Chronic Pseudomonas Aeruginosa InfectionPhase 2NCT06998043
Study With Phage for CF Subjects With Pseudomonas Lung Infection
A Phase 2 study testing BX004 in people with Chronic Pseudomonas Aeruginosa Infection and Cystic Fibrosis (CF), run by BiomX Ltd at 14 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis (CF)
- What is being tested?
- BX004
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 14 sitesUnited States
- Study dates
- 2 Jul 2025to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Not yet recruiting
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Study Coordinator, 907-212-3299, emlynnemae.villanos@providence.org
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Study Coordinator, 205-638-5599, kathrynmonroe@uabmc.edu
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Study Coordinator, 303-270-2517, wilsona@njhealth.org
- Recruiting
New York Medical College
Hawthorne, New York, 10593
Study Coordinator, 914-504-0152, zachary_messer@nymc.edu
- Not yet recruiting
Joe DiMaggio Children's Health
Hollywood, Florida, 33021
Study Coordinator, 954-265-6333, lancohen@mhs.net
- Not yet recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Study Coordinator, 501-686-5525, hickskathleent@uams.edu
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Study Coordinator, 615-343-4865, valencia.bryant@vumc.org
- Recruiting
Rutgers, Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Study Coordinator, 732-235-6402, warusaan@rwjms.rutgers.edu
- Recruiting
Northwell Health
New York, New York, 10028
Study Coordinator, 212-434-4790, Tdemarco3@northwell.edu
- Recruiting
Central Florida Pulmonary Group
Orlando, Florida, 32803
Study Coordinator, 407-841-1100, dserr@cfpulmonary.com
- Not yet recruiting
Stanford University
Palo Alto, California, 94061
Study Coordinator, 650-723-6381, jmzirbes@stanford.edu
- Recruiting
Avanza Medical Center
Pensacola, Florida, 32503
Study Coordinator, 850-477-7900, startup@avanzaresearch.com
- Not yet recruiting
University of Utah
Salt Lake City, Utah, 84132
Study Coordinator, 801-703-5353, judy.jensen@hsc.utah.edu
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Study Coordinator, 415-476-8073, Legna.Betancourt@ucsf.edu
About this study
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
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).
Read the 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.
- Being tested
- BX004, Placebo
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BX004Biological
Also called Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa
Bacteriophage
PlaceboOther
Also called Nebulized placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BX004 | Experimental | Participants will be randomized to receive standard dose of nebulized bacteriophage Receives: Biological: BX004 |
| Placebo | Placebo comparator | Participants will be randomized to receive nebulized placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sputum Pseudomonas aeruginosa (PsA) burden at 8 weeks (EOT)
Change from baseline in PsA colony-forming units (CFU) per g of sputum
Measured: 8 weeks
Secondary outcomes (6)
Change in lung function at D8, D29, D43, D57 (EOT), D85, 3 months post-dose, and 6 months post-dose
Change from baseline in % predicted FEV1
Measured: from Day 8 until 6 months after last dose (end of study)
Change from Baseline in CFQ-R respiratory domain
Cystic Fibrosis Questionnaire - Revised (CFQ-R) respiratory domain: change at D29, D43, D57 (EOT), D85, 3 months post-dose, and 6 months post-dose (range 0-100; higher score=better outcome)
Measured: until 6 months after last dose of study drug
Change from Baseline in CFRSD-CRISS
Cystic Fibrosis Respiratory Symptom Diary and Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) weekly changes through D14 (daily completion), weekly changes from D21 through D85, and at 3 months post-dose, and 6 months post-dose (range 0-100; higher score=worse outcome)
Measured: until 6 months after last dose of study drug
Change in sputum PsA burden
Change from baseline in sputum PsA CFU/g at D8, D29, D43, D85, 3 months post-dose and 6 months post-dose
Measured: until 6 months after last dose of study drug
Efficacy of BX004 on obtaining negative sputum cultures for PsA
Proportion of subjects with negative sputum cultures for PsA, time to negative sputum cultures, durability of negative sputum cultures
Measured: until 6 months after last dose of study drug
Incidence of treatment-emergent adverse events [safety and tolerability]
Incidence of treatment-emergent adverse events
Measured: until 6 months after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start2 Jul 2025
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pseudomonas Aeruginosa InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BiomX Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Urania Rappo, MD, Study director, BiomX, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998043
- Sponsor's protocol ID
- BMX-04-002
- Status last verified
- Jul 2025
- First submitted
- 10 May 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Blinded clinical trial
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06998043
- Acronym / sponsor ID
- BMX-04-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- BiomX LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BX004 | Experimental | Biological: BX004Participants will be randomized to receive standard dose of nebulized bacteriophage |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be randomized to receive nebulized placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BX004Also: Combination of nebulized bacteriophages targeting Pseudomonas aeruginosaBacteriophage | Biological | BX004 |
| PlaceboAlso: Nebulized placeboPlacebo | Other | Placebo |
Primary outcome
Change in sputum Pseudomonas aeruginosa (PsA) burden at 8 weeks (EOT)
Time frame: 8 weeks
Change from baseline in PsA colony-forming units (CFU) per g of sputum
6 secondary outcomes
Change in lung function at D8, D29, D43, D57 (EOT), D85, 3 months post-dose, and 6 months post-dose
Time frame: from Day 8 until 6 months after last dose (end of study)
Change from Baseline in CFQ-R respiratory domain
Time frame: until 6 months after last dose of study drug
Change from Baseline in CFRSD-CRISS
Time frame: until 6 months after last dose of study drug
Change in sputum PsA burden
Time frame: until 6 months after last dose of study drug
Efficacy of BX004 on obtaining negative sputum cultures for PsA
Time frame: until 6 months after last dose of study drug
Incidence of treatment-emergent adverse events [safety and tolerability]
Time frame: until 6 months after last dose of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No. Blinded clinical trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Urania Rappo, MD study director
BiomX, Inc.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BX004 in people with Chronic Pseudomonas Aeruginosa Infection and Cystic Fibrosis (CF), run by BiomX Ltd at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Urania Rappo, MD (1-617-256-2625, uraniar@biomx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sputum Pseudomonas aeruginosa (PsA) burden at 8 weeks (EOT) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.