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RECRUITING

NCT05943535

PHASE3

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

Sponsor: United Therapeutics

View on ClinicalTrials.gov

Summary

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

698

Start Date

2023-10-30

Completion Date

2027-11

Last Updated

2026-07-13

Healthy Volunteers

Conditions

Progressive Pulmonary Fibrosis Interstitial Lung Disease

Interventions

DRUG

Placebo

Placebo administered QID

DRUG

Inhaled Treprostinil

Inhaled treprostinil (6 mcg/breath) administered QID

DEVICE

Treprostinil Ultrasonic Nebulizer

Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.

Inclusion 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. Concomitant use of both nintedanib and pirfenidone is not permitted. 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. i. Medically acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable) and barrier methods (such as a condom or diaphragm) when used with a spermicide. Women who are successfully sterilized (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months) are not considered to be of reproductive potential. 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. Exclusion Criteria: 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), soluble guanylate cyclase stimulators, or activin signaling inhibitors (sotatercept) 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. 13. Subject has received nerandomilast within 60 days prior to Baseline.

Locations (165)

UAB Lung Health Center

Birmingham, Alabama, United States

Banner University Medical Center Phoenix Lung Institute

Phoenix, Arizona, United States

Norton Thoracic Institute

Phoenix, Arizona, United States

Peter Morton Medical Building

Los Angeles, California, United States

NewportNativeMD, Inc.

Newport Beach, California, United States

University of California Irvine Medical Center

Orange, California, United States

Paradigm Clinical Research

Redding, California, United States

UC Davis Health Medical Center

Sacramento, California, United States

Paradigm Clinical Research

San Diego, California, United States

Stanford University Medical Center

Stanford, California, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Ascension Medical Group St. Vincent's Lung Institute

Jacksonville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

TGH/USF Center for Advanced Lung Disease and Lung Transplant

Tampa, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

The Emory Clinic

Atlanta, Georgia, United States

Northwestern Memorial Hospital, Clinical Research Unit

Chicago, Illinois, United States

Rush University Medical Center Outpatient Pulmonary Clinic

Chicago, Illinois, United States

UI Health Hospital

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

University of Louisville Healthcare Outpatient Research Clinic

Louisville, Kentucky, United States

Tulane Medical Center

New Orleans, Louisiana, United States

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Adventist Healthcare White Oak Medical Center

Silver Spring, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Infinity Medical Center

North Dartmouth, Massachusetts, United States

Corewell Health Grand Rapids Hospitals - Butterworth

Grand Rapids, Michigan, United States

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, United States

University of Minnesota Health Clinical Research Unit (CRU)

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Hospital at Gulfport

Gulfport, Mississippi, United States

The Lung Research Center, LLC

Chesterfield, Missouri, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of New Mexico

Albuquerque, New Mexico, United States

Northwell Health

New Hyde Park, New York, United States

Weill Cornell Medicine, New York-Presbyterian Hospital

New York, New York, United States

Stony Brook Advanced Specialty Care

Stony Brook, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

PulmonIx LLC

Greensboro, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

St. Luke's Univeristy Health Network-Pulmonary & Critical Care

Cincinnati, Ohio, United States

The Ohio State University Wexner Medical CEnter

Columbus, Ohio, United States

Mercy Health St.Vincent Medical Center LLC

Toledo, Ohio, United States

Pennsylvania State Hershey Medical Center and College of Medicine

Hershey, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Jefferson Honickman Center

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Medical University of South Carolina-Nexus

Charleston, South Carolina, United States

Prisma Health Pulmonology-Richland

Columbia, South Carolina, United States

Clinical Trials Center of Middle Tennessee, LLC

Franklin, Tennessee, United States

StatCare Pulmonary Consultants, PLLC

Knoxville, Tennessee, United States

The Vanderbilt Lung Institute

Nashville, Tennessee, United States

Baylor University Medical Center

Dallas, Texas, United States

UT Southwestern Medical Center-Advanced Lung Clinic

Dallas, Texas, United States

Houston Methodist Outpatient Center

Houston, Texas, United States

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

Houston, Texas, United States

A & A Research Consultants, LLC

McAllen, Texas, United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas, United States

Methodist Hospital

San Antonio, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Utah Health

Salt Lake City, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Christopher King, MD

Falls Church, Virginia, United States

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, United States

University Hospital and UW Health Clinics

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Instituto Ave Pulmo - Fundacion enfisema

Mar del Plata, Buenos Aires, Argentina

Instituto Medico Rio Cuarto

Río Cuarto, Córdoba Province, Argentina

Sanatorio Parque de Rosario - Consultorios Externos

Rosario, Santa Fe Province, Argentina

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

CIMER-Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, Tucumán Province, Argentina

CINME Centro de Investigaciones Metabolicas

Buenos Aires, Argentina

Fundación Respirar

Buenos Aires, Argentina

Instituto de Medicina Respiratoria

Córdoba, Argentina

Sanatorio Allende Cerro

Córdoba, Argentina

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

The Prince Charles Hospital

Brisbane, Queensland, Australia

Lung Research QLD

Chermside, Queensland, Australia

Eastern Health Box Hill Hospital

Box Hill, Victoria, Australia

Monash Health-Monash Medical Centre

Clayton, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Institute for Respiratory Health - Midland

Midland, Western Australia, Australia

Institute for Respiratory Health

Nedlands, Western Australia, Australia

AZORG

Aalst, Belgium

ZAS Middelheim

Antwerp, Belgium

CUB Hopital Erasmde

Brussels, Belgium

Cliniques Universitaires St.-Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

CHU de Liège

Liège, Belgium

St.Paul's Hospital

Vancouver, British Columbia, Canada

And 65 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (165)