A Study to Evaluate Solrikitug in Participants With COPD (ZION)

Официальное название

A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants With Chronic Obstructive Pulmonary Disease (ZION)

Обзор

A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (COPD).

Подробное описание

This is a 12-week randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 2 dose levels of solrikitug versus placebo on top of standard of care in participants with COPD.

Approximately 171 eligible participants with COPD will be randomized at approximately 60-90 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 12-week treatment period. The study also includes a post-treatment follow-up period of 16 weeks.

Вмешательства

• Биопрепарат Biological: Solrikitug low dose
  Solrikitug subcutaneous injection
• Биопрепарат Biological: Solrikitug high dose
  Solrikitug subcutaneous injection
• Другое Placebo
  Placebo subcutaneous injection

Первичные конечные точки

• Change from baseline in blood eosinophil counts [Срок оценки: Through week 12]

Вторичные конечные точки (1)

• Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: Through week 12 To week 28]

Критерии участия

Критерии включения

• At least 40 years of age and no older than 75 years.
• Documented diagnosis of COPD for at least 12 months prior to Screening, defined by the GOLD Guidelines (2023), and elevated blood eosinophils at screening.
• At Screening FEV1/FVC ratio must be <0.70, and Post-bronchodilator FEV1 must be ≥40% to <80% predicted normal value calculated using Global Lung Function Initiative (GLI) reference equations (Cooper et al 2017).
• Symptomatic (COPD Assessment Test \[CAT\] Score ≥10) at Screening Visit 1.
• Participants must be on 2 or more inhaled maintenance medications for management of their COPD, for at least 3 months prior to screening.

Критерии исключения

• Female participant who is pregnant or breastfeeding.
• Participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody.
• Participant has history or evidence of any clinically significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the Investigator or Medical Monitor might obfuscate the study data.
• Any other pulmonary disease than COPD that in the opinion of the Investigator, the severity of the disorder would impact the conduct of the study.
• Undergone major lung surgery, within 1 year of Screening Visit 1.
• Participant has a lower respiratory tract infection that required antibiotics within 6 weeks prior to Screening.

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

США · 101 центр

• University of Alabama at Birmingham Hospital — Birmingham
• Syed Research Consultants — Sheffield
• Phoenix Medical Group — Peoria
• Epic Medical Research-Surprise — Sun City
• Alliance for Multispecialty Research — Tempe
• Novak Clinical Research — Tucson
• Antelope Valley Clinical Trials — Lancaster
• Ark Clinical Research - Ballinger — Long Beach
• … и ещё 93 центра

Новая Зеландия · 7 центров

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Великобритания · 5 центров

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Австралия · 4 центра

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Канада · 1 центр

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Идентификаторы

NCT: NCT06496620 · NSI-8226-205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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