A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease
Public ClinicalTrials.gov record NCT02394028. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs. The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.
Study identification
- NCT ID
- NCT02394028
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,035 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 20, 2015 (Actual)
- Primary completion
- Sep 7, 2021 (Actual)
- Completion
- Sep 7, 2021 (Actual)
- Last update posted
- Nov 16, 2022
2015 – 2021
United States locations
- U.S. sites
- 62
- U.S. states
- 25
- U.S. cities
- 56
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Valley Gastroenterology Consultants | Arcadia | California | 91006 | — |
| University of California San Diego Medical Center | La Jolla | California | 92093-5354 | — |
| VA Long Beach Healthcare System | Long Beach | California | 90822 | — |
| Digestive Care Associates, A Medical Corporation | San Carlos | California | 94070 | — |
| SDG Clinical Research | San Diego | California | 92103 | — |
| University of California at San Francisco (PARENT); Gastroenterology, Hepatology & Nutrition | San Francisco | California | 94158 | — |
| Peak Gastroenterology Associates; Gastroenterology | Colorado Springs | Colorado | 80907 | — |
| Innovative Medical Research of South Florida | Aventura | Florida | 33180 | — |
| West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | 33762 | — |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | — |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | — |
| IMIC, Inc | Miami Beach | Florida | 33140 | — |
| FQL Research, LLC | Miramar | Florida | 33025 | — |
| Advanced Research Institute, Inc. | Trinity | Florida | 34655 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Emory University Hospital | Atlanta | Georgia | 30308 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| Gastrointestinal Diseases Research | Columbus | Georgia | 31904 | — |
| Atlanta Center for Gastroenterology, PC | Decatur | Georgia | 30033 | — |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | — |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | — |
| Advanced Clinical Research | Meridian | Idaho | 83642 | — |
| Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology | Chicago | Illinois | 60611 | — |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Southwest Gastroenterology; DM Clinical Research | Oak Lawn | Illinois | 60453-3767 | — |
| Carle Foundation Hospital | Urbana | Illinois | 61801-2500 | — |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | 66606 | — |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | — | — |
| Commonwealth Clinical Studies | Brockton | Massachusetts | 02302 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109-0666 | — |
| Gastroenterology Associates of Western Michigan, P.L.C. | Grand Rapids | Michigan | 49506 | — |
| Center for Digestive Health | Troy | Michigan | 48098 | — |
| Henry Ford Health System | West Bloomfield | Michigan | 48322 | — |
| Mayo Clinic - Rochester; Gastrology | Rochester | Minnesota | 55905 | — |
| University of Mississippi Medical Center; Division of Gastroenterology | Jackson | Mississippi | 39216 | — |
| Ehrhardt Clinical Research, LLC | Belton | Missouri | 64012 | — |
| Concorde Medical Group | New York | New York | 10016 | — |
| Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) | New York | New York | 10021 | — |
| Lenox Hill Hospital | New York | New York | 10075 | — |
| University of North Carolina At Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Charlotte Gastroenterology and Hepatology, P.L.L.C | Charlotte | North Carolina | 28207 | — |
| Kinston Medical Specialists | Kinston | North Carolina | 28501 | — |
| Consultants for Clinical Research Inc. | Cincinnati | Ohio | 45219 | — |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | — |
| Digestive Disease Specialists, Inc. | Oklahoma City | Oklahoma | 73112 | — |
| Great Lakes Medical Research, LLC | Harrisburg | Pennsylvania | 17110 | — |
| Innovative Clinical Research | Greenville | South Carolina | 29604 | — |
| Gastroenterology Center of the MidSouth PC | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Digestive Disease Consultants - Dallas | Dallas | Texas | 75231 | — |
| University of Texas Southwestern Medical Center; Internal Medicne | Dallas | Texas | 75390-9151 | — |
| Baylor College of Medicine; Gastroenterology | Houston | Texas | 77030 | — |
| Methodist Hospital Research Institute | Houston | Texas | 77030 | — |
| Wellness Clinical Research Center | San Antonio | Texas | 78232 | — |
| Texas Digestive Disease Consultants - Southlake | Southlake | Texas | 76092 | — |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | — |
| Ericksen Research and Development | Clinton | Utah | 84015 | — |
| University of Utah School of Medicine | Salt Lake City | Utah | 84132 | — |
| McGuire Research Institute; Gastroenterology | Richmond | Virginia | 23249 | — |
| Digestive Disease Institute; Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 265 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02394028, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 16, 2022 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02394028 live on ClinicalTrials.gov.