NCT05943535

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 698 (estimated)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study RIN-PF-305 is a Phase 3, multinational, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of inhaled treprostinil in subjects with PPF 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 (forced vital capacity \[FVC\]), time to clinical worsening, time to first acute exacerbation of interstitial lung disease (ILD), 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.

Conditions

• Progressive Pulmonary Fibrosis
• Interstitial Lung Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-30
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2023-07-13
• Last updated: 2026-03-31

Locations

150 sites across 15 countries: United States, Argentina, Australia, Belgium, Canada, Chile, France, Germany, Israel, Italy, New Zealand, Peru, South Korea, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study