A Phase 2B Study of Nebulized CSL787 in Adults in Non-Cystic Fibrosis Bronchiestasis
Research type
Research Study
Full 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
IRAS ID
1011627
Contact name
Michael Larbig
Contact email
Sponsor organisation
CSL Behring LLC
Eudract number
2024-518821-13
Research 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 6 to 12 months to prolong the time to first (TTF) exacerbation as a primary endpoint.
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 over a period of greater than or equal to (>=) 6 months but not exceeding 12 months toward prolonging the TTF exacerbation.
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 over a period of greater than or equal to (>=) 6 months but not exceeding 12 months toward prolonging the TTF exacerbation.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
25/SW/0065
Date of REC Opinion
4 Jul 2025
REC opinion
Further Information Favourable Opinion