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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07048262




Registration number
Help: Registration number
NCT07048262
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
24/06/2025
Date registered
Help: Date registered
2/07/2025
Date last updated
Help: Date last updated
19/10/2026

Titles & IDs
Public title
Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
Scientific 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
Additional trial identifiers [1] 0 0
2024-518821-13-00
Additional trial identifiers [2] 0 0
CSL787_2001
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Non-cystic Fibrosis Bronchiectasis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Other - CSL787
Treatment: Drugs - Placebo
Treatment: Devices - Nebulizer

Experimental: CSL787 High Dose - Participants in this arm will receive a high dose of CSL787.

Experimental: CSL787 Low Dose - Participants in this arm will receive a low dose of CSL787.

Placebo comparator: Placebo - Participants in this arm will receive placebo.


Treatment: Other: CSL787
CSL787 high or low doses once daily (QD) will be administered via inhalation over a period of 52 weeks.

Treatment: Drugs: Placebo
Participants will receive a matching volume of placebo QD over a period of 52 weeks.

Treatment: Devices: Nebulizer
The nebulizer is a CE-marked device.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Devices
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Time to first (TTF) Exacerbation
Timepoint [1] 0 0
Up to Week 52
Secondary outcome [1] 0 0
Number of exacerbations over the Treatment and Observation Period
Timepoint [1] 0 0
Up to Week 52
Secondary outcome [2] 0 0
Number of Participants Achieving a Minimally Clinically Important Difference (MCID) in the Quality of Life-Bronchiectasis (QoL-B) Respiratory Symptoms Scale
Timepoint [2] 0 0
Up to Week 52
Secondary outcome [3] 0 0
Percentage of Participants Achieving a MCID in the QoL-B Respiratory Symptoms Scale
Timepoint [3] 0 0
Up to Week 52
Secondary outcome [4] 0 0
Change From Baseline in QoL-B Respiratory Symptoms Scale
Timepoint [4] 0 0
Baseline to Week 52
Secondary outcome [5] 0 0
Change From Baseline in Total Colony-forming Unit (CFUs) for Pathogenic Bacteria Isolated from Sputum
Timepoint [5] 0 0
Baseline up to Week 52
Secondary outcome [6] 0 0
Number of Participants with Treatment-emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [6] 0 0
Up to Week 56
Secondary outcome [7] 0 0
Percentage of Participants with TEAEs and SAEs
Timepoint [7] 0 0
Up to Week 56

Eligibility
Key inclusion criteria
* Adult between the ages of 18 to 85 years
* Capable of spontaneous sputum production at Screening.
* 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 documented 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 one of the following:
* greater than or equal (=) 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 greater than (>) 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 percent predicted forced expiratory volume in 1 second (FEV1%) > 35% and forced expiratory volume in 1 second (FEV1) = 1 L obtained in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) standards for spirometry during Screening and at Baseline on Day 1.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
* History of severe or uncontrolled asthma, or 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 immunoglobulins.
* Primary diagnosis of other pulmonary disorders, including chronic obstructive pulmonary disease (COPD), asthma, or diffuse panbronchiolitis (DPB), as determined by the investigator.
* Use of oral, IV, or inhaled antibiotic therapy to treat a pulmonary exacerbation or any other condition within 4 weeks before Baseline measurements on Day 1.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/09/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/06/2029
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Queensland
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Queensland
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
Japan
State/province [1] 0 0
Chikushino-shi
Country [2] 0 0
Japan
State/province [2] 0 0
Fukuoka
Country [3] 0 0
Japan
State/province [3] 0 0
Ibaraki
Country [4] 0 0
Japan
State/province [4] 0 0
Iizuka-shi
Country [5] 0 0
Japan
State/province [5] 0 0
Kyoto
Country [6] 0 0
Japan
State/province [6] 0 0
Mie
Country [7] 0 0
Japan
State/province [7] 0 0
Osaka
Country [8] 0 0
Japan
State/province [8] 0 0
Shimonoseki-shi
Country [9] 0 0
Japan
State/province [9] 0 0
Tokyo
Country [10] 0 0
Japan
State/province [10] 0 0
Tsu

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CSL Behring
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
CSL Behring
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Registration Coordinator
Address 0 0
Country 0 0
Phone 0 0
+1 610-878-4697
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at [email protected].

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Requests for IPD will generally be considered once review by major regulatory authorities (i.e. FDA, EMA) is complete and the primary publication is available.
Available to whom?
Proposed research should seek to answer a previously unanswered important medical or scientific question.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07048262