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

Primary Purpose

Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BX004-A
Placebo
Sponsored by
BiomX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pseudomonas Aeruginosa Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Alabama at Birmingham
  • Providence Alaska Medical Center
  • University of Arkansas for Medical Sciences
  • Yale University
  • Children's National Medical Center
  • University of Florida
  • Joe DiMaggio Children's Hospital
  • Central Florida Pulmonary Group
  • Boston Children's Hospital
  • New York Medical College
  • Cincinnati Children's Hospital
  • University Hospitals Rainbow Babies and Children's Hospital
  • Nationwide Children's Hospital
  • Penn State Health Milton S. Hershey Medical Center
  • Medical University of South Carolina
  • Baylor College of Medicine, Texas Children Clinic
  • University of Utah
  • Seattle Children's Hospital
  • University Hospital in Motol
  • Rambam Health Care Campus (RHCC) - Ruth Rappaport Children's Hospital
  • Carmel Medical Center
  • Hadassah University Medical Center
  • Schneider Children's Medical Center of Israel
  • The Chaim Sheba Medical Center
  • Amsterdam Medical Center
  • University Medical Center Utrecht
  • Hospital Clinico Universitario Virgen de la Arrixaca
  • Vall d'Hebron Barcelona Hospital Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BX004-A

Placebo

Arm Description

Participants will be randomized to receive standard dose of nebulized bacteriophage

Participants will be randomized to receive nebulized placebo

Outcomes

Primary Outcome Measures

Safety and tolerability
Incidence of treatment emergent adverse events following single and multiple doses of BX004-A administered by inhalation

Secondary Outcome Measures

Full Information

First Posted
August 11, 2021
Last Updated
October 17, 2023
Sponsor
BiomX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05010577
Brief Title
Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 21, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BiomX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BX004-A
Arm Type
Experimental
Arm Description
Participants will be randomized to receive standard dose of nebulized bacteriophage
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to receive nebulized placebo
Intervention Type
Drug
Intervention Name(s)
BX004-A
Other Intervention Name(s)
Bacteriophage
Intervention Description
Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle buffer
Intervention Description
Nebulized placebo
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Incidence of treatment emergent adverse events following single and multiple doses of BX004-A administered by inhalation
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
PsA burden in sputum at various timepoints
Description
Change in PsA colony-forming units (CFU) per gram of sputum
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 1 year 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urania Rappo, MD
Organizational Affiliation
BiomX, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Joe DiMaggio Children's Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Central Florida Pulmonary Group
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
University Hospitals Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Baylor College of Medicine, Texas Children Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
University Hospital in Motol
City
Prague
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Rambam Health Care Campus (RHCC) - Ruth Rappaport Children's Hospital
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Hadassah University Medical Center
City
Jerusalem
ZIP/Postal Code
91999
Country
Israel
Facility Name
Schneider Children's Medical Center of Israel
City
Petach Tikvah
ZIP/Postal Code
4920235
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Amsterdam Medical Center
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584EA
Country
Netherlands
Facility Name
Hospital Clinico Universitario Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Vall d'Hebron Barcelona Hospital Campus
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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