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Completed Phase 3 Interventional Results available

A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors

ClinicalTrials.gov ID: NCT02100696

Public ClinicalTrials.gov record NCT02100696. 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.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 11:38 AM EDT

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, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.

Study identification

NCT ID
NCT02100696
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
609 participants

Conditions and interventions

Interventions

Drug

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
May 21, 2014 (Actual)
Primary completion
Apr 16, 2020 (Actual)
Completion
Apr 16, 2020 (Actual)
Last update posted
Aug 13, 2021

2014 – 2020

United States locations

U.S. sites
38
U.S. states
19
U.S. cities
35
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 —
University of California San Diego Medical Center La Jolla California 92093-5354 —
Clinical Applications Laboratories, Inc. San Diego California 92103 —
Precision Research Institute, LLC San Diego California 92114 —
University of California at San Francisco San Francisco California 94115 —
Rocky Mountain Gastroenterology Associates Denver Colorado 80222 —
Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology Lakewood Colorado 80215 —
FQL Research, LLC Miramar Florida 33025 —
Center For Digestive Health Orlando Florida 32803 —
Internal Medicine Specialists Orlando Florida 32806 —
Shafran Gastroenterology Center Winter Park Florida 32789 —
Gastroenterology Associates of Central Georgia Macon Georgia 31201 —
Gastrointestinal Specialists of Georgia, PC Marietta Georgia 30060 —
Atlanta Gastroenterology Specialists, PC Suwanee Georgia 30024 —
Northwestern University Feinberg School Of Medicine Chicago Illinois 60611 —
Southwest Gastroenterology Oak Lawn Illinois 60453 —
Cotton-O'Neil Clinical Research Center, Digestive Health Topeka Kansas 66606 —
Gastroenterology Associates, LLC Baton Rouge Louisiana 70809 —
Louisiana Research Center, LLC Shreveport Louisiana — —
Massachusetts General Hospital; Crohn's & Colitis Center Boston Massachusetts 02114 —
University of Michigan; Michigan Institute for Clinical and Health Research (MICHR) Ann Arbor Michigan 48109 —
Henry Ford Health System Detroit Michigan 48202 —
Center for Digestive Health Troy Michigan 48098 —
Kansas City Research Institute, LLC Kansas City Missouri 64131 —
Clinica Peruano Americana S.A. Great Neck New York 11021 —
Weill Cornell Medical College-New York Presbyterian Hospital New York New York 10021 —
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599 —
Consultants for Clinical Research Inc. Cincinnati Ohio 45219 —
UC Health, LLC. Cincinnati Ohio 45219 —
Great Lakes Gastroenterology Research, LLC Mentor Ohio 44060 —
Gastroenterology Center of the Midsouth, P.C. Memphis Tennessee 38120 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
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 —
Digestive and Liver Disease Specialists, Ltd. Norfolk Virginia 23502 —
McGuire Research Institute; Gastroenterology Richmond Virginia 23249 —
Washington Gastroenterology 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 146 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02100696, 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 13, 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 NCT02100696 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →