To compare the effect of daily oral dosing of leramistat over 12 weeks with placebo in participants aged 40 years or older with idiopathic pulmonary fibrosis (IPF).
This will be a Phase 2, double-blind, placebo-controlled, 2-arm, parallel-group, multi-centre study to investigate leramistat treatment of patients aged 40 years or older with IPF. The study is planned to consist of the following parts: Screening period: 1 to 28 days (Weeks -4 to -1). Treatment period: a 12-week blinded, placebo-controlled treatment period (Weeks 1 to 12). Follow up period: 56 days (Weeks 13 to 20). All participants will return for a follow-up visit 56 days after their final dose. Randomization will be stratified by concomitant use of an approved anti-fibrotic drug (nintedanib or pirfenidone) at randomization versus no concomitant use of an approved anti-fibrotic drug at randomization. Number of Participants: Approximately 150 participants will be enrolled and randomly assigned in a 2:1 ratio to receive either leramistat or matched placebo. If the participant is receiving nintedanib or pirfenidone treatment, it should be stable for at least 8 weeks prior to study entry and be predicted to remain stable during the course of the study. The maximum duration of participation (including screening period and follow-up) is 24 weeks. Data Monitoring/Other Committee: A DSMB has been appointed for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Drug: Leramistat
Placebo comparator
Forced vital capacity (FVC)
Change from baseline in FVC versus placebo up to Week 12
Time frame: 12 weeks
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Denver, Colorado, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Reliant Medical Research
Miami, Florida, United States
US Associates in Research Inc
Miami, Florida, United States
GCP Clinical Research, LLC
Tampa, Florida, United States
GCP Clinical Research
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Southern Medical Research, LLC
Macon, Georgia, United States
GenHarp Clinical Solutions
Chicago, Illinois, United States
IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine
Muncie, Indiana, United States
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