Study With Phage for CF Subjects With Pseudomonas Lung Infection

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
BiomX Ltd
Study ID
NCT06998043
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pseudomonas Aeruginosa Infection
  • Cystic Fibrosis (CF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BX004 — BIOLOGICAL
    Bacteriophage
  • Placebo — OTHER
    Placebo

Study Details

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).

Key Dates

Start date
Jul 2, 2025
Status verified
Jul 2025
Primary completion
Mar 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
63 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BX004
    Participants will be randomized to receive standard dose of nebulized bacteriophage
  • Placebo Comparator: Placebo
    Participants will be randomized to receive nebulized placebo

Primary Outcome Measure

Change in sputum Pseudomonas aeruginosa (PsA) burden at 8 weeks (EOT) [ Time Frame: 8 weeks ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Study Coordinator
[email protected]
205-638-5599
Providence Alaska Medical CenterAnchorageAlaska99508
Study Coordinator
[email protected]
907-212-3299
University of Arkansas for Medical SciencesLittle RockArkansas72205
Study Coordinator
[email protected]
501-686-5525
Stanford UniversityPalo AltoCalifornia94061
Study Coordinator
[email protected]
650-723-6381
University of California San FranciscoSan FranciscoCalifornia94143
Study Coordinator
[email protected]
415-476-8073
National Jewish HealthDenverColorado80206
Study Coordinator
[email protected]
303-270-2517
Joe DiMaggio Children's HealthHollywoodFlorida33021
Study Coordinator
[email protected]
954-265-6333
Central Florida Pulmonary GroupOrlandoFlorida32803
Study Coordinator
[email protected]
407-841-1100
Avanza Medical CenterPensacolaFlorida32503
Study Coordinator
[email protected]
850-477-7900
Rutgers, Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901
Study Coordinator
[email protected]
732-235-6402
New York Medical CollegeHawthorneNew York10593
Study Coordinator
[email protected]
914-504-0152
Northwell HealthNew YorkNew York10028
Study Coordinator
[email protected]
212-434-4790
Vanderbilt University Medical CenterNashvilleTennessee37232
Study Coordinator
[email protected]
615-343-4865
University of UtahSalt Lake CityUtah84132
Study Coordinator
[email protected]
801-703-5353

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By research site
University of Alabama at Birmingham· Birmingham, ALProvidence Alaska Medical Center· Anchorage, AKUniversity of Arkansas for Medical Sciences· Little Rock, ARStanford University· Palo Alto, CAUniversity of California San Francisco· San Francisco, CANational Jewish Health· Denver, CO

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