An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

Official title:

A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497469
• Other study ID #: MLN0002-3026
• Secondary ID: U1111-1168-67132
• Status: Completed
• Phase: Phase 3
• Start date: June 29, 2015
• Est. completion date: January 18, 2019

Study information

• Verified date: January 2020
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

Description:

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis. This study will look at the stool frequency, rectal bleeding and findings on endoscopy of people who take vedolizumab compared to those who take adalimumab.

The study will enroll approximately 658 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

• Vedolizumab 300 mg IV

• Adalimumab 160 mg on Day 1 followed by 80 mg on Week 2 then 40 mg every 2 weeks SC

All participants will receive 1 intravenous infusion on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. All participants will also receive 4 SC injections on Day 1 or 2 SC injections each on Days 1 and 2, followed by 2 SC injections in 1 day on Week 2 and then 1 SC injection every 2 weeks for up to Week 50. All participants will be asked to record the symptoms of ulcerative colitis in a daily diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 79 weeks. Participants will make approximately 11 visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 771
• Est. completion date: January 18, 2019
• Est. primary completion date: September 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Has a diagnosis of ulcerative colitis established at least 3 months prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.

2. Has moderately to severely active ulcerative colitis as determined by a Mayo score of 6 to 12 with an endoscopic subscore greater than or equal to >=2 within 14 days prior to the randomization.

3. Has evidence of ulcerative colitis proximal to the rectum (>=15 centimeter [cm] of involved colon).

4. With extensive colitis (up to the hepatic flexure) or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (may be performed during the Screening Period).

5. The participant:

1. Has had previous treatment with tumor necrosis factor- alpha (TNF-alpha) antagonists without documented clinical response to treatment (example, due to lack of response [primary nonresponders], loss of response, or intolerance [secondary nonresponders]), or

2. Has previously used a TNF-alpha antagonists (except adalimumab), and discontinued its use due to reasons other than safety, or

3. Is naïve to TNF-alpha antagonist therapy but is failing current treatment (example, corticosteroids, 5-aminosalicylate [5-ASA], or immunomodulators).

Exclusion Criteria:

1. Clinical evidence of abdominal abscess or toxic megacolon at Screening.

2. Has had an extensive colonic resection, subtotal or total colectomy.

3. Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

4. Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.

5. Has received any of the following for the treatment of underlying disease within 30 days of randomization:

1. Non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide) other than those specifically listed in Section Permitted Medications For Treatment of UC.

2. An approved non-biologic therapy in an investigational protocol.

6. Has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half lives prior to the screening (whichever is longer).

7. Has previously received natalizumab, efalizumab, adalimumab, AMG-181, anti-mucosal addressin cell adhesion molecule-1 antibodies, or rituximab.

8. Has previously received vedolizumab.

9. Has history or evidence of adenomatous colonic polyps that have not been removed, or colonic mucosal dysplasia.

10. Evidence of an active infection during Screening.

11. Evidence of, or treatment for, Clostridium difficile (C. difficile) or other intestinal pathogen within 28 days prior to the 1st dose of study drug.

12. Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV) infection (* HBV immune participants, ie, being hepatitis B surface antigen [HBsAg], may participate).

13. Has active or latent TB, regardless of treatment history.

14. Has used a topical (rectal) treatment with (5-ASA) or corticosteroid enemas/suppositories within 2 weeks of the administration of the 1st dose of study drug.

15. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• Vedolizumab
Vedolizumab infusion
• Adalimumab placebo
Adalimumab placebo-matching injection
• Adalimumab
Adalimumab injection
• Vedolizumab placebo
Vedolizumab placebo-matching infusion

Locations

Country	Name	City	State
Argentina	Expertia S.A- Mautalen Salud e Investigacion	Ciudad Autonoma Buenos Aires
Argentina	Centro de Investigaciones Clinicas Instituto del Corazon	Cordoba
Argentina	Instituto de Investigaciones Clinicas-Mar del Plata	Mar del Plata	Buenos Aires
Argentina	Instituto Medico CER	Quilmes	Buenos Aires
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Ballarat Base Hospital	Ballarat	Victoria
Australia	Tennyson Centre Day Hospital	Bedford Park	South Australia
Australia	Monash Medical Centre Moorabbin	Clayton	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St Frances Xavier Cabrini Hospital	Malvern	Victoria
Australia	Mater Adult Hospital	South Brisbane	Queensland
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	Universitair Ziekenhuis Gent	Gent
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska	Banja Luka
Bosnia and Herzegovina	University Clinical Hospital Mostar	Mostar
Bosnia and Herzegovina	University Clinic Centre Sarajevo	Sarajevo
Bulgaria	MHAT - Pazardzhik AD	Pazardzhik
Bulgaria	MHAT 'Avis Medica' OOD	Pleven
Bulgaria	UMHAT 'Dr. Georgi Stranski', EAD	Pleven
Bulgaria	MHAT "Hadzhi Dimitar", OOD	Sliven
Bulgaria	"City Clinic UMHAC" EOOD	Sofia
Bulgaria	Fourth MHAT - Sofia EAD	Sofia
Bulgaria	Medical Center "Excelsior", OOD	Sofia
Bulgaria	Military Medical Academy - MHAT - Sofia	Sofia
Bulgaria	UMHAT "Sv. Ivan Rilski", EAD	Sofia
Bulgaria	UMHAT 'Sveta Anna' AD	Sofia
Bulgaria	UMHAT 'Tsaritsa Yoanna - ISUL', EAD	Sofia
Bulgaria	Medical Center "Nov Rehabilitatsionen Tsentar", EOOD	Stara Zagora
Bulgaria	MHAT 'Sv. Marina', EAD	Varna
Canada	University of Alberta	Edmonton	Alberta
Canada	McMaster University Health Sciences Center	Hamilton	Ontario
Canada	Hotel Dieu Hospital	Kingston	Ontario
Canada	LHSC - University Hospital	London	Ontario
Canada	LHSC - Victoria Hospital	London	Ontario
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Toronto Digestive Disease Associates, Inc.	Vaughan	Ontario
Colombia	Fundacion Oftalmologica de Santander - FOSCAL	Floridablanca
Colombia	Instituto de Coloproctologia ICO S.A.S.	Medellin
Croatia	Clinical Hospital Centre Osijek	Osijek
Croatia	General Hospital Pula	Pula
Croatia	Polyclinic Medico	Rijeka
Croatia	Clinical Hospital Center "Sestre Milosrdnice"	Zagreb
Croatia	Clinical Hospital Centre Zagreb	Zagreb
Croatia	Clinical Hospital Dubrava	Zagreb
Croatia	Clinical Hospital Merkur	Zagreb
Czechia	CCBR - Brno - CZ	Brno
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Hepato-Gastroenterologie HK, s.r.o.	Hradec Kralove
Czechia	CCBR Czech, a.s	Pardubice
Czechia	A-Shine	Plzen
Czechia	CCBR - Prague - CZ	Praha 3
Czechia	Thomayerova nemocnice	Praha 4 - Krc
Czechia	Klinicke centrum ISCARE Lighthouse	Praha 7
Czechia	Axon Clinical, s.r.o.	Praha 8
Denmark	Nordsjallands Hospital, Frederikssund	Frederikssund
Denmark	Hvidovre_Hospital	Hvidovre
Denmark	Koge Sygehus	Koge
Denmark	Odense Universitetshospital	Odense C
Estonia	North Estonia Medical Centre Foundation	Tallinn
Estonia	West Tallinn Central Hospital	Tallinn
Estonia	Tartu University Hospital	Tartu
France	CHU Amiens - Hopital Sud	Amiens Cedex	Somme
France	Hopital Beaujon	Clichy cedex	Hauts De Seine
France	Centre Hospitalier Departemental Les Oudairies	La Roche S/ Yon Cedex 9	Vendee
France	Hopital Claude Huriez - CHU Lille	Lille cedex	Nord
France	Hopital Saint Joseph	Marseille	Bouches-du-Rhone
France	Hopital Nord - CHU Marseille	Marseille cedex 20	Bouches-du-Rhone
France	CHU Nice - Hopital de l'Archet 2	Nice Cedex 3	Alpes Maritimes
France	Groupe Hospitalier Sud - Hopital Haut-Leveque	Pessac	Gironde
France	CHU Saint Etienne - Hopital Nord	Saint Etienne	Loire
France	CHU de Toulouse - Hopital Rangueil	Toulouse Cedex 09	Haute Garonne
France	Hopital de Brabois Adultes	Vandoeuvre les Nancy	Meurthe Et Moselle
Germany	Charite - Campus Virchow-Klinikum	Berlin
Germany	Krankenhaus Waldfriede e. V.	Berlin
Germany	Klinikum der Johann Wolfgang Goethe-Universitaet	Frankfurt	Hessen
Germany	Asklepios Klinik Hamburg	Hamburg
Germany	Universitaetsklinikum Heidelberg	Heidelberg	Baden Wuerttemberg
Germany	Universitaetsklinikum Schleswig-Holstein - Campus Kiel	Kiel	Schleswig Holstein
Germany	Universitaetsklinikum Koeln	Koeln	Nordrhein Westfalen
Germany	EUGASTRO GmbH	Leipzig	Sachsen
Germany	Universitaetsklinikum Schleswig-Holstein - Campus Luebeck	Lubeck	Schleswig Holstein
Germany	Universitaetsklinikum Magdeburg A.oe.R	Magdeburg	Sachsen Anhalt
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz	Mainz	Rheinland Pfalz
Germany	Universitaetsklinikum Tuebingen	Tuebingen	Baden Wuerttemberg
Hong Kong	The University of Hong Kong	Hong Kong
Hong Kong	Tuen Mun Hospital	Medicine & Geriatrics
Hong Kong	The Chinese University of Hong Kong	Shatin
Hungary	Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza	Bekescsaba
Hungary	Pannonia Maganorvosi Centrum	Budapest
Hungary	Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Markhot Ferenc Oktatokorhaz es Rendelointezet	Eger
Hungary	Pecsi Tudomanyegyetem	Pecs
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont	Szeged
Hungary	Tolna Megyei Balassa Janos Korhaz	Szekszard
Israel	HaEmek Medical Center	Afula
Israel	Barzilai Medical Center	Ashkelon
Israel	Hillel Yaffe Medical	Hadera
Israel	Wolfson Medical Center	Holon
Israel	Clalit Health Services-Lev Talpiyot	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar- Saba
Israel	Galilee Medical Center	Nahariya
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rechovot
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi	Bologna
Italy	Azienda Ospedaliera Ospedale Cannizzaro	Catania
Italy	Azienda Ospedaliero Universitaria San Martino	Genova
Italy	Azienda Ospedaliera Universitaria Policlinico G. Martino	Messina
Italy	Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)	Milano
Italy	A.O.U. Policlinico di Modena	Modena
Italy	Azienda Ospedaliera Universitaria "Federico II"	Napoli
Italy	Seconda Universita degli Studi di Napoli	Napoli
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Azienda Ospedaliera Vincenzo Cervello	Palermo
Italy	Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone	Palermo
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Italy	I.R.C.C.S Policlinico San Donato	San Donato Milanese	Milano
Italy	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Kyungpook National University Hospital	Daegu	Gyeongsangbuk-do
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Hanyang Univerisy Guri Hospital	Guri-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Marys Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon-si	Gyeonggi-do
Latvia	Digestive Diseases Center "Gastro"	Riga
Latvia	Pauls Stradins Clinical University Hospital SLLC	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics	Kaunas
Lithuania	Klaipeda Republican Hospital, Public Institution	Klaipeda
Lithuania	Klaipeda University Hospital, Public Institution	Klaipeda
Lithuania	Vilnius University Hospital Santariskiu Clinic, Public Institution	Vilnius
Mexico	Instituto de Investigaciones Aplicadas a la Neurociencia A.C.	Durango
Mexico	Centro de Investigacion Farmacologica del Bajio, S.C.	Leon	Guanajuato
Mexico	Morales Vargas Centro de Investigacion, S.C.	Leon	Guanajuato
Mexico	Christus Muguerza Sur S.A. de C.V.	Monterrey	Nuevo Leon
Mexico	Sociedad de Metabolismo y Corazon S.C	Veracruz
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis, Locatie Oost	Amsterdam
Netherlands	Universitair Medisch Centrum Groningen (UMCG)	Groningen
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Erasmus Medisch Centrum	Rotterdam
Poland	SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego	Bialystok
Poland	NZOZ Vitamed	Bydgoszcz
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	SP CSK im. prof. K. Gibinskiego SUM	Katowice
Poland	Gabinet Endoskopii Przewodu Pokarmowego	Krakow
Poland	Santa Familia Centrum Badan, Profilaktyki i Leczenia	Lodz
Poland	SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM	Lodz
Poland	GASTROMED Sp. z o.o.	Lublin
Poland	SOLUMED Centrum Medyczne	Poznan
Poland	Twoja Przychodnia-Szczecinskie Centrum Medyczne	Szczecin
Poland	Centralny Szpital Kliniczny MSW w Warszawie	Warszawa
Poland	Centrum Onkologii-Instytut im. M. Sklodowskiej Curie	Warszawa
Poland	Centrum Zdrowia Matki, Dziecka i Mlodziezy	Warszawa
Poland	Nzoz Vivamed	Warszawa
Poland	Ars-Medica S.C Rybak Maria, Rybak Zbigniew	Wroclaw
Poland	EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu	Wroclaw
Poland	LexMedica Osrodek Badan Klinicznych	Wroclaw
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar e Universitario de Coimbra E.P.E	Coimbra
Portugal	Centro Hospitalar Cova da Beira	Covilha
Portugal	Hospital da Senhora da Oliveira Guimaraes	Guimaraes
Portugal	Centro Hospitalar do Alto Minho - Unidade Local de Saude do Alto Minho, EPE	Viana do Castelo
Portugal	Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E	Vila Nova de Gaia
Romania	Institutul Clinic Fundeni	Bucuresti
Romania	Spitalul Clinic Colentina	Bucuresti
Romania	S.C Centrul de Gastroenterologie Dr. Goldis S.R.L	Timisoara
Russian Federation	SBEI HPE "Kazan State Medical University" of the MoH of the RF	Kazan
Russian Federation	TSBIH "Territorial Clinical Hospital"	Krasnoyarsk
Russian Federation	FSBI State Scientific Centre of Coloproctology" of the MoH of RF	Moscow
Russian Federation	FSBIH "Central Clinical Hospital of Russian Academy of Sciences"	Moscow
Russian Federation	Research Institute of Gastroenterology	Moscow
Russian Federation	SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"	Nizhny Novgorod
Russian Federation	FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS	Novosibirsk
Russian Federation	SBEIHPE Novosibirsk State Medical University	Novosibirsk
Russian Federation	BHI of Omsk region Clinical Oncology Dispensary	Omsk
Russian Federation	SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF	Omsk
Russian Federation	SBEI HPE "Rostov State Medical University" of the MoH of the RF	Rostov-on-Don
Russian Federation	FSMEI HPE Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia	Saint-Petersburg
Russian Federation	SPb SBIH "City Hospital # 26"	Saint-Petersburg
Russian Federation	SPb SBIH "City Hospital # 9"	Saint-Petersburg
Russian Federation	Private Educational Institution of Higher Education "Medical University "REAVIZ"	Samara
Russian Federation	SIH "Regional Clinical Hospital "	Saratov
Russian Federation	SPb SBIH "City Hospital # 40 of Kurortnyi region"	Sestroretsk
Russian Federation	RSBIH "Smolensk Regional Clinical Hospital"	Smolensk
Russian Federation	SPb SBIH "City Hospital of Saint Martyr Elizaveta"	St. Petersburg
Russian Federation	SBIH of Yaroslavl region " Regional Clinical Hospital "	Yaroslavl
Serbia	Clinical Center Bezanijska kosa	Belgrade
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Clinical Center Zemun	Belgrade
Serbia	Clinical Center Zvezdara	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Clinical Center Nis	Nis
Serbia	Clinical Center of Vojvodina	Novi Sad
Slovakia	IBDcentrum s.r.o.	Bratislava
Slovakia	Univerzitna nemocnica Bratislava, Nemocnica Ruzinov	Bratislava
Slovakia	Gastroped s.r.o.	Kosice
Slovakia	KM Management spol. s r.o.	Nitra
Slovakia	Gastro I, s.r.o.	Presov
Slovakia	Frantisek Horvath- GEA	Sahy
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Turkey	Ankara University Medical Faculty	Ankara
Turkey	Acibadem Fulya Hospital	Istanbul
Turkey	Haydarpasa Numune Training and Research Hospital	Istanbul
Turkey	Marmara University Pendik Research and Training Hospital	Istanbul
Turkey	Kocaeli Derince Training and Research Hospital	Kocaeli
Turkey	Mersin University Medical Faculty	Mersin
Ukraine	RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU	Chernivtsi
Ukraine	SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU	Dnipropetrovsk
Ukraine	Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU	Ivano-Frankivsk
Ukraine	CI of PH Kharkiv CCH #2	Kharkiv
Ukraine	CI A.and O. Tropiny City Clinical Hospital	Kherson
Ukraine	Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus	Kirovohrad
Ukraine	CI of Kyiv RC Kyiv Regional Clinical Hospital	Kyiv
Ukraine	Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU	Kyiv
Ukraine	Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE	Kyiv
Ukraine	MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE	Kyiv
Ukraine	CI of TRC Ternopil University Hospital	Lviv
Ukraine	Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU	Lviv
Ukraine	CI Odesa Regional Clinical Hospital	Odesa
Ukraine	SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU	Uzhgorod
Ukraine	MCIC MC LLC Health Clinic	Vinnytsia
Ukraine	Private Small Enterprise Medical Center Pulse	Vinnytsia
Ukraine	SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU	Vinnytsia
Ukraine	Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU	Vinnytsia
Ukraine	CI City Clinical Hospital #6 Dept of Gastroenterology	Zaporizhzhia
Ukraine	SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU	Zaporizhzhia
United Kingdom	University Hospital Coventry	Coventry	West Midlands
United Kingdom	Glasgow Royal Infirmary	Glasgow	Strathclyde
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Norfolk
United Kingdom	Derriford Hospital	Plymouth	Devon
United Kingdom	Salford Royal	Salford	Greater Manchester
United Kingdom	Royal Wolverhampton hospital	Wolverhampton	West Midlands
United States	Emory University Hospital	Atlanta	Georgia
United States	Innovative Medical Research of South Florida, Inc.	Aventura	Florida
United States	Gastroenterology Associates, LLC	Baton Rouge	Louisiana
United States	Ehrhardt Clinical Research, LLC	Belton	Missouri
United States	Digestive Disease Associates	Catonsville	Maryland
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Consultants for Clinical Research Inc.	Cincinnati	Ohio
United States	Iowa Digestive Disease Center	Clive	Iowa
United States	Ohio State University Clinical Trials Management Office	Columbus	Ohio
United States	WCCT Global (PH 1 Unit)	Costa Mesa	California
United States	Baylor University Hospital	Dallas	Texas
United States	Texas Digestive Disease Consultants - Dallas	Dallas	Texas
United States	Dayton Gastroenterology, Inc	Dayton	Ohio
United States	Advanced Clinical Research of Miami	Doral	Florida
United States	AGA Clinical Research Associates, LLC	Egg Harbor Township	New Jersey
United States	MedResearch, Inc	El Paso	Texas
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
United States	Gastroenterology Consultants of South Texas, PA	Harlingen	Texas
United States	Wellness Clinical Research	Hialeah Gardens	Florida
United States	Gulf Coast Research Group LLC	Houston	Texas
United States	Nature Coast Clinical Research, LLC	Inverness	Florida
United States	Texas Digestive Disease Consultants - Irving	Irving	Texas
United States	Truman Medical Centers, Inc.	Kansas City	Missouri
United States	Lafayette General Medical Center	Lafayette	Louisiana
United States	Mount Sinai - PRIME	Lake Success	New York
United States	Rocky Mountain Gastroenterology	Lakewood	Colorado
United States	Florida Center for Gastroenterology	Largo	Florida
United States	Gastro-Enterology Research of Lima	Lima	Ohio
United States	Arkansas Primary Care Clinic, PA	Little Rock	Arkansas
United States	University of Louisville	Louisville	Kentucky
United States	Gastroenterology Associates of Central Georgia	Macon	Georgia
United States	University of Wisconsin	Madison	Wisconsin
United States	Main Line Gastroenterology Associates	Malvern	Pennsylvania
United States	Clinical Trials Management, LLC	Metairie	Louisiana
United States	Gastro Health	Miami	Florida
United States	Medical Professional Clinical Research	Miami	Florida
United States	Tellus Clinical Research, Inc.	Miami	Florida
United States	South Florida Research Phase I-IV	Miami Springs	Florida
United States	Allegiance Research Specialists, LLC	Milwaukee	Wisconsin
United States	IMC - Diagnostic and Medical Clinic	Mobile	Alabama
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Gastroenterology of Southern Associates	New Albany	Indiana
United States	Digestive Disease Care	New Hyde Park	New York
United States	California Medical Research Associates Inc.	Northridge	California
United States	Digestive Health Center PA	Ocean Springs	Mississippi
United States	Alegent Creighton Clinic Gastroenterology	Omaha	Nebraska
United States	Internal Medicine Specialists	Orlando	Florida
United States	Research Concierge, LLC	Owensboro	Kentucky
United States	Arizona Arthritis & Rheumatology Research, PLLC	Phoenix	Arizona
United States	Advanced Clinical Research Associates	Plano	Texas
United States	BRCR Medical Center, Inc.	Plantation	Florida
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	The Oregon Clinic-West Hills Gastroenterology	Portland	Oregon
United States	Premier Medical Group of the Hudson Valley, PC	Poughkeepsie	New York
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Sutter Institute for Medical Research	Sacramento	California
United States	Gastroenterology Research of San Antonio, LLC	San Antonio	Texas
United States	Virginia Mason Seattle Main Clinic	Seattle	Washington
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Texas Digestive Disease Consultants - Southlake	Southlake	Texas
United States	Cotton-O'Neil Clinical Research Center, Digestive Health	Topeka	Kansas
United States	Center for Digestive Health and Nutritional Excellence	Troy	Michigan
United States	Options Health Research	Tulsa	Oklahoma
United States	Digestive Health Specialists of Tyler	Tyler	Texas
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Wenatchee Valley Hospital & Clinics	Wenatchee	Washington
United States	Invocare Clinical Research Center	West Columbia	South Carolina
United States	Shafran Gastroenterology Center	Winter Park	Florida
United States	Gastroenterology Associates of Western Michigan, P.L.C.	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Colombia,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved Clinical Remission	Clinical remission was defined as a complete Mayo score of =2 points and no individual subscore >1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).	Week 52
Secondary	Percentage of Participants Who Achieved Mucosal Healing	Mucosal healing was defined as a Mayo score endoscopic subscore of <= 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).	Week 52
Secondary	Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission	Corticosteroid-free remission was defined as participants using oral corticosteroids at Baseline (Week 0) who had discontinued oral corticosteroids and were in clinical remission at Week 52. Clinical remission was defined as a complete Mayo score of = 2 points and no individual subscore > 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).	Week 52