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NCT05176951 (Treprostinil Palmitil in Pulmonary Hypertension): BVCT ex-ante prediction vs. reported outcome

On 1 Jan 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 28 May 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient for phase 2a.

Clinical Trial

NCTID
NCT05176951
Drug Name
Treprostinil Palmitil
Drug MoA
synthetic prostacyclin analog
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Pulmonary Hypertension
Human Patients
39
Sponsor
Insmed
Phase
Phase 2

Prediction of , index 435

Prospective Prediction
Prediction Index
435
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
148 days in advance
Readout Data Interpretation
significant better tolerability than placebo and 30 meter placebo-adjusted 6MWD improvement (exploratory endpoint with large CI).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient for phase 2a
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Phase
Phase 2
Status
Completed
Enrollment
39
Lead sponsor
Insmed Incorporated
Conditions
Pulmonary Hypertension
Interventions
DRUG: Treprostinil Palmitil; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-12-22
Primary completion
2024-03-14
Completion
2024-03-14
Primary outcomes
  • Number of Participants Who Experience Any Number of Treatment Emergent Adverse Events (TEAEs) (Up to Day 140)
  • Number of Participants Who Experience Any Number of Serious Adverse Events (SAEs) (Up to Day 140)
  • Change from Baseline in Saturation of Peripheral Capillary Oxygenation (SpO2) Levels (Pre-, during, and post- 6-minute walk test (6MWT) at Baseline, Week 5, Week 10, and Week 16)

NCT05176951 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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