* STARSCAPE
Research type
Research Study
Full title
A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS
IRAS ID
291518
Contact name
Joanna Porter
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2020-000791-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 18 days
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 the efficacy and safety of PRM-151 in patients with IPF. After completing screening procedures over up to 4 weeks, approximately 658 participants will be randomised 1:1 to receive either PRM-151 or placebo. Neither the doctor nor the patient will know whether the patient is receiving PRM-151 or placebo. 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 for 48 weeks. Patients who complete treatment will be offered a chance to continue receiving PRM-151 in an extension study (STARSCAPE OLE). Patients who discontinue treatment early or do not want to receive PRM-151 after completing treatment will be asked to participate in follow-up.
Male or female IPF patients aged between 40 and 85 with adequate lung function and general state of health may be eligible for the study. Study assessments include physical examinations, vital signs, ECGs, evaluations of lung function, blood and urine tests, High Resolution CT scans, questionnaires. Around 300-400 sites globally will participate in the study. Of these, 12 sites will be in the UK.REC name
London - Fulham Research Ethics Committee
REC reference
21/LO/0070
Date of REC Opinion
12 Mar 2021
REC opinion
Further Information Favourable Opinion