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)

Status: Recruiting
Location: See all (146) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

• Subject is ≥18 years of age, inclusive, at the time of signing informed consent.

• Subject has radiological evidence of pulmonary fibrosis of \>10% extent on an HRCT scan in the previous 12 months (confirmed by central review).

• 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:

∙ Clinically significant decline in % predicted FVC based on ≥10% relative decline

‣ Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with worsening of respiratory symptoms

‣ Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with increasing extent of fibrotic changes on chest imaging

‣ Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging

• FVC ≥45% predicted at Screening (confirmed by central review).

• Subjects must be on 1 of the following:

∙ On nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, are planning to continue treatment through the study

‣ 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.

• 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.

• 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:

∙ Abstain from intercourse (when it is in line with their preferred and usual lifestyle)

‣ 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.

• 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.

⁃ 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
UAB Lung Health Center
RECRUITING
Birmingham
Arizona
Norton Thoracic Institute
RECRUITING
Phoenix
California
Peter Morton Medical Building
RECRUITING
Los Angeles
NewportNativeMD, Inc.
RECRUITING
Newport Beach
University of California Irvine Medical Center
RECRUITING
Orange
Paradigm Clinical Research
RECRUITING
Redding
UC Davis Health Medical Center
RECRUITING
Sacramento
Paradigm Clinical Research
RECRUITING
San Diego
Stanford University Medical Center
RECRUITING
Stanford
Washington, D.c.
Georgetown University Hospital
RECRUITING
Washington D.c.
Florida
Ascension Medical Group St. Vincent's Lung Institute
RECRUITING
Jacksonville
Mayo Clinic
RECRUITING
Jacksonville
TGH/USF Center for Advanced Lung Disease and Lung Transplant
RECRUITING
Tampa
Georgia
The Emory Clinic
RECRUITING
Atlanta
Illinois
Northwestern Memorial Hospital, Clinical Research Unit
RECRUITING
Chicago
Rush University Medical Center Outpatient Pulmonary Clinic
RECRUITING
Chicago
UI Health Hospital
RECRUITING
Chicago
Loyola University Medical Center
RECRUITING
Maywood
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Kentucky
University of Kentucky
RECRUITING
Lexington
University of Louisville Healthcare Outpatient Research Clinic
RECRUITING
Louisville
Louisiana
Tulane Medical Center
RECRUITING
New Orleans
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Infinity Medical Center
RECRUITING
North Dartmouth
Maryland
Johns Hopkins Asthma and Allergy Center
RECRUITING
Baltimore
Adventist Healthcare White Oak Medical Center
RECRUITING
Silver Spring
Michigan
Beaumont Hospital, Royal Oak
RECRUITING
Royal Oak
Minnesota
University of Minnesota Health Clinical Research Unit (CRU)
RECRUITING
Minneapolis
Mayo Clinic
RECRUITING
Rochester
Missouri
The Lung Research Center, LLC
RECRUITING
Chesterfield
Saint Luke's Hospital of Kansas City
RECRUITING
Kansas City
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Duke University Medical Center
RECRUITING
Durham
PulmonIx LLC
RECRUITING
Greensboro
East Carolina University
RECRUITING
Greenville
New Mexico
University of New Mexico
RECRUITING
Albuquerque
New York
Northwell Health
RECRUITING
New Hyde Park
Weill Cornell Medicine, New York-Presbyterian Hospital
RECRUITING
New York
Stony Brook Advanced Specialty Care
RECRUITING
Stony Brook
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
The Ohio State University Wexner Medical CEnter
RECRUITING
Columbus
Mercy Health St.Vincent Medical Center LLC
RECRUITING
Toledo
Pennsylvania
Pennsylvania State Hershey Medical Center and College of Medicine
RECRUITING
Hershey
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Temple University Hospital
RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina-Nexus
RECRUITING
Charleston
Prisma Health Pulmonology-Richland
RECRUITING
Columbia
Tennessee
Clinical Trials Center of Middle Tennessee, LLC
RECRUITING
Franklin
StatCare Pulmonary Consultants, PLLC
RECRUITING
Knoxville
The Vanderbilt Lung Institute
RECRUITING
Nashville
Texas
Baylor University Medical Center
RECRUITING
Dallas
UT Southwestern Medical Center-Advanced Lung Clinic
RECRUITING
Dallas
Houston Methodist Outpatient Center
RECRUITING
Houston
The University of Texas Health Science Center at Houston, McGovern Medical School
RECRUITING
Houston
A & A Research Consultants, LLC
RECRUITING
Mcallen
Metroplex Pulmonary and Sleep Center
RECRUITING
Mckinney
Utah
Intermountain Medical Center
RECRUITING
Murray
University of Utah Health
RECRUITING
Salt Lake City
Virginia
University of Virginia Health System
RECRUITING
Charlottesville
Christopher King, MD
RECRUITING
Falls Church
Pulmonary Associates of Richmond, Inc.
RECRUITING
Richmond
Wisconsin
University Hospital and UW Health Clinics
RECRUITING
Madison
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Argentina
CINME Centro de Investigaciones Metabolicas
RECRUITING
Buenos Aires
Fundación Respirar
RECRUITING
Buenos Aires
Instituto de Medicina Respiratoria
RECRUITING
Córdoba
Sanatorio Allende Cerro
RECRUITING
Córdoba
Instituto Ave Pulmo - Fundacion enfisema
RECRUITING
Mar Del Plata
Instituto Medico Rio Cuarto
RECRUITING
Río Cuarto
Sanatorio Parque de Rosario - Consultorios Externos
RECRUITING
Rosario
CIMER-Centro Integral de Medicina Respiratoria
RECRUITING
San Miguel De Tucumán
Investigaciones en Patologias Respiratorias
RECRUITING
San Miguel De Tucumán
Australia
Eastern Health Box Hill Hospital
RECRUITING
Box Hill
The Prince Charles Hospital
RECRUITING
Brisbane
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Monash Health-Monash Medical Centre
RECRUITING
Clayton
Austin Health
RECRUITING
Heidelberg
St George Hospital
RECRUITING
Kogarah
Institute for Respiratory Health - Midland
RECRUITING
Midland
Institute for Respiratory Health
RECRUITING
Nedlands
Belgium
AZORG
RECRUITING
Aalst
ZAS Middelheim
RECRUITING
Antwerp
Cliniques Universitaires St.-Luc
RECRUITING
Brussels
CUB Hopital Erasmde
RECRUITING
Brussels
UZ Leuven
RECRUITING
Leuven
CHU de Liège
RECRUITING
Liège
Canada
Dynamic Drug Advancement Limited
RECRUITING
Ajax
St.Joseph's Healthcare Hamilton
RECRUITING
Hamilton
Hôpital Maisonneuve-Rosemont
RECRUITING
Montreal
CIC Mauricie inc.
RECRUITING
Québec
St.Paul's Hospital
RECRUITING
Vancouver
Chile
Centro de Investigacion Curico
RECRUITING
Curicó
Centro Respiratorio Integral LTDA. (CENRESIN)
RECRUITING
Quillota
Biocinetic Ltda.
RECRUITING
Santiago
CEC Centro Estudios Clinicos
RECRUITING
Santiago
Fundacion Medica San Cristobal
RECRUITING
Santiago
Centro de Investigación de Enfermedades Respiratorias e Inmunológicas (CIERI)
RECRUITING
Viña Del Mar
France
Hôpital Avicennes
RECRUITING
Bobigny
Hospices civils de Lyon - Hôpital Louis Pradel
RECRUITING
Bron
CHU Caen Normandie
RECRUITING
Caen
Assistance Publique Hôpitaux de Marseille - centre Hospitalier Régional de Marseille
RECRUITING
Marseille
Rouen University Hospital
RECRUITING
Rouen
Centre Hospitalier Régional Universitaire de Tours
RECRUITING
Tours
Germany
Zentralklinik Bad Berka GmbH Klinik für Pneumologie, Zentrum für Schlaf-und Beatmungsmedizin
RECRUITING
Bad Berka
Prufstelle der GWT am Fachkrankenhaus Coswig
RECRUITING
Coswig
SLK Kliniken Heilbronn GmbH
RECRUITING
Löwenstein
LMU Klinikum Medizinische Klinik und Poliklinik V
RECRUITING
München
RoMed Klinikum Rosenheim-Ellmaierstr. 23
RECRUITING
Rosenheim
Israel
Barzilai Medical Center
RECRUITING
Ashkelon
Hillel Yaffe Medical Center
RECRUITING
Hadera
Rabin Medical Center
RECRUITING
Haifa
Shaare Zedek Medical Center
RECRUITING
Jerusalem
The Hadassah University Medical Center Ein Kerem Hospital
RECRUITING
Jerusalem
Meir Medical Center
RECRUITING
Kfar Saba
Rabin Medical Center
RECRUITING
Petah Tikva
Kaplan Medical Center
RECRUITING
Rehovot
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Azienda Ospedaliero Universitaria Policlinico G. Rodolico - San Marco Presidio Ospedaliero Gaspare Rodolico
RECRUITING
Catania
Azienda Unita Sanitaria Locale Della Romagna Ospedale Gian Battista Morgagni - Luigi Pierantoni di Forlì
RECRUITING
Forlì
Azienda Ospedaliero-Universitaria di Modena Policlinico di Modena
RECRUITING
Modena
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Azienda Ospedaliero-Universitaria Senese
RECRUITING
Siena
New Zealand
Aotearoa Clinical Trials Trust- Middlemore Hospital
RECRUITING
Auckland
Canterbury Respiratory Research Group
RECRUITING
Christchurch
Peru
Hospital Nacional Adolfo Guevara Velasco
RECRUITING
Cusco
Centro de Investigacion de Enfermedades Respiratorias - Clinica Providencia
RECRUITING
Lima
Clinica Internacional - Sede Lima
RECRUITING
Lima
Clinica Ricardo Palma
RECRUITING
Lima
Hospital Central de la Fuerza Aerea del Peru
RECRUITING
Lima
Unidad de Investigacion de Enfermedades Respiratorias- Clinica San Pablo -Surco
RECRUITING
Lima
Republic of Korea
Gachon University Gil Medical Center
RECRUITING
Incheon
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
RECRUITING
Taichung
United Kingdom
Birmingham Heartlands Hospital
RECRUITING
Birmingham
Royal Papworth Hospital
RECRUITING
Cambridge
NHS Lothian, Royal INfirmary of Edingburgh
RECRUITING
Edinburgh
Guy's Hospital
RECRUITING
London
Manchester University NHS Foundation Trust, North Manchester General Hospital
RECRUITING
Manchester
NHS Tayside, Perth Royal Infirmary
RECRUITING
Perth
Contact Information
Primary
United Therapeutics Global Medical Information
clinicaltrials@unither.com
919-485-8350
Time Frame
Start Date: 2023-10-30
Estimated Completion Date: 2027-11
Participants
Target number of participants: 698
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