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 (HICKORY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02100696

Recruitment Status : Completed

First Posted : April 1, 2014

Results First Posted : June 15, 2021

Last Update Posted : August 13, 2021

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Ulcerative Colitis	Drug: Etrozulimab Drug: Placebo	Phase 3

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	609 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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
Actual Study Start Date :	May 21, 2014
Actual Primary Completion Date :	April 16, 2020
Actual Study Completion Date :	April 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort 1: Etrolizumab (Open-Label Induction (OLI) Phase) Participants assigned to this arm will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) for 14 weeks during the induction phase.	Drug: Etrozulimab Participants will receive 105 mg etrolizumab administered by SC injection Q4W. Other Names: PRO145223 RO5490261 RG7413
Placebo Comparator: Cohort 2: Placebo (Double-Blind Induction Phase) Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the induction phase.	Drug: Placebo Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.
Experimental: Cohort 2: Etrolizumab (Double-Blind Induction Phase) Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase.	Drug: Etrozulimab Participants will receive 105 mg etrolizumab administered by SC injection Q4W. Other Names: PRO145223 RO5490261 RG7413
Placebo Comparator: Placebo Responders: Placebo (Maintenance Phase) Participants who received placebo during the induction phase, Cohort 2: Placebo (Double-Blind Induction Phase), and achieve a clinical response with placebo at Week 14 will continue to receive blinded placebo from Week 16 up to Week 66 during the maintenance phase.	Drug: Placebo Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.
Placebo Comparator: Etrolizumab Responders: Placebo (Maintenance Phase) Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive placebo SC injection Q4W from Week 16 up to Week 66.	Drug: Placebo Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.
Experimental: Etrolizumab Responders: Etrolizumab (Maintenance Phase) Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive etrolizumab 105 mg SC injection Q4W from Week 16 up to Week 66.	Drug: Etrozulimab Participants will receive 105 mg etrolizumab administered by SC injection Q4W. Other Names: PRO145223 RO5490261 RG7413

Outcome Measures

Primary Outcome Measures :

Induction Phase: Percentage of Participants With Remission at Week 14, as Determined by the Mayo Clinic Score (MCS) [ Time Frame: Week 14 ]
The Mayo Clinic Score (MCS) ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0.
Maintenance Phase: Percentage of Participants With Remission at Week 66 Among Participants Who Had Achieved a Clinical Response at Week 14, as Determined by the MCS [ Time Frame: Week 66 ]
The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1.

Secondary Outcome Measures :

Induction Phase: Percentage of Participants With Clinical Remission at Week 14, as Determined by the MCS [ Time Frame: Week 14 ]
The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Clinical Remission is MCS ≤2 with individual subscores ≤1.
Induction Phase: Percentage of Participants With Clinical Response at Week 14, as Determined by the MCS [ Time Frame: Week 14 ]
The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1.
Induction Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 14, as Determined by the MCS Endoscopic Subscore [ Time Frame: Baseline and Week 14 ]
The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Improvement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1.
Induction Phase: Percentage of Participants With Endoscopic Remission at Week 14, as Determined by the MCS Endoscopic Subscore [ Time Frame: Week 14 ]
The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Endoscopic Remission is Endoscopy subscore = 0.
Induction Phase: Percentage of Participants With Histologic Remission at Week 14, as Determined by the Nancy Histological Index [ Time Frame: Week 14 ]
Nancy Histological Index (NHI) is a 5-level classification ranging from grade 0 (No histologically significant disease) to grade 4 (severely active disease). Histologic remission is defined as a Nancy Histological Index of 0 or 1.
Induction Phase: Change From Baseline to Week 6 in MCS Rectal Bleed Subscore [ Time Frame: Baseline and Week 6 ]
Rectal bleeding data were collected via the participant's diaries and each day a participant provided a score from 0 to 3 according to the following definitions: 0 = no blood in the stool; 1 = streaks of blood with stool less than half the time; 2 = obvious blood with stool most of the time; 3 = blood alone passed. The Mayo Clinic Score (MCS) rectal bleeding subscore was calculated as the worst value of three days of daily diary scores closest to anchor dates at baseline and post-baseline. The data was considered non-parametric and was reported using RANK analysis of covariance (ANCOVA). Participants were stratified by concomitant treatment with corticosteroids or immunosuppressants at randomization and disease activity measured during screening (MCS ≤9/MCS ≥10); the model adjusted for these stratification factors along with the baseline rectal bleeding (RB) subscore.
Induction Phase: Change From Baseline to Week 6 in MCS Stool Frequency Subscore [ Time Frame: Baseline and Week 6 ]
Stool frequency data were collected via the participant's diaries and each day a participant provided a score from 0 to 3 according to the following definitions: 0 = normal number of stools; 1 = 1 to 2 more stools than normal; 2 = 3 to 4 more stools than normal; 3 = 5 or more stools than normal. The Mayo Clinic Score (MCS) stool frequency subscore was calculated as the average of three days daily diary scores closest to anchor dates at baseline and post-baseline. The data was considered non-parametric and was reported using RANK analysis of covariance (ANCOVA). Participants were stratified by concomitant treatment with corticosteroids or immunosuppressants at randomization and disease activity measured during screening (MCS ≤9/MCS ≥10); the model adjusted for these stratification factors along with the baseline stool frequency (SF) subscore.
Induction Phase: Change From Baseline to Week 14 in UC Bowel Movement Signs and Symptoms, as Assessed by the Ulcerative Colitis Patient-Reported Outcome Signs and Symptoms (UC-PRO/SS) Questionnaire [ Time Frame: Baseline and Week 14 ]
The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
Induction Phase: Change From Baseline to Week 14 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire [ Time Frame: Baseline and Week 14 ]
The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.
Induction Phase: Change From Baseline to Week 14 in Health-Related Quality of Life, as Assessed by the Overall Score of the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline and Week 14 ]
The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66 Among Participants Who Had Achieved Clinical Remission at Week 14, as Determined by the MCS [ Time Frame: Week 66 ]
The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0. Clinical Remission is MCS ≤2 with individual subscores ≤1.
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, as Determined by the MCS [ Time Frame: Week 66 ]
The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0. Clinical Remission is MCS ≤2 with individual subscores ≤1.
Maintenance Phase: Percentage of Participants With Remission at Week 66 Among Participants Who Had Achieved Remission at Week 14, as Determined by the MCS [ Time Frame: Week 66 ]
The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0.
Maintenance Phase: Percentage of Participants With Improvement From Baseline in Endoscopic Appearance of the Mucosa at Week 66, as Determined by the MCS Endoscopic Subscore [ Time Frame: Baseline and Week 66 ]
The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Improvement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1.
Maintenance Phase: Percentage of Participants With Histologic Remission at Week 66, as Determined by the Nancy Histological Index [ Time Frame: Week 66 ]
Nancy Histological Index (NHI) is a 5-level classification ranging from grade 0 (No histologically significant disease) to grade 4 (severely active disease). Histologic remission is defined as a Nancy Histological Index of 0 or 1.
Maintenance Phase: Percentage of Participants With Endoscopic Remission at Week 66, as Determined by the MCS Endoscopic Subscore [ Time Frame: Week 66 ]
The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Endoscopic Remission is Endoscopy subscore = 0.
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 66 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS [ Time Frame: Week 66 ]
The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Corticosteroid-Free analysis was conducted only on a subgroup of participants who were randomized into the maintenance phase and receiving Corticosteroids (CS) at baseline. Participants were defined as being off CS if they had no record of taking CS on the date that was 24 weeks prior to Week 66.
Maintenance Phase: Percentage of Participants With Corticosteroid-Free Remission at Week 66 Among Participants Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS [ Time Frame: Week 66 ]
The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Corticosteroid-Free analysis was conducted only on a subgroup of participants who were randomized into the maintenance phase and receiving Corticosteroids (CS) at baseline. Participants were defined as being off CS if they had no record of taking CS on the date that was 24 weeks prior to Week 66.
Maintenance Phase: Change From Baseline to Week 66 in UC Bowel Movement Signs and Symptoms, as Assessed by the UC-PRO/SS Questionnaire [ Time Frame: Baseline and Week 66 ]
The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The bowel domain score ranges from 0-27, with a higher score indicating a worse disease state.
Maintenance Phase: Change From Baseline to Week 66 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire [ Time Frame: Baseline and Week 66 ]
The UC-PRO questionnaire is collected in the e-diary and completed by participants for at least 9-12 consecutive days prior to a study visit. The UC-PRO is being reported in three domains; two domains are key endpoints and reported as UC-PRO Signs and Symptoms (UC-PRO/SS). The functional (abdominal symptoms) domain score ranges from 0-12, with a higher score indicating a worse disease state.
Maintenance Phase: Change From Baseline to Week 66 in Health-Related Quality of Life, as Assessed by the Overall Score of the IBDQ [ Time Frame: Baseline and Week 66 ]
The IBDQ is used to assess participant's health-related quality of life (QOL). The IBDQ score is a Total Score summed up from across all 32 questions on the questionnaire. The Total Score range is from 32 to 224 with higher scores representing a better quality of life.
Number of Participants With at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) [ Time Frame: From Baseline up to Week 78 ]
All Adverse Events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.
Number of Participants With Adverse Events Leading to Study Drug Discontinuation [ Time Frame: From Baseline up to Week 78 ]
Number of Participants With Serious Infection-Related Adverse Events [ Time Frame: From Baseline up to Week 78 ]
Number of Participants With Infection-Related Adverse Events [ Time Frame: From Baseline up to Week 78 ]
All Adverse Events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.
Number of Participants With Injection-Site Reaction-Related Adverse Events [ Time Frame: From Baseline up to Week 78 ]
Number of Participants With Hypersensitivity Reaction-Related Adverse Events [ Time Frame: From Baseline up to Week 78 ]
Number of Participants With Malignancies [ Time Frame: From Baseline up to Week 78 ]
Number of Participants With Anti-Therapeutic Antibodies to Etrolizumab at Baseline and During the Study [ Time Frame: Pre-dose at Baseline, Weeks 4, 14, 24, 44, and 66, and Early Termination/End of Safety Follow-Up (up to Week 78) ]
A tiered strategy was used to detect and characterize etrolizumab antibodies within this clinical study. When determining post baseline incidence, participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following etrolizumab drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were ADA negative or had missing data at baseline and all post baseline samples were negative, or if they were ADA positive at baseline but did not have any post baseline samples with a titer that was at least 0.60 titer unit greater than the titer of the baseline sample (treatment unaffected).
Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ) [ Time Frame: Pre-dose (0 hour) at Baseline and Weeks 14, 24, 44 and 66 ]
As per Protocol, the timepoints for each arm where more than a third of the samples were above the lower limit of quantification (LLOQ), full summary statistics (Mean and Standard Deviation) were reported. For timepoints below the LLOQ, only the Median and Max were reported as a separate outcome measure below.
Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ) [ Time Frame: Weeks 44 and 66 ]
As per Protocol, the timepoints for each arm where more than a third of the samples were below the LLOQ only the Median and Max were reported.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of UC established at least 3 months prior to Day 1
Moderately to severely active UC as determined by the Mayo Clinic Score (MCS) assessment
Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
Washout of anti-TNF therapy for at least 8 weeks preceding Day 1
Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
Use of highly effective contraception as defined by the protocol
Must have received a colonoscopy within the past year or be willing to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening

Exclusion Criteria:

A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
Prior or planned surgery for UC
Past or present ileostomy or colostomy
Any prior treatment with etrolizumab or other anti-integrin agents (including natalizumab, vedolizumab, and efalizumab)
Any prior treatment with anti-adhesion molecules (e.g. anti-MAdCAM-1)
Any prior treatment with rituximab
Any treatment with tofacitinib during screening
Congenital or acquired immune deficiency, chronic hepatitis B or C infection, human immunodeficiency virus (HIV) positive, or history of tuberculosis (active or latent)
Evidence of or treatment for Clostridium difficile or clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1
Evidence of or treatment for other intestinal pathogens within 30 days prior to Day 1
History of recurrent opportunistic infections and/or severe disseminated viral infections
History of organ transplant
Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening
Received a live attenuated vaccine within 4 weeks prior to Day 1

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100696

Locations

Show 184 study locations

Layout table for location information

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California San Diego Medical Center
La Jolla, California, United States, 92093-5354
Clinical Applications Laboratories, Inc.
San Diego, California, United States, 92103
Precision Research Institute, LLC
San Diego, California, United States, 92114
University of California at San Francisco
San Francisco, California, United States, 94115
United States, Colorado
Rocky Mountain Gastroenterology Associates
Denver, Colorado, United States, 80222
Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology
Lakewood, Colorado, United States, 80215
United States, Florida
FQL Research, LLC
Miramar, Florida, United States, 33025
Center For Digestive Health
Orlando, Florida, United States, 32803
Internal Medicine Specialists
Orlando, Florida, United States, 32806
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
United States, Georgia
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States, 31201
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States, 30060
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, United States, 30024
United States, Illinois
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States, 60611
Southwest Gastroenterology
Oak Lawn, Illinois, United States, 60453
United States, Kansas
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States, 66606
United States, Louisiana
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States, 70809
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
United States, Massachusetts
Massachusetts General Hospital; Crohn's & Colitis Center
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
Center for Digestive Health
Troy, Michigan, United States, 48098
United States, Missouri
Kansas City Research Institute, LLC
Kansas City, Missouri, United States, 64131
United States, New York
Clinica Peruano Americana S.A.
Great Neck, New York, United States, 11021
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States, 10021
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Consultants for Clinical Research Inc.
Cincinnati, Ohio, United States, 45219
UC Health, LLC.
Cincinnati, Ohio, United States, 45219
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States, 44060
United States, Tennessee
Gastroenterology Center of the Midsouth, P.C.
Memphis, Tennessee, United States, 38120
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Tyler Research Institute, LLC
Tyler, Texas, United States, 75701
United States, Utah
Ericksen Research and Development
Clinton, Utah, United States, 84015
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
United States, Virginia
Digestive and Liver Disease Specialists, Ltd.
Norfolk, Virginia, United States, 23502
McGuire Research Institute; Gastroenterology
Richmond, Virginia, United States, 23249
United States, Washington
Washington Gastroenterology
Bellevue, Washington, United States, 98004
Argentina
Hospital Provincial del Centenario
Rosario, Argentina, 2000
Australia, Queensland
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Mater Adult Hospital
South Brisbane, Queensland, Australia, 4101
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, Tasmania
Launceston General Hospital; Gastroenterology Research
Launceston, Tasmania, Australia, 7250
Australia, Victoria
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Footscray Hospital; Gastroenterology
Footscray, Victoria, Australia, 3011
St Frances Xavier Cabrini Hospital
Malvern, Victoria, Australia, 3144
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Austria
Klinikum Klagenfurt am Wörtersee; Acute geriatric care
Klagenfurt, Austria, 9020
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, Austria, 5020
Medizinische Universität Wien
Wien, Austria, 1090
Belgium
Imeldaziekenhuis
Bonheiden, Belgium, 2820
CHU St Pierre (St Pierre)
Brussels, Belgium, 1000
UZ Brussel
Brussel, Belgium, 1090
UZ Gent
Gent, Belgium, 9000
AZ Sint Elisabeth Herentals
Herentals, Belgium, 2200
UZ Leuven; Neurology
Leuven, Belgium, 3000
CHU de Liège; Tour de Pathologie
Liège, Belgium, 4000
AZ Delta (Stedelijk Ziekenhuis)
Roeselare, Belgium, 8800
Brazil
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
Goiânia, GO, Brazil, 74535-170
Hospital Felicio Rocho
Belo Horizonte, MG, Brazil, 30110-068
Centro Digestivo de Curitiba
Curitiba, PR, Brazil, 80430-160
Hospital Universitario Clementino Fraga Filho - UFRJ
Rio de Janeiro, RJ, Brazil, 21941-913
Hospital Moinhos de Vento
Porto Alegre, RS, Brazil, 90035-001
Hospital de Clínicas de Porto Alegre X
Porto Alegre, RS, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, SP, Brazil, 18618-970
CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
Campinas, SP, Brazil, 13087-567
Hospital Estadual Mario Covas
Santo Andre, SP, Brazil, 09190-610
Canada, Alberta
University of Calgary; Heritage Medical Research Clinic
Calgary, Alberta, Canada, T2N 4Z6
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
Pacific Gastroenterology Associates
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Taunton Health Centre
Oshawa, Ontario, Canada, L1H 7K4
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Toronto Liver Centre
Toronto, Ontario, Canada, M6H 3M1
Toronto Digestive Disease Associates
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
Hotel Dieu de Levis
Levis, Quebec, Canada, G6V 3Z1
Hôpital Maisonneuve - Rosemont
Montreal, Quebec, Canada, H1T 2M4
Czechia
Fakultni nemocnice Brno; Interni kardiologicka klinika
Brno, Czechia, 625 00
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, Czechia, 500 12
Pardubicka krajska nemocnice, a.s.
Pardubice, Czechia, 532 03
Nemocnice Na Bulovce
Prague, Czechia, 180 01
ISCARE a.s.
Praha 7, Czechia, 170 04
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
Usti Nad Labem, Czechia, 401 13
Denmark
Rigshospitalet; Medicinsk gastroenterologisk klinik
København Ø, Denmark, 2100
Ålborg Universitets Hospital; Gastromedicinsk
Ålborg, Denmark, 9000
France
CHU Amiens - Hopital Sud; Pharmacie - Secteur des Essais cliniques
Amiens Cedex01, France, 80054
Hôpital Beaujon
Clichy cedex, France, 92110
Hopital Claude Huriez - CHU Lille
Lille, France, 59037
Hôpital Nord - CHU Marseille; Gastroenterology and Hepatology
Marseille cedex 20, France, 13915
CHU Nice - Hopital de l'Archet 2
Nice, France, 06202
Hôpital Saint-Louis
Paris, France, 75475
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
Pessac, France, 33604
CHU Saint Etienne - Hôpital Nord
Saint Etienne, France, 42055
Höpital Hautepierre; Pediatrie1
Strasbourg, France, 67098
CHU de Toulouse - Hôpital Rangueil
Toulouse Cedex 09, France, 31059
Hôpital de Brabois Adultes
Vandoeuvre-les-nancy, France, 54511
Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, Germany, 10117
DRK Kliniken Berlin Westend
Berlin, Germany, 14050
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, Germany, 60590
Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation
Freiburg, Germany, 79106
Universitaetsklinikum Halle (Saale)
Halle, Germany, 06120
Hamburgisches Forschungsinstitut fuer CED
Hamburg, Germany, 20148
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Gastroenterologie Eppendorfer Baum
Hamburg, Germany, 20249
Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
Hannover, Germany, 30625
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24116
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, Germany, 68167
Universitaetsklinikum Muenster
Muenster, Germany, 48149
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Greece
Anticancer Hospital of Thessaliniki " Theagenio"
Thessaloniki, Greece, 54007
Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
Bekescsaba, Hungary, 5600
Obudai Egeszsegugyi Centrum Kft.
Budapest, Hungary, 1036
Semmelweis Egyetem
Budapest, Hungary, 1083
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
Budapest, Hungary, 1125
Pannonia Maganorvosi Centrum
Budapest, Hungary, 1135
Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Budapest, Hungary, H-1077
Debreceni Egyetem
Debrecen, Hungary, 4032
Markhot Ferenc Oktato Korhaz es Rendelointezet
Eger, Hungary, 3300
Petz Aladar Megyei Oktato Korhaz
Gyor, Hungary, 9024
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat
Miskolc, Hungary, 3526
Pecsi Tudomanyegyetem
Pecs, Hungary, 7624
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Hungary, 8000
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Hadassah University Hospital - Ein Kerem; Neurosurgery
Jerusalem, Israel, 9112001
Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute
Petach Tiqwa, Israel, 49100
Kaplan Medical Center
Rehovot, Israel, 7610001
Assaf Harofeh
Rishon Lezion, Israel, 7505001
Italy
Azienda Ospedaliera S. Orsola-Malpighi
Bologna, Emilia-Romagna, Italy, 40138
A.O.U. Policlinico di Modena
Modena, Emilia-Romagna, Italy, 40124
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, Lazio, Italy, 00133
Azienda Ospedaliera San Camillo Forlanini
Roma, Lazio, Italy, 00152
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Lazio, Italy, 00168
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milano, Lombardia, Italy
Ospedale di Circolo; Neuropsichiatria Infantile
Rho, Lombardia, Italy, 20017
Istituto Clinico Humanitas
Rozzano (MI), Lombardia, Italy, 20089
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardia, Italy, 20097
Azienda Ospedaliera Universitaria Careggi
Firenze, Toscana, Italy, 50141
Azienda Ospedaliera Di Padova
Padova, Veneto, Italy, 35128
Korea, Republic of
Kyungpook National University Hospital; Opthalmology
Daegu, Korea, Republic of, 700-721
Korea University Ansan Hospital
Gyeonggi-do, Korea, Republic of, 15355
Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of, 13605
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University
Seoul, Korea, Republic of, 03722
Samsung Medical Center
Seoul, Korea, Republic of, 06531
Asan Medical Center.
Seoul, Korea, Republic of, 138-736
The Catholic University of Korea St. Vincent's Hospital
Suwon-si,, Korea, Republic of, 442-723
Lithuania
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas, Lithuania, 50009
Vilnius University Hospital Santariskiu Clinic Public Insti
Vilnius, Lithuania, 08661
Mexico
Centro Regiomontano de Estudios Clínicos Roma S.C.
Monterrey, Nuevo LEON, Mexico, 64610
Netherlands
Amsterdam UMC, Locatie VUMC; Neurology
Amsterdam, Netherlands, 1081 HV
Amsterdam UMC Location AMC
Amsterdam, Netherlands, 1105 AZ
Rijnstate; Internal Medicine Department
Arnhem, Netherlands, 6815 AD
Radboudumc
NL -nijmegen, Netherlands, 6525 GA
Poland
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, Poland, 85-312
Nzoz All-Medicus
Katowice, Poland, 40-660
Gabinet Lekarski, Bartosz Korczowski
Rzeszów, Poland, 35-302
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
Szczecin, Poland, 70-351
Centrum Zdrowia MDM
Warszawa, Poland, 00-631
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warszawa, Poland, 02-781
Nzoz Vivamed
Warszawa, Poland, 03-580
LexMedica Osrodek Badan Klinicznych
Wroclaw, Poland, 53-114
EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
Wroclaw, Poland, 54-144
PlanetMed
Wrocław, Poland, 52-210
Romania
SC Euroclinic Hospital SA
Bucuresti, Romania, 014461
Spain
Fundacion Hospital de Alcorcon; Servicio de Digestivo
Alcorcon, Madrid, Spain, 28922
Hospital Universitari de Girona Dr Josep Trueta
Girona, Spain, 17007
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Hospital Universitario de Fuenlabrada
Madrid, Spain, 28942
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Switzerland
Inselspital-Universitaetsspital Bern; Institut fuer Spitalpharmazie
Bern, Switzerland, 3010
Cliniques Universitaires Saint-Luc; Nephrology
Bern, Switzerland, 3012
Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
Bern, Switzerland, 3012
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Royal Devon and Exeter Hospital (Wonford)
Exeter, United Kingdom, EX2 5DW
The Royal London Hospital
London, United Kingdom, E1 2ES
University College London Hospital
London, United Kingdom, NW1 - 2PG
St Thomas Hospital
London, United Kingdom, SE1 7EH
King's College London
London, United Kingdom, SE5 9NU
Fairfield General Hospital
Manchester, United Kingdom, M8 5RB
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Nottingham University Hospitals; QMC Campus
Nottingham, United Kingdom, NG7 2UH
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Layout table for investigator information

Study Director:	Clinical Trials	Hoffmann-La Roche

Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol [PDF] July 11, 2018

Statistical Analysis Plan [PDF] May 4, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Peyrin-Biroulet L, Hart A, Bossuyt P, Long M, Allez M, Juillerat P, Armuzzi A, Loftus EV Jr, Ostad-Saffari E, Scalori A, Oh YS, Tole S, Chai A, Pulley J, Lacey S, Sandborn WJ; HICKORY Study Group. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):128-140. doi: 10.1016/S2468-1253(21)00298-3. Epub 2021 Nov 17.

Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

Layout table for additonal information

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT02100696
Other Study ID Numbers:	GA28950 2013-004278-88 ( EudraCT Number )
First Posted:	April 1, 2014 Key Record Dates
Results First Posted:	June 15, 2021
Last Update Posted:	August 13, 2021
Last Verified:	July 2021

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases	Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases Etrolizumab Gastrointestinal Agents Immunologic Factors Physiological Effects of Drugs

To Top