What this study is
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).
What's being tested
- BX004
Intervention · BIOLOGICAL
Bacteriophage
- Placebo
Intervention · OTHER
Placebo
Study details
- Official title
- 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
- Sponsor
- BiomX Ltd
- Conditions
- Chronic Pseudomonas Aeruginosa Infection · Cystic Fibrosis (CF)
- Enrolling
- 63 people
- Starts
- 2025-07-02
- Est. completion
- 2026-09
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (14)
14 openUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
- Study Coordinator · Contact205-638-5599kathrynmonroe@uabmc.edu
RecruitingProvidence Alaska Medical Center
Anchorage, Alaska, United States
- Study Coordinator · Contact907-212-3299emlynnemae.villanos@providence.org
Not yet recruitingUniversity of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
- Study Coordinator · Contact501-686-5525hickskathleent@uams.edu
Not yet recruitingStanford University
Palo Alto, California, United States
- Study Coordinator · Contact650-723-6381jmzirbes@stanford.edu
Not yet recruitingUniversity of California San Francisco
San Francisco, California, United States
- Study Coordinator · Contact415-476-8073Legna.Betancourt@ucsf.edu
RecruitingNational Jewish Health
Denver, Colorado, United States
- Study Coordinator · Contact303-270-2517wilsona@njhealth.org
RecruitingJoe DiMaggio Children's Health
Hollywood, Florida, United States
- Study Coordinator · Contact954-265-6333lancohen@mhs.net
Not yet recruitingCentral Florida Pulmonary Group
Orlando, Florida, United States
- Study Coordinator · Contact407-841-1100dserr@cfpulmonary.com
RecruitingAvanza Medical Center
Pensacola, Florida, United States
- Study Coordinator · Contact850-477-7900startup@avanzaresearch.com
RecruitingRutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
- Study Coordinator · Contact732-235-6402warusaan@rwjms.rutgers.edu
RecruitingNew York Medical College
Hawthorne, New York, United States
- Study Coordinator · Contact914-504-0152zachary_messer@nymc.edu
RecruitingNorthwell Health
New York, New York, United States
- Study Coordinator · Contact212-434-4790Tdemarco3@northwell.edu
RecruitingVanderbilt University Medical Center
Nashville, Tennessee, United States
- Study Coordinator · Contact615-343-4865valencia.bryant@vumc.org
RecruitingUniversity of Utah
Salt Lake City, Utah, United States
- Study Coordinator · Contact801-703-5353judy.jensen@hsc.utah.edu
Not yet recruiting
Study team
Sponsor
BiomX Ltd
Study ID BMX-04-002
Study director
Urania Rappo, MD
BiomX, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.