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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04708782
Other study ID # RIN-PF-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 1, 2021
Est. completion date June 2025

Study information

Verified date June 2024
Source United Therapeutics
Contact United Therapeutics Global Medical Information
Phone 919-485-8350
Email clinicaltrials@unither.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Study RIN-PF-301 is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute FVC in subjects with IPF over a 52-week period. Subjects will be randomly allocated 1:1 to receive inhaled treprostinil or placebo. All subjects will initiate inhaled treprostinil or placebo at a dose of 3 breaths administered 4 times daily (QID) and will titrate to a target dosing regimen of 12 breaths QID. Study drug doses may be titrated up as tolerated, until the target dose or maximum clinically tolerated dose is achieved. Once eligible, 6 Treatment Period visits to the clinic will be required at Weeks 4, 8, 16, 28, 40, and 52. Efficacy assessments include spirometry (FVC), time to clinical worsening, time to first acute exacerbation of IPF, overall survival, King's Brief Interstitial Lung Disease (K-BILD) questionnaire, plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration, supplemental oxygen use, and lung diffusion capacity (DLCO). Safety assessments include the development of adverse events (AEs)/serious adverse events (SAEs), vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters. Subjects who complete the Week 52 Visit may be offered the opportunity to enter an open-label extension (OLE) study after completing the final study visit.


Recruitment information / eligibility

Status Recruiting
Enrollment 576
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: 1. Subject gives voluntary informed consent to participate in the study. 2. Subject is =40 years of age, inclusive, at the time of signing informed consent. 3. 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. 4. FVC =45% predicted at Screening. 5. 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. 6. 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. 7. 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. 8. 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: FEV1/FVC <0.70 at Screening. 3. The 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. 4. The 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 of any study-related efficacy assessments. 5. Use of any of the following medications: azathioprine (AZA), cyclosporine, mycophenolate mofetil, tacrolimus, oral corticosteroids (OCS) >20 mg/day or the combination of OCS+AZA+N-acetylcysteine within 30 days prior to Baseline; cyclophosphamide within 60 days prior to Baseline; or rituximab within 6 months prior to Baseline. 6. The subject is receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline. 7. Exacerbation of IPF 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 IPF or a pulmonary or upper respiratory infection, subjects must have been discharged more than 90 days prior to Baseline to be eligible. 8. Uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline. 9. 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. 10. 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. 11. Life expectancy <6 months due to IPF or a concomitant illness. 12. Acute pulmonary embolism within 90 days prior to Baseline.

Study Design


Intervention

Drug:
Placebo
Placebo administered QID
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.

Locations

Country Name City State
Canada Dynamic Drug Advancement Limited Ajax Ontario
Canada Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia
Canada St. Joseph's Healthcare Hamilton Hamilton Ontario
Canada Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite Quebec
Canada Toronto General Hospital Toronto Ontario
Canada Centre d'investigation Clinique Mauricie Trois-Rivières Quebec
Canada St.Paul's Hospital Vancouver British Columbia
United States University of New Mexico Health Sciences Center Albuquerque New Mexico
United States University of Michigan Int Med Pulmonary and critical care Ann Arbor Michigan
United States Emory University Hospital Atlanta Georgia
United States Piedmont Healthcare Atlanta Atlanta Georgia
United States Johns Hopkins Asthma & Allergy Center Baltimore Maryland
United States The University of Alabama at Birmingham Birmingham Alabama
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Medical University of South Carolina Charleston South Carolina
United States University of Virginia Health System Charlottesville Virginia
United States The Lung Research Center Chesterfield Missouri
United States Northwestern Memorial Hospital Chicago Illinois
United States Rush University Medical Center Outpatient Pulmonary Clinic Chicago Illinois
United States University of Illinois at Chicago Chicago Illinois
United States University of Cincinnati Cincinnati Ohio
United States St. Francis Sleep Allergy & Lung Institute Clearwater Florida
United States Cleveland Clinic Cleveland Ohio
United States Prisma Health Midlands Columbia South Carolina
United States The Ohio State University Wexner Medical Center - Martha Morehouse Medical Pavilion Columbus Ohio
United States Baylor University Medical Center Dallas Texas
United States Univrsity of Texas Southwestern Medical Center Dallas Texas
United States Premier Pulmonary Critical Care and Sleep Medicine Denison Texas
United States National Jewish Health Denver Colorado
United States Henry Ford Hospital Detroit Michigan
United States Inova Fairfax Hospital Falls Church Virginia
United States Clinical Trials Center of Middle Tennessee Franklin Tennessee
United States University of Florida Health at Shands Gainesville Florida
United States PulmonIx, LLC Greensboro North Carolina
United States East Carolina University and Leo Jenkins Cancer Center Greenville North Carolina
United States Penn State Milton S. Hershey Medical Center/Penn State College of Medicine Hershey Pennsylvania
United States The Queen's Medical Center Honolulu Hawaii
United States Baylor Clinic-Baylor College of Medicine Houston Texas
United States The University of Texas Health Science Center at Houston Houston Texas
United States Community Health Network Indianapolis Indiana
United States University of Mississippi Medical Center Jackson Mississippi
United States Ascension St. Vincent's Jacksonville Florida
United States Mayo Clinic Florida Jacksonville Florida
United States University of Florida Jacksonville Florida
United States Jasper Summit Research, LLC Jasper Alabama
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States The University of Kansas Medical Center Kansas City Kansas
United States Pulmonary Disease Specialists, PA d/b/a PDS Research Kissimmee Florida
United States Statecare Pulmonary Consultants Knoxville Tennessee
United States UC San Diego Health La Jolla California
United States St Joseph's Physician's Pulmonary Health Liverpool New York
United States David Geffen School of Medicine at UCLA Los Angeles California
United States Louisville Pulmonary Care,PLLC Louisville Kentucky
United States Norton Pulmonary Specialists Louisville Kentucky
United States University of Louisville Louisville Kentucky
United States University of Wisconsin School of Medicine and Public health Madison Wisconsin
United States Loyola University Medical Center Maywood Illinois
United States A & A Research Consultants, LLC McAllen Texas
United States Metroplex Pulmonary and Sleep Center PA McKinney Texas
United States Medical College of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States Intermountain Medical Center Murray Utah
United States Vanderbilt University Medical Center Nashville Tennessee
United States Northwell Health New Hyde Park New York
United States LSU Health Sciences Center New Orleans New Orleans Louisiana
United States Tulane University Medical Center New Orleans Louisiana
United States NewportNativeMD, Inc Newport Beach California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Creighton University Clinical Research Office Omaha Nebraska
United States University of California, Irvine Orange California
United States Central Florida Pulmonary Group, PA Orlando Florida
United States Advanced Pulmonary Research Institute Palm Beach Florida
United States Palmtree Clinical Research, Inc. Palm Springs California
United States Temple Lung Center Philadelphia Pennsylvania
United States Thoams Jefferson,Hospital University Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Arizona Pulmonary Specialists, Ltd. Phoenix Arizona
United States Banner University Medical Center-Phoenix Phoenix Arizona
United States St. Joseph's Hospital and Medical Center - Norton Thoracic Institute Phoenix Arizona
United States Pinehurst Medical Clinic, Inc. Pinehurst North Carolina
United States The Oregon Clinic, PC Portland Oregon
United States Pulmonary Associates of Richmond, Inc. Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States University of Rochester Medical center Rochester New York
United States Clinical Research of Rock Hill Rock Hill South Carolina
United States UC Davis Health Medical Center Sacramento California
United States J&L Research, LLC Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Coastal Pulmonary & Critical Care PLC Saint Petersburg Florida
United States University of Utah Health Salt Lake City Utah
United States University of California - San Francisco San Francisco California
United States LSU Health Science Center Shreveport Shreveport Louisiana
United States Adventist Healthcare White Oak Medical CEnter Silver Spring Maryland
United States Stanford University Medical Center Stanford California
United States University of South Florida Health Tampa Florida
United States Renovatio Clinical Consultants, LLC The Woodlands Texas
United States University of Arizona Tucson Arizona
United States Georgetown University Hospital Washington District of Columbia
United States Cleveland Clinic Florida Weston Florida
United States Southeastern Research Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
United Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Absolute FVC from Baseline to Week 52 The FVC measurement indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath. Baseline to Week 52
Secondary Time to Clinical Worsening Clinical worsening was monitored from randomization until 1 of the following criteria were met: death (all causes), hospitalization due to a respiratory indication, or 10% relative decline in % predicted FVC. Baseline to Week 52
Secondary Time to First Acute Exacerbation of IPF An exacerbation of IPF is defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality. Baseline to Week 52
Secondary Overall Survival at Week 52 Vital status will be assessed for all subjects at Week 52, including those who discontinue the study prematurely or who withdraw consent. Week 52
Secondary Change in % Predicted FVC from Baseline to Week 52 The FVC measurement indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath. Percent predicted FVC is calculated based on factors such as ethnicity, sex, age, height, and weight. Baseline to Week 52
Secondary Change in K-BILD Questionnaire Score from Baseline to Week 52 The K-BILD is a self-administered, 15-item questionnaire validated for patients with interstitial lung disease (ILD) consisting of 3 domains (breathlessness and activities, psychological, and chest symptoms). Baseline to Week 52
Secondary Change in DLCO from Baseline to Week 52 The DLCO measurement measures how well oxygen moves from the lungs to the blood. Baseline to Week 52
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