Non-cystic Fibrosis BronchiectasisPhase 2NCT07048262
Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
A Phase 2 study testing CSL787 and Nebulizer in people with Non-cystic Fibrosis Bronchiectasis, run by CSL Behring at 13 sites in 2 countries.
Trial summary
This study is a proof-of-concept phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose selection study designed to explore the efficacy, safety, and tolerability of 2 active treatment regimens of CSL787 (human normal immunoglobulin G [IgG] inhalation solution) compared with placebo… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- CSL787 and Nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 3 Sep 2025to 6 Jun 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
Japan11 sites, 11 recruiting
- Recruiting
Fukuoka University Chikushi Hopsital
Chikushino-shi
- Recruiting
Kyusho Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuoka
- Recruiting
Ibaraki Prefectural Central Hospital
Ibaraki
- Recruiting
Kazunori Tobino Iizuka Hospital
Iizuka-shi
- Recruiting
National Hospital Organization Minami Kyoto Hospital
Kyoto
- Recruiting
Matsusaka Municipal Hospital
Mie
- Recruiting
National Hospital Organization Kinki Chuo Chest Medical Center
Osaka
- Recruiting
Shimonoseki City Hospital
Shimonoseki-shi
- Recruiting
Japan Anti-Tuberculosis Association, Fukujuji Hospital
Tokyo
- Recruiting
Keio University Hospital
Tokyo
- Recruiting
National Hospital Organization Mie Chuo Medical Center
Tsu
Australia2 sites, 2 recruiting
- Recruiting
The Prince Charles Hospital
Queensland
- Recruiting
Westmead Hospital
Westmead
About this study
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
This study is a proof-of-concept phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose selection study designed to explore the efficacy, safety, and tolerability of 2 active treatment regimens of CSL787 (human normal immunoglobulin G [IgG] inhalation solution) compared with placebo over 52 weeks.
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 time to first (TTF) exacerbation.
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Being tested
- CSL787, Placebo, Nebulizer
- Keywords
- Chronic respiratory disease, Inflammation, Chronic bacterial infection
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL787Biological
CSL787 high or low doses once daily (QD) will be administered via inhalation over a period of 52 weeks.
PlaceboDrug
Participants will receive a matching volume of placebo QD over a period of 52 weeks.
NebulizerDevice
The nebulizer is a CE-marked device.
| Study group | Role | What they receive |
|---|---|---|
| CSL787 High Dose | Experimental | Participants in this arm will receive a high dose of CSL787. Receives: Biological: CSL787; Device: Nebulizer |
| CSL787 Low Dose | Experimental | Participants in this arm will receive a low dose of CSL787. Receives: Biological: CSL787; Device: Nebulizer |
| Placebo | Placebo comparator | Participants in this arm will receive placebo. Receives: Drug: Placebo; Device: Nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first (TTF) Exacerbation
TTF exacerbation, where an exacerbation is defined as a deterioration in ≥ 3 of the following symptoms for ≥ 48 hours: cough; sputum volume and / or consistency; sputum purulence; breathlessness and / or exercise tolerance; fatigue and / or malaise; hemoptysis AND a clinician determines that antibiotic therapy is required.
Measured: Up to Week 52
Secondary outcomes (7)
Number of exacerbations over the Treatment and Observation Period
Measured: Up to Week 52
Number of Participants Achieving a Minimally Clinically Important Difference (MCID) in the Quality of Life-Bronchiectasis (QoL-B) Respiratory Symptoms Scale
The QoL-B questionnaire is a self-administered measure assessing symptoms, functioning, and health-related quality of life for patients with NCFB. This questionnaire contains 37 items on 8 different scales (Respiratory symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions, and Treatment Burden). For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life.
Measured: Up to Week 52
Percentage of Participants Achieving a MCID in the QoL-B Respiratory Symptoms Scale
The QoL-B questionnaire is a self-administered measure assessing symptoms, functioning, and health-related quality of life for patients with NCFB. This questionnaire contains 37 items on 8 different scales (Respiratory symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions, and Treatment Burden). For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life.
Measured: Up to Week 52
Change From Baseline in QoL-B Respiratory Symptoms Scale
The QoL-B questionnaire is a self-administered measure assessing symptoms, functioning, and health-related quality of life for patients with NCFB. This questionnaire contains 37 items on 8 different scales (Respiratory symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions, and Treatment Burden). For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life.
Measured: Baseline to Week 52
Change From Baseline in Total Colony-forming Unit (CFUs) for Pathogenic Bacteria Isolated from Sputum
Measured: Baseline up to Week 52
Number of Participants with Treatment-emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to Week 56
Percentage of Participants with TEAEs and SAEs
Measured: Up to Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start3 Sep 2025
- Primary completion6 May 2029 (estimated)
- Study completion6 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, parallel-group, placebo-controlled study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048262
- Sponsor's protocol ID
- CSL787_2001
- Other IDs
- 2024-518821-13-00
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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 clinicaltrials@cslbehring.com.