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)

PHASE2CompletedINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

October 26, 2018

Primary Completion Date

December 15, 2021

Study Completion Date

December 15, 2021

Conditions
Ulcerative Colitis
Interventions
DRUG

UTTR1147A

UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.

DRUG

UTTR1147A Placebo

The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.

DRUG

Vedolizumab

Vedolizumab will be administered IV, as specified in the prescribing information.

DRUG

Vedolizumab Placebo

The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.

Trial Locations (72)

1134

Magyar Honvédség Egészségügyi Központ; Országos Haemophilia Központ, Budapest

2091

"Med Center of International Institute of Clinical Trials LLC; Medical Center OK!Clinic+", Kyiv

4000

MHAT Saint Karidad EAD, Plovdiv

8800

Multiprofile Hospital for Active Treatment Hadji Dimitar OOD, Sliven

10008

Medical Centre of PE First Private Clinic, Zhytomyr

10318

Gastroenterologische Spezialpraxis-Berlin-Karlshorst, Berlin

11000

Clinical Hospital Center Zvezdara, Belgrade

KBC Dr Dragisa Misovic Dedinje, Belgrade

11080

University Hospital Medical Center Bezanijska kosa, Belgrade

Clinical Hospital Centre Zemun, Zemun

20089

Istituto Clinico Humanitas, Rozzano (MI)

20900

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

21029

City Clinical Hospital #1; Department of Gastroenterology, Vinnytsia

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

23000

General Hospital Djordje Joanovic - Zrenjanin, Zrenjanin

23538

Universitatsklinikum Schleswig-Holstein, Lübeck

25005

Treatment and Diagnostic Center of LLC MRT Elit, Kropyvnytskyi

26300

General Hospital Vrsac, Vršac

27834

Carolina Digestive Diseases, Greenville

28850

Hospital Universitario de Torrejon, Torrejón de Ardoz

34000

Clinical Center Kragujevac; Clinic Of Psychiatry, Kragujevac

35010

Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo, Las Palmas de Gran Canaria

35128

Azienda Ospedaliera Di Padova, Padua

46002

Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology, Ternopil

49005

ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council, Dnipro

49600

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

54645

EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department, Thessaloniki

58001

Regional Municipal Institution Chernivtsi Regional Clinical Hospital; Gastroenterology department, Chernivtsi

67067

St. Marien Krankenhaus; Med. Klinik, Ludwigshafen

69035

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

69076

Medical Center of LLC Diaservis, Zaporizhzhia

69600

Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council, Zaporizhzhia

84132

University of Utah School of Medicine; Gastroenterology Division, Salt Lake City

88000

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

89081

Universitätsklinikum Ulm; Klinik für Innere Medizin II, Ulm

191015

North-West State Medical University n.a. I.I. Mechnikov, Saint Petersburg

195257

Saint Martyr Elizabeth City Hospital, Saint Petersburg

344022

Rostov State Medical University; Cardiorheumatology Department, Rostov-on-Don

443011

Medical University Reaviz, Samara

664033

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

9103102

Shaare Zedek Medical Center; Bait Vagan, Jerusalem

0112

LLC ARENSIA Exploratory Medicine, Tbilisi

01307

Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden

175 62

Iatriko Palaiou Falirou; Gastrointestinal Department, Palaió Fáliro

Unknown

Portiuncula Hospital, Ballinasloe, Co Galway

00128

Policlinico Universitario Campus Biomedico Di Roma, Rome

00168

Complesso Integrato Columbus, Rome

MD-2025

ICS ARENSIA Exploratory Medicine, Chisinau

90-153

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

85-168

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

42-202

Synexus Polska Sp. z o.o. Oddzial w Czestochowie, Cz?stochowa

80-382

Synexus Polska Sp. z o.o. Oddzial w Gdansku, Gda?sk

40-040

Synexus - Katowice, Katowice

40-660

Economicus - NZOZ ALL-MEDICUS; Zaklad Gastroenterologii, Katowice

25-355

ETG Kielce, Kielce

20-582

Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej, Lublin

97-300

Klimed Marek Klimkiewicz, Piotrkow Trybunalski

60-702

Synexus Polska Sp. z o.o. Oddzial w Poznaniu, Późna

61-731

Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa, Późna

81-756

Endoskopia Sp. z o.o., Sopot

87-100

Gastromed Kopon Zmudzinski i, Toru?

00-635

Centrum Zdrowia MDM, Warsaw

00-728

Jaroslaw Kierkus Prywatna Prakyka Lekarska, Warsaw

50-220

Przychodnia EuroMediCare, Wroc?aw

50-381

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Wroc?aw

50-449

Melita Medical, Wroc?aw

01001

Medical Center of LLC Medical Clinic Blagomed, Kyiv

01135

Medical Center of Limited Liability Company ?Harmoniya krasy?, Kyiv

02000

Medical Center of LLC Medical Center Dopomoga Plus, Kyiv

02002

Medical Center of Edelweiss Medics LLC, Kyiv

03037

Synexus Affiliate - MC of LLC Medbud-Clinic, Kyiv

SW9 8RR

Kings College Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY