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Pentraxin
A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis (STARSCAPE 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 1 year
Awards & highlights
Pivotal Trial
Summary
This trial is testing a lab-made protein called pentraxin-2 in people with idiopathic pulmonary fibrosis (IPF). The goal is to see if it can reduce lung inflammation and scarring. This could help improve breathing for people with this serious lung disease. PRM-151, a lab-made protein, has shown promise in reducing fibrosis in earlier studies and was well tolerated.
Eligible Conditions
- Idiopathic Pulmonary Fibrosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in St. George Respiratory Questionnaire (SGRQ) Total Score
Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ)
Survival
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Zinpentraxin AlfaExperimental Treatment1 Intervention
Participants will receive intravenous (IV) infusions of Zinpentraxin Alfa over 50-70 minutes on Days 1, 3 and 5, then followed by infusions every 4 weeks (Q4W) to Week 48.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,463 Previous Clinical Trials
1,102,499 Total Patients Enrolled
16 Trials studying Idiopathic Pulmonary Fibrosis
3,894 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,233 Previous Clinical Trials
901,628 Total Patients Enrolled
16 Trials studying Idiopathic Pulmonary Fibrosis
4,159 Patients Enrolled for Idiopathic Pulmonary Fibrosis