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Recruiting NCT06998043

Study With Phage for CF Subjects With Pseudomonas Lung Infection

Phase II Interventional Chronic Pseudomonas Aeruginosa Infection Cystic Fibrosis (CF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BX004, Placebo.
Who it may be relevant to
Registry conditions: Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis (CF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2b, 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

Overview

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).

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 BX004 reduces the PsA burden in the sputum of CF subjects with chronic PsA pulmonary infection. Secondary endpoints are to see how well BX004 works in improving lung function and quality of life, reducing the amount of PsA in the sputum, getting negative sputum cultures for PsA, and safety and tolerability. Clinically stable CF subjects with a confirmed diagnosis of CF and chronic PsA pulmonary infection will be enrolled. Subjects will be included in a 6-month post-dose safety follow-up. A Data Safety Monitoring Board of the CF Foundation will monitor safety.

Interventions

  • Biological BX004
    Bacteriophage
  • Other Placebo
    Placebo

Primary outcome measures

  • Change in sputum Pseudomonas aeruginosa (PsA) burden at 8 weeks (EOT) [Time frame: 8 weeks]
Secondary outcome measures (6)
  • Change in lung function at D8, D29, D43, D57 (EOT), D85, 3 months post-dose, and 6 months post-dose [Time frame: from Day 8 until 6 months after last dose (end of study)]
  • Change from Baseline in CFQ-R respiratory domain [Time frame: until 6 months after last dose of study drug]
  • Change from Baseline in CFRSD-CRISS [Time frame: until 6 months after last dose of study drug]
  • Change in sputum PsA burden [Time frame: until 6 months after last dose of study drug]
  • Efficacy of BX004 on obtaining negative sputum cultures for PsA [Time frame: until 6 months after last dose of study drug]
  • Incidence of treatment-emergent adverse events [safety and tolerability] [Time frame: until 6 months after last dose of study drug]

Eligibility criteria

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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 14 centers
  • University of Alabama at Birmingham — Birmingham
  • Providence Alaska Medical Center — Anchorage
  • University of Arkansas for Medical Sciences — Little Rock
  • Stanford University — Palo Alto
  • University of California San Francisco — San Francisco
  • National Jewish Health — Denver
  • Joe DiMaggio Children's Health — Hollywood
  • Central Florida Pulmonary Group — Orlando
  • … and 6 more centers

Identifiers

NCT: NCT06998043 · BMX-04-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗