Clinical trial NCT05616221: Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection
Official title: A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-cystic Fibrosis Bronchiectasis
Pseudomonas Aeruginosa
Lung Infection
Keywords: Bacteriophage
Phage
NCFB
BE
Pseudomonas
Pseudomonas Aeruginosa
Lead sponsor: Armata Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized, placebo-controlled
Primary purpose: TREATMENT

Brief summary: A phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 administered in subjects with non-cystic fibrosis bronchiectasis and chronic pulmonary Pseudomonas aeruginosa infection.

Detailed description: This study will be conducted in two cohorts running in parallel: Cohort A will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have not received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Cohort B will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Subjects in both Cohorts A and B will be followed for approximately 4 weeks after last dose of study drug and evaluated for safety, tolerability, and efficacy.

Eligibility criteria: Key Inclusion Criteria:

* ≥ 18 years old
* Body mass index (BMI) of ≥ 18 kg/m2
* Evidence of bronchiectasis per CT
* Evidence of chronic pulmonary Pseudomonas aeruginosa infection
* Willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum samples at all other timepoints (for subjects who are able to expectorate)
* FEV1 ≥ 35% of predicted normal \[per Global Lung Function Initiative (GLI) standards\] at Screening
* For Cohort A: have not received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1
* For Cohort B: have received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1

Key Exclusion Criteria:

* Abnormal vital signs at Screening
* History of lung transplantation
* History of cystic fibrosis
* History of α1-antitrypsin deficiency
* History of primary or acquired immunodeficiency syndromes
* History of COPD
* History of pulmonary malignancy or any other malignancy requiring treatment
* History of prolonged QT syndrome
* History of hemoptysis
* Recent significant weight loss
* Recent use of supplemental oxygen during the day while at rest
* Recent use of cigarettes, cigars, or pipes, or used tobacco or other nicotine source by vaping
* Recent changes in either the treatment regimen or initiation of treatment with: oral macrolides, hypertonic saline, mucolytics, bronchodilator medications, or oral corticosteroids
* Currently receiving treatment for active infection at any site
* Female pregnant of breastfeeding

Primary outcomes:
measure: P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation
timeFrame: Day 1 pre-dose through 7 days post last dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Velocity Clinical Research
state: Alabama
city: Los Angeles
country: United States
facility: Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower
state: California
city: Farmington
country: United States
facility: UCONN Health
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine
state: District of Columbia
city: Fort Myers
country: United States
facility: Southwest General Healthcare Center
state: Florida
city: Hollywood
country: United States
facility: TecTum Medical Research, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Boise
country: United States
facility: St. Lukes Hospital
state: Idaho
city: Kansas City
country: United States
facility: The University of Kansas Medical Center / Dept of Medicine
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Hawthorne
country: United States
facility: New York Medical College
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati - College of Medicine
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennslyvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Tyler
country: United States
facility: University of Texas Health Science Center at Tyler
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University (VCU)
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Armata Pharmaceuticals, Inc.
name: Mina Pastagia, MD
role: STUDY_DIRECTOR
References: