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) // A Multinational, Uncontrolled, Usability Evaluation Study of the TD-300/A Tyvaso Inhalation Device Used in RIN-PF-303

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) // A Multinational, Uncontrolled, Usability Evaluation Study of the TD-300/A Tyvaso Inhalation Device Used in RIN-PF-303 - RIN-PF-303 // RIN-PF304

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56203

Enrollment

Registered

2022-10-03

Start date

2023-06-16

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease (ILD)

Interventions

Daily treatment duirng 52 weeks with inhaled treprostinil or placebo using the TD-300 ultrasonic nebulizer.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Eligible subjects must be >=40 years of age at the time of signing informed consent; have 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 imaging and if available, surgical lung biopsy; and have a FVC >=45% predicted. Subjects on pirfenidone or nintedanib must be on a stable and optimized dose for >=30 days prior to Baseline.

Exclusion criteria

Exclusion criteria: Subjects with forced expiratory volume in 1 second (FEV1)/FVC 10 L/min of supplemental oxygen at rest at Baseline, and women who are pregnant or lactating will not be eligible to participate in the study.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the change in absolute FVC in subjects with IPF from baseline to Week 52. Safety will be assessed by reviewing the following parameters: • Adverse events (AEs) and serious adverse events (SAEs) • Clinical laboratory parameters • Vital signs, including saturation of peripheral capillary oxygenation (SpO2) • 12-lead electrocardiograms (ECGs)	—

Secondary

Measure	Time frame
Secondary efficacy endpoints of the study are: • Time to clinical worsening (including time to death, respiratory hospitalization, or >=10% relative decline in % predicted FVC) • Time to first acute exacerbation of IPF • Overall survival at Week 52 • Change from baseline in % predicted FVC at Week 52 • Change from baseline in King*s Brief Interstitial Lung Disease Questionnaire score at Week 52 • Change from baseline in diffusion capacity of lungs for carbon monoxide (DLCO) at Week 52 Exploratory efficacy endpoints of the study are: • Change from baseline in absolute FVC at Weeks 16, 28, and 40 • Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP) at Week 52 • Change from baseline in resting supplemental oxygen use at Week 52	—

Measure

Time frame

Secondary efficacy endpoints of the study are: • Time to clinical worsening (including time to death, respiratory hospitalization, or >=10% relative decline in % predicted FVC) • Time to first acute exacerbation of IPF • Overall survival at Week 52 • Change from baseline in % predicted FVC at Week 52 • Change from baseline in King*s Brief Interstitial Lung Disease Questionnaire score at Week 52 • Change from baseline in diffusion capacity of lungs for carbon monoxide (DLCO) at Week 52 Exploratory efficacy endpoints of the study are: • Change from baseline in absolute FVC at Weeks 16, 28, and 40 • Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP) at Week 52 • Change from baseline in resting supplemental oxygen use at Week 52

—

Countries

Argentina, Australia, Belgium, Chile, Denmark, France, Germany, Israel, Italy, Mexico, Netherlands, New Zealand, Peru, South Korea, Spain, Taiwan

Contacts

Public ContactRP Regulatory Department

United Therapeutics Corp.

rtpregulatory@unither.com+19194255431

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026