NCT06998043 Study With Phage for CF Subjects With Pseudomonas Lung Infection
| NCT ID | NCT06998043 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | BiomX Ltd |
| Condition | Chronic Pseudomonas Aeruginosa Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 63 participants in total. It began in 2025-07-02 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Urania Rappo, MD
STUDY DIRECTOR
BiomX, Inc.
Frequently Asked Questions
Who can join the NCT06998043 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pseudomonas Aeruginosa Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06998043 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06998043 currently recruiting?
Yes, NCT06998043 is actively recruiting participants. Contact the research team at uraniar@biomx.com for enrollment information.
Where is the NCT06998043 trial being conducted?
This trial is being conducted at Birmingham, United States, Anchorage, United States, Little Rock, United States, Palo Alto, United States and 10 additional locations.
Who is sponsoring the NCT06998043 clinical trial?
NCT06998043 is sponsored by BiomX Ltd. The principal investigator is Urania Rappo, MD at BiomX, Inc.. The trial plans to enroll 63 participants.