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

PHASE3TerminatedINTERVENTIONAL
Enrollment

279

Participants

Timeline

Start Date

December 5, 2017

Primary Completion Date

July 15, 2020

Study Completion Date

October 6, 2020

Conditions
Ulcerative Colitis
Interventions
DRUG

Ontamalimab

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

DRUG

Placebo

Participants will receive 1 mL of sterile aqueous buffered solution.

Trial Locations (207)

1000

Medical Center Excelsior OOD - PPDS, Sofia

1023

Auckland City Hospital, Grafton

1062

Magyar Honvédség Egészségügyi Központ, Budapest

1136

Pannónia Magánorvosi Centrum Kft, Budapest

1139

ENDOMEDIX Kft., Budapest

1202

Second Multiprofile Hospital for Active Treatment Sofia, Sofia

1431

Diagnostic and Consulting Center Aleksandrovska EOOD, Sofia

University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD, Sofia

1527

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD, Sofia

1680

Medical Center Convex EOOD, Sofia

1750

University Multiprofile Hospital for Active Treatment Sveta Anna, Sofia

1784

Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD, Sofia

2600

Jávorszky Ödön Kórház, Vác

3000

UZ Gasthuisberg, Leuven

3240

Waikato Hospital, Hamilton

4004

Multiprofile Hospital for Active Treatment Eurohospital, Plovdiv

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

5400

Medical Center-1-Sevlievo EOOD, Sevlievo

5600

Bekes Megyei Kozponti Korhaz, Békéscsaba

5700

Bekes Megyei Kozponti Korhaz, Gyula

5800

University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD, Pleven

6021

Wellington Hospital, Newtown

6600

Csongrad Megyei Dr. Bugyi Istvan Korhaz, Szentes

7002

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS, Rousse

7100

Tolna Megyei Balassa János Kórház, Szekszárd

7700

CHU Mouscron, Mouscron

Mohacsi Korhaz, Mohács

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8091

Universität Zürich, Zurich

8200

Csolnoky Ferenc Korhaz, Veszprém

8500

AZ Groeninge, Kortrijk

9000

UZ Gent, Ghent

Diagnostic Consultative Centre Mladost - M OOD, Varna

9016

Dunedin Hospital, Dunedin

10021

Weill Cornell Medical College, New York

10617

West Tallinn Central Hospital, Tallinn

11021

NYU Langone Long Island Clinical Research Associates, Great Neck

11527

Ippokrateio General Hospital of Athens, Athens

13496

CHA Bundang Medical Center, CHA University, Seongnam

14004

C.H. Regional Reina Sofia - PPDS, Córdoba

14127

Southtowns Gastroenterology, PLLC, Orchard Park

15240

Veterans Research Foundation of Pittsburgh - NAVREF - PPDS, Pittsburgh

16247

The Catholic University of Korea, St. Vincent's Hospital, Suwon

20116

Centro de Investigación Médica Aguascalientes, Aguascalientes

20815

Chevy Chase Clinical Research, Chevy Chase

21001

Municipal Nonprofit Enterprise Vinnytsia City Clinical Hospital #1, Vinnytsia

21005

Hospital Universitario Juan Ramon Jimenez, Huelva

21009

Medical Clinical Research Center of Medical Center LLC Health Clinic, Vinnytsia

21018

Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC, Vinnytsia

Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC, Vinnytsia

21029

City Clinical Hospital #1, Vinnytsia

"Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital №1", Vinnytsia

22601

Winchester Gastroenterology Associates, Winchester

24333

Mid Atlantic Health Specialists, Galax

26426

Yonsei University Wonju Severance Christian Hospital, Wŏnju

26504

University General Hospital of Patras, Pátrai

28006

Hospital Universitario de La Princesa, Madrid

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28046

Hospital Universitario La Paz - PPDS, Madrid

28546

East Carolina Gastroenterology, Jacksonville

28942

Hospital Universitario de Fuenlabrada, Fuenlabrada

30024

Atlanta Gastroenterology Specialists, PC, Suwanee

30033

Atlanta Center For Gastroenterology PC, Decatur

30349

Infinite Clinical Trials, Atlanta

31025

East Viru Central Hospital, Kohta-Järve

32256

ENCORE Borland-Groover Clinical Research - ERN - PPDS, Jacksonville

33064

Alliance Medical Research LLC, Lighthouse PT

33065

Crystal Biomedical Research, Miami Lakes

33134

Hi Tech and Global Research, LLc, Coral Gables

33157

Sanchez Clinical Research, Inc, Miami

33169

Mersin University Medical Faculty, Mersin

33321

DBC Research, Tamarac

33322

BRCR Medical Center Inc., Plantation

33756

Gastro Florida, Clearwater

33781

Accel Research Sites - St. Petersburg - ERN - PPDS, Pinellas Park

33991

Renaissance Research Medical Group, INC, Cape Coral

34000

Instituto de Investigaciones Aplicadas a la Neurociencia A.C., Durango

34098

Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul

34110

Pharma Research International Inc, Naples

34655

Bayside Clinical Research - New Port Richey, New Port Richey

34741

SIH Research, Kissimmee

36312

CHUVI - H.U. Alvaro Cunqueiro, Vigo

41013

Hospital Universitario Virgen del Rocio - PPDS, Seville

41701

Gastroenterology Associates of Hazard, Hazard

41944

Kyungpook National University Hospital, Daegu

42415

Yeungnam University Hospital, Daegu

44060

Ohio Clinical Research Partners LLC, Mentor

45005

Prestige Clinical Research, Franklin

45030

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V., Zapopan, Jalisco

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

48047

Clinical Research Institute of Michigan, Chesterfield

48108

Inje University Haeundae Paik Hospital, Busan

48109

University of Michigan, Ann Arbor

48212

National Clinical, LLC, Hamtramck

49005

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

49038

LLC Medical Center Family Medicine Clinic, Dnipro

49074

"State Institution Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine", Dnipro

49241

Pusan National University Hospital, Busan

50056

Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council, Kryvyi Rih

54007

Theageneio Anticancer Oncology Hospital of Thessaloniki, Thessaloniki

54055

Clinical Research Institute, Tlalnepantla

54601

Mayo Clinic Health System - PPDS, La Crosse

54645

Euromedica - PPDS, Thessaloniki

54769

Phylasis Clinicas Research S. de R.L. de C.V., Cuautitlán Izcalli

58001

"Regional Municipal Non-profit Enterprise Chernivtsi Regional Clinical Hospital", Chernivtsi

60031

IL Gastroenterology Group, Gurnee

60141

Edward Hines Jr VA Hospital - NAVREF - PPDS, Hines

60181

Dupage Medical Group, Oakbrook Terrace

60644

Loretto Hospital, Chicago

61037

Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council, Kharkiv

61039

Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine, Kharkiv

61058

Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital, Kharkiv

61166

MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection, Kharkiv

62170

Clinica de Higado y Gastroenterologia Integral, S.C., Cuernavaca

62290

JM Research S.C, Cuernavaca

63110

Washington University in St. Louis, St Louis

63128

St Louis Center For Clinical Research, St Louis

64000

Accelerium, S. de R.L. de C.V., Monterrey

65025

Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council, Odesa

69000

Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council, Zaporizhzhia

69035

MNPE City Hospital No. 6 of Zaporizhzhia City Council, Zaporizhzhia

70360

CroNOLA, LLC., Houma

73000

Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh, Kherson

73104

Veteran's Research and Education Foundation - NAVREF - PPDS, Oklahoma City

75044

Digestive Health Associates of Texas, P.A.dba DHAT Research Institute, Garland

77039

Precision Research Institute, LLC, Houston

77043

Biopharma Informatic Inc., Houston

77074

Southwest Clinical Trials, Houston

77079

Aztec Medical Research, Houston

77084

BI Research Center, Houston

78000

Clinical Center Banja Luka, Banja Luka

78229

Southern Star Research Institute LLC, San Antonio

79007

Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway, Lviv

79059

Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital, Lviv

80010

OÜ LV Venter, Pärnu

85018

Elite Clinical Studies - Phoenix - Clinedge - PPDS, Phoenix

85206

Arizona Digestive Health Mesa - East, Mesa

88000

MNPE Central City Clinical Hospital of Uzhhorod City Council, Uzhhorod

89086

Encompass Care, North Las Vegas

89123

Advanced Biomedical Research of America, Las Vegas

90822

VA Long Beach Healthcare System - NAVREF - PPDS, Long Beach

91345

Facey Medical Foundation, Mission Hills

92024

United Medical Doctors, Encinitas

92037

University of California San Diego, La Jolla

92064

Alliance Clinical Research-(Vestavia Hills), Poway

92563

United Medical Doctors, Murrieta

92805

Advanced Research Center, Anaheim

92879

Kindred Medical Institute for Clinical Trials, LLC, Corona

94158

University of California San Francisco, San Francisco

94806

Care Access Research, San Pablo, San Pablo

97000

Unidad de Atencion Medica e Investigacion en Salud, Mérida

111121

Fundación Clínica Shaio, Bogota

680003

Servimed S.A.S, Bucaramanga

02302

Commonwealth Clinical Studies LLC, Brockton

01655

UMass Memorial Medical Center, Worcester

T4000DGI

Sanatorio 9 de Julio SA, San Miguel de Tucumán

C1093AAS

Fundación Favaloro, Buenos Aires

Unknown

Hospital Privado Centro Médico de Córdoba, Córdoba

IPS Centro Médico Julián Coronel S.A.S. - PPDS, Santiago de Cali

Rafik Hariri University Hospital, Beirut

Hammoud Hospital University Medical Center, Saida

V8P 2P5

Percuro Clinical Research LTD, Victoria

M3N 2V7

Toronto Digestive Disease Associates Inc, Toronto

050034

Hospital Pablo Tobón Uribe, Medellín

Dublin 4

St Vincent's University Hospital, Dublin

060-8543

Sapporo Medical University Hospital, Sapporo

650-0015

Medical Corporation Aoyama Clinic, Kobe

663-8501

Hyogo College of Medicine, Nishinomiya-shi

070-0061

Kunimoto Hospital, Asahikawa

818-8502

Fukuoka University Chikushi Hospital, Chikushino-shi

390-0814

Aizawa Hospital, Matsumoto-shi

530-0003

Chiinkai Dojima General & Gastroenterology Clinic, Osaka

530-0011

Kinshukai Infusion Clinic, Osaka

533-0024

Yodogawa Christian Hospital, Osaka

870-0823

Ishida Clinic of IBD and Gastroenterology, Ōita

599-8247

Bellland General Hospital, Sakai

285-8741

Toho University Sakura Medical Center, Sakura

981-8563

Tohoku Rosai Hospital, Sendai

321-0293

Dokkyo Medical University Hospital, Shimotsuga-gun

569-0086

Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital, Takatsuki

103-0028

Nihonbashi Egawa Clinic, Tokyo

150-0013

Koukokukai Ebisu Clinic, Tokyo

03810

Health Pharma Professional Research S.A de C.V., Mexico City

07020

Centro de Investigacion Clinica Acelerada, S.C., Distrito Federal

4710-243

Hospital de Braga, Braga

4835-044

Hospital Senhora da Oliveira - Guimaraes, E.P.E, Guimarães

1500-650

Hospital da Luz, Lisbon

8500-338

Centro Hospitalar do Algarve - Hospital de Portimao, Portimão

2910-446

Hospital de São Bernardo, Setúbal

851 07

Univerzitna nemocnica Bratislava, Bratislava

949 01

KM Management, spol. s r.o., Nitra

080 01

Gastro LM, s.r.o., Prešov

702-210

Kyungpook National University Chilgok Hospital, Daegu

405-760

Gachon University Gil Medical Center, Incheon

02447

Kyung Hee University Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03181

Kangbuk Samsung Hospital, Seoul

03722

Severance Hospital Yonsei University Health System - PPDS, Seoul

05505

Asan Medical Center - PPDS, Seoul

06351

Samsung Medical Center PPDS, Seoul

100-032

Inje University Seoul Paik Hospital, Seoul

08022

Centro Medico Teknon - Grupo Quironsalud, Barcelona

01023

Medical Center of LLC Medical Clinic Blagomed, Kyiv

01030

Kyiv City Clinical Hospital #18, Kyiv

01033

"Treatment and Diagnostic Center Healthy and Happy of LLC Healthy and Happy", Kyiv

04073

Municipal Institution of KRC Kyiv Regional Hospital #2, Kyiv

04107

Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT03259308 - Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis | Biotech Hunter | Biotech Hunter