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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)

Primary Purpose

Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa, Lung Infection

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AP-PA02
Placebo
Sponsored by
Armata Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-cystic Fibrosis Bronchiectasis focused on measuring Bacteriophage, Phage, NCFB, BE, Pseudomonas, Pseudomonas Aeruginosa

Eligibility Criteria

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

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

Sites / Locations

  • Velocity Clinical ResearchRecruiting
  • Southern California Institute for Respiratory Diseases Cedars-Sinai West TowerRecruiting
  • UCONN HealthRecruiting
  • Georgetown University Hospital / Pulmonary Critical Care and Sleep MedicineRecruiting
  • Southwest General Healthcare CenterRecruiting
  • TecTum Medical Research, Inc.Recruiting
  • Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
  • University of MiamiRecruiting
  • St. Lukes HospitalRecruiting
  • The University of Kansas Medical Center / Dept of MedicineRecruiting
  • Mayo Clinic
  • Rutgers Robert Wood Johnson Medical SchoolRecruiting
  • Oregon Health & Science UniversityRecruiting
  • Medical University of South CarolinaRecruiting
  • University of Texas Health Science Center at TylerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AP-PA02

Placebo

Arm Description

Anti-pseudomonal bacteriophage

Inactive isotonic solution

Outcomes

Primary Outcome Measures

P. aeruginosa recovery in sputum following multiple doses of AP-PA02 administered by inhalation

Secondary Outcome Measures

Full Information

First Posted
November 7, 2022
Last Updated
August 16, 2023
Sponsor
Armata Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05616221
Brief Title
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
Acronym
Tailwind
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Armata Pharmaceuticals, 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa, Lung Infection
Keywords
Bacteriophage, Phage, NCFB, BE, Pseudomonas, Pseudomonas Aeruginosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, randomized, placebo-controlled
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AP-PA02
Arm Type
Experimental
Arm Description
Anti-pseudomonal bacteriophage
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inactive isotonic solution
Intervention Type
Biological
Intervention Name(s)
AP-PA02
Intervention Description
Bacteriophage administered via inhalation
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Inactive Placebo administered via inhalation
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Kyme, PhD
Phone
310-665-2928
Ext
234
Email
pkyme@armatapharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mina Pastagia, MD
Organizational Affiliation
Armata Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Velocity Clinical Research
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danny Kakish
Phone
251-263-5669
Email
dkakish@velocityclinical.com
First Name & Middle Initial & Last Name & Degree
Lawrence Sindel, MD
Facility Name
Southern California Institute for Respiratory Diseases Cedars-Sinai West Tower
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Caputo
Phone
310-657-1230
Ext
127
Email
fcaputo@towertrials.com
First Name & Middle Initial & Last Name & Degree
Andrew Watchtel, MD
Facility Name
UCONN Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malik Qasim
Phone
860-679-4219
Email
qmalik@uchc.edu
First Name & Middle Initial & Last Name & Degree
Mark Metersky, MD
Facility Name
Georgetown University Hospital / Pulmonary Critical Care and Sleep Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amen Hamed
Phone
202-444-8830
Email
Amen.M.Hamed@gunet.georgetown.edu
First Name & Middle Initial & Last Name & Degree
Anne O'Donnell, MD
Facility Name
Southwest General Healthcare Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Pargas
Phone
239-931-3368
Email
daniela.swghcc@gmail.com
First Name & Middle Initial & Last Name & Degree
Jose Rodriguez, MD
Facility Name
TecTum Medical Research, Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Navas
Phone
954-322-8985
Email
carla.navas@tectumresearch.com
First Name & Middle Initial & Last Name & Degree
Juan C Rondon, MD
Facility Name
Mayo Clinic/Pulmonary, Critical Care, and Sleep Medicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Whitaker
Phone
305-243-2568
Email
yiw2@miami.edu
First Name & Middle Initial & Last Name & Degree
Maria Tupayachi, MD
Facility Name
St. Lukes Hospital
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lejla Godusevic
Phone
208-381-4717
Email
godusevl@slhs.org
First Name & Middle Initial & Last Name & Degree
Karen Miller, MD
Facility Name
The University of Kansas Medical Center / Dept of Medicine
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Behrman
Phone
913-588-6031
Email
mbehrman@kumc.edu
First Name & Middle Initial & Last Name & Degree
Andreas Schmid, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rutgers Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halina Malveaux
Phone
732-235-6402
Email
malveaha@rwjms.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Sugeet Jagpal, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Siegel
Phone
503-494-1384
Email
siegels@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Kevin Winthrop, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Millare
Phone
843-792-3167
Email
millare@musc.edu
First Name & Middle Initial & Last Name & Degree
Patrick Flume, MD
Facility Name
University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Greenlee
Phone
903-877-5986
Email
Kimberly.Greenlee@uthct.edu
First Name & Middle Initial & Last Name & Degree
Pamela McShane, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://armatapharma.com
Description
Armata Pharmaceuticals, Inc.

Learn more about this trial

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

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