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NCT05032066 (Fipaxalparant in Idiopathic Pulmonary Fibrosis): BVCT ex-ante prediction vs. reported outcome

On 5 Feb 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 30 Oct 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

Drug Name
Fipaxalparant (HZN825)
Drug MoA
LPAR1 antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Idiopathic Pulmonary Fibrosis (IPF)
Human Patients
153
Sponsor
Amgen
Phase
Phase 2

Prediction of , index 1448

Prospective Prediction
Prediction Index
1448
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to bexotegrast)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
268 days in advance
Readout Data Interpretation
fipaxalparant failed to achieve any primary/secondary endpoints and further development discontinued
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis
Phase
Phase 2
Status
Terminated
Enrollment
153
Lead sponsor
Amgen
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
DRUG: HZN-825; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-01-20
Primary completion
2024-07-22
Completion
2025-01-02
Results first posted
2025-12-03
Primary outcomes
  • Core Phase: Change in FVC % Predicted From Baseline to Week 52 (Baseline and Week 52)
  • Extension Phase: Change in FVC % Predicted From OLE Baseline to Week 104 (OLE baseline (Week 52) and Week 104)

NCT05032066 on ClinicalTrials.gov

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