A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors
Public ClinicalTrials.gov record NCT02165215. 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
Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely active UC who are naive to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.
Study identification
- NCT ID
- NCT02165215
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 359 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
- Aug 12, 2014 (Actual)
- Primary completion
- Apr 6, 2020 (Actual)
- Completion
- Apr 6, 2020 (Actual)
- Last update posted
- Aug 19, 2021
2014 – 2020
United States locations
- U.S. sites
- 33
- U.S. states
- 17
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Irvine Medical Center | Orange | California | 92868 | — |
| Clinical Applications Laboratories, Inc. | San Diego | California | 92103 | — |
| University of California at San Francisco | San Francisco | California | 94115 | — |
| Ventura Clinical Trials | Ventura | California | 93003 | — |
| Peak Gastroenterology Associates; Gastroenterology | Colorado Springs | Colorado | 80907 | — |
| Clinical Research of the Rockies | Lafayette | Colorado | 80026 | — |
| West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | 33762 | — |
| Regenerate Clinical Trials | Miami | Florida | 33155 | — |
| IMIC, Inc | Miami Beach | Florida | 33140 | — |
| Advanced Research Institute, Inc. | Trinity | Florida | 34655 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology | Chicago | Illinois | 60611 | — |
| Southwest Gastroenterology | Oak Lawn | Illinois | 60453 | — |
| Aquiant Research | New Albany | Indiana | 47150 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | — | — |
| Commonwealth Clinical Studies | Brockton | Massachusetts | 02302 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Center for Digestive Health | Troy | Michigan | 48098 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Ehrhardt Clinical Research, LLC | Belton | Missouri | 64012 | — |
| Manhattan Clinical Research | New York | New York | 10016 | — |
| Weill Cornell Medical College-New York Presbyterian Hospital | New York | New York | 10021 | — |
| Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | 28801 | — |
| UNC at Chapel Hill - Dpt of Family Medicine; Center for Functional GI and Motility Disorders | Chapel Hill | North Carolina | 27599 | — |
| Kinston Medical Specialists | Kinston | North Carolina | 28501 | — |
| Texas Digestive Disease Consultants - Dallas | Dallas | Texas | 75231 | — |
| Texas Digestive Disease Consultants - Southlake | Southlake | Texas | 76092 | — |
| Digestive Health Specialists of Tyler | 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 | — |
| Northwest Gastroenterology Associates | Bellevue | Washington | 98004 | — |
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 71 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02165215, 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 Aug 19, 2021 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02165215 live on ClinicalTrials.gov.