Nebulized CSL787 (inhaled IgG) to reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group dose-ranging study comparing two active dosing regimens of nebulized CSL787 versus placebo over 6 to 12 months. Adults with non-cystic fibrosis bronchiectasis confirmed by chest CT and with a recent history of exacerbations are eligible. Participants will inhale CSL787 or placebo via a nebulizer on a scheduled regimen while investigators record time to first pulmonary exacerbation, safety, and tolerability. The trial is designed to characterize dose response and the overall effect of inhaled CSL787 on prolonging time to first exacerbation.

Why it matters

Who can join: the full rules

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.

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.

Where it's running

• The Prince Charles Hospital
  Queensland, Australia Recruiting
• Westmead Hospital
  Westmead, Australia Recruiting
• Fukuoka University Chikushi Hopsital
  Chikushino-shi, Japan Recruiting
• Kyusho Central Hospital of the Mutual Aid Association of Public School Teachers
  Fukuoka, Japan Recruiting
• Ibaraki Prefectural Central Hospital
  Ibaraki, Japan Recruiting
• Kazunori Tobino Iizuka Hospital
  Iizuka-shi, Japan Recruiting

Study contacts

• Study coordinator: Trial Registration Coordinator
• Email: clinicaltrials@cslbehring.com
• Phone: +1 610-878-4697

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Galvokimig vs placebo for non-CF bronchiectasis in adults

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• Azithromycin added to usual care to see if it lowers bronchiectasis flare-ups

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• Bronchiectasis Phenotype Identification Model for Adults

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• BASE: Aiming to test a simple, objective way to gauge bronchiectasis severity and predict flare-ups

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• Assessing a new treatment for non-cystic fibrosis bronchiectasis

  This study is testing a new treatment called HSK31858 to see if it can help people with non-cystic fibrosis bronchiectasis feel better and have fewer flare-ups.

  Recruiting at 2 sites Phase 3 Haisco Pharmaceutical Group Co., Ltd. · Guangzhou, Guangdong and 1 other locations · NCT06660992

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.