Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Официальное название

A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease

Обзор

The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.

Подробное описание

The maximum study duration was 66 weeks per participants, including a screening period of up to 6 weeks, a 52-week randomized treatment period, and a 8-week follow-up period.

Вмешательства

• Препарат 611
  611 subcutaneous (SC) injection
• Препарат Placebo
  placebo Q2W, subcutaneous (SC) injection

Первичные конечные точки

• Annualized rate of moderate or severe COPD Exacerbations [Срок оценки: Baseline to Week 52]

Вторичные конечные точки (12)

• Change from baseline in pre-bronchodilator FEV1 at Week 24 [Срок оценки: Baseline, Week 24]
• Time to first Moderate or severe COPD exacerbation [Срок оценки: Baseline to Week 52]
• Annualized rate of severe COPD Exacerbations [Срок оценки: Baseline to Week 52]
• Change from baseline in pre-bronchodilator FEV1 [Срок оценки: Baseline to Week 52]
• Change from baseline in SGRQ scores [Срок оценки: Baseline to Week 52]
• Percentage of participants with a decrease in SGRQ total score of ≥ 4 points from baseline [Срок оценки: Baseline to Week 16]
• Change from baseline in post-bronchodilator FEV1 [Срок оценки: Baseline to Week 52]
• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [Срок оценки: Up to 60 Weeks]
• 611 Concentration in Serum [Срок оценки: Baseline to Week 60]
• Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies [Срок оценки: Baseline to Week 60]
• Change in serum concentrations of Pulmonary and activation-regulated chemokine (PARC) [Срок оценки: Baseline to Week 60]
• Change in serum concentrations of IgE [Срок оценки: Baseline to Week 60]

Критерии участия

Критерии включения

• Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
• Male or female adults ages 40 to 85 years old when signing the informed consent.
• Current or former smokers with a smoking history of ≥10 pack-years.
• Documented diagnosis of COPD for at least 12 months prior to enrolment
• Moderate-to-severe COPD.
• Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
• Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥ 1 month prior to randomization; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
• Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose.

Критерии исключения

• Presence of a known pre-existing, clinically important lung condition other than COPD.
• A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
• Diagnosis of α-1 anti-trypsin deficiency.
• Presence of an active autoimmune disease.
• Subjects who have any malignant tumors within 5 years prior to enrollment.
• Known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled.
• Diagnosed active parasitic infection, suspected or high risk of parasitic infection.
• Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
• Known with allergic or intolerant to any biological product.
• Any reason which, in the opinion of investigator, would prevent the subject from participating 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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• China-Japan Friendship Hospital — Пекин
• Shenzhen People's Hospital — Шэньчжэнь
• Jiangsu Province Hospital — Нанкин
• ZheJiang Provincial People's Hospital — Ханчжоу

Идентификаторы

NCT: NCT07039669 · SSGJ-611-COPD-III-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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