Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)

Официальное название

A Phase 2b, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 Years) With Non-cystic Fibrosis Bronchiectasis

Обзор

This study is a phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose range finding study designed to explore the efficacy, safety, and tolerability of 2 active treatment regimens of CSL787 (immunoglobulin G \[IgG\] inhalation solution) compared with placebo over a period of 6 to 12 months independent of the occurrence of pulmonary exacerbations. The primary aim of the study is to characterize the overall effect of CSL787 as well as the dose response of 2 active treatment regimens of inhaled CSL787 administered to participants with NCFB toward prolonging the TTF exacerbation.

Вмешательства

• Биопрепарат CSL787
  CSL787 high or low doses once daily (QD) will be administered via inhalation over a period of 6 to 12 months.
• Препарат Placebo
  Participants will receive a matching volume of placebo QD over a period of 6 to 12 months.
• Устройство Nebulizer
  The nebulizer is a CE-marked device.

Первичные конечные точки

• Time to first (TTF) Exacerbation [Срок оценки: Up to Month 12]

Вторичные конечные точки (7)

• Annualized Exacerbation Rate (AER) (Exacerbation Event Rate Per-participant Year) [Срок оценки: Up to Month 12]
• Number of Participants Achieving a Clinically Important Difference in the Quality of Life-Bronchiectasis (QoL-B) Respiratory Symptoms Scale [Срок оценки: Up to Month 12]
• Percentage of Participants Achieving a Clinically Important Difference in the QoL-B Respiratory Symptoms Scale [Срок оценки: Up to Month 12]
• Change From Baseline in QoL-B Respiratory Symptoms Scale [Срок оценки: From Baseline to Months 6 and 12]
• Change From Baseline in Total Colony-forming Unit (CFUs) for Pathogenic Bacteria Isolated from Sputum [Срок оценки: From Baseline to Month 1]
• Number of Participants with Treatment-emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to Month 13]
• Percentage of Participants with TEAEs and SAEs [Срок оценки: Up to Month 13]

Критерии участия

Критерии включения

• Adult between the ages of 18 to 85 years
• Primary diagnosis of NCFB confirmed by chest computed tomography (CT) scan, where bronchiectasis has been documented by a radiologist. Diagnosis in the medical records based on historical scans is acceptable if the chest CT scan confirming the participant's NCFB diagnosis was performed within 12 months before enrollment. Participants for whom no chest CT scan results are available within the previous 12 months will undergo a chest CT scan during the Screening Period
• Exacerbation history within the previous 1 year defined as either 1 of the following:
• >= 2 documented exacerbations requiring oral and/or intravenous (IV) antibiotic therapy to treat a pulmonary infection.

OR

• 1 documented exacerbation requiring oral and/or IV antibiotic therapy to treat a pulmonary infection and a St. George's Respiratory Questionnaire (SGRQ) Symptoms score of > 40 at Screening.
• Note: Other medications to treat NCFB such as: oral macrolides, or dipeptidyl peptidase-1 (DPP-1) inhibitors are allowed, provided >= 1 historical exacerbation occurred while on the medication for >= 3 months at a stable dose.
• Postbronchodilator percentage of the predicted normal forced expiratory volume in 1 second of expiration \[FEV1% predicted\] > 35% and forced expiratory volume in 1 second (FEV1) >= 1 liter (L) obtained in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) standards for spirometry during Screening and at Baseline.

Критерии исключения

• History of bronchospasm in response to inhaled therapies including inhaled antibiotics
• Known or suspected hypersensitivity, or other severe reactions, to the investigational product (IP), to any excipients of the IP, or to other immunoglobulin.
• Primary diagnosis of other pulmonary disorders, including chronic obstructive pulmonary disease (COPD) asthma or, diffuse panbronchiolitis (DPB), as determined by the investigator.
• Pulmonary exacerbation requiring antibiotic therapy within the 4 weeks before Baseline.

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

Япония · 11 центров

• Fukuoka University Chikushi Hopsital — Chikushino-shi
• Kyusho Central Hospital of the Mutual Aid Association of Public School Teachers — Fukuoka
• Ibaraki Prefectural Central Hospital — Ibaraki
• Kazunori Tobino Iizuka Hospital — Iizuka-shi
• National Hospital Organization Minami Kyoto Hospital — Kyoto
• Matsusaka Municipal Hospital — Mie
• National Hospital Organization Kinki Chuo Chest Medical Center — Osaka
• Shimonoseki City Hospital — Shimonoseki-shi
• … и ещё 3 центра

Австралия · 2 центра

• The Prince Charles Hospital — Queensland
• Westmead Hospital — Westmead

Идентификаторы

NCT: NCT07048262 · CSL787_2001 · 2024-518821-13-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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