Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Zinpentraxin Alfa (PRM-151) in Idiopathic Pulmonary Fibrosis
NCT04552899Phase 3
Key facts
- Status
- Terminated
- Start
- Mar 2021
- Primary completion
- Feb 2023
- Countries
- 35
- Sponsor
- Roche
- Modality
- rProtein (Recombinant Protein), Biologic
- Drugs
- zinpentraxin alfa
- Conditions
- idiopathic pulmonary fibrosis (IPF)
01
Overview
Phase 3, randomised, double-blind trial in idiopathic pulmonary fibrosis (IPF) comparing Zinpentraxin Alfa with Placebo (2 arms). Primary endpoint: Absolute Change in Forced Vital Capacity at 52 weeks. Started Mar 2021; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Zinpentraxin Alfa
Zinpentraxin alfa 10 mg/kg IV infusions
Placebo
Placebo IV infusions
03
Who it enrols
Adults 40-85 years with documented IPF, FVC >= 45% predicted, and DLCO 30-90% predicted. Patients may be on stable pirfenidone or nintedanib, or not on antifibrotic treatment.
04
Endpoints
Primary
Absolute Change in Forced Vital Capacity
Secondary
Absolute Change in 6-minute Walk Distance
Absolute Change in FVC % Predicted
Time to Disease Progression
Time to First Respiratory-related Hospitalizations
Change in University of California, San Diego-Shortness of Breath Questionnaire
Change in St. George Respiratory Questionnaire Total Score
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Change in Carbon Monoxide Diffusing Capacity
05
Results
Not all primary endpoints met
Beyond the preview
Go deeper on NCT04552899.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT04552899.