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Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection

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ClinicalTrials.gov Identifier: NCT05010577
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
BiomX, Inc.

Brief Summary:
This is a Phase 1b/2a study with the primary objective to determine if BX004-A is safe and tolerable. Exploratory objectives include whether BX004-A reduces sputum Pseudomonas aeruginosa (PsA) bacterial load in CF subjects with chronic PsA pulmonary infection.

Condition or disease Intervention/treatment Phase
Chronic Pseudomonas Aeruginosa Infection Cystic Fibrosis Drug: BX004-A Drug: Placebo Phase 1 Phase 2

Detailed Description:
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and tolerability of BX004-A in CF subjects with chronic PsA pulmonary infection. The study is divided into two parts, a single-ascending and multiple-dose phase (Part 1) and a multiple dose phase (Part 2). Subjects in both parts will be included in a 6-month safety follow-up. A Data Safety Monitoring Board will monitor safety in both parts. The purpose of the study is to evaluate safety and tolerability of BX004-A, and whether BX004-A reduces the PsA burden in the sputum of CF subjects with chronic PsA pulmonary infection. Clinically stable CF subjects with a confirmed diagnosis of CF and chronic PsA pulmonary infection will be enrolled.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1b/2a, 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
Actual Study Start Date : June 21, 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : August 2023


Arm Intervention/treatment
Experimental: BX004-A
Participants will be randomized to receive standard dose of nebulized bacteriophage
Drug: BX004-A
Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa
Other Name: Bacteriophage

Placebo Comparator: Placebo
Participants will be randomized to receive nebulized placebo
Drug: Placebo
Nebulized placebo
Other Name: Vehicle buffer




Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 6 months ]
    Incidence of treatment emergent adverse events following single and multiple doses of BX004-A administered by inhalation


Other Outcome Measures:
  1. PsA burden in sputum at various timepoints [ Time Frame: 1 month ]
    Change in PsA colony-forming units (CFU) per gram of sputum



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications
  • Age ≥ 18 years
  • FEV1 ≥ 40% 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
  • Recovery of Burkholderia species from respiratory tract within 2 years prior to screening
  • Currently receiving treatment for allergic bronchopulmonary aspergillosis
  • Currently receiving treatment for active infection with non-tuberculous mycobacteria
  • History of severe neutropenia
  • History of lung transplant
  • History of solid organ transplant
  • Acquired or primary immunodeficiency syndrome
  • Initiation or change in CF modulator therapy less than 3 months prior to screening
  • Pregnant or breastfeeding female

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05010577


Contacts
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Contact: Physician 203-786-6316 ext 108 xillau@biomx.com

Locations
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United States, Florida
Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Lance Cohen, MD         
Central Florida Pulmonary Group Recruiting
Orlando, Florida, United States, 32803
Contact: Daniel Layish, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02130
Contact: Ahmet Uluer, DO, MPH         
United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Alison Lennox, MD         
United States, Ohio
University Hospitals Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Erica Roesch, MD         
United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Judie Howrylak, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Jonathan Cogen, MD         
Israel
Hadassah University Medical Center Recruiting
Jerusalem, Israel, 91999
Contact: Malena Cohen-Cymberknoh, MD         
Sponsors and Collaborators
BiomX, Inc.
Investigators
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Study Director: Xilla Ussery, MD BiomX, Inc.
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Responsible Party: BiomX, Inc.
ClinicalTrials.gov Identifier: NCT05010577    
Other Study ID Numbers: BMX-04-001
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Pseudomonas Infections
Cystic Fibrosis
Fibrosis
Disease Attributes
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses