NCT05255991

Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 597 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Study RIN-PF-303 is a multinational study designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.

Detailed description

Study RIN-PF-303 is a multinational, 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.

Conditions

• Idiopathic 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: 2022-10-04
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2022-02-25
• Last updated: 2025-08-15

Locations

108 sites across 16 countries: Argentina, Australia, Belgium, Chile, Denmark, France, Germany, Israel, Italy, Mexico, Netherlands, New Zealand, Peru, South Korea, Spain, Taiwan

Regulatory

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