A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active Ulcerative Colitis

Status: Active_not_recruiting
Location: See all (472) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 80
Healthy Volunteers: f
View:

• Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization

• Has moderately to severely active UC

• Weight ≥40 kg

• Satisfies at least 1 of the following criteria:

‣ Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments

⁃ Protocol specified corticosteroid dependence

⁃ Has been intolerant to 1 or more protocol-specified UC treatments

• Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable

• Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority

• A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and Is not a participant of childbearing potential (POCBP); or is a POCBP and uses an acceptable contraceptive method, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention, medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy

Locations
United States
Alabama
Digestive Health Specialists ( Site 0135)
Dothan
IMC-Gulf Coast Gastroenterology ( Site 0157)
Fairhope
Arizona
Research Solutions of Arizona ( Site 3816)
Litchfield Park
One of a Kind Clinical Research Center ( Site 3852)
Scottsdale
GI Alliance - Sun City ( Site 0103)
Sun City
California
Clinnova Research ( Site 3803)
Anaheim
Southern California Research Center ( Site 3828)
Coronado
UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113)
La Jolla
Cedars-Sinai Medical Center ( Site 0119)
Los Angeles
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851)
Orange
Colorado
University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172)
Aurora
Peak Gastroenterology Associates ( Site 0116)
Colorado Springs
South Denver Gastroenterology, PC ( Site 3849)
Englewood
Rocky Mountain Gastroenterology/Topography Health ( Site 3838)
Littleton
Connecticut
Connecticut Clinical Research Institute ( Site 0126)
Bristol
Medical Research Center of Connecticut ( Site 0151)
Hamden
Yale University School of Medicine-Digestive Disease ( Site 0163)
New Haven
Washington, D.c.
Emerson Clinical Research Institute ( Site 3820)
Washington D.c.
Florida
Gastroenterology Consultants of Clearwater ( Site 0152)
Clearwater
University of Florida College of Medicine-Gastroenterology ( Site 3821)
Gainesville
Nature Coast Clinical Research - Inverness ( Site 3806)
Inverness
Central Florida Gastro Research ( Site 0124)
Kissimmee
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810)
Miami
Orlando Health ( Site 0145)
Orlando
USF Health ( Site 0169)
Tampa
Georgia
Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115)
Atlanta
Emory University School of Medicine ( Site 3818)
Atlanta
Atlanta Center for Gastroenterology ( Site 0155)
Decatur
Iowa
Iowa Digestive Disease Center ( Site 0123)
Clive
Illinois
University of Chicago Medical Center ( Site 0134)
Chicago
GI Alliance - Glenview ( Site 0168)
Glenview
GI ALLIANCE - GURNEE ( Site 0107)
Gurnee
Kentucky
University of Louisville Hospital-Clinical Trials Unit ( Site 0165)
Louisville
Louisiana
Baton Rouge General Medical Center - Bluebonnet ( Site 0112)
Baton Rouge
Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 0154)
New Orleans
Massachusetts
Massachusetts General Hospital-Crohn's and Colitis Center ( Site 0132)
Boston
Maryland
Walter Reed National Military Medical Center ( Site 0121)
Bethesda
Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 3835)
Glen Burnie
Michigan
University of Michigan ( Site 0143)
Ann Arbor
Clinical Research Institute of Michigan, LLC ( Site 0108)
Clinton Township
Michigan Center of Medical Research (MICHMER) ( Site 3850)
Farmington Hills
Clinical Research Institute of Michigan, LLC ( Site 0150)
Troy
Huron Gastroenterology ( Site 3836)
Ypsilanti
Minnesota
Mayo Clinic in Rochester, Minnesota ( Site 0147)
Rochester
Missouri
BVL Research - Kansas ( Site 3847)
Liberty
Washington University School of Medicine ( Site 0129)
St Louis
North Carolina
University of North Carolina Medical Center ( Site 0140)
Chapel Hill
Carolina Digestive Diseases and Endoscopy Center ( Site 3809)
Greenville
New York
Circuit Clinical /Middletown Medical PC ( Site 3831)
Middletown
Lenox Hill Hospital ( Site 0128)
New York
New York Gastroenterology Associates ( Site 0159)
New York
NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 3846)
New York
Pennsylvania
Hospital of the University of Pennsylvania ( Site 0170)
Philadelphia
Rhode Island
University Gastroenterology ( Site 0164)
Providence
South Carolina
Gastroenterology Associates of Orangeburg ( Site 0149)
Orangeburg
Tennessee
Quality Medical Research ( Site 3807)
Nashville
Vanderbilt Inflammatory Bowel Disease Clinic ( Site 0131)
Nashville
Texas
GI Alliance - Garland ( Site 0109)
Garland
Baylor College of Medicine Medical Center ( Site 3812)
Houston
Clinical Trial Network ( Site 3819)
Houston
The University of Texas Health Science Center at Houston-Internal Medicine-Division of Gastroentero ( Site 0144)
Houston
Caprock Gastro Research ( Site 0101)
Lubbock
GI Alliance - Lubbock ( Site 0167)
Lubbock
GI Alliance: Mansfield ( Site 0161)
Mansfield
CARTA - Clinical Associates In Research Therapeutics Of America ( Site 0122)
San Antonio
Southern Star Research Institute ( Site 0106)
San Antonio
GI Alliance - San Marcos ( Site 0130)
San Marcos
GI Alliance - Southlake ( Site 0104)
Southlake
Tyler Research Institute ( Site 0105)
Tyler
Texas Digestive Disease Consultants ( Site 0136)
Webster
Utah
Velocity Clinical Research, Salt Lake City ( Site 3801)
West Jordan
Virginia
Richmond VA Medical Center ( Site 3845)
Richmond
Washington
Washington Gastroenterology - Bellevue ( Site 3844)
Bellevue
University of Washington Medical Center - Montlake ( Site 0137)
Seattle
Washington Gastroenterology - Tacoma ( Site 0102)
Tacoma
Wisconsin
MEDICAL COLLEGE OF WISCONSIN ( Site 0141)
Milwaukee
Other Locations
Argentina
Centro de Investigaciones Médicas Mar del Plata ( Site 2101)
Mar Del Plata
CER medical Institute-Gastroenterology ( Site 2110)
Quilmes
Hospital Provincial del Centenario ( Site 2108)
Rosario
C.I.C.E. 9 de Julio-CICE 9 DE JULIO ( Site 2103)
San Miguel De Tucumán
Australia
Royal Adelaide Hospital-Gastroenterology/Hepatology ( Site 2504)
Adelaide
Mater Misericordiae Limited-Gastroenterology ( Site 2506)
Brisbane
Royal Brisbane and Women's Hospital ( Site 2500)
Brisbane
Monash Health-Gastroenterology ( Site 2505)
Clayton
Nepean Hospital-Gastroenterology/Hepatology ( Site 2501)
Kingswood
St Vincent's Hospital ( Site 2510)
Melbourne
The Alfred Hospital-Gastroenterology ( Site 2503)
Melbourne
Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 2508)
Sydney
Austria
Universitaetsklinik fuer Innere Medizin I Innsbruck ( Site 0200)
Innsbruck
Uniklinikum Salzburg-Innere Medizin I ( Site 0201)
Salzburg
Medizinische Universität Wien-Klinik für Innere Medizin III - Abteilung für Gastroenterologie und H ( Site 0202)
Vienna
Belgium
UZ Gent ( Site 0300)
Ghent
UZ Leuven-Gastroenterology - Inflammatory Bowel Disease ( Site 0301)
Leuven
Brazil
L2IP - Instituto de Pesquisas Clínicas ( Site 5104)
Brasília
Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida - Galileo Pesquisa Clínica ( Site 5100)
Juiz De Fora
Hospital Moinhos de Vento ( Site 5108)
Porto Alegre
Pesquisare Saude ( Site 5112)
Santo André
Centro de Pesquisa Kaiser - CEPEK ( Site 5103)
São José Do Rio Preto
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 5107)
São José Do Rio Preto
Bulgaria
Medconsult Pleven ( Site 0410)
Pleven
DKC V - Plovdiv ( Site 0402)
Plovdiv
MC Rusemed ( Site 0408)
Rousse
MHAT Hadzhi Dimitar-Gastroenterology ( Site 0403)
Sliven
4th MHAT ( Site 0409)
Sofia
Diagnostic - Consultative Center XX - Sofia EOOD ( Site 0407)
Sofia
Diagnostic Consultative Center 22 - Sofia ( Site 0401)
Sofia
Medica Plus Medical Center ( Site 0404)
Veliko Tarnovo
MC Velingrad 2017 EOOD ( Site 0406)
Velingrad
Canada
Barrie GI Associates ( Site 0012)
Barrie
Heritage Medical Research Clinic ( Site 0004)
Calgary
Gastroenterology and internal medicine research institute ( Site 0010)
Edmonton
Private Practice - Dr. Bruce Musgrave ( Site 0011)
Kentville
Prairie Institute of Liver and Luminal Advanced Research ( Site 0013)
Lethbridge
Centre Intégré de Santé et Service Sociaux de Chaudière-Appalaches ( Site 0015)
Lévis
University Hospital - London Health Sciences Centre ( Site 0002)
London
Victoria Hospital & Children's Hospital - London Health Sciences Centre ( Site 0007)
London
West GTA Research Inc. ( Site 0017)
Mississauga
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0018)
Montreal
Montreal General Hospital ( Site 0003)
Montreal
Fraser Clinical Trials Inc. ( Site 0019)
New Westminster
ABP Research Services Corp. ( Site 0016)
Ontario
Diex Recherche Quebec ( Site 0008)
Québec
Toronto Immune & Digestive Health Institute ( Site 0005)
Toronto
G.I.R.I. GI Research Institute Foundation ( Site 0001)
Vancouver
Toronto Digestive Disease Associates ( Site 0006)
Vaughan
Chile
CECIM ( Site 2200)
Santiago
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 2203)
Santiago
Clínica Alemana de Santiago ( Site 2209)
Santiago
Clínica MEDS La Dehesa ( Site 2207)
Santiago
Clínica Universidad de Los Andes ( Site 2202)
Santiago
FALP-UIDO ( Site 2208)
Santiago
Pontificia Universidad Catolica de Chile-CICUC ( Site 2205)
Santiago
Clinical Research Chile SpA ( Site 2201)
Valdivia
China
Beijing Friendship Hospital Affiliate of Capital University ( Site 3923)
Beijing
Beijing Luhe Hospital Capital Medical University ( Site 3911)
Beijing
Peking University Third Hospital ( Site 3909)
Beijing
Binzhou Medical University Hospital ( Site 3953)
Binzhou
The Second Xiangya Hospital of Central South University ( Site 3930)
Changsha
Changzhou No.2 People's Hospital ( Site 3950)
Changzhou
West China Hospital, Sichuan University ( Site 3951)
Chengdu
Chongqing University Three Gorges Hospital ( Site 3928)
Chongqing
Dongguan People's Hospital-Gastroenterology department ( Site 3944)
Dongguan
The First Affiliated Hospital Of Fujian Medical University ( Site 3904)
Fuzhou
Guangzhou Medical University 2nd Hospital ( Site 3908)
Guangzhou
Southern Medical University Nanfang Hospital-Gastroenterology ( Site 3914)
Guangzhou
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 3906)
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-GI Medicine ( Site 3916)
Hangzhou
Anhui Provincial Hospital ( Site 3947)
Hefei
The First Affiliated Hospital of Anhui Medical University ( Site 3957)
Hefei
Huizhou Municipal Central Hospital ( Site 3917)
Huizhou
First Affiliated Hospital of Kunming Medical University ( Site 3925)
Kunming
The First Affiliated Hospital of Nanchang University ( Site 3926)
Nanchang
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 3900)
Nanjing
Zhongda Hospital Southeast University ( Site 3919)
Nanjing
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 3915)
Shanghai
Ruijin Hospital Shanghai Jiaotong University School of Medicine-Gastroneterology ( Site 3903)
Shanghai
Shanghai East Hospital ( Site 3922)
Shanghai
Yuebei People's Hospital Guangdong ( Site 3948)
Shaoguan
Shenzhen Hospital of Southern Medical University ( Site 3905)
Shenzhen
The University of Hong Kong-Shenzhen Hospital ( Site 3955)
Shenzhen
The Second Hospital of Hebei Medical University ( Site 3934)
Shijiazhuang
Taihe Hospital ( Site 3941)
Shiyan
Taian City Central Hospital-gastroenterology department ( Site 3946)
Taian
Tianjin Medical University General Hospital ( Site 3945)
Tianjin
The First Teaching Hospital of Xinjiang Medical University. ( Site 3937)
Ürümqi
Renmin Hospital of Wuhan University ( Site 3912)
Wuhan
The Central Hospital of Wuhan ( Site 3939)
Wuhan
Wuxi People's Hospital ( Site 3920)
Wuxi
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 3929)
Xi'an
The First Affiliated hospital of Xiamen University-Gastroenterology ( Site 3954)
Xiamen
The Second Affiliated Hospital of Zhengzhou University ( Site 3935)
Zhengzhou
Colombia
Clinica de la Costa S.A.S. ( Site 2305)
Barranquilla
Fundacion Santa Fe de Bogota ( Site 2316)
Bogota
Fundación Valle del Lili ( Site 2307)
Cali
Clínica las Américas ( Site 2318)
Medellín
Clinica Medellin S.A ( Site 2317)
Medellín
Oncologos del Occidente ( Site 2310)
Pereira
Clinica Somer-Unidad de Investigacion y Docencia ( Site 2303)
Rionegro
Croatia
Poliklinika Borzan ( Site 0500)
Osijek
Klinički Bolnički Centar Split ( Site 0503)
Split
Klinička bolnica Merkur ( Site 0505)
Zagreb
Klinički bolnički centar Zagreb ( Site 0501)
Zagreb
Poliklinika Bates ( Site 0504)
Zagreb
Poliklinika Solmed ( Site 0502)
Zagreb
Dominican Republic
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 3601)
Santo Domingo
Finland
Pohjois-Karjalan keskussairaala ( Site 4302)
Joensuu
Tampereen yliopistollinen sairaala ( Site 4300)
Tampere
Turku University Hospital ( Site 4301)
Turku
France
CHU d'Amiens-Picardie - Hôpital Sud-Hepato-gastroentérology ( Site 0712)
Amiens
CHU Besançon ( Site 0710)
Besançon
Hopital Beaujon ( Site 0716)
Clichy
Hopital Henri Mondor ( Site 0717)
Créteil
Clinique des Cèdres ( Site 0719)
Échirolles
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0715)
Le Kremlin-bicêtre
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0714)
Marseille
CHU SAINT ELOI ( Site 0711)
Montpellier
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0701)
Nantes
CMC Ambroise Paré Hartmann - Institut des MICI ( Site 0709)
Neuilly-sur-seine
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0706)
Nice
C.H.U. de Nimes. Hopital Caremeau ( Site 0718)
Nîmes
Hôpital Saint Antoine ( Site 0703)
Paris
Hôpital Saint-Louis ( Site 0702)
Paris
CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0700)
Pessac
centre hospitalier lyon sud ( Site 0707)
Pierre-bénite
Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré ( Site 0705)
Reims
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 0708)
Vandœuvre-lès-nancy
Georgia
LTD High Technology Hospital Medcenter ( Site 0802)
Batumi
Caraps Medline ( Site 0803)
Tbilisi
Caucasus Medical Centre ( Site 0801)
Tbilisi
New Hospitals ( Site 0800)
Tbilisi
Germany
Charité Campus Virchow-Klinikum ( Site 0906)
Berlin
Universitätsklinikum Brandenburg an der Havel ( Site 0905)
Brandenburg
MVZ Dachau ( Site 0918)
Dachau
Stadtische Kliniken Duisburg, Abtlg. Innere Medizin ( Site 0916)
Duisburg
Agaplesion Markus Krankenhaus ( Site 0904)
Frankfurt Am Main
Medizinische Hochschule Hannover ( Site 0913)
Hanover
Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0903)
Kiel
Universitätsklinikum Leipzig ( Site 0909)
Leipzig
St. Marien und St. Annastift Krankenhaus ( Site 0901)
Ludwighafen Am Rhein
Klinikum Lüneburg ( Site 0908)
Lüneburg
Gastroenterologische Gemeinschaftspraxis Minden ( Site 0911)
Minden
Klinikum der Universität München Großhadern-Medizinische Klinik und Poliklinik II ( Site 0907)
Munich
Medizinisches Versorgungszentrum Portal 10 ( Site 0914)
Münster
Universitaetsklinikum Ulm. ( Site 0902)
Ulm
Greece
Evangelismos General Hospital of Athens ( Site 4001)
Athens
THORACIC GENERAL HOSPITAL OF ATHENS I SOTIRIA-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 4000)
Athens
University General Hospital of Heraklion-GASTROENTEROLOGY & HEPATOLOGY ( Site 4003)
Heraklion
General Hospital of Nikaia-Piraeus Agios Panteleimon ( Site 4006)
Nikaia Piraeus
Ippokrateio General Hospital of Thessaloniki ( Site 4004)
Thessaloniki
Hungary
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1007)
Békéscsaba
Pannónia Magánorvosi Centrum ( Site 1004)
Budapest
Semmelweis Egyetem ( Site 1006)
Budapest
Synexus Magyarorszag Kft. (Budapest DRS) ( Site 1009)
Budapest
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1012)
Eger
Gyöngyösi Bugát Pál Kórház ( Site 1011)
Gyöngyös
Csőszi Endoszkópos KFT ( Site 1001)
Kecskemét
Mohácsi Kórház ( Site 1008)
Mohács
Komarom-Esztergom Varmegyei Szent Borbala Korhaz ( Site 1010)
Tatabánya
VeszLife Magánklinika ( Site 1002)
Veszprém
Israel
Emek Medical Center ( Site 1106)
Afula
Barzilai Medical Center ( Site 1109)
Ashkelon
Bnai Zion Medical Center ( Site 1103)
Haifa
Rambam Health Care Campus ( Site 1101)
Haifa
Edith Wolfson Medical Center ( Site 1104)
Holon
Shaare Zedek Medical Center ( Site 1108)
Jerusalem
Meir Medical Center. ( Site 1102)
Kfar Saba
Rabin Medical Center ( Site 1107)
Petah Tikva
Sheba Medical Center ( Site 1100)
Ramat Gan
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1208)
Bologna
ASST Fatebenefratelli Sacco-UOC Gastroenterologia ( Site 1200)
Milan
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Gastroenterology and Endoscopy Unit ( Site 1202)
Milan
Ospedale San Raffaele-Gastroenterology and Gastrointestinal Endoscopy ( Site 1205)
Milan
Policlinico Universitario Monserrato-SC Gastroenterologia ( Site 1207)
Monserrato
A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 1217)
Naples
Ospedale Sacro Cuore Don G. Calabria ( Site 1212)
Negrar
Azienda Ospedale - Università Padova-Surgery Oncology and Gastroenterology ( Site 1211)
Padua
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-U.O.S.D. Malattie Infiammatorie Croniche Intestinali ( Site 1210)
Palermo
Fondazione IRCCS Policlinico San Matteo-General Medicine ( Site 1206)
Pavia
Ospedale Di Circolo-U.O.C. di Gastroenterologia ed Endoscopia Digestiva ( Site 1216)
Rho
Azienda Ospedaliera San Camillo Forlanini ( Site 1204)
Rome
Fatebenefratelli Isola Tiberina - Gemelli Isola ( Site 1214)
Rome
Fondazione Policlinico Tor Vergata ( Site 1209)
Rome
Istituto Clinico Humanitas-IBD center ( Site 1201)
Rozzano
IRCCS Casa Sollievo della Sofferenza ( Site 1213)
San Giovanni Rotondo
Japan
Tokatsu Tsujinaka Hospital ( Site 2832)
Abiko
Asahikawa City Hospital ( Site 2840)
Asahikawa
Asahikawa Medical University Hospital ( Site 2815)
Asahikawa
Institute of Science Tokyo Hospital ( Site 2827)
Bunkyō
Ginza Central Clinic ( Site 2824)
Chūō
Sai Gastroenterology/Proctology Clinic ( Site 2814)
Fujiidera
Fukui Prefectural Hospital ( Site 2844)
Fukui
Fukuoka University Hospital ( Site 2818)
Fukuoka
National Hospital Organization Fukuyama Medical Center ( Site 2831)
Fukuyama
Hamamatsu University Hospital ( Site 2874)
Hamamatsu
Matsuda Hospital ( Site 2826)
Hamamatsu
Kansai Medical University Hospital ( Site 2823)
Hirakata
Hiroshima University Hospital ( Site 2845)
Hiroshima
Hitachi General Hospital ( Site 2856)
Hitachi
Kagoshima IBD Gastroenterology Clinic ( Site 2821)
Kagoshima
Kagoshima University Hospital ( Site 2848)
Kagoshima
Gokeikai Ofuna Chuo Hospital ( Site 2801)
Kamakura
Ishikawa Prefectural Central Hospital ( Site 2835)
Kanazawa
Kanazawa University Hospital ( Site 2839)
Kanazawa
Tsujinaka Hospital - Kashiwanoha ( Site 2802)
Kashiwa
St. Marianna University Hospital ( Site 2852)
Kawasaki
Kitakyushu Municipal Medical Center ( Site 2873)
Kitakyushu
Yamanashi Prefectural Central Hospital ( Site 2836)
Kofu
Kurume University Hospital ( Site 2846)
Kurume
National Hospital Organization Kyoto Medical Center ( Site 2813)
Kyoto
University Hospital,Kyoto Prefectural University of Medicine ( Site 2819)
Kyoto
Gunma University Hospital ( Site 2850)
Maebashi
Ehime Prefectural Central Hospital ( Site 2868)
Matsuyama
The Jikei University Hospital ( Site 2843)
Minato
Kitasato University Kitasato Institute Hospital ( Site 2817)
Minato-ku
Toranomon Hospital ( Site 2828)
Minato-ku
Kyorin University Hospital ( Site 2804)
Mitaka-shi
Iwate Medical University Uchimaru Medical Center ( Site 2833)
Morioka
Aichi Medical University Hospital ( Site 2841)
Nagakute
Hyogo Medical University Hospital ( Site 2830)
Nishinomiya
Ishida Clinic of IBD and Gastroenterology ( Site 2820)
Ōita
Okayama University Hospital ( Site 2870)
Okayama
Infusion Clinic ( Site 2806)
Osaka
National Hospital Organization Osaka National Hospital ( Site 2869)
Osaka
Saga University Hospital ( Site 2812)
Saga
Tokitokai Tokito Clinic Coloproctology Center ( Site 2811)
Saitama
Toho University Sakura Medical Center ( Site 2805)
Sakura
Medical Corporation Sapporo IBD Clinic ( Site 2842)
Sapporo
Sapporo Medical University Hospital ( Site 2829)
Sapporo
Sapporo Tokushukai Hospital ( Site 2808)
Sapporo
Sapporohigashi Tokushukai Hospital ( Site 2860)
Sapporo
National Hospital Organization Shizuoka Medical Center ( Site 2837)
Shimizu
NTT Medical Center Tokyo ( Site 2834)
Shinagawa-ku
Tokyo Yamate Medical Center ( Site 2803)
Tokyo
Toyama Prefectural Central Hospital ( Site 2807)
Toyama
Mie University Hospital ( Site 2838)
Tsu
Yamagata University Hospital ( Site 2849)
Yamagata
Matsushima Hospital ( Site 2822)
Yokohama
Yokohama City University Medical Center ( Site 2865)
Yokohama
Latvia
SIA M & M Centrs ( Site 4502)
Ādaži
Liepaja Regional Hospital ( Site 4501)
Liepāja
P.Stradins Clinical University Hospital Center of Gastroenterology Hepatology and Nutrition ( Site 4503)
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 4600)
Kaunas
VUL SANTAROS KLINIKOS ( Site 4601)
Vilnius
Malaysia
Hospital Ampang ( Site 4703)
Ampang
Hospital Sultanah Aminah ( Site 4702)
Johor Bahru
Hospital Universiti Sains Malaysia ( Site 4704)
Kubang Kerian
Hospital Tuanku Jaafar Seremban ( Site 4705)
Seremban
Mexico
ICARO Investigaciones en Medicina ( Site 2405)
Chihuahua City
PanAmerican Clinical Research - Guadalajara ( Site 2400)
Guadalajara
Morales Vargas Centro de Investigacion ( Site 2411)
León
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 2407)
Mérida
Centro de Investigación y Gastroenterología - S.C. ( Site 2410)
Mexico City
Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 2406)
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 2409)
Monterrey
Oaxaca Site Management Organization S.C. ( Site 2404)
Oaxaca City
Centro Medico Clinico Quirurgico Especializado en Investigación ( Site 2403)
Tlajumulco De Zuniga
Netherlands
Amsterdam UMC, locatie VUmc-IBD Trial Unit ( Site 1400)
Amsterdam
Onze Lieve Vrouwe Gasthuis ( Site 1405)
Amsterdam
Deventer Ziekenhuis ( Site 1411)
Deventer
Radboudumc ( Site 1402)
Nijmegen
Erasmus Medisch Centrum ( Site 1410)
Rotterdam
Franciscus Gasthuis & Vlietland, Locatie Gasthuis ( Site 1406)
Rotterdam
ETZ Elisabeth-Department of Gastroenterology and Hepatology ( Site 1403)
Tilburg
Ziekenhuis Bernhoven-Researchbureau ( Site 1401)
Uden
Universitair Medisch Centrum Utrecht ( Site 1404)
Utrecht
New Zealand
Aotearoa Clinical Trials ( Site 2900)
Auckland
Waikato Hospital ( Site 2903)
Hamilton
Hutt Valley District Health board HVDHB ( Site 2902)
Lower Hutt
Norway
Akershus Universitetssykehus ( Site 4200)
Lørenskog
Oslo Universitetssykehus Ullevål ( Site 4201)
Oslo
Poland
M2M Med ( Site 1526)
Chorzów
Vita Longa Sp. Zoo ( Site 1527)
Katowice
PROMED P. LACH R. GLOWACKI SP. J. ( Site 1529)
Krakow
Topolowa Medicenter Ryszawa & Wspolnicy sp.j. ( Site 1500)
Krakow
AmiCare Centrum Medyczne - Zgierska ( Site 1517)
Lodz
Med-Gastr Sp. z o.o., sp.k ( Site 1515)
Lodz
Allmedica ( Site 1508)
Nowy Targ
Pratia Poznan ( Site 1530)
Poznan
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.,Twoja Przychodnia PCM ( Site 1523)
Poznan
Sonomed Sp. z o. o. ( Site 1516)
Szczecin
Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 1502)
Szczecin
Gastromed Sp. z o. o. ( Site 1513)
Torun
NZOZ FOR MED sp. z o.o. ( Site 1511)
Wadowice
Centrum Zdrowia MDM ( Site 1512)
Warsaw
ETG Warszawa ( Site 1525)
Warsaw
Vivamed Sp. z o.o. ( Site 1510)
Warsaw
WIP Warsaw IBD Point Profesor Kierkuś ( Site 1503)
Warsaw
EMC Instytut Medyczny SA ( Site 1505)
Wroclaw
Melita Medical ( Site 1519)
Wroclaw
Planetmed ( Site 1506)
Wroclaw
Vistamed & Vertigo Sp. z o.o. ( Site 1528)
Wroclaw
Portugal
Unidade Local de Saude de Braga - Hospital de Braga ( Site 3300)
Braga
Hospital dos Lusíadas Lisboa ( Site 3303)
Lisbon
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3305)
Lisbon
Unidade Local de Saude Lisboa Ocidental - Hospital Egas Moniz ( Site 3306)
Lisbon
ULSAM - Hospital de Santa Luzia ( Site 3302)
Viana Do Castelo
Unidade Local de Saude Dão-Lafões - Hospital de São Teotónio ( Site 3308)
Viseu
Republic of Korea
Dong-A University Hospital ( Site 3010)
Busan
Yeungnam University Medical Center ( Site 3004)
Daegu
The Catholic University of Korea, Daejeon St. Mary's Hospital ( Site 3011)
Daejeon
Chung-Ang University Hospital ( Site 3008)
Dongjak-gu
Inje University Haeundae Paik Hospital ( Site 3009)
Haeundae-gu
Asan Medical Center ( Site 3007)
Seoul
Kangbuk Samsung Hospital-Internal Medicine ( Site 3002)
Seoul
Kyung Hee University Hospital ( Site 3013)
Seoul
Samsung Medical Center ( Site 3001)
Seoul
Seoul National University Hospital ( Site 3005)
Seoul
Severance Hospital, Yonsei University Health System-Department of Internal Medicine ( Site 3000)
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3012)
Seoul
The Catholic University Of Korea St. Vincent's Hospital-Gastroenterology ( Site 3006)
Suwon
Wonju Severance Christian Hospital-Internal Medicine ( Site 3003)
Wŏnju
Romania
Fundeni Clinical Institute-Gastroenterology and Hepatology Center ( Site 1608)
Bucharest
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 1606)
Bucharest
Monza Ares SRL ( Site 1604)
Bucharest
GastroMed ( Site 1609)
Cluj-napoca
Spitalul Clinic Judetean de Urgenta Cluj Napoca-Gastroenterology ( Site 1605)
Cluj-napoca
Spitalul Clinic Judetean Mures-Gastroenterology ( Site 1607)
Târgu Mureş
Asociatia Oncohelp ( Site 1610)
Timișoara
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L-Gastroenterology ( Site 1601)
Timișoara
Serbia
Clinical Hospital Center Dragisa Misovic ( Site 1708)
Belgrade
Clinical Hospital Center Zvezdara-Gastroenterology and hepatology Department ( Site 1705)
Belgrade
University Medical Center Bezanijska kosa-Gastroenterology and hepatology ( Site 1704)
Belgrade
Clinical Center Kragujevac ( Site 1703)
Kragujevac
General Hospital Djordje Joanovic ( Site 1707)
Zrenjanin
Singapore
Singapore General Hospital ( Site 4801)
Singapore
Tan Tock Seng Hospital-Gastroenterology and Hepatology ( Site 4800)
Singapore
Slovakia
Cliniq s.r.o. ( Site 1800)
Bratislava
Breznianske centrum gastroenterologie ( Site 1806)
Brezno
ENDOMED ( Site 1801)
Košice
KM Management ( Site 1804)
Nitra
GASTRO I ( Site 1807)
Prešov
Gastro LM ( Site 1808)
Prešov
Accout Center ( Site 1805)
Šahy
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica ( Site 1802)
Slovakia
South Africa
Life Kingsbury Hospital ( Site 3203)
Cape Town
Panorama Medical Centre ( Site 3209)
Cape Town
Private Practice - Dr. M.N. Rajabally ( Site 3213)
Cape Town
Spoke Research ( Site 3210)
Cape Town
Wits Clinical Research-Research ( Site 3208)
Johannesburg
Wits Clinical Research-Wits Clinical Research Bara ( Site 3206)
Soweto
Spain
Hospital Germans Trias i Pujol ( Site 3413)
Badalona
Hospital Universitario de Fuenlabrada-Digestive ( Site 3415)
Fuenlabrada
Hospital Galdakao-Usansolo ( Site 3409)
Galdakao-usansolo
Fundación Jimenez Diaz ( Site 3420)
Madrid
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Aparato Digestivo ( Site 3403)
Madrid
Hospital La Princesa-Gastroenterology ( Site 3411)
Madrid
Hospital Universitario La Paz-Unidad de Enfermedad Inflamatoria Intestinal ( Site 3402)
Madrid
Hospital Universitari Mutua Terrassa ( Site 3416)
Terrassa
Hospital Universitario de Torrejon ( Site 3417)
Torrejón De Ardoz
HOSPITAL CLINICO DE VALENCIA ( Site 3406)
Valencia
Hospital Universitari i Politecnic La Fe-Enfermedad Inflamatoria Intestinal ( Site 3405)
Valencia
Sweden
Danderyds Sjukhus ( Site 4401)
Danderyd
Universitetssjukhuset i Linköping ( Site 4402)
Linköping
Karolinska Universitetssjukhuset Solna ( Site 4400)
Stockholm
Akademiska Sjukhuset ( Site 4403)
Uppsala
Switzerland
INTESTO-Gastroenterologische Praxis / Crohn-Colitis Zentrum Bern ( Site 1902)
Bern
Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 1901)
Sankt Gallen
UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 1900)
Zurich
Taiwan
Changhua Christian Hospital ( Site 3104)
Changhua County
China Medical University Hospital ( Site 3100)
Taichung
National Taiwan University Hospital ( Site 3102)
Taipei
Chang Gung Medical Foundation-Linkou Branch ( Site 3101)
Taoyuan District
National Taiwan University BioMedical Park Hospital ( Site 3103)
Zhubei
Turkey
Ankara Bilkent Şehir Hastanesi-Gastroenterology ( Site 3501)
Ankara
ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 3507)
Ankara
Hacettepe Universite Hastaneleri ( Site 3500)
Ankara
Antalya Egitim ve Arastirma Hastanesi ( Site 3508)
Antalya
Trakya University Medical Faculty Hospital ( Site 3510)
Edirne
Eskisehir Osmangazi University Faculty of Medicine ( Site 3512)
Eskişehir
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 3505)
Istanbul
Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3503)
Istanbul- Fatih
Kocaeli University Medical Faculty Hospital ( Site 3509)
Kocaeli
Ukraine
Communal non-profit enterprise Regional clinical hospital of Ivano-Frankivsk Regional Council ( Site 4115)
Ivano-frankivsk
Center of Family Medicine Plus-Treatment Prevention Unit ( Site 4103)
Kyiv
Dobrobut Medical Center ( Site 4101)
Kyiv
Medical Center of Private Enterprise Sygma ( Site 4108)
Kyiv
Medical Center Universal Clinic Oberig of Limited Liability Company Kapytal ( Site 4100)
Kyiv
Municipal Enterprise Volyn Regional Clinical Hospital of V-surgery department (abdominal, colopro ( Site 4113)
Lutsk
Communal Non-profit Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital-proctology ( Site 4109)
Lviv
Communal Non-Commercial Enterprise Vinnytsia City Clinical -Clinical Therapeutic Department #1 ( Site 4111)
Vinnytsia
Limited liability company Medical center Health Clinic-Gastroenterology, Hepatology and Endocrino ( Site 4107)
Vinnytsia
Municipal Nonprofit Enterprise Vinnytsia Regional Clinical -Gastroenterology department ( Site 4114)
Vinnytsia
United Kingdom
Southmead Hospital ( Site 2004)
Bristol
Addenbrooke's Hospital ( Site 2005)
Cambridge
Doncaster Royal Infirmary ( Site 2006)
Doncaster
Royal Devon & Exeter Hospital-IBD Research Group ( Site 2001)
Exeter
Huddersfield Royal Infirmary ( Site 2010)
Huddersfield
St. George's Hospital ( Site 2007)
London
University College London Hospital-Clinical Research Facility ( Site 2002)
London
Whipps Cross University Hospital-Clinical Research Unit ( Site 2000)
London
Southampton General Hospital-Gastroenterology ( Site 2003)
Southampton
Walsall Manor Hospital ( Site 2009)
West Midlands
Time Frame
Start Date: 2023-10-25
Completion Date: 2029-08-01
Participants
Target number of participants: 1020
Treatments
Experimental: Study 1: High Dose Induction, High Dose Maintenance
Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.
Experimental: Study 1: High Dose Induction, Low Dose Maintenance
Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Experimental: Study 1: Low Dose Induction, Low Dose Maintenance
Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Placebo_comparator: Study 1: Placebo
Participants receive IV placebo, followed by an SC placebo regimen.
Experimental: Study 1: High Dose Extension
Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Experimental: Study 1: Low Dose Extension
Participants receive a low dose SC tulisokibart and placebo regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Experimental: Study 2: High Dose Induction
Participants receive high dose IV tulisokibart.
Experimental: Study 2: Low Dose Induction
Participants receive low dose IV tulisokibart.
Placebo_comparator: Study 2: Placebo
Participants receive IV placebo.
Experimental: Study 2: High Dose Extension
Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Experimental: Study 2: Low Dose Extension
Participants receive a low dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Sponsors
Leads: Merck Sharp & Dohme LLC
Collaborators: PPD, Part of Thermo Fisher Scientific

This content was sourced from clinicaltrials.gov