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RECRUITING
NCT07048262
PHASE2

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

Sponsor: CSL Behring

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2025-09-03

Completion Date

2028-03-28

Last Updated

2025-11-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

CSL787

CSL787 high or low doses once daily (QD) will be administered via inhalation over a period of 6 to 12 months.

DRUG

Placebo

Participants will receive a matching volume of placebo QD over a period of 6 to 12 months.

DEVICE

Nebulizer

The nebulizer is a CE-marked device.

Locations (13)

The Prince Charles Hospital

Queensland, Australia

Westmead Hospital

Westmead, Australia

Fukuoka University Chikushi Hopsital

Chikushino-shi, Japan

Kyusho Central Hospital of the Mutual Aid Association of Public School Teachers

Fukuoka, Japan

Ibaraki Prefectural Central Hospital

Ibaraki, Japan

Kazunori Tobino Iizuka Hospital

Iizuka-shi, Japan

National Hospital Organization Minami Kyoto Hospital

Kyoto, Japan

Matsusaka Municipal Hospital

Mie, Japan

National Hospital Organization Kinki Chuo Chest Medical Center

Osaka, Japan

Shimonoseki City Hospital

Shimonoseki-shi, Japan

Japan Anti-Tuberculosis Association, Fukujuji Hospital

Tokyo, Japan

Keio University Hospital

Tokyo, Japan

National Hospital Organization Mie Chuo Medical Center

Tsu, Japan