Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Idiopathic Pulmonary Fibrosis
In brief
The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.
Key facts
- Study ID
- NCT01769196
- Run by
- Gilead Sciences
- People needed
- 544
- Starts
- 2013-01-31
- Expected to finish
- 2016-02-23
- Last updated by the study team
- 2017-05-30
Who can join
Age: 45 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arizona Pulmonary Specialists, Ltd. — Phoenix, Arizona, United States
- Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
- Arizona Pulmonary Specialists, Ltd. — Scottsdale, Arizona, United States
- Mayo Clinic Arizona — Scottsdale, Arizona, United States
- The University of Arizona — Tucson, Arizona, United States
- University of California San Diego — La Jolla, California, United States
- David Geffen School of Medicine at University of California, Los Angeles — Los Angeles, California, United States
- University of California Davis Medical Center — Sacramento, California, United States
- University of California San Francisco — San Francisco, California, United States
- Sansum Clinic — Santa Barbara, California, United States
- Stanford University Medical Center — Stanford, California, United States
- National Jewish Health — Denver, Colorado, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- Bay Area Chest Physicians — Clearwater, Florida, United States
- University of Florida — Jacksonville, Florida, United States
- Mayo Clinic Florida — Jacksonville, Florida, United States
- University of Miami — Miami, Florida, United States
- Sarasota Memorial Hospital — Sarasota, Florida, United States
- Tampa General Hospital — Tampa, Florida, United States
- Cleveland Clinic Florida — Weston, Florida, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Southeastern Lung Care — Decatur, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
- Rush University Medical Center — Chicago, Illinois, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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