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Recruiting Phase 2

Study With Phage for CF Subjects With Pseudomonas Lung Infection

NCT06998043 · tracked via the Priya Life Science USA tracker
Sponsor
BiomX Ltd
Phase
Phase 2
Started
2025-07-02
Last updated
2025-07-22

Condition(s) studied

Chronic Pseudomonas Aeruginosa InfectionCystic Fibrosis (CF)

Investigational drug(s) / intervention(s)

BX004Placebo

BX004: Bacteriophage

Placebo: Placebo

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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

Primary outcome measure(s)

  • Change in sputum Pseudomonas aeruginosa (PsA) burden at 8 weeks (EOT) — 8 weeks
    Change from baseline in PsA colony-forming units (CFU) per g of sputum

Trial sites (14)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Providence Alaska Medical Center Anchorage Alaska Not Yet Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Not Yet Recruiting
Stanford University Palo Alto California Not Yet Recruiting
University of California San Francisco San Francisco California Recruiting
National Jewish Health Denver Colorado Recruiting
Joe DiMaggio Children's Health Hollywood Florida Not Yet Recruiting
Central Florida Pulmonary Group Orlando Florida Recruiting
Avanza Medical Center Pensacola Florida Recruiting
Rutgers, Robert Wood Johnson Medical School New Brunswick New Jersey Recruiting
New York Medical College Hawthorne New York Recruiting
Northwell Health New York New York Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
University of Utah Salt Lake City Utah Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06998043 on ClinicalTrials.gov ↗ ← All trials in the USA