The goal of this clinical trial is to learn if the investigational drug CAL101 can help prevent further decline in lung function in adults with Idiopathic Pulmonary Fibrosis. Researchers will compare CAL101 with placebo to compare change from baseline in forced vital capacity (FVC). Participants will be randomly assigned to a study group that will receive an IV infusion of either the study medication or placebo about once a month for 6 months.
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CAL101 in participants with IPF, either as standalone treatment or in addition to currently approved antifibrotic treatments.. The study will consist of a 28-days Screening Period, intravenous (IV) infusions of CAL101 or placebo once every 4 weeks over 24 weeks, and a 16 week Follow-up Period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Change from baseline in forced vital capacity (FVC) compared to placebo
Time frame: 28 weeks
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Keck School of Medicine at USC
Los Angeles, California, United States
National Jewish Health
Denver, Colorado, United States
Y & L Advance Health Care, Inc. d/b/a Elite Clinical Research
Miami, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Pulmonix, LLC
Greensboro, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Utah Health
Salt Lake City, Utah, United States
Aarhus University Hospital
Aarhus, Denmark
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