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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03283085
• Other study ID #: SHP647-304
• Secondary ID: 2017-000574-11
• Status: Completed
• Phase: Phase 3
• Start date: February 27, 2018
• Est. completion date: December 13, 2023

Study information

• Verified date: January 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: December 13, 2023
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• 25 mg Ontamalimab
Ontamalimab sterile aqueous buffered solution will be administered in dose of 25 mg subcutaneously.
• 75 mg Ontamalimab
Ontamalimab sterile aqueous buffered solution will be administered in dose of 75 mg subcutaneously.

Locations

Country	Name	City	State
Argentina	Fundación Favaloro	Buenos Aires
Argentina	Hospital Privado Centro Médico de Córdoba	Córdoba
Argentina	Sanatorio 9 de Julio SA	San Miguel de Tucumán
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Alfred Hospital	Box Hill	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Royal Brisbane & Women's Hospital	Herston	Queensland
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	St Vincents Hospital Melbourne - PPDS	Melbourne	Victoria
Australia	Mater Hospital Brisbane	South Brisbane	Queensland
Austria	LKH-Universitätsklinikum Klinikum Graz	Graz	Steiermark
Austria	Klinikum Klagenfurt Am Woerthersee	Klagenfurt am Wörthersee
Austria	Salzburger Landeskliniken	Salzburg
Austria	Universitätsklinikum St. Pölten	St. Pölten
Austria	A.ö. Krankenhaus der Barmherzigen Brüder	St. Veit an der Glan	Kärnten
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Austria	Medizinische Universitat Wien (Medical University of Vienna)	Wien
Belgium	UZ Gent	Gent	Oost-Vlaanderen
Belgium	AZ Groeninge	Kortrijk	West-Vlaanderen
Belgium	UZ Leuven- Gasthuisberg Campus	Leuven	Vlaams Brabant
Belgium	CHU Mouscron	Mouscron
Bosnia and Herzegovina	Clinical Center Banja Luka	Banja Luka
Bulgaria	University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD	Pleven
Bulgaria	Multiprofile Hospital for Active Treatment Eurohospital	Plovdiv
Bulgaria	Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS	Ruse
Bulgaria	Medical Center-1-Sevlievo EOOD	Sevlievo
Bulgaria	Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD	Sofia	Sofia-Grad
Bulgaria	Diagnostic and Consulting Center Aleksandrovska EOOD	Sofia
Bulgaria	Medical Center Convex EOOD	Sofia
Bulgaria	Medical Center Excelsior OOD - PPDS	Sofia
Bulgaria	Second Multiprofile Hospital for Active Treatment Sofia	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Sveta Anna	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD	Sofia
Bulgaria	Diagnostic Consultative Centre Mladost - M OOD	Varna
Canada	Toronto Digestive Disease Associates Inc	Toronto	Ontario
Canada	Percuro Clinical Research LTD	Victoria	British Columbia
Colombia	Servimed S.A.S	Bucaramanga	Santander
Colombia	Fundación Valle Del Lili	Cali	Valle Del Cauca
Colombia	IPS Centro Médico Julián Coronel S.A.S. - PPDS	Cali
Colombia	Hospital Pablo Tobón Uribe	Medellin	Antioquia
Croatia	Opca bolnica Bjelovar	Bjelovar
Croatia	Opca Bolnica Karlovac	Karlovac	Karlovacka Županija
Croatia	Clinical Hospital Centre Osijek	Osijek
Croatia	University Hospital Centre Split	Split
Croatia	General Hospital Virovitica	Virovitica
Croatia	General County Hospital Vukovar and Croatian Veterans Hospital	Vukovar
Croatia	General Hospital Zadar	Zadar
Croatia	University Hospital Center Zagreb	Zagreb	Grad Zagreb
Czechia	Hepato-Gastroenterologie HK, s. r. o.	Hradec Králové	Královéhradecký Kraj
Czechia	PreventaMed s.r.o.	Olomouc	Olomoucký Kraj
Czechia	Institut Klinicke A Experimentalni Mediciny	Praha 4
Czechia	ISCARE I.V.F. a.s.	Praha 7
Czechia	Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.	Usti nad Labem
Czechia	Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice	Usti nad Orlici
Estonia	East Viru Central Hospital	Kohta-Järve
Estonia	OÜ LV Venter	Pärnu	Pärnumaa
Estonia	West Tallinn Central Hospital	Tallinn
Germany	Universitätsklinikum der RWTH Aachen	Aachen	Nordrhein-Westfalen
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Gastroenterologische Facharztpraxis am Mexikoplatz	Berlin-Zehlendorf
Germany	Sana Klinikum Biberach	Biberach an der Riss
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	Asklepios Westklinikum Hamburg Ggmbh	Hamburg
Germany	Universitatsklinikum Jena	Jena	Thüringen
Germany	Universitatsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	Uniklinik Köln	Köln	Nordrhein-Westfalen
Germany	Klinikum rechts der Isa der Technischen Universitaet Muenchen	Munich
Germany	Gastro Campus Research GbR	Münster	Nordrhein-Westfalen
Germany	Universitätsklinikum Ulm	Ulm	Baden-Württemberg
Greece	Ippokrateio General Hospital of Athens	Athens	Attiki
Greece	University General Hospital of Heraklion	Heraklion
Greece	Iatriko Palaiou Falirou	Paliao Faliro
Greece	University General Hospital of Patras	Patras
Greece	Euromedica - PPDS	Thessaloniki
Greece	Theageneio Anticancer Oncology Hospital of Thessaloniki	Thessaloniki
Hungary	Bekes Megyei Kozponti Korhaz	Békéscsaba
Hungary	ENDOMEDIX Kft.	Budapest
Hungary	Magyar Honvédség Egészségügyi Központ	Budapest
Hungary	Pannónia Magánorvosi Centrum Kft	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Bekes Megyei Kozponti Korhaz	Gyula
Hungary	Mohacsi Korhaz	Mohacs
Hungary	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Székesfehérvár
Hungary	Tolna Megyei Balassa János Kórház	Szekszard
Hungary	Csongrad Megyei Dr. Bugyi Istvan Korhaz	Szentes
Hungary	Jávorszky Ödön Kórház	Vác
Hungary	Csolnoky Ferenc Korhaz	Veszprém
Ireland	St Vincent's University Hospital	Dublin
Israel	Hadassah Medical Center - PPDS	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Galilee Medical Center	Nahariya
Israel	Nazareth EMMS Hospital	Nazareth
Israel	Tel Aviv Sourasky Medical Center PPDS	Tel Aviv
Israel	Baruch Padeh Poriya Medical Center	Tiberias
Italy	Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi	Bologna	Emilia-Romagna
Italy	Azienda Ospedaliera Mater Domini Di Catanzaro	Catanzaro	Calabria
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze	Toscana
Italy	Azienda Ospedaliero Universitaria Di Modena Policlinico	Modena	Emilia-Romagna
Italy	IRCCS Ospedale Sacro Cuore Don Calabria	Negrar	Veneto
Italy	A.O.U. Maggiore della Carità	Novara
Italy	Azienda Ospedale Università Padova	Padova	Veneto
Italy	Fondazione IRCCS Policlinico San Matteo di Pavia	Pavia
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma	Lazio
Italy	Fondazione Policlinico Universitario A Gemelli	Roma
Italy	La Sapienza-Università di Roma-Policlinico Umberto I	Roma
Italy	Istituto Clinico Humanitas	Rozzano (MI)
Italy	Ospedale Casa Sollievo Della Sofferenza IRCCS	San Giovanni Rotondo (FG)	Puglia
Italy	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Torino
Italy	Azienda Ospedaliera Ordine Mauriziano di Torino	Torino
Japan	Tokatsu Tsujinaka Hospital	Abiko
Japan	Kunimoto Hospital	Asahikawa
Japan	Shinbeppu Hospital	Beppu	Ôita
Japan	Fukuoka University Chikushi Hospital	Chikushino
Japan	Nihonbashi Egawa Clinic	Chuo-Ku	Tokyo
Japan	Hakodate Koseiin Hakodate Goryoukaku Hospital	Hakodate
Japan	Medical Corporation Aoyama Clinic	Kobe-shi	Hyôgo
Japan	Yuai Memorial Hospital	Koga
Japan	Kawabe Clinic	Koganei
Japan	Dokkyo Medical University Saitama Medical Center	Koshigaya	Saitama
Japan	Hidaka Coloproctology Clinic	Kurume-shi
Japan	Aizawa Hospital	Matsumoto-shi
Japan	Jikei University Hospital	Minato-ku	Tokyo
Japan	Kitasato University Kitasato Institute Hospital	Minato-ku	Tokyo
Japan	Aichi Medical University Hospital	Nagakute
Japan	Nishinomiya Municipal Central Hospital	Nishinomiya
Japan	Hyogo College of Medicine	Nishinomiya-shi	Hyôgo
Japan	Ishida Clinic of IBD and Gastroenterology	Oita-city	Ôita
Japan	Ome Municipal General Hospital	Ome	Tokyo
Japan	Onomichi General Hospital	Onomichi
Japan	Chiinkai Dojima General & Gastroenterology Clinic	Osaka
Japan	Yodogawa Christian Hospital	Osaka	Ôsaka
Japan	Kinshukai Infusion Clinic	Osaka-shi
Japan	Shiga University of Medical Science Hospital	Otsu-Shi
Japan	Sagamihara Kyodo Hospital	Sagamihara	Kanagawa
Japan	Bellland General Hospital	Sakai
Japan	Toho University Sakura Medical Center	Sakura
Japan	Sapporo Higashi Tokushukai Hospital	Sapporo
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaidô
Japan	Sapporo Tokushukai Hospital	Sapporo-shi	Hokkaidô
Japan	Tohoku Rosai Hospital	Sendai
Japan	Dokkyo Medical University Hospital	Shimotsuga-gun
Japan	Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital	Takatsuki
Japan	Koukokukai Ebisu Clinic	Tokyo
Japan	Colo-Proctology Center Matsushima Clinic	Yokohama
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Kyungpook National University Hospital	Daegu	Daegu Gwang'yeogsi
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam	Gyeonggido
Korea, Republic of	Asan Medical Center - PPDS	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Samsung Medical Center PPDS	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System - PPDS	Seoul
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon	Gyeonggido
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju	Gang'weondo
Lebanon	Al Zahraa University Hospital	Beirut
Lebanon	Rafik Hariri University Hospital	Beirut
Lebanon	Hammoud Hospital University Medical Center	Saida
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics	Kaunas
Lithuania	Vilnius City Clinical Hospital	Vilnius
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius
Mexico	Centro de Investigación Médica Aguascalientes	Aguascalientes
Mexico	Phylasis Clinicas Research S. de R.L. de C.V.	Cuautitlán Izcalli
Mexico	Clinica de Higado y Gastroenterologia Integral, S.C.	Cuernavaca	Morelos
Mexico	JM Research S.C	Cuernavaca	Morelos
Mexico	Instituto de Investigaciones Aplicadas a la Neurociencia A.C.	Durango
Mexico	Unidad de Atencion Medica e Investigacion en Salud	Merida	Yucatán
Mexico	Accelerium, S. de R.L. de C.V.	Monterrey
Mexico	Accelerium, S. de R.L. de C.V. - PPDS	Monterrey	Nuevo León
Mexico	Centro de Investigacion Clinica Acelerada, S.C.	Tepeyac Insurgentes	Distrito Federal
Mexico	Clinical Research Institute	Tlalnepantla De Baz
Mexico	Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.	Zapopan	Jalisco
Netherlands	NWZ, location Alkmaar	Alkmaar	Noord-Holland
Netherlands	Amsterdam UMC - Meibergdreef 9	Amsterdam
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid-Holland
Netherlands	ETZ-Elisabeth	Tilburg	Noord-Brabant
New Zealand	Dunedin Hospital	Dunedin	South Island
New Zealand	Auckland City Hospital	Grafton	Auckland
New Zealand	Waikato Hospital	Hamilton
New Zealand	Wellington Hospital	Newtown	Wellington
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok	Podlaskie
Poland	Centrum Medyczne Bydgoszcz- PRATIA - PPDS	Bydgoszcz
Poland	Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Vitamed Galaj i Cichomski sp.j.	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne Czestochowa - PRATIA - PPDS	Czestochowa
Poland	Centrum Medyczne Gdynia - PRATIA - PPDS	Gdynia
Poland	BioVirtus Centrum Medyczne	Jozefow	Mazowieckie
Poland	NZOZ All Medicus	Katowice
Poland	Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach	Katowice	Slaskie
Poland	Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii	Konskie	Swietokrzyskie
Poland	Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska	Krakow
Poland	Krakowskie Centrum Medyczne	Krakow	Malopolskie
Poland	Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.	Ksawerow
Poland	Med Gastr Sp.z.o.o Sp.k	Lodz
Poland	Instytut Centrum Zdrowia Matki Polki	Lódz	Lódzkie
Poland	Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny	Lódz	Lódzkie
Poland	Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow	Lódz	Lódzkie
Poland	Twoja Przychodnia NCM	Nowa Sól
Poland	Centrum Innowacyjnych Terapii	Piaseczno
Poland	Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia, Medic-R Spólka Komandytowa	Poznan
Poland	Korczowski Bartosz, Gabinet Lekarski	Rzeszow
Poland	Endoskopia Sp. z o.o.	Sopot	Pomorskie
Poland	Sonomed Sp. z o.o.	Szczecin
Poland	Sonomed Sp. z o.o.	Szczecin
Poland	Twoja Przychodnia SCM	Szczecin	Zachodniopomorskie
Poland	H-T. Centrum Medyczne Endoterapia	Tychy
Poland	Centralny Szpital Kliniczny MSW	Warszawa
Poland	Centrum Medyczne Warszawa - PRATIA - PPDS	Warszawa
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Miedzyleski Szpital Specjalistyczny w Warszawie	Warszawa	Mazowieckie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy	Warszawa	Mazowieckie
Poland	Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED	Warszawa	Mazowieckie
Poland	Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.	Wloclawek	Kujawsko-pomorskie
Poland	Lexmedica	Wroclaw	Dolnoslaskie
Poland	Melita Medical	Wroclaw	Dolnoslaskie
Poland	Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II	Zamosc
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar do Algarve - Hospital de Portimao	Faro
Portugal	Hospital Senhora da Oliveira - Guimaraes, E.P.E	Guimarães
Portugal	Hospital da Luz	Lisboa
Portugal	Hospital de São Bernardo	Setubal
Romania	Colentina Clinical Hospital	Bucharest
Romania	Dr.Carol Davila Emergency University Central Military Hospital	Bucharest
Romania	Emergency University Hospital	Bucharest
Romania	Fundeni Clinical Institute	Bucharest
Romania	Prof. Dr. Matei Bals Institute of Infectious Diseases	Bucharest
Romania	Sana Monitoring SRL	Bucharest
Romania	SC Centrul Medical MEDICUM S.R.L.	Bucuresti
Romania	Cluj-Napoca Emergency Clinical County Hospital	Cluj-Napoca
Romania	Affidea Romania SRL	Constanta
Romania	Gastromedica SRL	Iasi
Romania	Dr. Tirnaveanu Amelita Private Practice	Oradea
Romania	Dr. Goldis Gastroenterology Center SRL	Timisoara
Russian Federation	Kazan State Medical University	Kazan
Russian Federation	Moscow Clinical Scientific Center	Moscow
Russian Federation	Moscow Regional Research Clinical Institute Na Mfvladimirskiy	Moscow
Russian Federation	Nizhegorodskaya Regional Clinical Hospital n.a. Semashko	Nizhny Novgorod
Russian Federation	Research Institute of Physiology and Basic Medicine	Novosibirsk
Russian Federation	Rostov State Medical University	Rostov-on-Don
Russian Federation	Rostov State Medical University	Rostov-on-Don
Russian Federation	Russian Medical Military Academy n.a. S.M. Kirov	Saint Petersburg
Russian Federation	Union Clinic, LLC	Saint Petersburg
Russian Federation	Medical Company Hepatolog, LLC	Samara
Russian Federation	Medical University Reaviz	Samara
Russian Federation	Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city	Samara
Russian Federation	SHI Regional Clinical Hospital	Saratov
Russian Federation	Smolensk Regional Clinical Hospital	Smoensk
Russian Federation	First St. Petersburg State Medical University n.a. I.P Pavlov	St. Petersburg
Russian Federation	St. Elizabeth Municipal Clinical Hospital	St. Petersburg	Sankt-Peterburg
Russian Federation	Stavropol State Medical University	Stavropol
Russian Federation	Regional Consulting and Diagnostics Centre	Tyumen
Serbia	Clinical Hospital Center Bezanijska Kosa	Belgrade
Serbia	University Clinical Center Kragujevac	Kragujevac	Šumadijski Okrug
Serbia	University Clinical Center Nis	Nis
Serbia	General Hospital Vrsac	Vrsac
Serbia	Clinical Hospital Center Zemun	Zemun
Slovakia	Univerzitna nemocnica Bratislava	Bratislava
Slovakia	KM Management, spol. s r.o.	Nitra
Slovakia	Gastro LM, s.r.o.	Presov
South Africa	Dr JP Wright	Claremont	Western Cape
South Africa	CLINRESCO, ARWYP Medical Suites	Johannesburg	Gauteng
South Africa	Dr. J Breedt	Pretoria	Gauteng
Spain	Centro Medico Teknon - Grupo Quironsalud	Barcelona
Spain	C.H. Regional Reina Sofia - PPDS	Cordoba	Córdoba
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitario Juan Ramon Jimenez	Huelva
Spain	Hospital General Universitario Gregorio Maranon	Madrid	Madrid, Communidad Delaware
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario La Paz - PPDS	Madrid
Spain	Hospital Universitario Virgen del Rocio - PPDS	Sevilla
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Spain	CHUVI - H.U. Alvaro Cunqueiro	Vigo	Pontevedra
Switzerland	Universität Zürich	Zürich	Zürich (de)
Turkey	Istanbul Universitesi Cerrahpasa Tip Fakultesi	Istanbul
Turkey	Mersin University Medical Faculty	Mersin
Ukraine	Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"	Chernivtsi	Chernivets'ka Oblast
Ukraine	LLC Medical Center Family Medicine Clinic	Dnipro
Ukraine	ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council	Dnipro
Ukraine	State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"	Dnipro
Ukraine	Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine	Kharkiv
Ukraine	MNPE of Kharkiv Regional Council Regional Clinical Specialised Dispensary of Radiation Protection	Kharkiv
Ukraine	Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council	Kharkiv	Kharkivs'ka Oblast
Ukraine	Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital	Kharkiv
Ukraine	Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh	Kherson
Ukraine	Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council	Kryvyi Rih
Ukraine	Communal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Hospital	Kyiv
Ukraine	Kyiv City Clinical Hospital #18	Kyiv
Ukraine	Medical Center of LLC Medical Center Dopomoga-Plus	Kyiv
Ukraine	Medical Center of LLC Medical Clinic Blagomed	Kyiv
Ukraine	Medical Center OK!Clinic+LLC International Institute of Clinical Research	Kyiv
Ukraine	Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital	Kyiv
Ukraine	Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"	Kyiv
Ukraine	Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway	Lviv
Ukraine	MNE Lviv Territorial Med Ass-n Multidisciplinary Clinical Hospital for Intensive Care and Ambulance	Lviv
Ukraine	Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council	Odesa
Ukraine	MNPE Central City Clinical Hospital of Uzhhorod City Council	Uzhhorod
Ukraine	Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1	Vinnytsia
Ukraine	Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VR	Vinnytsia	Vinnyts'ka Oblast
Ukraine	Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC	Vinnytsia
Ukraine	Medical Clinical Research Center of Medical Center LLC Health Clinic	Vinnytsia
Ukraine	MNPE City Hospital No. 6 of Zaporizhzhia City Council	Zaporizhzhia
Ukraine	Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council	Zaporizhzhia	Zaporiz'ka Oblast
United Kingdom	Aberdeen Royal Infirmary - PPDS	Aberdeen
United Kingdom	Western General Hospital Edinburgh - PPDS	Edinburh
United Kingdom	Fairfield General Hospital - PPDS	Lancashire	Bury
United Kingdom	Whipps Cross University Hospital	London	London, City Of
United Kingdom	Royal Gwent Hospital - PPDS	Newport
United Kingdom	North Tyneside General Hospital	North Shields	Northumberland
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury	Shropshire
United Kingdom	New Cross Hospital	Wolverhampton
United States	Advanced Research Center	Anaheim	California
United States	University of Michigan	Ann Arbor	Michigan
United States	HP Clinical Research	Bountiful	Utah
United States	Commonwealth Clinical Studies LLC	Brockton	Massachusetts
United States	New York Total Medical Care PC	Brooklyn	New York
United States	Renaissance Research Medical Group, INC	Cape Coral	Florida
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Loretto Hospital	Chicago	Illinois
United States	Consultants For Clinical Research Inc	Cincinnati	Ohio
United States	Gastro Health Research	Cincinnati	Ohio
United States	Gastro Florida	Clearwater	Florida
United States	Asthma and Allergy Associates PC - CRN - PPDS	Colorado Springs	Colorado
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS	Columbus	Georgia
United States	Advanced Clinical Research Network	Coral Gables	Florida
United States	Alliance Medical Research LLC	Coral Springs	Florida
United States	Kindred Medical Institute for Clinical Trials, LLC	Corona	California
United States	Northside Gastroenterology	Cypress	Texas
United States	Atlanta Center For Gastroenterology PC	Decatur	Georgia
United States	Mayo Clinic Health System - PPDS	Duluth	Minnesota
United States	Exemplar Research, Inc. - Elkins	Elkins	West Virginia
United States	United Medical Doctors	Encinitas	California
United States	Medisphere Medical Research Center LLC	Evansville	Indiana
United States	Consultants For Clinical Research Inc	Fairfield	Ohio
United States	Prestige Clinical Research	Franklin	Ohio
United States	Mid Atlantic Health Specialists	Galax	Virginia
United States	Digestive Health Associates of Texas, P.A.dba DHAT Research Institute	Garland	Texas
United States	Gastro One	Germantown	Tennessee
United States	NYU Langone Long Island Clinical Research Associates	Great Neck	New York
United States	IL Gastroenterology Group	Gurnee	Illinois
United States	National Clinical, LLC	Hamtramck	Michigan
United States	Gastroenterology Associates of Hazard	Hazard	Kentucky
United States	Edward Hines Jr VA Hospital - NAVREF - PPDS	Hines	Illinois
United States	CroNOLA, LLC.	Houma	Louisiana
United States	Aztec Medical Research	Houston	Texas
United States	Biopharma Informatic Inc.	Houston	Texas
United States	Biopharma Informatic Research Center	Houston	Texas
United States	Precision Research Institute, LLC	Houston	Texas
United States	Southwest Clinical Trials	Houston	Texas
United States	East Carolina Gastroenterology	Jacksonville	North Carolina
United States	ENCORE Borland-Groover Clinical Research - ERN - PPDS	Jacksonville	Florida
United States	SIH Research	Kissimmee	Florida
United States	University of California San Diego	La Jolla	California
United States	Clinical Trials of SWLA LLC	Lake Charles	Louisiana
United States	OM Research LLC - Lancaster - ClinEdge - PPDS	Lancaster	California
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Atria Clinical Research - Clinedge - PPDS	Little Rock	Arkansas
United States	Tibor Rubin VA Medical Center - NAVREF	Long Beach	California
United States	VA Long Beach Healthcare System - NAVREF - PPDS	Long Beach	California
United States	Ohio Clinical Research Partners LLC	Mentor	Ohio
United States	Arizona Digestive Health Mesa - East	Mesa	Arizona
United States	Advanced Clinical Research Network	Miami	Florida
United States	Hi Tech and Global Research, LLc	Miami	Florida
United States	Nuren Medical and Research Center	Miami	Florida
United States	Sanchez Clinical Research, Inc	Miami	Florida
United States	Crystal Biomedical Research	Miami Lakes	Florida
United States	Laporte County Institute For Clinical Research	Michigan City	Indiana
United States	Facey Medical Foundation	Mission Hills	California
United States	West Virginia University Hospital	Morgantown	West Virginia
United States	Infinite Clinical Trials	Morrow	Georgia
United States	United Medical Doctors	Murrieta	California
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Pharma Research International Inc	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	DelRicht Clinical Research, LLC - ClinEdge - PPDS	New Orleans	Louisiana
United States	Bayside Clinical Research - New Port Richey	New Port Richey	Florida
United States	Weill Cornell Medical College	New York	New York
United States	Encompass Care	North Las Vegas	Nevada
United States	Dupage Medical Group	Oakbrook Terrace	Illinois
United States	Digestive Health Center PA	Ocean Springs	Mississippi
United States	Veteran's Research and Education Foundation - NAVREF - PPDS	Oklahoma City	Oklahoma
United States	Southtowns Gastroenterology, PLLC	Orchard Park	New York
United States	Omega Research Consultants LLC - Clinedge - PPDS	Orlando	Florida
United States	Elite Clinical Studies - Phoenix - Clinedge - PPDS	Phoenix	Arizona
United States	Accel Research Sites - St. Petersburg - ERN - PPDS	Pinellas Park	Florida
United States	Veterans Research Foundation of Pittsburgh - NAVREF - PPDS	Pittsburgh	Pennsylvania
United States	BRCR Medical Center, Inc	Plantation	Florida
United States	Alliance Clinical Research-(Vestavia Hills)	Poway	California
United States	Inland Empire Liver Foundation	Rialto	California
United States	East Coast Institute for Research, LLC	Saint Augustine	Florida
United States	St Louis Center For Clinical Research	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Minnesota Gastroenterology PA	Saint Paul	Minnesota
United States	Southern Star Research Institute LLC	San Antonio	Texas
United States	University of California San Francisco	San Francisco	California
United States	Care Access Research, San Pablo	San Pablo	California
United States	Louisiana Research Center LLC	Shreveport	Louisiana
United States	Penn State Hershey Medical Group	State College	Pennsylvania
United States	Piedmont Healthcare	Statesville	North Carolina
United States	Arizona Digestive Health	Sun City	Arizona
United States	Atlanta Gastroenterology Specialists, PC	Suwanee	Georgia
United States	CHI Franciscan Digestive Care Associates	Tacoma	Washington
United States	DBC Research	Tamarac	Florida
United States	DM Clinical Research - ERN - PPDS	Tomball	Texas
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	CATS Research Center - University of Arizona	Tucson	Arizona
United States	Advanced Gastroenterology-Union City	Union City	Tennessee
United States	Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS	Webster	Texas
United States	Winchester Gastroenterology Associates	Winchester	Virginia
United States	UMass Memorial Medical Center	Worcester	Massachusetts
United States	Gastroenterology Associates of Western Michigan, PLC	Wyoming	Michigan
United States	Digestive Disease Associates	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Colombia,  Croatia,  Czechia,  Estonia,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Lebanon,  Lithuania,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	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)
Primary	Number of Participants With Serious Infections	Number of participants with serious infections will be assessed.	Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
Primary	Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as an Adverse Event	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)
Primary	Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event	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)
Primary	Number of Participants With Clinically Significant Change in Vital Signs Reported as an Adverse Event	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	Number of Participants with Ulcerative Colitis with Treatment Response Over Time	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)
Secondary	Number of Participants with Crohn's Disease with Treatment Response Over Time	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)

External Links

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