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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria shortened, about 8 wordsv4 See this version in full on ClinicalTrials.gov ↗
  2. Trial status: Not Yet Recruiting to Recruiting Primary endpoint revised · Study sites: 0 to 13 · Start date changed from estimate of Sep 27, 2025 to Sep 3, 2025 · 2 morev3 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 0 to 13
    • Start date changed from estimate of Sep 27, 2025 to Sep 3, 2025
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (7)

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Jul 27, 2025 to Sep 27, 2025v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
CSL Behring
30 trials monitored
See 2 trials at risk
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.
Trial Details
NCT Number NCT07048262
Lead Sponsor CSL Behring
Conditions Non-cystic Fibrosis Bronchiectasis
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov