RECRUITING

Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)

Conditions

Progressive Pulmonary Fibrosis Interstitial Lung Disease Treprostinil PPF ILD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.

Official Title

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

Quick Facts

Study Start:2023-10-30

Study Completion:2027-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05943535

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject gives voluntary informed consent to participate in the study. 2. Subject is ≥18 years of age, inclusive, at the time of signing informed consent. 3. Subject has radiological evidence of pulmonary fibrosis of \>10% extent on an HRCT scan in the previous 12 months (confirmed by central review). 4. Subject has a diagnosis of PPF (other than IPF) that fulfills at least 1 of the following criteria for progression within 24 months of screening despite standard treatment of ILD, as assessed by the Investigator: 1. Clinically significant decline in % predicted FVC based on ≥10% relative decline 2. Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with worsening of respiratory symptoms 3. Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with increasing extent of fibrotic changes on chest imaging 4. Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging 5. FVC ≥45% predicted at Screening (confirmed by central review). 6. Subjects must be on 1 of the following: 1. On nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, are planning to continue treatment through the study 2. Not on treatment with nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, not planning to initiate either treatment during the study. 7. Subjects treated with immunosuppressive agents (eg, mycophenolate, methotrexate, azathioprine, oral corticosteroids, rituximab) need to be on treatment for at least 120 days prior to Baseline and, in the Investigator's clinical opinion, must be refractory to treatment. 8. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and non-lactating, and will agree to do 1 of the following: 1. Abstain from intercourse (when it is in line with their preferred and usual lifestyle) 2. Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug. 9. Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug. 10. 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.	1. Subject is pregnant or lactating. 2. Subject has primary obstructive airway physiology (forced expiratory volume in 1 second/FVC \<0.70 at Screening) or greater extent of emphysema than fibrosis on HRCT (confirmed by central review). 3. Subject has a diagnosis of IPF. 4. Subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy. 5. Subject has received any PAH-approved therapy, including prostacyclin therapy (epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonists (selexipag), endothelin receptor antagonists, phosphodiesterase type 5 inhibitors (PDE5-Is), or soluble guanylate cyclase stimulators within 60 days prior to Baseline. As needed use of a PDE5-I for erectile dysfunction is permitted, provided no doses are taken within 48 hours prior to any study-related efficacy assessments. 6. Subject is receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline. 7. Exacerbation of ILD or active pulmonary or upper respiratory infection within 30 days prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for treatment of the infection or acute exacerbation more than 30 days prior to Baseline to be eligible. If hospitalized for an acute exacerbation of ILD or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible. 8. Subject has uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline. 9. Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement) within 30 days prior to Screening. Subjects participating in non-interventional, observational, or registry studies are eligible. 10. Acute pulmonary embolism within 90 days prior to Baseline. 11. In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or would impair study participation or cooperation. 12. In the opinion of the Investigator, life expectancy \<12 months due to ILD or a concomitant illness.

Inclusion Criteria

Exclusion Criteria

1. Subject gives voluntary informed consent to participate in the study.
2. Subject is ≥18 years of age, inclusive, at the time of signing informed consent.
3. Subject has radiological evidence of pulmonary fibrosis of \>10% extent on an HRCT scan in the previous 12 months (confirmed by central review).
4. Subject has a diagnosis of PPF (other than IPF) that fulfills at least 1 of the following criteria for progression within 24 months of screening despite standard treatment of ILD, as assessed by the Investigator:
1. Clinically significant decline in % predicted FVC based on ≥10% relative decline
2. Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with worsening of respiratory symptoms
3. Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with increasing extent of fibrotic changes on chest imaging
4. Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging
5. FVC ≥45% predicted at Screening (confirmed by central review).
6. Subjects must be on 1 of the following:
1. On nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, are planning to continue treatment through the study
2. Not on treatment with nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, not planning to initiate either treatment during the study.
7. Subjects treated with immunosuppressive agents (eg, mycophenolate, methotrexate, azathioprine, oral corticosteroids, rituximab) need to be on treatment for at least 120 days prior to Baseline and, in the Investigator's clinical opinion, must be refractory to treatment.
8. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at Screening and Baseline) and non-lactating, and will agree to do 1 of the following:
1. Abstain from intercourse (when it is in line with their preferred and usual lifestyle)
2. Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
9. Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
10. 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.

1. Subject is pregnant or lactating.
2. Subject has primary obstructive airway physiology (forced expiratory volume in 1 second/FVC \<0.70 at Screening) or greater extent of emphysema than fibrosis on HRCT (confirmed by central review).
3. Subject has a diagnosis of IPF.
4. Subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
5. Subject has received any PAH-approved therapy, including prostacyclin therapy (epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonists (selexipag), endothelin receptor antagonists, phosphodiesterase type 5 inhibitors (PDE5-Is), or soluble guanylate cyclase stimulators within 60 days prior to Baseline. As needed use of a PDE5-I for erectile dysfunction is permitted, provided no doses are taken within 48 hours prior to any study-related efficacy assessments.
6. Subject is receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
7. Exacerbation of ILD or active pulmonary or upper respiratory infection within 30 days prior to Baseline. Subjects must have completed any antibiotic or steroid regimens for treatment of the infection or acute exacerbation more than 30 days prior to Baseline to be eligible. If hospitalized for an acute exacerbation of ILD or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible.
8. Subject has uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline.
9. Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement) within 30 days prior to Screening. Subjects participating in non-interventional, observational, or registry studies are eligible.
10. Acute pulmonary embolism within 90 days prior to Baseline.
11. In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or would impair study participation or cooperation.
12. In the opinion of the Investigator, life expectancy \<12 months due to ILD or a concomitant illness.

Contacts and Locations

Study Contact

United Therapeutics Global Medical Information

CONTACT

919-485-8350

clinicaltrials@unither.com

Study Locations (Sites)

UAB Lung Health Center

Birmingham, Alabama, 35233

United States

Norton Thoracic Institute

Phoenix, Arizona, 85013

United States

Peter Morton Medical Building

Los Angeles, California, 90095

United States

NewportNativeMD, Inc.

Newport Beach, California, 92663

United States

University of California Irvine Medical Center

Orange, California, 92868

United States

UC Davis Health Medical Center

Sacramento, California, 95817

United States

Paradigm Clinical Research

San Diego, California, 92108

United States

Stanford University Medical Center

Stanford, California, 94305

United States

Georgetown University Hospital

Washington, District of Columbia, 20007

United States

Ascension Medical Group St. Vincent's Lung Institute

Jacksonville, Florida, 32204

United States

Mayo Clinic

Jacksonville, Florida, 32224

United States

TGH/USF Center for Advanced Lung Disease and Lung Transplant

Tampa, Florida, 33606

United States

The Emory Clinic

Atlanta, Georgia, 45227

United States

Northwestern Memorial Hospital, Clinical Research Unit

Chicago, Illinois, 60611

United States

Rush University Medical Center Outpatient Pulmonary Clinic

Chicago, Illinois, 60612

United States

UI Health Hospital

Chicago, Illinois, 60612

United States

Loyola University Medical Center

Maywood, Illinois, 60153

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

University of Kentucky

Lexington, Kentucky, 45227

United States

University of Louisville Healthcare Outpatient Research Clinic

Louisville, Kentucky, 40202

United States

Tulane Medical Center

New Orleans, Louisiana, 45227

United States

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224

United States

Adventist Healthcare White Oak Medical Center

Silver Spring, Maryland, 20904

United States

Tufts Medical Center

Boston, Massachusetts, 02111

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Infinity Medical Center

North Dartmouth, Massachusetts, 02747

United States

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, 48073

United States

University of Minnesota Health Clinical Research Unit (CRU)

Minneapolis, Minnesota, 55455

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

The Lung Research Center, LLC

Chesterfield, Missouri, 63017

United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

University of New Mexico

Albuquerque, New Mexico, 87131

United States

Montefiore Medical Center

Bronx, New York, 10467

United States

Northwell Health

New Hyde Park, New York, 11042

United States

Weill Cornell Medicine, New York-Presbyterian Hospital

New York, New York, 10065

United States

Stony Brook Advanced Specialty Care

Stony Brook, New York, 11794-8172

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

PulmonIx LLC

Greensboro, North Carolina, 27403

United States

East Carolina University

Greenville, North Carolina, 27834

United States

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219

United States

The Ohio State University Wexner Medical CEnter

Columbus, Ohio, 43201

United States

Mercy Health St.Vincent Medical Center LLC

Toledo, Ohio, 43608

United States

Pennsylvania State Hershey Medical Center and College of Medicine

Hershey, Pennsylvania, 17033

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Medical University of South Carolina-Nexus

Charleston, South Carolina, 29425

United States

Prisma Health Pulmonology-Richland

Columbia, South Carolina, 29203

United States

Clinical Trials Center of Middle Tennessee, LLC

Franklin, Tennessee, 37067

United States

StatCare Pulmonary Consultants, PLLC

Knoxville, Tennessee, 37919

United States

The Vanderbilt Lung Institute

Nashville, Tennessee, 37204

United States

Baylor University Medical Center

Dallas, Texas, 75246

United States

Houston Methodist Outpatient Center

Houston, Texas, 77030

United States

The University of Texas Health Science Center at Houston, McGovern Medical School

Houston, Texas, 77030

United States

A & A Research Consultants, LLC

McAllen, Texas, 78503

United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas, 75069

United States

Intermountain Medical Center

Murray, Utah, 84107

United States

University of Utah Health

Salt Lake City, Utah, 84108

United States

University of Virginia Health System

Charlottesville, Virginia, 22903

United States

Christopher King, MD

Falls Church, Virginia, 22042

United States

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, 23230

United States

University Hospital and UW Health Clinics

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: United Therapeutics

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 Registration Dates

Study Start Date2023-10-30

Study Completion Date2027-11

Study Record Updates

Study Start Date2023-10-30

Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

Treprostinil
PPF
ILD

Additional Relevant MeSH Terms

Progressive Pulmonary Fibrosis
Interstitial Lung Disease