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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)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Etrozulimab
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • University of California San Diego Medical Center
  • Clinical Applications Laboratories, Inc.
  • Precision Research Institute, LLC
  • University of California at San Francisco
  • Rocky Mountain Gastroenterology Associates
  • Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology
  • FQL Research, LLC
  • Center For Digestive Health
  • Internal Medicine Specialists
  • Shafran Gastroenterology Center
  • Gastroenterology Associates of Central Georgia
  • Gastrointestinal Specialists of Georgia, PC
  • Atlanta Gastroenterology Specialists, PC
  • Northwestern University Feinberg School Of Medicine
  • Southwest Gastroenterology
  • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Gastroenterology Associates, LLC
  • Louisiana Research Center, LLC
  • Massachusetts General Hospital; Crohn's & Colitis Center
  • University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)
  • Henry Ford Health System
  • Center for Digestive Health
  • Kansas City Research Institute, LLC
  • Clinica Peruano Americana S.A.
  • Weill Cornell Medical College-New York Presbyterian Hospital
  • University of North Carolina at Chapel Hill
  • Consultants for Clinical Research Inc.
  • UC Health, LLC.
  • Great Lakes Gastroenterology Research, LLC
  • Gastroenterology Center of the Midsouth, P.C.
  • Vanderbilt University Medical Center
  • Tyler Research Institute, LLC
  • Ericksen Research and Development
  • University of Utah School of Medicine
  • Digestive and Liver Disease Specialists, Ltd.
  • McGuire Research Institute; Gastroenterology
  • Washington Gastroenterology
  • Hospital Provincial del Centenario
  • Royal Brisbane and Women's Hospital
  • Mater Adult Hospital
  • Princess Alexandra Hospital
  • Launceston General Hospital; Gastroenterology Research
  • St Vincent's Hospital Melbourne
  • Footscray Hospital; Gastroenterology
  • St Frances Xavier Cabrini Hospital
  • Fiona Stanley Hospital
  • Klinikum Klagenfurt am Wörtersee; Acute geriatric care
  • LKH - Universitätsklinikum der PMU Salzburg
  • Medizinische Universität Wien
  • Imeldaziekenhuis
  • CHU St Pierre (St Pierre)
  • UZ Brussel
  • UZ Gent
  • AZ Sint Elisabeth Herentals
  • UZ Leuven; Neurology
  • CHU de Liège; Tour de Pathologie
  • AZ Delta (Stedelijk Ziekenhuis)
  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
  • Hospital Felicio Rocho
  • Centro Digestivo de Curitiba
  • Hospital Universitario Clementino Fraga Filho - UFRJ
  • Hospital Moinhos de Vento
  • Hospital de Clínicas de Porto Alegre X
  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
  • CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
  • Hospital Estadual Mario Covas
  • University of Calgary; Heritage Medical Research Clinic
  • Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology
  • Pacific Gastroenterology Associates
  • Queen Elizabeth II Health Sciences Centre; Gastroenterology Research
  • Taunton Health Centre
  • Mount Sinai Hospital
  • Toronto Liver Centre
  • Toronto Digestive Disease Associates
  • Hotel Dieu de Levis
  • Hôpital Maisonneuve - Rosemont
  • Fakultni nemocnice Brno; Interni kardiologicka klinika
  • Hepato-Gastroenterologie HK, s.r.o.
  • Pardubicka krajska nemocnice, a.s.
  • Nemocnice Na Bulovce
  • ISCARE a.s.
  • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
  • Rigshospitalet; Medicinsk gastroenterologisk klinik
  • Ålborg Universitets Hospital; Gastromedicinsk
  • CHU Amiens - Hopital Sud; Pharmacie - Secteur des Essais cliniques
  • Hôpital Beaujon
  • Hopital Claude Huriez - CHU Lille
  • Hôpital Nord - CHU Marseille; Gastroenterology and Hepatology
  • CHU Nice - Hopital de l'Archet 2
  • Hôpital Saint-Louis
  • Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
  • CHU Saint Etienne - Hôpital Nord
  • Höpital Hautepierre; Pediatrie1
  • CHU de Toulouse - Hôpital Rangueil
  • Hôpital de Brabois Adultes
  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
  • DRK Kliniken Berlin Westend
  • Universitaetsklinikum Erlangen
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation
  • Universitaetsklinikum Halle (Saale)
  • Hamburgisches Forschungsinstitut fuer CED
  • Universitätsklinikum Hamburg-Eppendorf
  • Gastroenterologie Eppendorfer Baum
  • Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie
  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  • Klinikum Mannheim GmbH Universitätsklinikum
  • Universitaetsklinikum Muenster
  • Universitaetsklinikum Ulm
  • Anticancer Hospital of Thessaliniki " Theagenio"
  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
  • Obudai Egeszsegugyi Centrum Kft.
  • Semmelweis Egyetem
  • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo
  • Pannonia Maganorvosi Centrum
  • Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
  • Debreceni Egyetem
  • Markhot Ferenc Oktato Korhaz es Rendelointezet
  • Petz Aladar Megyei Oktato Korhaz
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat
  • Pecsi Tudomanyegyetem
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Shaare Zedek Medical Center
  • Hadassah University Hospital - Ein Kerem; Neurosurgery
  • Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute
  • Kaplan Medical Center
  • Assaf Harofeh
  • Azienda Ospedaliera S. Orsola-Malpighi
  • A.O.U. Policlinico di Modena
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Azienda Ospedaliera San Camillo Forlanini
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
  • Ospedale di Circolo; Neuropsichiatria Infantile
  • Istituto Clinico Humanitas
  • I.R.C.C.S Policlinico San Donato
  • Azienda Ospedaliera Universitaria Careggi
  • Azienda Ospedaliera Di Padova
  • Kyungpook National University Hospital; Opthalmology
  • Korea University Ansan Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University
  • Samsung Medical Center
  • Asan Medical Center.
  • The Catholic University of Korea St. Vincent's Hospital
  • Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
  • Vilnius University Hospital Santariskiu Clinic Public Insti
  • Centro Regiomontano de Estudios Clínicos Roma S.C.
  • Amsterdam UMC, Locatie VUMC; Neurology
  • Amsterdam UMC Location AMC
  • Rijnstate; Internal Medicine Department
  • Radboudumc
  • Nasz Lekarz Osrodek Badan Klinicznych
  • Nzoz All-Medicus
  • Gabinet Lekarski, Bartosz Korczowski
  • Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
  • Centrum Zdrowia MDM
  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
  • Nzoz Vivamed
  • LexMedica Osrodek Badan Klinicznych
  • EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu
  • PlanetMed
  • SC Euroclinic Hospital SA
  • Fundacion Hospital de Alcorcon; Servicio de Digestivo
  • Hospital Universitari de Girona Dr Josep Trueta
  • Hospital Universitario de la Princesa
  • Hospital Universitario de Fuenlabrada
  • Hospital Universitari i Politecnic La Fe
  • Hospital Universitario Miguel Servet
  • Inselspital-Universitaetsspital Bern; Institut fuer Spitalpharmazie
  • Cliniques Universitaires Saint-Luc; Nephrology
  • Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner
  • Addenbrooke's Hospital
  • Royal Devon and Exeter Hospital (Wonford)
  • The Royal London Hospital
  • University College London Hospital
  • St Thomas Hospital
  • King's College London
  • Fairfield General Hospital
  • Royal Victoria Infirmary
  • Nottingham University Hospitals; QMC Campus
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Placebo Comparator

Experimental

Arm Label

Cohort 1: Etrolizumab (Open-Label Induction (OLI) Phase)

Cohort 2: Placebo (Double-Blind Induction Phase)

Cohort 2: Etrolizumab (Double-Blind Induction Phase)

Placebo Responders: Placebo (Maintenance Phase)

Etrolizumab Responders: Placebo (Maintenance Phase)

Etrolizumab Responders: Etrolizumab (Maintenance Phase)

Arm Description

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.

Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Induction Phase: Percentage of Participants With Remission at Week 14, as Determined by the Mayo Clinic Score (MCS)
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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)
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
Number of Participants With Serious Infection-Related Adverse Events
Number of Participants With Infection-Related Adverse Events
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
Number of Participants With Hypersensitivity Reaction-Related Adverse Events
Number of Participants With Malignancies
Number of Participants With Anti-Therapeutic Antibodies to Etrolizumab at Baseline and During the Study
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)
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)
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.

Full Information

First Posted
March 27, 2014
Last Updated
July 22, 2021
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02100696
Brief Title
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
Acronym
HICKORY
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 21, 2014 (Actual)
Primary Completion Date
April 16, 2020 (Actual)
Study Completion Date
April 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
609 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Etrolizumab (Open-Label Induction (OLI) Phase)
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2: Placebo (Double-Blind Induction Phase)
Arm Type
Placebo Comparator
Arm Description
Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the induction phase.
Arm Title
Cohort 2: Etrolizumab (Double-Blind Induction Phase)
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase.
Arm Title
Placebo Responders: Placebo (Maintenance Phase)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Etrolizumab Responders: Placebo (Maintenance Phase)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Etrolizumab Responders: Etrolizumab (Maintenance Phase)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Etrozulimab
Other Intervention Name(s)
PRO145223, RO5490261, RG7413
Intervention Description
Participants will receive 105 mg etrolizumab administered by SC injection Q4W.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.
Primary Outcome Measure Information:
Title
Induction Phase: Percentage of Participants With Remission at Week 14, as Determined by the Mayo Clinic Score (MCS)
Description
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.
Time Frame
Week 14
Title
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
Description
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.
Time Frame
Week 66
Secondary Outcome Measure Information:
Title
Induction Phase: Percentage of Participants With Clinical Remission at Week 14, as Determined by the MCS
Description
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.
Time Frame
Week 14
Title
Induction Phase: Percentage of Participants With Clinical Response at Week 14, as Determined by the MCS
Description
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.
Time Frame
Week 14
Title
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
Description
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.
Time Frame
Baseline and Week 14
Title
Induction Phase: Percentage of Participants With Endoscopic Remission at Week 14, as Determined by the MCS Endoscopic Subscore
Description
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.
Time Frame
Week 14
Title
Induction Phase: Percentage of Participants With Histologic Remission at Week 14, as Determined by the Nancy Histological Index
Description
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.
Time Frame
Week 14
Title
Induction Phase: Change From Baseline to Week 6 in MCS Rectal Bleed Subscore
Description
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.
Time Frame
Baseline and Week 6
Title
Induction Phase: Change From Baseline to Week 6 in MCS Stool Frequency Subscore
Description
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.
Time Frame
Baseline and Week 6
Title
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
Description
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.
Time Frame
Baseline and Week 14
Title
Induction Phase: Change From Baseline to Week 14 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire
Description
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.
Time Frame
Baseline and Week 14
Title
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)
Description
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.
Time Frame
Baseline and Week 14
Title
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
Description
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.
Time Frame
Week 66
Title
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 66, as Determined by the MCS
Description
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.
Time Frame
Week 66
Title
Maintenance Phase: Percentage of Participants With Remission at Week 66 Among Participants Who Had Achieved Remission at Week 14, as Determined by the MCS
Description
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.
Time Frame
Week 66
Title
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
Description
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.
Time Frame
Baseline and Week 66
Title
Maintenance Phase: Percentage of Participants With Histologic Remission at Week 66, as Determined by the Nancy Histological Index
Description
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.
Time Frame
Week 66
Title
Maintenance Phase: Percentage of Participants With Endoscopic Remission at Week 66, as Determined by the MCS Endoscopic Subscore
Description
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.
Time Frame
Week 66
Title
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
Description
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.
Time Frame
Week 66
Title
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
Description
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.
Time Frame
Week 66
Title
Maintenance Phase: Change From Baseline to Week 66 in UC Bowel Movement Signs and Symptoms, as Assessed by the UC-PRO/SS Questionnaire
Description
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.
Time Frame
Baseline and Week 66
Title
Maintenance Phase: Change From Baseline to Week 66 in UC Functional Symptoms, as Assessed by the UC-PRO/SS Questionnaire
Description
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.
Time Frame
Baseline and Week 66
Title
Maintenance Phase: Change From Baseline to Week 66 in Health-Related Quality of Life, as Assessed by the Overall Score of the IBDQ
Description
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.
Time Frame
Baseline and Week 66
Title
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)
Description
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.
Time Frame
From Baseline up to Week 78
Title
Number of Participants With Adverse Events Leading to Study Drug Discontinuation
Time Frame
From Baseline up to Week 78
Title
Number of Participants With Serious Infection-Related Adverse Events
Time Frame
From Baseline up to Week 78
Title
Number of Participants With Infection-Related Adverse Events
Description
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.
Time Frame
From Baseline up to Week 78
Title
Number of Participants With Injection-Site Reaction-Related Adverse Events
Time Frame
From Baseline up to Week 78
Title
Number of Participants With Hypersensitivity Reaction-Related Adverse Events
Time Frame
From Baseline up to Week 78
Title
Number of Participants With Malignancies
Time Frame
From Baseline up to Week 78
Title
Number of Participants With Anti-Therapeutic Antibodies to Etrolizumab at Baseline and During the Study
Description
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).
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)
Title
Etrolizumab Serum Trough Concentration (for Arms/Timepoints Above LLOQ)
Description
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.
Time Frame
Pre-dose (0 hour) at Baseline and Weeks 14, 24, 44 and 66
Title
Etrolizumab Serum Trough Concentration (for Arms/Timepoints Below LLOQ)
Description
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.
Time Frame
Weeks 44 and 66

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
34798039
Citation
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.
Results Reference
derived
PubMed Identifier
32445184
Citation
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.
Results Reference
derived

Learn more about this trial

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

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