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 (Tailwind)

December 21, 2023 updated by: Armata Pharmaceuticals, Inc.

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Alabama
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • Velocity Clinical Research
        • Principal Investigator:
          • Lawrence Sindel, MD
        • Contact:
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower
        • Contact:
        • Principal Investigator:
          • Andrew Watchtel, MD
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • UCONN Health
        • Principal Investigator:
          • Mark Metersky, MD
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine
        • Principal Investigator:
          • Anne O'Donnell, MD
        • Contact:
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Recruiting
        • Southwest General Healthcare Center
        • Principal Investigator:
          • Jose Rodriguez, MD
        • Contact:
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • TecTum Medical Research, Inc.
        • Contact:
        • Principal Investigator:
          • Juan C Rondon, MD
      • Jacksonville, Florida, United States, 32224
        • Active, not recruiting
        • Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
      • Miami, Florida, United States, 33146
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Maria Tupayachi, MD
    • Idaho
      • Boise, Idaho, United States, 83702
        • Recruiting
        • St. Lukes Hospital
        • Contact:
        • Principal Investigator:
          • Karen Miller, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • The University of Kansas Medical Center / Dept of Medicine
        • Contact:
        • Principal Investigator:
          • Andreas Schmid, MD
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins University School of Medicine
        • Contact:
        • Principal Investigator:
          • Daniel Belz, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Active, not recruiting
        • Mayo Clinic
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Robert Wood Johnson Medical School
        • Principal Investigator:
          • Sugeet Jagpal, MD
        • Contact:
    • New York
      • Hawthorne, New York, United States, 10595
        • Recruiting
        • New York Medical College
        • Contact:
        • Principal Investigator:
          • John Welter, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals of Cleveland Medical Center
        • Principal Investigator:
          • Alex Gifford, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Kevin Winthrop, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Patrick Flume, MD
        • Contact:
    • Texas
      • Tyler, Texas, United States, 75708
        • Recruiting
        • University of Texas Health Science Center at Tyler
        • Principal Investigator:
          • Pamela McShane, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Principal Investigator:
          • Christopher Goss, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AP-PA02
Anti-pseudomonal bacteriophage
Bacteriophage administered via inhalation
Placebo Comparator: Placebo
Inactive isotonic solution
Inactive Placebo administered via inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation
Time Frame: Day 1 pre-dose through 7 days post last dose of study drug
Day 1 pre-dose through 7 days post last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Mina Pastagia, MD, Armata Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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