A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

January 25, 2024 updated by: Shire

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

556

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • St. Pölten, Austria, 3100
        • Universitätsklinikum St. Pölten
      • 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
    • 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 Leuven- Gasthuisberg Campus
    • 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, 1000
        • Medical Center Excelsior OOD - PPDS
      • Sofia, Bulgaria, 1709
        • University Multiprofile Hospital for Active Treatment Sveta Anna
      • Varna, Bulgaria, 9000
        • Diagnostic Consultative Centre Mladost - M OOD
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1784
        • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
  • 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 Tobon Uribe
    • Santander
      • Bucaramanga, Santander, Colombia
        • Servimed S.A.S
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760026
        • Fundacion Valle del Lili
  • 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.
      • Usti 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
      • Tallinn, Estonia, 10617
        • West Tallinn Central Hospital
    • Pärnumaa
      • Pärnu, Pärnumaa, Estonia, 80010
        • OÜ LV Venter
  • 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
        • Universitatsklinikum 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 Koln
      • Münster, Nordrhein-Westfalen, Germany, 48159
        • Gastro Campus Research GbR
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein
    • Thüringen
      • Jena, Thüringen, Germany, 07747
        • Universitätsklinikum Jena
  • Greece
      • Heraklion, Greece, 71110
        • University General Hospital of Heraklion
      • Paliao Faliro, Greece, 17562
        • Iatriko Palaiou Falirou
      • 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
        • Jávorszky Ödön Kórház
  • Ireland
      • Dublin, Ireland, DUBLIN 4
        • 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 (FG), 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 Universita Padova
  • 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
      • 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
      • 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
      • Yokohama, Japan, 220-0045
        • Colo-Proctology Center Matsushima Clinic
    • Hokkaidô
      • Sapporo, Hokkaidô, Japan, 060-8543
        • Sapporo Medical University Hospital
      • Sapporo-shi, Hokkaidô, Japan, 004-0041
        • Sapporo Tokushukai 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, 874-8538
        • Shinbeppu Hospital
      • Oita-city, Ôita, Japan, 870-0823
        • Ishida Clinic of IBD and Gastroenterology
    • 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
      • 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
    • 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
      • Beirut, Lebanon
        • Al Zahraa 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.
      • 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
    • Distrito Federal
      • Tepeyac Insurgentes, Distrito Federal, Mexico, 07020
        • Centro de Investigación Clinica Acelerada, S.C.
    • Jalisco
      • Zapopan, Jalisco, 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
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64000
        • Accelerium, S. de R.L. de C.V. - PPDS
    • 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
        • Amsterdam UMC - Meibergdreef 9
    • 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 Bydgoszcz- PRATIA - PPDS
      • 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 Ncm
      • Piaseczno, Poland, 05-500
        • Centrum Innowacyjnych Terapii
      • Poznan, Poland
        • 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, 70-361
        • Sonomed Sp. z o.o.
      • 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.
      • 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, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
      • 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 SCM
  • 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
      • Lisboa, Portugal, 1500-650
        • Hospital da Luz
      • Setubal, Portugal, 2910-446
        • Hospital de São Bernardo
  • 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, 050098
        • Emergency University Hospital
      • Bucharest, Romania, 011025
        • Sana Monitoring SRL
      • Bucuresti, Romania, 031864
        • SC Centrul Medical MEDICUM S.R.L.
      • Cluj-Napoca, Romania, 400006
        • Cluj-Napoca Emergency Clinical County Hospital
      • 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
  • 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
      • Smoensk, Russian Federation, 214018
        • Smolensk Regional 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
    • Sankt-Peterburg
      • St. Petersburg, Sankt-Peterburg, Russian Federation, 195257
        • St. Elizabeth Municipal Clinical Hospital
  • Serbia
      • Belgrade, Serbia, 11080
        • Clinical hospital center Bezanijska Kosa
      • Nis, Serbia, 18000
        • University Clinical Center Nis
      • Vrsac, Serbia, 26300
        • General Hospital Vrsac
      • Zemun, Serbia
        • Clinical Hospital Center Zemun
    • 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
    • Madrid, Communidad Delaware
      • Madrid, Madrid, Communidad Delaware, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
    • 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, 61039
        • Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine
      • Kharkiv, Ukraine, 61058
        • Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital
      • Kharkiv, Ukraine, 61166
        • MNPE of Kharkiv Regional Council Regional Clinical Specialised 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, 02091
        • Medical Center OK!Clinic+LLC International Institute of Clinical Research
      • Kyiv, Ukraine, 02132
        • Medical Center of LLC Medical Center Dopomoga-Plus
      • Kyiv, Ukraine, 01030
        • Kyiv City Clinical Hospital #18
      • Kyiv, Ukraine, 01033
        • Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"
      • Kyiv, Ukraine, 04107
        • Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
      • Kyiv, Ukraine, 04073
        • Communal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Hospital
      • Lviv, Ukraine, 79007
        • Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway
      • Lviv, Ukraine, 79059
        • MNE Lviv Territorial Med Ass-n Multidisciplinary Clinical Hospital for Intensive Care and Ambulance
      • 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
    • Vinnyts'ka Oblast
      • Vinnytsia, Vinnyts'ka Oblast, Ukraine, 21018
        • Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VR
    • Zaporiz'ka Oblast
      • Zaporizhzhia, Zaporiz'ka Oblast, Ukraine, 69005
        • Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary - PPDS
      • 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
    • 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
      • Sun City, Arizona, United States, 85351
        • Arizona Digestive Health
      • Tucson, Arizona, United States, 85724
        • CATS Research Center - University of Arizona
    • 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
      • Long Beach, California, United States, 90822
        • Tibor Rubin VA Medical Center - NAVREF
      • 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, Florida, United States, 33174
        • Advanced Clinical Research Network
      • Miami Lakes, Florida, United States, 33065
        • Crystal Biomedical Research
      • Naples, Florida, United States, 34102
        • Gastroenterology Group of Naples
      • Naples, Florida, United States, 34110
        • Pharma Research International Inc
      • New Port Richey, Florida, United States, 34655
        • Bayside Clinical Research - New Port Richey
      • 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
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS
      • Decatur, Georgia, United States, 30033
        • Atlanta Center For Gastroenterology PC
      • Morrow, Georgia, United States, 30260
        • Infinite Clinical Trials
      • Suwanee, Georgia, United States, 30024
        • Atlanta Gastroenterology Specialists, PC
    • Illinois
      • Chicago, Illinois, United States, 60644
        • Loretto Hospital
      • Gurnee, Illinois, United States, 60041
        • 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
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
    • 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
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Clinical Research, LLC - ClinEdge - PPDS
      • 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, LLC
      • Hamtramck, Michigan, United States, 48212
        • National Clinical, LLC
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan, PLC
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Mayo Clinic Health System - PPDS
      • Saint Paul, Minnesota, United States, 55114
        • Minnesota Gastroenterology PA
    • 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
      • Great Neck, New York, United States, 11021
        • 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, 45249
        • Consultants For Clinical Research Inc
      • Cincinnati, Ohio, United States, 45219
        • Gastro Health Research
      • 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
      • State College, Pennsylvania, United States, 16803
        • Penn State Hershey Medical Group
      • 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
      • 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, 77079
        • Aztec Medical Research
      • Houston, Texas, United States, 77084
        • Biopharma Informatic Research Center
      • San Antonio, Texas, United States, 78229
        • Southern Star Research Institute LLC
      • Tomball, Texas, United States, 77375
        • DM Clinical Research - ERN - PPDS
      • Webster, Texas, United States, 77598
        • Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 78 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants with Ulcerative Colitis (UC):

  • 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 been enrolled previously in study SHP647-301 (NCT03259334), SHP647-302 (NCT03259308), and are in the treatment period of Study SHP647-303, completed the early termination (ET) or Week 52 visit in maintenance study SHP647-303 (NCT03290781), had responded to ontamalimab treatment (in the induction and/or maintenance studies), and meet one of the following criteria:

    a. Participants are on placebo at the maintenance study ET or Week 52 visit: they received ontamalimab in the induction studies and fulfilled the maintenance study response criteria, OR b. Participants have received ontamalimab at the maintenance study ET or Week 52 visit: i) Clinical composite score that has decreased by >or=2 points and >or=30%, with an accompanying decrease in the subscore for RB >or=1 point or a subscore for RB <or=1, compared to the baseline value for induction studies, and/or ii) Composite score that has decreased by >or=30% and >or=3 points compared to the baseline value for induction studies.

  • Participants receiving any treatment(s) for UC are eligible provided they have been on a stable dose for the designated period of time.

Participants with Crohn's Disease:

  • 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 been enrolled previously in Study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and are in the treament period of Study SHP647-307 (NCT03627091), completed the ET or Week 52 visit in maintenance study SHP647-307, had responded to ontamalimab treatment (in the induction or maintenance studies) and meet one of the following criteria:

    1. Participants are on placebo at the maintenance study ET or Week 52 visit: they received ontamalimab in the induction study and fulfilled the maintenance study response criteria, OR
    2. Participants have received ontamalimab at the maintenance study ET or Week 52 visit:

    i) CDAI score that has decreased by >or=100 points at EOT visit compared to the baseline value for induction studies, and/or ii) SES-CD that has decreased by >or=25% compared to the baseline value for induction studies.

  • Participants receiving any treatment(s) for CD are eligible provided they have been on a stable dose for the designated period of time.

Exclusion Criteria:

Participants with UC:

  • Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-301, SHP647-302, or SHP647-303.
  • Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in study SHP647-301, SHP647-302, or SHP647-303.
  • Participants who are likely to require major surgery for UC.
  • Participants are females who became pregnant during study SHP647-301, SHP647-302, or SHP647-303, females who are lactating, 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 (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 [e.g.], renal, hepatic, hematologic, gastrointestinal [except disease under study], endocrine, cardiovascular, pulmonary, immunologic [e.g. 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 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 study SHP647-301 (NCT03259334) or SHP647-302 (NCT03259308) and who have been advised to require treatment for latent or active disease, but 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 other investigational studies (other than SHP647-301, SHP647-302, or SHP647-303) or plan to participate in other investigational studies during long-term extension study SHP647-304.

Participants with Crohn's Disease:

  • Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-305, SHP647-306 or SHP647-307.
  • Participants who permanently discontinued investigational product because of an adverse events (AE), regardless of relatedness to investigational product, in study SHP647-305, SHP647-306 or SHP647-307.
  • Participants who are likely to require major surgery for CD or developed acute severe complications of CD (with or without fulfilling the treatment failure criteria in the maintenance study) that required immediate intervention (e.g. need for immediate biologic treatment with proven effect) and/or Crohn's Disease Activity Index (CDAI) score more than (>) 450.
  • Participants are females who became pregnant during study SHP647-305, SHP647-306 or SHP647-307, females who are lactating, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue appropriate contraception methods (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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 25 mg Ontamalimab
Participants will be receiving 25 milligram (mg) of ontamalimab solution for injection subcutaneously (SC) every 4 weeks until the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study, or the program is stopped.
Drug: 25 mg Ontamalimab
Ontamalimab sterile aqueous buffered solution will be administered in dose of 25 mg subcutaneously.
Other Names:
  • SHP647
  • PF-00547659
Experimental: 75 mg Ontamalimab
Participants will be receiving 75 mg of ontamalimab solution for injection SC every 4 weeks until the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study, or the program is stopped.
Drug: 75 mg Ontamalimab
Ontamalimab sterile aqueous buffered solution will be administered in dose of 75 mg subcutaneously.
Other Names:
  • SHP647
  • PF-00547659

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline upto 12 weeks post end of treatment (EOT) (upto a maximum of 3 years)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) are defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product. The TEAEs will be further categorized based on severity as mild (may require only minimal treatment) to severe (may require intensive therapeutic intervention).
Baseline upto 12 weeks post end of treatment (EOT) (upto a maximum of 3 years)
Number of Participants With Serious Infections
Time Frame: Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
Number of participants with serious infections will be assessed.
Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as an Adverse Event
Time Frame: Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
Clinical laboratory assessments include hematology, serum chemistry and urinalysis. Any clinically significant change in the clinical laboratory value from baseline will be recorded as an AE.
Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event
Time Frame: Baseline upto EOT (upto a maximum of 3 years)
12-lead ECG will be recorded. Any clinically significant change in ECG will be recorded as an AE.
Baseline upto EOT (upto a maximum of 3 years)
Number of Participants With Clinically Significant Change in Vital Signs Reported as an Adverse Event
Time Frame: Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
Vital sign assessments include blood pressure, pulse, respiratory rate and temperature. Any clinically significant change in vital signs from baseline will be recorded as an AE.
Baseline upto 12 weeks post EOT (upto a maximum of 3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Ulcerative Colitis with Treatment Response Over Time
Time Frame: Baseline upto 12 weeks post end of treatment (EOT) (upto a maximum of 3 years)
Treatment response over time is defined as clinical composite score that has decreased by greater than or equal to (>or= 2) points and >or=30 percentage (%), with an accompanying decrease in the sub score for RB >or= 1 point or a subscore for rectal bleeding (RB) >or=1, and/or composite score that has decreased by >or= 30% and >or=3 points compared to the baseline value for induction studies. The clinical composite score is a measure consisting of sub scores RB (0-3) plus stool frequency (0-3) with higher scores indicating more severe disease.
Baseline upto 12 weeks post end of treatment (EOT) (upto a maximum of 3 years)
Number of Participants with Crohn's Disease with Treatment Response Over Time
Time Frame: Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
Treatment response over time defined as CDAI score that has decreased >or= 100 points compared to baseline value for induction studies and/or simple endoscopic score for Crohn's disease (SES-CD) that has decreased by >or= 25% compared to baseline value for induction studies. SES-CD is simple scoring system based on 4 endoscopic variables measured in same 5 ileocolonic segments as Crohn's disease index of severity. Overall values on SES-CD range from 0-56, with higher values indicating more severe disease. 4 endoscopic variables are scored from 0-3 in each bowel segment: ileum, right/transverse/left colon, rectum. Presence and size of ulcers (none= score 0; diameter 0.1-0.5centimetre(cm)= score 1; 0.5-2cm= score 2; diameter >2cm= score 3); extent of ulcerated surface (none= 0; <10%=1; 10%-30%= 2; >30%= 3); extent of affected surface (none= 0; <50%= 1; 50%-75%= 2; >75%= 3); Presence and type of narrowing (none=0; single can be passed=1; multiple can be passed=2; cannot be passed=3).
Baseline upto 12 weeks post EOT (upto a maximum of 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Investigators

  • Study Director: Study Director, Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2018

Primary Completion (Actual)

December 13, 2023

Study Completion (Actual)

December 13, 2023

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 14, 2017

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHP647-304
  • 2017-000574-11 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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