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
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alaska
Providence Alaska Medical Center
NOT_YET_RECRUITING
Anchorage
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arkansas
University of Arkansas for Medical Sciences
NOT_YET_RECRUITING
Little Rock
California
Stanford University
NOT_YET_RECRUITING
Palo Alto
University of California San Francisco
RECRUITING
San Francisco
Colorado
National Jewish Health
RECRUITING
Denver
Florida
Joe DiMaggio Children's Health
NOT_YET_RECRUITING
Hollywood
Central Florida Pulmonary Group
RECRUITING
Orlando
Avanza Medical Center
RECRUITING
Pensacola
New Jersey
Rutgers, Robert Wood Johnson Medical School
RECRUITING
New Brunswick
New York
New York Medical College
RECRUITING
Hawthorne
Northwell Health
RECRUITING
New York
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Utah
University of Utah
NOT_YET_RECRUITING
Salt Lake City
Contact Information
Primary
Urania Rappo, MD
uraniar@biomx.com
1-617-256-2625
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2026-09
Participants
Target number of participants: 63
Treatments
Experimental: BX004
Participants will be randomized to receive standard dose of nebulized bacteriophage
Placebo_comparator: Placebo
Participants will be randomized to receive nebulized placebo
Related Therapeutic Areas
Sponsors
Leads: BiomX Ltd