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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
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514761-19-00
Acronym
RIN-PF-303
Enrollment
382
Registered
2024-08-26
Start date
2023-01-25
Completion date
2025-06-25
Last updated
2025-01-31

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

Conditions

Idiopathic Pulmonary Fibrosis

Brief summary

The primary endpoint of the study is the change in absolute FVC in subjects with IPF from baseline to Week 52.

Detailed description

• 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 at Week 52

Interventions

DRUGThe Placebo Nebuliser Solution is a solution dosage form for nebulisation identical to Treprostinil Nebuliser Solution drug product except for the absence of the treprostinil drug substance.
DRUGTreprostinil

Sponsors

United Therapeutics Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is the change in absolute FVC in subjects with IPF from baseline to Week 52.—

Secondary

MeasureTime frame
• 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 at Week 52—

Countries

Belgium, Denmark, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026