* STARSCAPE OLE
Research type
Research Study
Full title
A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF)
IRAS ID
293135
Contact name
Joanna Porter
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2020-001429-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 7 months, 4 days
Research summary
Research Summary:
Idiopathic pulmonary fibrosis (IPF) is a progressive lung-scarring disease of unknown cause characterised by loss of lung function. The disease affects primarily older adults and typically has a survival of 2.5-3.5 years. Existing drug therapies are only able to slow down the process of scarring and new treatment options are needed.
PRM-151 is a synthetic version of pentraxin-2, a protein naturally found in the body that plays an important role in tissue repair. PRM-151 has been shown to slow down fibrosis of the lungs.
The main purpose of this study is to investigate long-term safety and efficacy of PRM-151 in patients with IPF. Three group of patients will be enrolled in the study. Patients in group A will have completed study PRM-151-202. Patients in group B will have completed study WA42293. Patients in group C will have discontinued treatment in study WA42293 early or have completed treatment but no longer wish to receive PRM-151. Patients in groups A and B will complete screening procedures over up to 4 weeks to receive PRM-151 during the treatment phase. The drug will be given as an infusion into a vein over approximately 1 hour. After 3 loading doses over 5 days, participants will continue receiving the drug every 4 weeks. Patients in groups A and B who discontinue treatment will be asked to participate in group C. After signing informed consent, patients in group C will be followed up for survival every 6 months.
Male or female IPF patients with adequate lung function and general state of health who participated in either PRM-151-202 or WA42293 study may be eligible for the study. Study assessments in groups A and B include physical examinations, vital signs, ECGs, evaluations of lung function, blood and urine tests, High Resolution CT scans, questionnaires. Approximately 700 patients at around 400 sites globally will participate in the study. Of these, 12 sites will be in the UK.
Summary of Results:
The lay person summary is not available for WA42294 study. Roche didn’t have to prepare one as this was not under CTR and because the information letter was shared with the sites when the study terminated earlyREC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0317
Date of REC Opinion
11 Mar 2021
REC opinion
Further Information Favourable Opinion