критерии исключения

• A current diagnosis of asthma or a history of asthma.
• Presence of other significant pulmonary diseases except COPD as judged by the Investigator.
• History of malignancy .
• A history of autoimmune diseases , or treatment with biologics or systemic immunosuppressants for inflammatory diseases within 8 weeks or 5 half-lives (whichever is longer) prior to signing the informed consent form.
• Presence of recurrent, chronic, or other active infections at screening.
• Currently receiving or planning to start long-term oxygen therapy or mechanical ventilation during the study period.
• Diagnosis of α1-antitrypsin deficiency.
• Active hepatitis B, active hepatitis C, positive human immunodeficiency virus (HIV) antibody, or positive Treponema pallidum antibody (TP-Ab).
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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 · 42 центра

• Anhui Provincial Chest Hospital — Хэфэй
• Wan Bei General Hospital of Wanbei Coal power Group — Сучжоу
• The Affiliated Bishan Hospital of Chongqing Medical University — Чунцин
• Zhongshan Hospital Xiamen University — Xiamen
• The first affiliated hospital of guangzhou medical university — Гуанчжоу
• The First Affiliated Hospital of Jinan University — Гуанчжоу
• The first affiliated hospital of guangzhou medical university — Гуанчжоу
• Huizhou Third People's Hospital — Huizhou
• … и ещё 34 центра

Идентификаторы

NCT: NCT07402551 · RJK-RC1416-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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