Study With Phage for CF Subjects With Pseudomonas Lung Infection
Start Date
7/2/2025
Completion Date
9/1/2026
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).
Detailed Description
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate BX004 in CF subjects with chronic PsA pulmonary infection. The main purpose of the study is to evaluate whether BX004 reduces the PsA burden in the sputum of CF subjects with chronic PsA pulmonary infection. Secondary endpoints are to see how well BX004 works in improving lung function and quality of life, reducing the amount of PsA in the sputum, getting negative sputum cultures for PsA, and safety and tolerability. Clinically stable CF subjects with a confirmed diagnosis of CF and chronic PsA pulmonary infection will be enrolled. Subjects will be included in a 6-month post-dose safety follow-up. A Data Safety Monitoring Board of the CF Foundation will monitor safety.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BX004
Placebo
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
United States
Providence Alaska Medical Center
Anchorage, Alaska 99508
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United States
Stanford University
Palo Alto, California 94061
United States
University of California San Francisco
San Francisco, California 94143
United States
National Jewish Health
Denver, Colorado 80206
United States
Joe DiMaggio Children's Health
Hollywood, Florida 33021
United States
Central Florida Pulmonary Group
Orlando, Florida 32803
United States
Avanza Medical Center
Pensacola, Florida 32503
United States
Rutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901
United States
New York Medical College
Hawthorne, New York 10593
United States
Northwell Health
New York, New York 10028
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
University of Utah
Salt Lake City, Utah 84132
United States