PRM-151-202
Research type
Research Study
Full title
A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
IRAS ID
184035
Contact name
Luca Richeldi
Contact email
Sponsor organisation
Promedior, Inc.
Eudract number
2014-004782-24
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
A study to test intravenous PRM-151 for efficacy and safety in people with Idiopathic Pulmonary Fibrosis (IPF)- a disorder where the lung tissue becomes damaged and scarred making it difficult to breathe. Patients who meet the eligibility criteria for the study will be randomly allocated to treatment with PRM-151 10mg/kg every 4 weeks or a placebo. Patients will receive study drug treatment for 24 weeks. Approximately 117 subjects will be included in the study. After completing 24 weeks of treatment, all patients will be offered the option to receive PRM-151 in an open-label study extension for up to an additional 96 weeks. Patients will participate in the study for up to 128 weeks, including a 4 week screening period, 24 week treatment period, and a 96 week open-label treatment extension period and a 4 week follow up visit.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/1477
Date of REC Opinion
16 Sep 2015
REC opinion
Favourable Opinion