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NCT05255991 (Inhaled Treprostinil in Idiopathic Pulmonary Fibrosis): BVCT ex-ante prediction vs. reported outcome

On 28 Jul 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 2 Sep 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (FVC) and commercially sufficient (moderately superior to nerandomilast in FVC).

Clinical Trial

NCTID
NCT05255991
Acronym
TETON-2
Drug Name
Inhaled Treprostinil
Drug MoA
synthetic analog of prostacyclin
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Idiopathic Pulmonary Fibrosis
Human Patients
597
Sponsor
United Therapeutics
Phase
Phase 3

Prediction of , index 1101

Prospective Prediction
Prediction Index
1101
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in FVC and OS moderately superior to nerandomilast)
Technical Prediction
SUCCESS (statistically significant clinical benefit in FVC and OS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
36 days in advance
Readout Data Interpretation
Tyvaso as an add-on treatment achieved a 95.6mL placebo-adjusted improvement in absolute FVC at week 52 (p<0.0001); moderately superior to nerandomilast that achieved a 68.8mL placebo-adjusted improvement in absolute FVC at week 52 (p<0.0001) (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (FVC) and commercially sufficient (moderately superior to nerandomilast in FVC)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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)
Phase
Phase 3
Status
Completed
Enrollment
597
Lead sponsor
United Therapeutics
Conditions
Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease
Interventions
DRUG: Placebo; DRUG: Inhaled Treprostinil; DEVICE: Treprostinil Ultrasonic Nebulizer
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-10-04
Primary completion
2025-06-30
Completion
2025-06-30
Primary outcomes
  • Change in Absolute FVC from Baseline to Week 52 (Baseline to Week 52)

NCT05255991 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials