Study With Phage for CF Subjects With Pseudomonas Lung Infection
BiomX Ltd · NCT06998043
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 63
- US sites recruiting
- 9
- Study start
- July 2, 2025
- Record last updated
- July 22, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: BX004; Placebo
Conditions: Chronic Pseudomonas Aeruginosa Infection; Cystic Fibrosis (CF)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
University of Alabama at Birmingham
Birmingham, AL 35233
Site contact: Study Coordinator · 205-638-5599 · kathrynmonroe@uabmc.edu
University of California San Francisco
San Francisco, CA 94143
Site contact: Study Coordinator · 415-476-8073 · Legna.Betancourt@ucsf.edu
National Jewish Health
Denver, CO 80206
Site contact: Study Coordinator · 303-270-2517 · wilsona@njhealth.org
Central Florida Pulmonary Group
Orlando, FL 32803
Site contact: Study Coordinator · 407-841-1100 · dserr@cfpulmonary.com
Avanza Medical Center
Pensacola, FL 32503
Site contact: Study Coordinator · 850-477-7900 · startup@avanzaresearch.com
Rutgers, Robert Wood Johnson Medical School
New Brunswick, NJ 08901
Site contact: Study Coordinator · 732-235-6402 · warusaan@rwjms.rutgers.edu
New York Medical College
Hawthorne, NY 10593
Site contact: Study Coordinator · 914-504-0152 · zachary_messer@nymc.edu
Northwell Health
New York, NY 10028
Site contact: Study Coordinator · 212-434-4790 · Tdemarco3@northwell.edu
Vanderbilt University Medical Center
Nashville, TN 37232
Site contact: Study Coordinator · 615-343-4865 · valencia.bryant@vumc.org
Study contacts (from the official record)
- Urania Rappo, MD · 1-617-256-2625 · uraniar@biomx.com