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Completed Phase 3 Interventional Results available

A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors

ClinicalTrials.gov ID: NCT02163759

Public ClinicalTrials.gov record NCT02163759. 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 Jul 23, 2026, 11:04 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, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors

Study identification

NCT ID
NCT02163759
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
358 participants

Conditions and interventions

Interventions

  • Adalimumab Drug
  • Adalimumab Placebo Other
  • Etrolizumab Drug
  • Etrolizumab Placebo Other

Drug · Other

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
Nov 3, 2014
Primary completion
Feb 18, 2020
Completion
Mar 18, 2020
Last update posted
Jul 22, 2021

2014 – 2020

United States locations

U.S. sites
9
U.S. states
6
U.S. cities
9
Facility City State ZIP Site status
Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology Lakewood Colorado 80215
Center for Advanced Gastroenterology Maitland Florida 32751
Gastroenterology Group of Naples Naples Florida 34102
Gastroenterology Associates of Central Georgia Macon Georgia 31201
University of Chicago Medical Center Chicago Illinois 60637
Center for Digestive Health Troy Michigan 48098
Huron Gastroenterology Associates Ypsilanti Michigan 48197
Wellness Clinical Research Center San Antonio Texas 78232
Tyler Research Institute, LLC Tyler Texas 75701

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 79 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02163759, 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 Jul 22, 2021 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02163759 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →