A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-1)

Who is this study for? Patients with idiopathic pulmonary fibrosis
What treatments are being studied? Treprostinil
Status: Active_not_recruiting
Location: See all (99) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Subject gives voluntary informed consent to participate in the study.

• Subject is ≥40 years of age, inclusive, at the time of signing informed consent.

• The subject has a diagnosis of IPF based on the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline (Raghu 2018) and confirmed by central review of high-resolution computed tomography (HRCT) (performed within the previous 12 months), and if available, surgical lung biopsy.

• FVC ≥45% predicted at Screening.

• Subjects on pirfenidone or nintedanib must be on a stable and optimized dose for ≥30 days prior to Baseline. Concomitant use of both pirfenidone and nintedanib is not permitted.

• Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and non-lactating, and will abstain from intercourse (when it is in line with their preferred and usual lifestyle) or use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.

• Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.

• In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.

Locations
United States
Alabama
The University of Alabama at Birmingham
Birmingham
Arizona
Arizona Pulmonary Specialists, Ltd.
Phoenix
Banner University Medical Center-Phoenix
Phoenix
St. Joseph's Hospital and Medical Center - Norton Thoracic Institute
Phoenix
University of Arizona
Tucson
California
UC San Diego Health
La Jolla
David Geffen School of Medicine at UCLA
Los Angeles
NewportNativeMD, Inc
Newport Beach
University of California, Irvine
Orange
Palmtree Clinical Research, Inc.
Palm Springs
UC Davis Health Medical Center
Sacramento
University of California - San Francisco
San Francisco
Stanford University Medical Center
Stanford
Colorado
National Jewish Health
Denver
Florida
St. Francis Sleep Allergy & Lung Institute
Clearwater
University of Florida Health at Shands
Gainesville
Ascension St. Vincent's
Jacksonville
Mayo Clinic Florida
Jacksonville
University of Florida
Jacksonville
Pulmonary Disease Specialists, PA d/b/a PDS Research
Kissimmee
Central Florida Pulmonary Group, PA
Orlando
Coastal Pulmonary & Critical Care PLC
St. Petersburg
University of South Florida Health
Tampa
Cleveland Clinic Florida
Weston
Georgia
Emory University Hospital
Atlanta
Piedmont Healthcare Atlanta
Atlanta
Hawaii
The Queen's Medical Center
Honolulu
Illinois
Northwestern Memorial Hospital
Chicago
Rush University Medical Center Outpatient Pulmonary Clinic
Chicago
Loyola University Medical Center
Maywood
Indiana
Community Health Network
Indianapolis
Kansas
The University of Kansas Medical Center
Kansas City
Kentucky
Norton Pulmonary Specialists
Louisville
University of Louisville
Louisville
Louisiana
LSU Health Sciences Center New Orleans
New Orleans
Tulane University Medical Center
New Orleans
LSU Health Science Center Shreveport
Shreveport
Massachusetts
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
Tufts Medical Center
Boston
Maryland
Johns Hopkins Asthma & Allergy Center
Baltimore
Adventist Healthcare White Oak Medical CEnter
Silver Spring
Michigan
University of Michigan Int Med Pulmonary and critical care
Ann Arbor
Henry Ford Hospital
Detroit
Corewell Health William Beaumont Hospital
Royal Oak
Minnesota
University of Minnesota
Minneapolis
Mayo Clinic
Rochester
Missouri
The Lung Research Center
Chesterfield
Saint Luke's Hospital of Kansas City
Kansas City
Washington University School of Medicine
St Louis
Mississippi
University of Mississippi Medical Center
Jackson
North Carolina
PulmonIx, LLC
Greensboro
East Carolina University and Leo Jenkins Cancer Center
Greenville
Southeastern Research Center
Winston-salem
Nebraska
Creighton University Clinical Research Office
Omaha
New Mexico
University of New Mexico Health Sciences Center
Albuquerque
New York
St Joseph's Physician's Pulmonary Health
Liverpool
Northwell Health
New Hyde Park
University of Rochester Medical center
Rochester
Stony Brook Advanced Specialty Care
Stony Brook
Montefiore Medical Center
The Bronx
Ohio
University of Cincinnati
Cincinnati
Cleveland Clinic
Cleveland
The Ohio State University Wexner Medical Center - Martha Morehouse Medical Pavilion
Columbus
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
The Oregon Clinic, PC
Portland
Pennsylvania
Penn State Milton S. Hershey Medical Center/Penn State College of Medicine
Hershey
Temple Lung Center
Philadelphia
Thoams Jefferson,Hospital University
Philadelphia
University of Pennsylvania
Philadelphia
South Carolina
Medical University of South Carolina
Charleston
Prisma Health Midlands
Columbia
Clinical Research of Rock Hill
Rock Hill
Tennessee
Clinical Trials Center of Middle Tennessee
Franklin
Statecare Pulmonary Consultants
Knoxville
Vanderbilt University Medical Center
Nashville
Texas
Baylor University Medical Center
Dallas
Univrsity of Texas Southwestern Medical Center
Dallas
Premier Pulmonary Critical Care and Sleep Medicine
Denison
Baylor Clinic-Baylor College of Medicine
Houston
The University of Texas Health Science Center at Houston
Houston
A & A Research Consultants, LLC
Mcallen
Metroplex Pulmonary and Sleep Center PA
Mckinney
Renovatio Clinical Consultants, LLC
The Woodlands
Utah
Intermountain Medical Center
Murray
University of Utah Health
Salt Lake City
Virginia
University of Virginia Health System
Charlottesville
Inova Fairfax Hospital
Falls Church
Pulmonary Associates of Richmond, Inc.
Richmond
Wisconsin
University of Wisconsin School of Medicine and Public health
Madison
Medical College of Wisconsin
Milwaukee
Other Locations
Canada
Dynamic Drug Advancement Limited
Ajax
St. Joseph's Healthcare Hamilton
Hamilton
Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite
Québec
Toronto General Hospital
Toronto
Centre d'investigation Clinique Mauricie
Trois-rivières
St.Paul's Hospital
Vancouver
Chile
Centro Respiratorio Integral LTDA. (CENRESIN)
Quillota
Fundacion Medica San Cristobal
Santiago
Time Frame
Start Date: 2021-06-01
Completion Date: 2026-01
Participants
Target number of participants: 576
Treatments
Placebo_comparator: Placebo
Matching placebo inhaled using an ultrasonic nebulizer QID
Experimental: Inhaled Treprostinil
Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled QID and titrated up to a target of 12 breaths QID or until the subject reaches their maximum clinically tolerated dose.
Sponsors
Leads: United Therapeutics

This content was sourced from clinicaltrials.gov