Study With Phage for CF Subjects With Pseudomonas Lung Infection
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects With Chronic Pseudomonas Aeruginosa (PsA) Pulmonary Infection
BiomX Ltd
63 participants
Jul 2, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this Phase 2b clinical trial is to see if nebulized phage (BX004) can treat chronic Pseudomonas aeruginosa (PsA) lung infection in CF subjects. The primary goal is to see if 8 weeks of twice daily BX004 can reduce the amount of PsA in the sputum compared to placebo (on top of background CF therapy).
Eligibility
Inclusion Criteria5
- Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care inhaled antibiotics (cycling or continuous regimen) or no inhaled antibiotics
- Age ≥ 18 years
- FEV1 40%-80% predicted
- Clinically stable lung disease
- Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits.
Exclusion Criteria11
- Known hypersensitivity to bacteriophages or excipients in the formulation.
- Receipt of prior bacteriophage therapy within the 6 months prior to Screening or Day 1
- Detection of Burkholderia cenocepacia from respiratory tract within 1 year prior to Screening or from Screening culture
- Currently receiving systemic treatment for allergic bronchopulmonary aspergillosis
- Currently receiving treatment for active infection with non-tuberculous mycobacteria or prior detection of Mycobacterium abscessus in 12 months prior to Screening
- History of severe neutropenia
- History of lung transplant
- History of solid organ transplant
- Acquired or primary immunodeficiency syndrome
- Initiation or change in type of CFTR modulator less than 3 months prior to Screening
- Pregnant or breastfeeding female
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Interventions
Bacteriophage
Placebo
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06998043