A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis (STARSCAPE-OLE Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline until study completion (up to approximately 1.5 years)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a lab-made protein given through an IV to help reduce lung scarring and inflammation in patients with a chronic lung disease called idiopathic pulmonary fibrosis (IPF). The study includes patients who have already participated in related research.

Eligible Conditions

Idiopathic Pulmonary Fibrosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline until study completion (up to approximately 1.5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline until study completion (up to approximately 1.5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until study completion (up to approximately 1.5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With Adverse Events (AEs)

Percentage of Participants With Infusion Related Reactions (IRRs) and Other AEs of Special Interest

Secondary study objectives

Percentage of Participants With ADAs During the Study

Plasma Concentrations of PRM-151 at Specified Timepoints

Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Zinpentraxin AlfaExperimental Treatment1 Intervention

Corhort A: Participants entering, following participation in study PRM-151-202. Cohort B: Participants entering, following participation in study WA42293.

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