Status:
RECRUITING
Study With Phage for CF Subjects With Pseudomonas Lung Infection
Lead Sponsor:
BiomX Ltd
Conditions:
Chronic Pseudomonas Aeruginosa Infection
Cystic Fibrosis (CF)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 twi...
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 BX...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
July 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06998043
Start Date
July 2 2025
End Date
September 1 2026
Last Update
July 22 2025
Active Locations (14)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
3
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
Stanford University
Palo Alto, California, United States, 94061