This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study of vismodegib in patients with IPF. Eligible patients will be randomized in a 2:1 ratio to one of two treatment arms: vismodegib or placebo. The duration of treatment will be 52 weeks. Study drug will be administered daily by the oral route. An 8-week safety follow-up period is included for all patients who receive at least one dose of study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
matching placebo administered daily orally
vismodegib 150 mg administered daily orally
Change in forced vital capacity (FVC) percent predicted
Time frame: From baseline to Week 52
Change in diffusion capacity of the lung for carbon dioxide (DLCO)
Time frame: From baseline to Week 52
Annualized rate of change in FVC
Time frame: Week 52
Progression-free survival
Time frame: Week 52
Time from randomization to first event of acute IPF exacerbation
Time frame: Up to 52 weeks
Change in Quality of Life measurements
Time frame: From baseline to Week 52
Safety: Incidence of adverse events (AEs)
Time frame: Approximately 60 weeks
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