Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Crohn's Disease
In brief
This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.
Key facts
- Study ID
- NCT02405442
- Run by
- Gilead Sciences
- People needed
- 187
- Starts
- 2015-04-30
- Expected to finish
- 2016-12-22
- Last updated by the study team
- 2019-04-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic — Scottsdale, Arizona, United States
- Cedars Sinai Medical Center — Los Angeles, California, United States
- South Denver Gastroenterology — Lone Tree, Colorado, United States
- University of Miami — Miami, Florida, United States
- Gastroenterology Group Of Naples — Naples, Florida, United States
- Gastroenterology Associates Of Central Georgia, LLC — Macon, Georgia, United States
- Medical Diagnostic Center (MDC)-Indiana University (IU) Health University Hospital — Indianapolis, Indiana, United States
- Iowa Digestive Disease Center — Clive, Iowa, United States
- Cotton-O'Neil Clinical Research Center, Digestive Health — Topeka, Kansas, United States
- Delta Research Partners — Monroe, Louisiana, United States
- Louisiana Research Center — Shreveport, Louisiana, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
- Mayo Clinic Rochester — Rochester, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
- AGA Clinical Research Associates, LLC — Egg Harbor, New Jersey, United States
- Columbia University Medical Center/ New York Presbyterian — New York, New York, United States
- Premier Medical Group Of The Hudson Valley — Poughkeepsie, New York, United States
- Mayo Clinic Rochester — Rochester, New York, United States
- Asheville Gastroenterology Associates — Asheville, North Carolina, United States
- Consultants For Clinical Research — Cincinnati, Ohio, United States
- Great Lakes Gastroenterology — Mentor, Ohio, United States
- Gastro One — Germantown, Tennessee, United States
- Digestive Health Specialists of The Southeast — Dothan, Alabama, United States
Full record on ClinicalTrials.gov
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