A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Study Purpose

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of UC - Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score - Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor [TNF] inhibitors [maximum of 2 prior TNF inhibitors]) and/or corticosteroid treatment - Use of highly effective contraception as defined by the protocol

Exclusion Criteria:

- History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis - History of cancer as defined by the protocol - Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC) - Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC - Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening - Suspicion of ischemic colitis, radiation colitis, or microscopic colitis - Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon - History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia - Prior treatment with UTTR1147A - Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents - Prior treatment with rituximab - Use of prohibited therapies, as defined by the protocol, prior to randomization - Congenital or acquired immune deficiency - Evidence or treatment of infections or history of infections, as defined by the protocol

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03558152

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Genentech, Inc.

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Bulgaria, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Poland, Russian Federation, Serbia, Spain, Ukraine, United Kingdom, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Ulcerative Colitis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Salt Lake City, Utah

Status

Recruiting

Address

University of Utah School of Medicine; Gastroenterology Division

Salt Lake City, Utah, 84132

BI Research Center, Houston, Texas

Status

Recruiting

Address

BI Research Center

Houston, Texas, 77089

Houston, Texas

Status

Recruiting

Address

Biopharma Informatic Inc.; Research Center

Houston, Texas, 77043

Houston, Texas

Status

Recruiting

Address

Baylor College of Medicine; Gastroenterology

Houston, Texas, 77030

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Gastro One, Germantown, Tennessee

Status

Recruiting

Address

Gastro One

Germantown, Tennessee, 38138

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Carolina Digestive Diseases, Greenville, North Carolina

Status

Recruiting

Address

Carolina Digestive Diseases

Greenville, North Carolina, 27834

VA Medical Center - Syracuse, Syracuse, New York

Status

Recruiting

Address

VA Medical Center - Syracuse

Syracuse, New York, 13210

University of Rochester Medical Center, Rochester, New York

Status

Recruiting

Address

University of Rochester Medical Center

Rochester, New York, 14642

Southtowns Gastroenterology, PLLC, Orchard Park, New York

Status

Recruiting

Address

Southtowns Gastroenterology, PLLC

Orchard Park, New York, 14127

Great Neck, New York

Status

Recruiting

Address

NYU Langone Long Island Clinical Research Associates

Great Neck, New York, 11021

Clin. Rsrch Inst. of Michigan, Chesterfield, Michigan

Status

Recruiting

Address

Clin. Rsrch Inst. of Michigan

Chesterfield, Michigan, 48047

Chicago, Illinois

Status

Recruiting

Address

University of Chicago Medical Center; Cancer Research Center

Chicago, Illinois, 60637-1470

Gastroenterology Group of Naples, Naples, Florida

Status

Recruiting

Address

Gastroenterology Group of Naples

Naples, Florida, 34102

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

LCC Medical Research Institute, Miami, Florida

Status

Recruiting

Address

LCC Medical Research Institute

Miami, Florida, 33126

QWay Research, Hialeah, Florida

Status

Not yet recruiting

Address

QWay Research

Hialeah, Florida, 33010

Care Access Research, San Pablo, California

Status

Recruiting

Address

Care Access Research

San Pablo, California, 94806

International Sites

Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom

Status

Not yet recruiting

Address

Royal Victoria Infirmary

Newcastle upon Tyne, , NE1 4LP

Kings College Hospital, London, United Kingdom

Status

Not yet recruiting

Address

Kings College Hospital

London, , SE5 9RS

Zaporizhzhia, Ukraine

Status

Recruiting

Address

Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3

Zaporizhzhia, , 69035

Uzhgorod, Ukraine

Status

Recruiting

Address

Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department

Uzhgorod, , 88000

Dnipr, Polissya Okruha, Ukraine

Status

Recruiting

Address

Medical Center of LLC Medical Center Family Medicine Clinic; Endoscopy & Gastroenterology

Dnipr, Polissya Okruha, 49600

Vinnytsia, Podolia Governorate, Ukraine

Status

Recruiting

Address

Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov

Vinnytsia, Podolia Governorate, 21029

Kyiv, KIEV Governorate, Ukraine

Status

Recruiting

Address

Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC

Kyiv, KIEV Governorate, 2091

Zaporizhzhia, Kharkiv Governorate, Ukraine

Status

Recruiting

Address

Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

Zaporizhzhia, Kharkiv Governorate, 69600

Vinnytsia, Kharkiv Governorate, Ukraine

Status

Not yet recruiting

Address

City Clinical Hospital #1; Department of Gastroenterology

Vinnytsia, Kharkiv Governorate, 21029

Medical Centre of LLC CARDIOCOM, Kozyn, Kharkiv Governorate, Ukraine

Status

Not yet recruiting

Address

Medical Centre of LLC CARDIOCOM

Kozyn, Kharkiv Governorate, 08711

Ternopil, Katerynoslav Governorate, Ukraine

Status

Recruiting

Address

Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology

Ternopil, Katerynoslav Governorate, 46002

Zhytomir, Crimean Regional Governmenta, Ukraine

Status

Recruiting

Address

Medical Centre of PE First Private Clinic

Zhytomir, Crimean Regional Governmenta, 10008

Chernivtsi, Chernihiv Governorate, Ukraine

Status

Recruiting

Address

Regional Municipal Institution Chernivtsi Regional Clinical Hospital; Gastroenterology department

Chernivtsi, Chernihiv Governorate, 58001

Valencia, Spain

Status

Recruiting

Address

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , 46026

Valencia, Spain

Status

Recruiting

Address

Hospital Clinico Universitario de Valencia

Valencia, , 46010

Salamanca, Spain

Status

Recruiting

Address

Complejo Asistencial Universitario de Salamanca - H. Clinico

Salamanca, , 37007

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario de La Princesa; Aparato Digestivo

Madrid, , 28006

Hospital Universitario de Torrejon, Torrejon de Ardoz, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario de Torrejon

Torrejon de Ardoz, Madrid, 28850

Las Palmas de Gran Canaria, LAS Palmas, Spain

Status

Recruiting

Address

Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo

Las Palmas de Gran Canaria, LAS Palmas, 35010

Zrenjanin, Serbia

Status

Not yet recruiting

Address

General Hospital Djordje Jovanovic - Zrenjanin

Zrenjanin, , 23000

Clinical Hospital Centre Zemun, Zemun, Serbia

Status

Not yet recruiting

Address

Clinical Hospital Centre Zemun

Zemun, , 11080

General Hospital Vrsac, Vrsac, Serbia

Status

Recruiting

Address

General Hospital Vrsac

Vrsac, , 26300

Clinical Center Nis, NIS, Serbia

Status

Not yet recruiting

Address

Clinical Center Nis

NIS, , 18000

Kragujevac, Serbia

Status

Recruiting

Address

Clinical Center Kragujevac; Clinic Of Psychiatry

Kragujevac, , 34000

Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia

Status

Not yet recruiting

Address

Clinical Hospital Center Bezanijska Kosa

Belgrade, , 11080

KBC Dr Dragisa Misovic Dedinje, Belgrade, Serbia

Status

Not yet recruiting

Address

KBC Dr Dragisa Misovic Dedinje

Belgrade, , 11000

Clinical Hospital Center Zvezdara, Belgrade, Serbia

Status

Recruiting

Address

Clinical Hospital Center Zvezdara

Belgrade, , 11000

Belgraade, Serbia

Status

Not yet recruiting

Address

Clinical Center of Serbia; Clinic of Gastroenterology

Belgraade, , 11000

St. Petersburg, Russian Federation

Status

Not yet recruiting

Address

Russian Medical Military Academy n.a. S.M. Kirov

St. Petersburg, , 194044

St. Petersburg, Russian Federation

Status

Not yet recruiting

Address

North-West State Medical University n.a. I.I. Mechnikov

St. Petersburg, , 191015

Medical University Reaviz, Samara, Russian Federation

Status

Recruiting

Address

Medical University Reaviz

Samara, , 443011

Rostov-na-Donu, Russian Federation

Status

Recruiting

Address

Rostov State Medical University; Cardiorheumatology Department

Rostov-na-Donu, , 344022

Kuban State Medical University, Krasnodar, Russian Federation

Status

Not yet recruiting

Address

Kuban State Medical University

Krasnodar, , 350000

Irkutsk, Russian Federation

Status

Not yet recruiting

Address

Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science

Irkutsk, , 664033

Saint Martyr Elizabeth City Hospital, Sankt-peterburg, Sankt Petersburg, Russian Federation

Status

Recruiting

Address

Saint Martyr Elizabeth City Hospital

Sankt-peterburg, Sankt Petersburg, 195257

Medical Center Stolitsa-Medikl, Moscow, Moskovskaja Oblast, Russian Federation

Status

Not yet recruiting

Address

Medical Center Stolitsa-Medikl

Moscow, Moskovskaja Oblast, 129329

Łódź, Poland

Status

Recruiting

Address

SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.

Łódź, , 90-153

PlanetMed, Wrocław, Poland

Status

Not yet recruiting

Address

PlanetMed

Wrocław, , 52-210

Melita Medical, Wrocław, Poland

Status

Recruiting

Address

Melita Medical

Wrocław, , 50-449

EMC Instytut Medyczny S.A., Wroclaw, Poland

Status

Not yet recruiting

Address

EMC Instytut Medyczny S.A.

Wroclaw, , 54-144

BioVirtus Research Site, Warszawa, Poland

Status

Recruiting

Address

BioVirtus Research Site

Warszawa, , 02-797

Centrum Medyczne NeuroProtect, Warszawa, Poland

Status

Recruiting

Address

Centrum Medyczne NeuroProtect

Warszawa, , 01-684

Centrum Zdrowia MDM, Warszawa, Poland

Status

Not yet recruiting

Address

Centrum Zdrowia MDM

Warszawa, , 00-635

Gastromed Kopon Zmudzinski i, Toruń, Poland

Status

Recruiting

Address

Gastromed Kopon Zmudzinski i

Toruń, , 87-100

Sosnowiec, Poland

Status

Recruiting

Address

PULMAG Arkadiusz Brodowski, Grzegorz Gasior S. C.

Sosnowiec, , 41-200

Endoskopia Sp. z o.o., Sopot, Poland

Status

Recruiting

Address

Endoskopia Sp. z o.o.

Sopot, , 81-756

Gabinet Lekarski, Bartosz Korczowski, Rzeszów, Poland

Status

Recruiting

Address

Gabinet Lekarski, Bartosz Korczowski

Rzeszów, , 35-302

Poznań, Poland

Status

Not yet recruiting

Address

Clinical Research Center Sp. z o.o. MEDIC-R Spółka Komandytowa

Poznań, , 60-848

Klimed Marek Klimkiewicz, Piotrków Trybunalski, Poland

Status

Recruiting

Address

Klimed Marek Klimkiewicz

Piotrków Trybunalski, , 97-300

Lublin, Poland

Status

Recruiting

Address

Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej

Lublin, , 20-582

ETG Kielce, Kielce, Poland

Status

Recruiting

Address

ETG Kielce

Kielce, , 25-355

Katowice, Poland

Status

Recruiting

Address

Economicus - NZOZ ALL-MEDICUS; Zaklad Gastroenterologii

Katowice, , 40-660

Bydgoszcz, Poland

Status

Not yet recruiting

Address

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej

Bydgoszcz, , 85-168

ETZ TweeSteden, Tilburg, Netherlands

Status

Not yet recruiting

Address

ETZ TweeSteden

Tilburg, , 5042AD

Azienda Ospedaliera Di Padova, Padova, Veneto, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Di Padova

Padova, Veneto, 35128

Firenze, Toscana, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Universitaria Careggi; Dip. Area Critica Medico-Chirurgica

Firenze, Toscana, 50134

Istituto Clinico Humanitas, Rozzano (MI), Lombardia, Italy

Status

Not yet recruiting

Address

Istituto Clinico Humanitas

Rozzano (MI), Lombardia, 20089

Monza, Lombardia, Italy

Status

Recruiting

Address

ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore

Monza, Lombardia, 20900

Complesso Integrato Columbus, Roma, Lazio, Italy

Status

Not yet recruiting

Address

Complesso Integrato Columbus

Roma, Lazio, 00168

Roma, Lazio, Italy

Status

Recruiting

Address

Policlinico Universitario Campus Biomedico Di Roma

Roma, Lazio, 00128

Roma, Emilia-Romagna, Italy

Status

Not yet recruiting

Address

La Sapienza-Università di Roma-Policlinico Umberto I

Roma, Emilia-Romagna, 00161

Bologna, Emilia-Romagna, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi; UO Farmacia Clinica

Bologna, Emilia-Romagna, 40138

Kaplan Medical Center, Rehovot, Israel

Status

Recruiting

Address

Kaplan Medical Center

Rehovot, , 76100

Ramat Gan, Israel

Status

Not yet recruiting

Address

Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit

Ramat Gan, , 52621

Rabin Medical Center; PPDS; Pharmacy, Petach Tiqwa, Israel

Status

Recruiting

Address

Rabin Medical Center; PPDS; Pharmacy

Petach Tiqwa, , 4910000

Galilee Medical Center, Nahariya, Israel

Status

Not yet recruiting

Address

Galilee Medical Center

Nahariya, , 22100

Meir Medical Center, Kfar Saba, Israel

Status

Recruiting

Address

Meir Medical Center

Kfar Saba, , 4428164

Shaare Zedek Medical Center; Bait Vagan, Jerusalem, Israel

Status

Not yet recruiting

Address

Shaare Zedek Medical Center; Bait Vagan

Jerusalem, , 9103102

Soroka University Medical Centre, Beer-Sheva, Israel

Status

Not yet recruiting

Address

Soroka University Medical Centre

Beer-Sheva, , 84101

Our Lady of Lourdes Hospital, Louth, County Louth, Ireland

Status

Recruiting

Address

Our Lady of Lourdes Hospital, Louth

County Louth, ,

Portiuncula Hospital, Ballinasloe, Co Galway, Ireland

Status

Recruiting

Address

Portiuncula Hospital, Ballinasloe

Co Galway, ,

Csolnoky Ferenc Kórház, Veszprém, Hungary

Status

Not yet recruiting

Address

Csolnoky Ferenc Kórház

Veszprém, , 8200

Székesfehérvár, Hungary

Status

Recruiting

Address

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz; I. sz. Belgyogyaszati Osztaly

Székesfehérvár, , 8000

Szent Pantaleon Korhaz; I. Belgyogyaszat, Dunaujvaros, Hungary

Status

Recruiting

Address

Szent Pantaleon Korhaz; I. Belgyogyaszat

Dunaujvaros, , 2400

Budapest, Hungary

Status

Recruiting

Address

Magyar Honvédség Egészségügyi Központ; Országos Haemophilia Központ

Budapest, , 1134

Budapest, Hungary

Status

Recruiting

Address

Szent Margit Korhaz; IV.sz. Belgyogyaszati Osztaly

Budapest, , 1032

Thessaloniki, Greece

Status

Recruiting

Address

EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department

Thessaloniki, , 54645

Palaio Faliro, Greece

Status

Recruiting

Address

Iatriko Palaiou Falirou; Gastrointestinal Department

Palaio Faliro, , 175 62

Larissa, Greece

Status

Not yet recruiting

Address

University General Hospital of Larissa; University Gastroenterology Clinic

Larissa, , 411 10

Heraklion, Greece

Status

Not yet recruiting

Address

University General Hospital of Heraklion; Department of Ophthalmology

Heraklion, , 71110

Ulm, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Ulm; Klinik für Innere Medizin II

Ulm, , 89081

Regensburg, Germany

Status

Not yet recruiting

Address

Klinikum der Universität Regensburg; Klinik und Poliklinik für Innere Medizin I

Regensburg, , 93053

Universitätsklinikum Münster, Münster, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Münster

Münster, , 48149

Mannheim, Germany

Status

Recruiting

Address

Klinikum Mannheim GmbH Universitätsklinikum

Mannheim, , 68167

St. Marien Krankenhaus; Med. Klinik, Ludwigshafen, Germany

Status

Not yet recruiting

Address

St. Marien Krankenhaus; Med. Klinik

Ludwigshafen, , 67067

Universitatsklinikum Schleswig-Holstein, Lubeck, Germany

Status

Not yet recruiting

Address

Universitatsklinikum Schleswig-Holstein

Lubeck, , 23538

Jena, Germany

Status

Recruiting

Address

Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena

Jena, , 07740

KRH Klinikum Siloah, Hannover, Germany

Status

Recruiting

Address

KRH Klinikum Siloah

Hannover, , 30459

Hamburg, Germany

Status

Not yet recruiting

Address

Asklepios Westklinikum Hamburg Ggmbh; Gastroenterologie

Hamburg, , 22559

Dresden, Germany

Status

Recruiting

Address

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, , 01307

Berlin, Germany

Status

Recruiting

Address

Gastroenterologische Spezialpraxis-Berlin-Karlshorst

Berlin, , 10318

MC Medica Plus, Veliko Tarnovo, Bulgaria

Status

Recruiting

Address

MC Medica Plus

Veliko Tarnovo, , 5000

Sofia, Bulgaria

Status

Recruiting

Address

Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, , 1431

Sliven, Bulgaria

Status

Recruiting

Address

Multiprofile Hospital for Active Treatment Hadji Dimitar OOD

Sliven, , 8800

MHAT Saint Karidad EAD, Plovdiv, Bulgaria

Status

Recruiting

Address

MHAT Saint Karidad EAD

Plovdiv, , 4000

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