An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)

The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: Placebo; Drug: Ontamalimab

• Study Type: Interventional
• Enrollment (Actual): 366
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1093AAS
    • Fundacion Favaloro
  • Córdoba, Argentina
    • Hospital Privado Centro Medico de Cordoba
  • San Miguel De Tucumán, Argentina
    • Sanatorio 9 de Julio SA
• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane & Women's Hospital
    • South Brisbane, Queensland, Australia, 4101
      • Mater Hospital Brisbane
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • The Alfred Hospital
    • Melbourne, Victoria, Australia, 3065
      • St Vincents Hospital Melbourne - PPDS
• Austria
  • Klagenfurt am Wörthersee, Austria, 9020
    • Klinikum Klagenfurt Am Woerthersee
  • Salzburg, Austria, 5020
    • Salzburger Landeskliniken
  • Wels, Austria, 4600
    • Klinikum Wels-Grieskirchen GmbH
  • Wien, Austria, 1090
    • Medizinische Universitat Wien (Medical University of Vienna)
  • Kärnten
    • St. Veit an der Glan, Kärnten, Austria, 9300
      • A.ö. Krankenhaus der Barmherzigen Brüder
  • Saint Pölten
    • St. Pölten, Saint Pölten, Austria, 3100
      • Universitätsklinikum St. Pölten
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • LKH-Universitätsklinikum Klinikum Graz
• Belgium
  • Mouscron, Belgium, 7700
    • CHU Mouscron
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UZ Gasthuisberg
  • West-Vlaanderen
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • AZ Groeninge
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • Clinical Center Banja Luka
• Bulgaria
  • Pleven, Bulgaria, 5800
    • University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD
  • Plovdiv, Bulgaria, 4004
    • Multiprofile Hospital for Active Treatment Eurohospital
  • Ruse, Bulgaria, 7002
    • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS
  • Sevlievo, Bulgaria, 5400
    • Medical Center-1-Sevlievo EOOD
  • Sofia, Bulgaria, 1680
    • Medical Center Convex EOOD
  • Sofia, Bulgaria, 1202
    • Second Multiprofile Hospital for Active Treatment Sofia
  • Sofia, Bulgaria, 1431
    • Diagnostic and Consulting Center Aleksandrovska EOOD
  • Sofia, Bulgaria, 1431
    • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
  • Sofia, Bulgaria, 1527
    • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
  • Sofia, Bulgaria, 1421
    • Medical Center Excelsior OOD - PPDS
  • Varna, Bulgaria, 9020
    • Diagnostic Consultative Centre Mladost - M OOD
  • Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1784
      • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
    • Sofia, Sofia-Grad, Bulgaria, 1750
      • University Multiprofile Hospital for Active Treatment Sveta Anna
• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8P 2P5
      • Percuro Clinical Research Ltd
  • Ontario
    • Toronto, Ontario, Canada, M3N 2V7
      • Toronto Digestive Disease Associates Inc
• Colombia
  • Cali, Colombia
    • IPS Centro Médico Julián Coronel S.A.S. - PPDS
  • Antioquia
    • Medellin, Antioquia, Colombia, 050034
      • Hospital Pablo Tobón Uribe
  • Santander
    • Bucaramanga, Santander, Colombia
      • Servimed S.A.S
• Croatia
  • Bjelovar, Croatia, 43000
    • Opca bolnica Bjelovar
  • Osijek, Croatia, 31000
    • Clinical Hospital Centre Osijek
  • Split, Croatia, 21000
    • University Hospital Centre Split
  • Virovitica, Croatia, 33000
    • General Hospital Virovitica
  • Vukovar, Croatia, 32000
    • General County Hospital Vukovar and Croatian Veterans Hospital
  • Zadar, Croatia, 23 000
    • General Hospital Zadar
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • University hospital center Zagreb
  • Karlovacka Županija
    • Karlovac, Karlovacka Županija, Croatia, 47000
      • Opca bolnica Karlovac
• Czechia
  • Praha 4, Czechia, 140 21
    • Institut Klinicke A Experimentalni Mediciny
  • Praha 7, Czechia, 170 00
    • ISCARE I.V.F. a.s.
  • Usti nad Labem, Czechia, 401 13
    • Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.
  • Ústi Nad Orlici, Czechia, 562 18
    • Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice
  • Královéhradecký Kraj
    • Hradec Králové, Královéhradecký Kraj, Czechia, 500 12
      • Hepato-Gastroenterologie HK, s. r. o.
  • Olomoucký Kraj
    • Olomouc, Olomoucký Kraj, Czechia, 779 00
      • PreventaMed s.r.o.
• Estonia
  • Kohta-Järve, Estonia, 31025
    • East Viru Central Hospital
  • Parnu, Estonia, 80010
    • OÜ LV Venter
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital
• Germany
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin
  • Berlin-Zehlendorf, Germany, 14163
    • Gastroenterologische Facharztpraxis am Mexikoplatz
  • Biberach an der Riss, Germany, 88400
    • Sana Klinikum Biberach
  • Frankfurt, Germany, 60596
    • Universitätsklinikum Frankfurt
  • Hamburg, Germany, 22559
    • Asklepios Westklinikum Hamburg Ggmbh
  • Munich, Germany, 81675
    • Klinikum rechts der Isa der Technischen Universitaet Muenchen
  • Baden-Württemberg
    • Ulm, Baden-Württemberg, Germany, 89081
      • Universitätsklinikum Ulm
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52074
      • Universitatsklinikum der RWTH Aachen
    • Köln, Nordrhein-Westfalen, Germany, 50937
      • Uniklinik Köln
    • Münster, Nordrhein-Westfalen, Germany, 48159
      • Gastro Campus Research GbR
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitatsklinikum Schleswig-Holstein
  • Thüringen
    • Jena, Thüringen, Germany, 07747
      • Universitätsklinikum Jena
• Greece
  • Patras, Greece, 26504
    • University General Hospital of Patras
  • Thessaloniki, Greece, 54645
    • Euromedica - PPDS
  • Thessaloniki, Greece, 54007
    • Theageneio Anticancer Oncology Hospital of Thessaloniki
  • Attiki
    • Athens, Attiki, Greece, 11527
      • Ippokrateio General Hospital of Athens
• Hungary
  • Budapest, Hungary, 1062
    • Magyar Honvedseg Egeszsegugyi Kozpont
  • Budapest, Hungary, 1139
    • ENDOMEDIX Kft.
  • Budapest, Hungary, 1136
    • Pannónia Magánorvosi Centrum Kft
  • Békéscsaba, Hungary, 5600
    • Békés Megyei Központi Kórház
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Gyula, Hungary, 5700
    • Békés Megyei Központi Kórház
  • Mohacs, Hungary, 7700
    • Mohacsi Korhaz
  • Szekszard, Hungary, 7100
    • Tolna Megyei Balassa János Kórház
  • Szentes, Hungary, 6600
    • Csongrád Megyei Dr. Bugyi István Kórház
  • Székesfehérvár, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Veszprém, Hungary, 8200
    • Csolnoky Ferenc Korhaz
  • Vác, Hungary, 2600
    • Javorszky Odon Korhaz
• Ireland
  • Dublin, Ireland
    • St Vincent's University Hospital
• Israel
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center - PPDS
  • Nahariya, Israel, 22100
    • Galilee Medical Center
  • Nazareth, Israel, 16100
    • Nazareth EMMS Hospital
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center PPDS
  • Tiberias, Israel, 15208
    • Baruch Padeh Poriya Medical Center
• Italy
  • Novara, Italy, 28100
    • A.O.U. Maggiore della Carità
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo di Pavia
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A Gemelli
  • Roma, Italy, 00161
    • La Sapienza-Università di Roma-Policlinico Umberto I
  • Rozzano (MI), Italy, 20089
    • Istituto Clinico Humanitas
  • Torino, Italy, 10126
    • Azienda Ospedaliera Citta della Salute e della Scienza di Torino
  • Torino, Italy, 10128
    • Azienda Ospedaliera Ordine Mauriziano di Torino
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • Azienda Ospedaliera Mater Domini di Catanzaro
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
    • Modena, Emilia-Romagna, Italy, 41124
      • Azienda Ospedaliero Universitaria Di Modena Policlinico
  • Lazio
    • Roma, Lazio, Italy, 00152
      • Azienda Ospedaliera San Camillo Forlanini
  • Puglia
    • San Giovanni Rotondo, Puglia, Italy, 71013
      • Ospedale Casa Sollievo Della Sofferenza IRCCS
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • Azienda Ospedaliera Universitaria Careggi
  • Veneto
    • Negrar, Veneto, Italy, 37024
      • IRCCS Ospedale Sacro Cuore Don Calabria
    • Padova, Veneto, Italy, 35128
      • Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino
• Japan
  • Abiko, Japan, 270-1166
    • Tokatsu Tsujinaka Hospital
  • Asahikawa, Japan, 070-0061
    • Kunimoto Hospital
  • Chikushino, Japan, 818-8502
    • Fukuoka University Chikushi Hospital
  • Hakodate, Japan, 040-0001
    • Hakodate Koseiin Hakodate Goryoukaku Hospital
  • Koga, Japan, 306-0232
    • Yuai Memorial Hospital
  • Koganei, Japan, 184-0003
    • Kawabe Clinic
  • Kurume-shi, Japan, 839-0809
    • Hidaka Coloproctology Clinic
  • Matsumoto-shi, Japan, 390-0814
    • Aizawa Hospital
  • Nagakute, Japan, 480-1195
    • Aichi Medical University Hospital
  • Nishinomiya, Japan, 663-8014
    • Nishinomiya Municipal Central Hospital
  • Oita, Japan, 870-0823
    • Ishida Clinic of IBD and Gastroenterology
  • Onomichi, Japan
    • Onomichi General Hospital
  • Osaka, Japan, 530-0003
    • Chiinkai Dojima General & Gastroenterology Clinic
  • Osaka-shi, Japan, 530-0011
    • Kinshukai Infusion Clinic
  • Otsu-Shi, Japan, 520-2192
    • Shiga University of Medical Science Hospital
  • Sakai, Japan, 599-8247
    • Bellland General Hospital
  • Sakura, Japan, 285-8741
    • Toho University Sakura Medical Center
  • Sapporo, Japan, 065-0033
    • Sapporo Higashi Tokushukai Hospital
  • Sapporo-shi, Japan, 065-0033
    • Sapporo Tokushukai Hospital
  • Sendai, Japan, 981-8563
    • Tohoku Rosai Hospital
  • Shimotsuga-gun, Japan, 321-0293
    • Dokkyo Medical University Hospital
  • Takatsuki, Japan, 569-0086
    • Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital
  • Tokyo, Japan, 150-0013
    • Koukokukai Ebisu Clinic
  • Hokkaidô
    • Sapporo, Hokkaidô, Japan, 060-8543
      • Sapporo Medical University Hospital
  • Hyôgo
    • Kobe-shi, Hyôgo, Japan, 650-0015
      • Medical Corporation Aoyama Clinic
    • Nishinomiya-shi, Hyôgo, Japan, 663-8501
      • Hyogo College of Medicine
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-5188
      • Sagamihara Kyodo Hospital
  • Saitama
    • Koshigaya, Saitama, Japan, 343-8555
      • Dokkyo Medical University Saitama Medical Center
  • Tokyo
    • Chuo-Ku, Tokyo, Japan, 103-0028
      • Nihonbashi Egawa Clinic
    • Minato-ku, Tokyo, Japan, 105-8471
      • Jikei University Hospital
    • Minato-ku, Tokyo, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital
    • Ome, Tokyo, Japan, 198-0042
      • Ome Municipal General Hospital
  • Ôita
    • Beppu, Ôita, Japan, 874-0833
      • Shinbeppu Hospital
  • Ôsaka
    • Osaka, Ôsaka, Japan, 533-0024
      • Yodogawa Christian Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Busan, Korea, Republic of, 48108
    • Inje University Haeundae Paik Hospital
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Hospital
  • Daegu, Korea, Republic of, 702-210
    • Kyungpook National University Chilgok Hospital
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 02447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center - PPDS
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University Health System - PPDS
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center PPDS
  • Seoul, Korea, Republic of, 100-032
    • Inje University Seoul Paik Hospital
  • Daegu Gwang'yeogsi
    • Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 41944
      • Kyungpook National University Hospital
  • Gang'weondo
    • Wonju, Gang'weondo, Korea, Republic of, 26426
      • Yonsei University Wonju Severance Christian Hospital
  • Gyeonggido
    • Seongnam, Gyeonggido, Korea, Republic of, 13496
      • CHA Bundang Medical Center, CHA University
    • Suwon, Gyeonggido, Korea, Republic of, 16247
      • The Catholic University of Korea, St. Vincent's Hospital
• Lebanon
  • Beirut, Lebanon
    • Rafik Hariri University Hospital
  • Saida, Lebanon
    • Hammoud Hospital University Medical Center
• Lithuania
  • Kaunas, Lithuania, LT-50009
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Vilnius, Lithuania, LT- 08661
    • Vilnius University Hospital Santaros Klinikos
  • Vilnius, Lithuania, LT-10207
    • Vilnius City Clinical Hospital
• Mexico
  • Aguascalientes, Mexico, 20116
    • Centro de Investigacion Medica Aguascalientes
  • Cuautitlán Izcalli, Mexico, 54769
    • Phylasis Clinicas Research S. de R.L. de C.V.
  • Distrito Federal, Mexico, 07020
    • Centro de Investigación Clinica Acelerada, S.C.
  • Durango, Mexico, 34000
    • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Monterrey, Mexico, 64000
    • Accelerium, S. de R.L. de C.V.
  • Tlalnepantla De Baz, Mexico, 54055
    • Clinical Research Institute
  • Zapopan, Mexico, 45030
    • Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62170
      • Clinica de Higado y Gastroenterologia Integral, S.C.
    • Cuernavaca, Morelos, Mexico, 62290
      • JM Research S.C
  • Yucatán
    • Merida, Yucatán, Mexico, 97000
      • Unidad de Atención Médica e Investigación en Salud
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU medisch centrum
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum Amsterdam
  • Noord-Brabant
    • Tilburg, Noord-Brabant, Netherlands, 5022 GC
      • ETZ-Elisabeth
  • Noord-Holland
    • Alkmaar, Noord-Holland, Netherlands, 1815 JD
      • NWZ, location Alkmaar
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Leids Universitair Medisch Centrum
• New Zealand
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
  • Auckland
    • Grafton, Auckland, New Zealand, 1023
      • Auckland City Hospital
  • South Island
    • Dunedin, South Island, New Zealand, 9016
      • Dunedin Hospital
  • Wellington
    • Newtown, Wellington, New Zealand, 6021
      • Wellington Hospital
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
  • Bydgoszcz, Poland, 85-796
    • Centrum Medyczne Pratia Bydgoszcz
  • Czestochowa, Poland, 42-200
    • Centrum Medyczne Czestochowa - PRATIA - PPDS
  • Gdynia, Poland, 81-338
    • Centrum Medyczne Gdynia - PRATIA - PPDS
  • Katowice, Poland, 40-659
    • Nzoz All Medicus
  • Krakow, Poland, 31-315
    • Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska
  • Ksawerow, Poland, 95-054
    • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska sp. j.
  • Lodz, Poland, 91-034
    • Med Gastr Sp.z.o.o Sp.k
  • Nowa Sól, Poland, 67-100
    • Twoja Przychodnia - Centrum Medyczne Nowa Sol
  • Piaseczno, Poland, 05-500
    • Centrum Innowacyjnych Terapii
  • Poznan, Poland, 60-856
    • Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa
  • Rzeszow, Poland, 35-302
    • Korczowski Bartosz, Gabinet Lekarski
  • Szczecin, Poland, 71-685
    • Sonomed Sp. z o.o.
  • Szczecin, Poland, 71-685
    • Bandurskiego 98/U12
  • Tychy, Poland, 43-100
    • H-T. Centrum Medyczne Endoterapia
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny MSW
  • Warszawa, Poland, 00-635
    • Centrum Zdrowia MDM
  • Warszawa, Poland, 01-868
    • Centrum Medyczne Warszawa - PRATIA - PPDS
  • Zamosc, Poland, 22-400
    • Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 50-449
      • Melita Medical
    • Wroclaw, Dolnoslaskie, Poland, 53-114
      • Lexmedica
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-079
      • Vitamed Galaj i Cichomski sp.j.
    • Torun, Kujawsko-pomorskie, Poland, 87-100
      • Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
    • Wloclawek, Kujawsko-pomorskie, Poland, 87-800
      • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
  • Lódzkie
    • Lódz, Lódzkie, Poland, 90-302
      • Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
    • Lódz, Lódzkie, Poland, 90-647
      • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
    • Lódz, Lódzkie, Poland, 93-338
      • Instytut Centrum Zdrowia Matki Polki
  • Malopolskie
    • Krakow, Malopolskie, Poland, 31-501
      • Krakowskie Centrum Medyczne
  • Mazowieckie
    • Jozefow, Mazowieckie, Poland, 05-410
      • BioVirtus Centrum Medyczne
    • Warszawa, Mazowieckie, Poland, 03-580
      • Niepubliczny Zakład Opieki Zdrowotnej VIVAMED
    • Warszawa, Mazowieckie, Poland, 04-749
      • Miedzyleski Szpital Specjalistyczny w Warszawie
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-276
      • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Pomorskie
    • Sopot, Pomorskie, Poland, 81-756
      • ENDOSKOPIA Sp. z o.o.
  • Slaskie
    • Katowice, Slaskie, Poland, 40-211
      • Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach
  • Swietokrzyskie
    • Konskie, Swietokrzyskie, Poland, 26-200
      • Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii
  • Zachodniopomorskie
    • Szczecin, Zachodniopomorskie, Poland, 71-434
      • Twoja Przychodnia - Szczecinskie Centrum Medyczne
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Faro, Portugal, 8000-385
    • Centro Hospitalar do Algarve - Hospital de Portimao
  • Guimarães, Portugal, 4835-044
    • Hospital Senhora da Oliveira - Guimaraes, E.P.E
  • Setubal, Portugal, 2910-446
    • Hospital de São Bernardo
  • Lisboa
    • Lisbon, Lisboa, Portugal, 1500-650
      • Hospital da Luz
• Romania
  • Bucharest, Romania, 022328
    • Fundeni Clinical Institute
  • Bucharest, Romania, 010825
    • Dr.Carol Davila Emergency University Central Military Hospital
  • Bucharest, Romania, 020125
    • Colentina Clinical Hospital
  • Bucharest, Romania, 021105
    • Prof. Dr. Matei Bals Institute of Infectious Diseases
  • Bucharest, Romania, 011025
    • Sana Monitoring SRL
  • Bucuresti, Romania, 031864
    • Centrul Medical Hifu Terramed Conformal S.R.L.
  • Constanta, Romania, RO-900591
    • Affidea Romania SRL
  • Iasi, Romania, 700506
    • GastroMedica SRL
  • Oradea, Romania, 410066
    • Dr. Tirnaveanu Amelita Private Practice
  • Timisoara, Romania, 300002
    • Dr. Goldis Gastroenterology Center SRL
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400006
      • Cluj-Napoca Emergency Clinical County Hospital
• Russian Federation
  • Kazan, Russian Federation, 420097
    • Kazan State Medical University
  • Moscow, Russian Federation, 111123
    • Moscow Clinical Scientific Center
  • Moscow, Russian Federation, 129110
    • Moscow Regional Research Clinical Institute Na Mfvladimirskiy
  • Nizhny Novgorod, Russian Federation, 603126
    • Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
  • Novosibirsk, Russian Federation, 630117
    • Research Institute of Physiology and Basic Medicine
  • Rostov-on-Don, Russian Federation, 344022
    • Rostov State Medical University
  • Rostov-on-Don, Russian Federation, 344091
    • Rostov State Medical University
  • Saint Petersburg, Russian Federation
    • Russian Medical Military Academy n.a. S.M. Kirov
  • Saint Petersburg, Russian Federation, 197110
    • Union Clinic, LLC
  • Samara, Russian Federation, 443011
    • Medical University REAVIZ
  • Samara, Russian Federation, 443029
    • Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city
  • Samara, Russian Federation, 443063
    • Medical Company Hepatolog, LLC
  • Saratov, Russian Federation, 410012
    • SHI Regional Clinical Hospital
  • Smolensk, Russian Federation, 214018
    • Smolensk Regional Clinical Hospital
  • St. Petersburg, Russian Federation, 195257
    • St. Elizabeth Municipal Clinical Hospital
  • St. Petersburg, Russian Federation, 197022
    • First St. Petersburg State Medical University n.a. I.P Pavlov
  • Stavropol, Russian Federation, 355017
    • Stavropol State Medical University
  • Tyumen, Russian Federation, 625026
    • Regional Consulting and Diagnostics Centre
• Serbia
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center Bezanijska Kosa
  • Nis, Serbia, 18000
    • University Clinical Center Nis
  • Vrsac, Serbia, 26300
    • General Hospital Vrsac
  • Šumadijski Okrug
    • Kragujevac, Šumadijski Okrug, Serbia, 34000
      • University Clinical Center Kragujevac
• Slovakia
  • Bratislava, Slovakia, 851 07
    • Univerzitna nemocnica Bratislava
  • Nitra, Slovakia, 949 01
    • KM Management, spol. s r.o.
  • Presov, Slovakia, 080 01
    • Gastro LM, s.r.o.
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1619
      • CLINRESCO, ARWYP Medical Suites
    • Pretoria, Gauteng, South Africa, 0002
      • Dr. J Breedt
  • Western Cape
    • Claremont, Western Cape, South Africa, 7708
      • Dr JP Wright
• Spain
  • Barcelona, Spain, 08022
    • Centro Medico Teknon - Grupo Quironsalud
  • Huelva, Spain, 21005
    • Hospital Universitario Juan Ramon Jimenez
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz - PPDS
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio - PPDS
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe de Valencia
  • Córdoba
    • Cordoba, Córdoba, Spain, 14004
      • C.H. Regional Reina Sofia - PPDS
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Hospital Universitario de Fuenlabrada
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • CHUVI - H.U. Alvaro Cunqueiro
• Switzerland
  • Zürich (de)
    • Zürich, Zürich (de), Switzerland, 8091
      • Universität Zürich
• Turkey
  • Istanbul, Turkey, 34098
    • Istanbul Universitesi Cerrahpasa Tip Fakultesi
  • Mersin, Turkey, 33169
    • Mersin University Medical Faculty
• Ukraine
  • Dnipro, Ukraine, 49038
    • LLC Medical Center Family Medicine Clinic
  • Dnipro, Ukraine, 49005
    • ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
  • Dnipro, Ukraine, 49074
    • State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
  • Kharkiv, Ukraine, 61058
    • Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital
  • Kharkiv, Ukraine, 61039
    • Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine
  • Kharkiv, Ukraine, 61166
    • MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection
  • Kherson, Ukraine, 73000
    • Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
  • Kryvyi Rih, Ukraine, 50056
    • Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council
  • Kyiv, Ukraine, 01023
    • Medical Center of LLC Medical Clinic Blagomed
  • Kyiv, Ukraine, 04073
    • Municipal Institution of KRC Kyiv Regional Hospital #2
  • Kyiv, Ukraine, 01030
    • Kyiv City Clinical Hospital #18
  • Kyiv, Ukraine, 01033
    • Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"
  • Lviv, Ukraine, 79059
    • Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
  • Lviv, Ukraine, 79007
    • Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway
  • Odesa, Ukraine, 65025
    • Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council
  • Uzhhorod, Ukraine, 88000
    • MNPE Central City Clinical Hospital of Uzhhorod City Council
  • Vinnytsia, Ukraine, 21029
    • Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
  • Vinnytsia, Ukraine, 21009
    • Medical Clinical Research Center of Medical Center LLC Health Clinic
  • Vinnytsia, Ukraine, 21018
    • Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
  • Zaporizhzhia, Ukraine, 69035
    • MNPE City Hospital No. 6 of Zaporizhzhia City Council
  • Chernivets'ka Oblast
    • Chernivtsi, Chernivets'ka Oblast, Ukraine, 58001
      • Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"
  • Kharkivs'ka Oblast
    • Kharkiv, Kharkivs'ka Oblast, Ukraine, 61037
      • Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council
  • Kyïv
    • Kyiv, Kyïv, Ukraine, 04107
      • Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
  • Vinnyts'ka Oblast
    • Vinnytsia, Vinnyts'ka Oblast, Ukraine, 21018
      • Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
  • Zaporiz'ka Oblast
    • Zaporizhzhia, Zaporiz'ka Oblast, Ukraine, 69005
      • Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council
• United Kingdom
  • Edinburh, United Kingdom, EH4 2XU
    • Western General Hospital Edinburgh - PPDS
  • Newport, United Kingdom, NP20 2UB
    • Royal Gwent Hospital - PPDS
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
  • Aberdeen City
    • Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
      • Aberdeen Royal Infirmary - PPDS
  • Bury
    • Lancashire, Bury, United Kingdom, BL9 7TD
      • Fairfield General Hospital - PPDS
  • London, City Of
    • London, London, City Of, United Kingdom, E11 1NR
      • Whipps Cross University Hospital
  • Northumberland
    • North Shields, Northumberland, United Kingdom, NE29 8NH
      • North Tyneside General Hospital
  • Shropshire
    • Shrewsbury, Shropshire, United Kingdom, SY3 8XQ
      • Royal Shrewsbury Hospital
• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Arizona Digestive Health Mesa - East
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies - Phoenix - Clinedge - PPDS
  • Arkansas
    • Little Rock, Arkansas, United States, 72209
      • Atria Clinical Research - Clinedge - PPDS
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center
    • Corona, California, United States, 92879
      • Kindred Medical Institute for Clinical Trials, LLC
    • Encinitas, California, United States, 92024-1350
      • United Medical Doctors
    • La Jolla, California, United States, 92093
      • University of California San Diego
    • Lancaster, California, United States, 93534
      • OM Research LLC - Lancaster - ClinEdge - PPDS
    • Long Beach, California, United States, 90822
      • VA Long Beach Healthcare System - NAVREF - PPDS
    • Mission Hills, California, United States, 91345
      • Facey Medical Foundation
    • Murrieta, California, United States, 92563
      • United Medical Doctors
    • Poway, California, United States, 92064
      • Alliance Clinical Research-(Vestavia Hills)
    • Rialto, California, United States, 92377
      • Inland Empire Liver Foundation
    • San Francisco, California, United States, 94158
      • University of California San Francisco
    • San Pablo, California, United States, 94806
      • Care Access Research, San Pablo
  • Colorado
    • Colorado Springs, Colorado, United States, 80903
      • Peak Gastroenterology Associates
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates PC - CRN - PPDS
  • Florida
    • Cape Coral, Florida, United States, 33991
      • Renaissance Research Medical Group, INC
    • Clearwater, Florida, United States, 33756
      • Gastro Florida
    • Coral Gables, Florida, United States, 33134
      • Advanced Clinical Research Network
    • Coral Springs, Florida, United States, 33071
      • Alliance Medical Research LLC
    • Jacksonville, Florida, United States, 32256
      • ENCORE Borland-Groover Clinical Research - ERN - PPDS
    • Kissimmee, Florida, United States, 34741
      • SIH Research
    • Miami, Florida, United States, 33135
      • Hi Tech and Global Research, LLC
    • Miami, Florida, United States, 33157
      • Sanchez Clinical Research, Inc
    • Miami, Florida, United States, 33144
      • Nuren Medical and Research Center
    • Miami Lakes, Florida, United States, 33065
      • Crystal Biomedical Research
    • Naples, Florida, United States, 34102
      • Gastroenterology Group of Naples
    • Naples, Florida, United States, 34102
      • Pharma Research International Inc
    • Orlando, Florida, United States, 32810
      • Omega Research Consultants LLC - Clinedge - PPDS
    • Pinellas Park, Florida, United States, 33781
      • Accel Research Sites - St. Petersburg - ERN - PPDS
    • Plantation, Florida, United States, 33322
      • BRCR Medical Center, Inc
    • Saint Augustine, Florida, United States, 32086
      • East Coast Institute for Research, LLC
    • Tamarac, Florida, United States, 33321
      • DBC Research
    • Tampa, Florida, United States, 33604
      • Bayside Clinical Research - New Port Richey
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Gastroenterology Specialists, PC
    • Atlanta, Georgia, United States, 30349
      • Infinite Clinical Trials
    • Columbus, Georgia, United States, 31904
      • Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS
    • Decatur, Georgia, United States, 30033
      • Atlanta Center For Gastroenterology PC
  • Illinois
    • Chicago, Illinois, United States, 60644
      • Loretto Hospital
    • Gurnee, Illinois, United States, 60031
      • IL Gastroenterology Group
    • Hines, Illinois, United States, 60141
      • Edward Hines Jr VA Hospital - NAVREF - PPDS
    • Oakbrook Terrace, Illinois, United States, 60181
      • DuPage Medical Group
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Medisphere Medical Research Center LLC
    • Michigan City, Indiana, United States, 46360
      • LaPorte County Institute for Clinical Research
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Gastroenterology Associates of Hazard
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • CroNOLA, LLC.
    • Lake Charles, Louisiana, United States, 70601
      • Clinical Trials of SWLA, LLC
    • Shreveport, Louisiana, United States, 71103
      • Louisiana Research Center LLC
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Chevy Chase Clinical Research
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Commonwealth Clinical Studies LLC
    • Worcester, Massachusetts, United States, 01655
      • UMASS Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan
    • Hamtramck, Michigan, United States, 48212
      • National Clinical, LLC
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Mayo Clinic Health System - PPDS
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • Digestive Health Center PA
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63128
      • St Louis Center For Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Advanced Biomedical Research of America
    • North Las Vegas, Nevada, United States, 89086
      • Encompass Care
  • New York
    • Brooklyn, New York, United States, 11215
      • New York Total Medical Care PC
    • Lake Success, New York, United States, 11042
      • NYU Langone Long Island Clinical Research Associates
    • New York, New York, United States, 10021
      • Weill Cornell Medical College
    • Orchard Park, New York, United States, 14127
      • Southtowns Gastroenterology, PLLC
  • North Carolina
    • Jacksonville, North Carolina, United States, 28546
      • East Carolina Gastroenterology
    • Statesville, North Carolina, United States, 28625
      • Piedmont Healthcare
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Consultants For Clinical Research Inc
    • Cincinnati, Ohio, United States, 45249
      • Consultants For Clinical Research Inc
    • Fairfield, Ohio, United States, 45014
      • Consultants For Clinical Research Inc
    • Franklin, Ohio, United States, 45005
      • Prestige Clinical Research
    • Mentor, Ohio, United States, 44060
      • Ohio Clinical Research Partners LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Veteran's Research and Education Foundation - NAVREF - PPDS
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • Veterans Research Foundation of Pittsburgh - NAVREF - PPDS
    • Wyomissing, Pennsylvania, United States, 19610
      • Digestive Disease Associates
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastro One
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
    • Union City, Tennessee, United States, 38237
      • Advanced Gastroenterology-Union City
  • Texas
    • Baytown, Texas, United States, 77521
      • Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS
    • Cypress, Texas, United States, 77429
      • Northside Gastroenterology
    • Garland, Texas, United States, 75044
      • Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
    • Houston, Texas, United States, 77074
      • Southwest Clinical Trials
    • Houston, Texas, United States, 77039
      • Precision Research Institute, LLC
    • Houston, Texas, United States, 77043
      • Biopharma Informatic Inc.
    • Houston, Texas, United States, 77084
      • BI Research Center
    • Houston, Texas, United States, 77079
      • Aztec Medical Research
    • San Antonio, Texas, United States, 78229
      • Southern Star Research Institute LLC
    • Tomball, Texas, United States, 77375
      • DM Clinical Research - ERN - PPDS
  • Utah
    • Bountiful, Utah, United States, 84010
      • HP Clinical Research
  • Virginia
    • Galax, Virginia, United States, 24333
      • Mid Atlantic Health Specialists
    • Winchester, Virginia, United States, 22601-2872
      • Winchester Gastroenterology Associates
  • Washington
    • Tacoma, Washington, United States, 98405
      • CHI Franciscan Digestive Care Associates
  • West Virginia
    • Elkins, West Virginia, United States, 26241
      • Exemplar Research, Inc. - Elkins
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 79 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
• Participants must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
• Participants must have completed the 12-week induction treatment period (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).

• Participants must have achieved clinical response in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). Clinical response is defined as:

  i) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in the composite score of patient reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub score for rectal bleeding greater than or equal to (>=) 1 point or a sub score for rectal bleeding less than or equal to (<=) 1 OR ii) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1.

For eligibility assessment, clinical response will be determined based on the centrally read endoscopy performed during screening and at Week 12 of induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).

- Participants receiving any treatment(s) for ulcerative colitis (UC) are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.

Exclusion Criteria:

• Participants who had major protocol deviation(s) (as determined by the sponsor) in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
• Participants who permanently discontinued investigational product because of an adverse event (AE), regardless of relatedness to investigational product, in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
• Participants who are likely to require surgery for UC during the study period.
• Participants are females who became pregnant during induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]), females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods (that is [i.e,] highly effective methods for female and medically appropriate methods for male study participants) through the conclusion of study participation.
• Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
• Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
• Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
• Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [eg], renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
• Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) and who are without a generally accepted course of treatment.
• Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.
• Participants who are participating in or plan to participate in other investigational studies (other than induction study SHP647- 301 [NCT03259334] and SHP647-302 [NCT03259308]) during study SHP647-303 [NCT03290781].

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ontamalimab 25 mg; Participants will receive 25 milligram (mg) of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 25 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.	Drug: Ontamalimab; Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).; Other Names: SHP647; PF-00547659
Experimental: Ontamalimab 75 mg; Participants will receive 75 mg of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 75 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.	Drug: Ontamalimab; Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).; Other Names: SHP647; PF-00547659
Placebo Comparator: Placebo; Participants will receive 25 mg or 75 mg ontamalimab or placebo matched to ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive placebo matched to ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.	Other: Placebo; Participants will receive 1 mL of sterile aqueous buffered solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Remission Based on Composite Score at Week 52	Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).	At Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Endoscopic Remission at Week 52	Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration).	At Week 52
Number of Participants With Clinical Remission at Week 52	Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal; 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.	At Week 52
Number of Participants With Sustained Remission at Week 52	Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).	At Week 52
Number of Participants With Clinical Response Based on Composite Score at Week 52	Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or a sub-score for rectal bleeding <= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood & 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease.	At Week 52
Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52	Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.	At Week 52
Number of Participants With Glucocorticoid-free Clinical Remission at Week 52	Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood & 3=blood alone passes).	At Week 52
Number of Participants With Glucocorticoid-free Remission at Week 52	Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.	At Week 52
Number of Participants With Remission Based on Total Mayo Score at Week 52	Remission defined as a total mayo score of less than or equal to (<=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1. The total mayo score ranges from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease [spontaneous bleeding, ulceration].	At Week 52
Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0	Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.	At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants With Sustained Endoscopic Remission at Week 52	Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among participants who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease.	At Week 52
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of participants with TEAEs were reported.	From start of study drug administration up to follow-up (Week 64)
Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab	Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of participants who developed positive results for ontamalimab were reported.	At Week 12, 24, 36 and 52

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Ulcerative colitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: SHP647-303; 2017-000573-37 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes