Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

PHASE3TerminatedINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

February 9, 2018

Primary Completion Date

July 22, 2020

Study Completion Date

October 23, 2020

Conditions
Ulcerative Colitis
Interventions
DRUG

Ontamalimab

Participants will receive 1 mL of SHP647 sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).

OTHER

Placebo

Participants will receive 1 mL of sterile aqueous buffered solution.

Trial Locations (207)

1090

Medizinische Universitat Wien (Medical University of Vienna), Vienna

1619

CLINRESCO, ARWYP Medical Suites, Johannesburg

2139

Concord Repatriation General Hospital, Concord

2170

Liverpool Hospital, Liverpool

3004

The Alfred Hospital, Melbourne

3065

St Vincents Hospital Melbourne - PPDS, Fitzroy

3100

Universitätsklinikum St. Pölten, Sankt Pölten

4029

Royal Brisbane & Women's Hospital, Herston

4101

Mater Hospital Brisbane, South Brisbane

4600

Klinikum Wels-Grieskirchen GmbH, Wels

5000

Royal Adelaide Hospital, Adelaide

5020

Salzburger Landeskliniken, Salzburg

7708

Dr JP Wright, Claremont

8036

LKH-Universitätsklinikum Klinikum Graz, Graz

9020

Klinikum Klagenfurt Am Woerthersee, Klagenfurt

9300

A.ö. Krankenhaus der Barmherzigen Brüder, Sankt Veit an der Glan

10000

University Hospital Center Zagreb, Zagreb

10126

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino

10128

Azienda Ospedaliera Ordine Mauriziano di Torino, Torino

11080

Clinical Hospital Center ''Bezanijska Kosa'', Belgrade

11215

New York Total Medical Care PC, Brooklyn

13353

Charité - Universitätsmedizin Berlin, Berlin

14163

Gastroenterologische Facharztpraxis am Mexikoplatz, Berlin-Zehlendorf

15208

Baruch Padeh Poriya Medical Center, Tiberias

15212

Allegheny Center For Digestive Health, Pittsburgh

16100

Nazareth EMMS Hospital, Nazareth

18000

University Clinical Center Nis, Niš

19610

Digestive Disease Associates, Wyomissing

20089

Istituto Clinico Humanitas, Rozzano (MI)

21000

University Hospital Centre Split, Split

22100

Galilee Medical Center, Nahariya

22559

Asklepios Westklinikum Hamburg Ggmbh, Hamburg

24105

Universitatsklinikum Schleswig-Holstein, Kiel

26241

Exemplar Research, Inc. - Elkins, Elkins

26300

General Hospital Vrsac, Vršac

26506

West Virginia University Hospital, Morgantown

27100

Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia

28100

A.O.U. Maggiore della Carità, Novara

28677

Piedmont Healthcare, Statesville

31000

Clinical Hospital Centre Osijek, Osijek

31904

Gastrointestinal Diseases, Inc. Research, Columbus

32000

General County Hospital Vukovar and Croatian Veterans Hospital, Vukovar

32086

East Coast Institute for Research, LLC, Saint Augustine

32810

Omega Research Consultants LLC - Clinedge - PPDS, Orlando

33000

General Hospital Virovitica, Virovitica

33134

Advanced Clinical Research Network, Coral Gables

33144

Nuren Medical and Research Center, Miami

34000

University Clinical Center Kragujevac, Kragujevac

34102

Gastroenterology Group of Naples, Naples

35128

Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino - INCIPIT - PIN, Padua

37024

Ospedale Sacro Cuore Don Calabria, Negrar

37232

Vanderbilt University Medical Center, Nashville

38138

Gastro One, Germantown

38261

Advanced Gastroenterology-Union City, Union City

39564

Digestive Health Center PA, Ocean Springs

40138

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi, Bologna

41124

Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena

43000

Opca bolnica Bjelovar, Bjelovar

45014

Consultants For Clinical Research Inc, Fairfield

45219

Consultants For Clinical Research Inc, Cincinnati

45249

Consultants For Clinical Research Inc, Cincinnati

46360

Laporte County Institute For Clinical Research, Michigan City

47000

Opca Bolnica Karlovac, Karlovac

47714

Medisphere Medical Research Center LLC, Evansville

48159

Gastro Campus Research GbR, Münster

50134

Azienda Ospedaliera Universitaria Careggi, Florence

50937

Uniklinik Köln, Cologne

52074

Universitätsklinikum der RWTH Aachen, Aachen

60590

Universitätsklinikum Frankfurt, Frankfurt

60611

Northwestern University, Chicago

60637

University of Chicago Medical Center, Chicago

70601

Clinical Trials of SWLA LLC, Lake Charles

71013

Ospedale Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo (FG)

71105

Louisiana Research Center LLC, Shreveport

72209

Atria Clinical Research - Clinedge - PPDS, Little Rock

77375

DM Clinical Research - ERN - PPDS, Tomball

77429

Northside Gastroenterology, Cypress

77521

Inquest Clinical Research/Coastal Gastroenterology Associates, PA, Baytown

80906

Peak Gastroenterology Associates, Colorado Springs

80907

Asthma and Allergy Associates PC - CRN - PPDS, Colorado Springs

81675

Klinikum rechts der Isa der Technischen Universitaet Muenchen, Munich

84010

HP Clinical Research, Bountiful

88100

Azienda Ospedaliera Mater Domini Di Catanzaro, Catanzaro

88400

Sana Klinikum Biberach, Biberach an der Riss

89081

Universitätsklinikum Ulm, Ulm

91031

Shaare Zedek Medical Center, Jerusalem

91120

Hadassah Medical Center - PPDS, Jerusalem

92377

Inland Empire Liver Foundation, Rialto

93534

OM Research LLC - Lancaster - ClinEdge - PPDS, Lancaster

98195

Digestive Health Center at UWMC, Seattle

University of Washington, Seattle

98405

CHI Franciscan Digestive Care Associates, Tacoma

111123

Moscow Clinical Scientific Center, Moscow

129110

Moscow Regional Research Clinical Institute Na Mfvladimirskiy, Moscow

191119

Union Clinic, LLC, Saint Petersburg

195257

St. Elizabeth Municipal Clinical Hospital, Saint Petersburg

197022

First St. Petersburg State Medical University n.a. I.P Pavlov, Saint Petersburg

214018

Smolensk Regional Clinical Hospital, Smoensk

300002

Dr. Goldis Gastroenterology Center SRL, Timișoara

344022

Rostov State Medical University, Rostov-on-Don

344091

Rostov State Medical University, Rostov-on-Don

355017

Stavropol State Medical University, Stavropol

400006

Cluj-Napoca Emergency Clinical County Hospital, Cluj-Napoca

410053

SHI Regional Clinical Hospital, Saratov

410066

Dr. Tirnaveanu Amelita Private Practice, Oradea

420064

Kazan State Medical University, Kazan'

443011

Medical University Reaviz, Samara

443029

Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city, Samara

443093

Medical Company Hepatolog, LLC, Samara

603126

Nizhegorodskaya Regional Clinical Hospital n.a. Semashko, Nizhny Novgorod

625026

Regional Consulting and Diagnostics Centre, Tyumen

630117

Research Institute of Physiology and Basic Medicine, Novosibirsk

700506

Gastromedica SRL, Iași

6423906

Tel Aviv Sourasky Medical Center PPDS, Tel Aviv

02114

Massachusetts General Hospital, Boston

74535-170

Instituto Goiano de Gastroenterologia E Endoscopia Digestiva Ltda, Goiânia

99010-260

Hospital Da Cidade de Passo Fundo, Passo Fundo

09190-510

CEMEC - Centro Multidisciplinar de Estudos Clínicos, Santo André

23 000

General Hospital Zadar, Zadar

500 12

Hepato-Gastroenterologie HK, s. r. o., Hradec Králové

779 00

PreventaMed s.r.o., Olomouc

140 21

Institut Klinicke A Experimentalni Mediciny, Prague

170 04

ISCARE I.V.F. a.s., Prague

401 13

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ústí nad Labem

562 18

Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Ústí nad Orlicí

07747

Universitätsklinikum Jena, Jena

00152

Azienda Ospedaliera San Camillo Forlanini, Rome

00161

La Sapienza-Università di Roma-Policlinico Umberto I, Roma

00168

Fondazione Policlinico Universitario A Gemelli, Roma

004-0041

Sapporo Tokushukai Hospital, Sapporo

252-5188

Sagamihara Kyodo Hospital, Sagamihara

105-8471

Jikei University Hospital, Minato-ku

108-8642

Kitasato University Kitasato Institute Hospital, Minato-ku

198-0042

Ome Municipal General Hospital, Ōme

270-1168

Tokatsu Tsujinaka Hospital, Abiko-shi, Chiba

040-0001

Hakodate Koseiin Hakodate Goryoukaku Hospital, Hakodate

306-0232

Yuai Memorial Hospital, Koga

184-0003

Kawabe Clinic, Koganei

343-8555

Dokkyo Medical University Saitama Medical Center, Koshigaya

839-0809

Hidaka Coloproctology Clinic, Kurume-shi

480-1195

Aichi Medical University Hospital, Nagakute

663-8014

Nishinomiya Municipal Central Hospital, Nishinomiya

Unknown

Onomichi General Hospital, Onomichi

Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa, Poznan

Russian Medical Military Academy n.a. S.M. Kirov, Saint Petersburg

520-2192

Shiga University of Medical Science Hospital, Ōtsu

065-0033

Sapporo Higashi Tokushukai Hospital, Sapporo

874-0833

Shinbeppu Hospital, Beppu

LT-50009

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas

LT- 08661

Vilnius University Hospital Santaros Klinikos, Vilnius

LT-10207

Vilnius City Clinical Hospital, Vilnius

5022 GC

ETZ-Elisabeth, Tilburg

1815 JD

NWZ, location Alkmaar, Alkmaar

2333 ZA

Leids Universitair Medisch Centrum, Leiden

1081 HV

VU Medisch Centrum, Amsterdam

1105 AZ

Academisch Medisch Centrum Amsterdam, Amsterdam

85-079

Vitamed Galaj i Cichomski sp.j., Bydgoszcz

87-100

Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj, Torun

87-800

Centrum Diagnostyczno - Lecznicze Barska sp. z o.o., Włocławek

31-501

Krakowskie Centrum Medyczne, Krakow

50-449

Melita Medical, Wroclaw

53-114

Lexmedica, Wroclaw

90-302

Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny, Lódz

90-647

SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej UM w Lodzi, Lódz

93-338

Instytut Centrum Zdrowia Matki Polki, Lódz

01-868

Centrum Medyczne Warszawa - PRATIA - PPDS, Warsaw

03-580

Niepubliczny Zakład Opieki Zdrowotnej VIVAMED, Warsaw

04-749

Miedzyleski Szpital Specjalistyczny w Warszawie, Warsaw

15-276

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

81-756

Endoskopia Sp. z o.o., Sopot

43-100

H-T. Centrum Medyczne Endoterapia, Tychy

71-434

Twoja Przychodnia - Szczecińskie Centrum Medyczne, Szczecin

85-168

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz

85-796

Centrum Medyczne Pratia Bydgoszcz, Bydgoszcz

42-200

Centrum Medyczne Czestochowa - PRATIA - PPDS, Częstochowa

81-338

Centrum Medyczne Gdynia - PRATIA - PPDS, Gdynia

05-410

BioVirtus Centrum Medyczne, Józefów

40-211

Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach, Katowice

40-659

NZOZ All Medicus, Katowice

31-315

Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska, Krakow

95-054

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J., Ksawerów

91-034

Med Gastr Sp.z.o.o Sp.k, Lodz

67-100

Twoja Przychodnia - Centrum Medyczne Nowa Sol, Nowa Sól

05-500

Centrum Innowacyjnych Terapii, Piaseczno

35-302

Korczowski Bartosz, Gabinet Lekarski, Rzeszów

71-685

Sonomed Sp. z o.o., Szczecin

00-635

Centrum Zdrowia MDM, Warsaw

02-507

Centralny Szpital Kliniczny MSW, Warsaw

22-400

Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II, Zamość

26-200

Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii, Gmina Końskie

010825

Dr.Carol Davila Emergency University Central Military Hospital, Bucharest

011025

Sana Monitoring SRL, Bucharest

020125

Colentina Clinical Hospital, Bucharest

021105

Prof. Dr. Matei Bals Institute of Infectious Diseases, Bucharest

022328

Fundeni Clinical Institute, Bucharest

031864

Centrul Medical Hifu Terramed Conformal S.R.L., Bucharest

RO-900591

Affidea Romania SRL, Constanța

0002

Dr. J Breedt, Pretoria

BL9 7TD

Fairfield General Hospital - PPDS, Lancashire

Pennine Acute Hospitals Trust, Lancashire

E11 1NR

Whipps Cross University Hospital, London

NE29 8NH

North Tyneside General Hospital, North Shields

SY3 8XQ

Royal Shrewsbury Hospital, Shrewsbury

AB25 2ZN

Aberdeen Royal Infirmary - PPDS, Aberdeen

EH4 2XU

Western General Hospital Edinburgh - PPDS, Edinburh

NP20 2UB

Royal Gwent Hospital - PPDS, Newport

WV10 0QP

New Cross Hospital, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT03259334 - Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis | Biotech Hunter | Biotech Hunter