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: Recruiting
Location: See all (468) 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)
RECRUITING
Dothan
IMC-Gulf Coast Gastroenterology ( Site 0157)
COMPLETED
Fairhope
Arizona
Research Solutions of Arizona ( Site 3816)
RECRUITING
Litchfield Park
One of a Kind Clinical Research Center ( Site 3852)
RECRUITING
Scottsdale
GI Alliance - Sun City ( Site 0103)
RECRUITING
Sun City
California
Clinnova Research ( Site 3803)
RECRUITING
Anaheim
Southern California Research Center ( Site 3828)
RECRUITING
Coronado
UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113)
RECRUITING
La Jolla
Cedars-Sinai Medical Center ( Site 0119)
RECRUITING
Los Angeles
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3851)
RECRUITING
Orange
Colorado
University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172)
RECRUITING
Aurora
Peak Gastroenterology Associates ( Site 0116)
RECRUITING
Colorado Springs
South Denver Gastroenterology, PC ( Site 3849)
RECRUITING
Englewood
Rocky Mountain Gastroenterology/Topography Health ( Site 3838)
RECRUITING
Littleton
Connecticut
Connecticut Clinical Research Institute ( Site 0126)
RECRUITING
Bristol
Medical Research Center of Connecticut ( Site 0151)
COMPLETED
Hamden
Yale University School of Medicine-Digestive Disease ( Site 0163)
RECRUITING
New Haven
Washington, D.c.
Emerson Clinical Research Institute ( Site 3820)
RECRUITING
Washington D.c.
Florida
Gastroenterology Consultants of Clearwater ( Site 0152)
RECRUITING
Clearwater
University of Florida College of Medicine-Gastroenterology ( Site 3821)
RECRUITING
Gainesville
Nature Coast Clinical Research - Inverness ( Site 3806)
RECRUITING
Inverness
Central Florida Gastro Research ( Site 0124)
RECRUITING
Kissimmee
Research Associates of South Florida - Miami - Southwest 8th Street ( Site 3810)
RECRUITING
Miami
Orlando Health ( Site 0145)
COMPLETED
Orlando
USF Health ( Site 0169)
RECRUITING
Tampa
Georgia
Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115)
RECRUITING
Atlanta
Emory University School of Medicine ( Site 3818)
RECRUITING
Atlanta
Atlanta Center for Gastroenterology ( Site 0155)
RECRUITING
Decatur
Iowa
Iowa Digestive Disease Center ( Site 0123)
RECRUITING
Clive
Illinois
University of Chicago Medical Center ( Site 0134)
RECRUITING
Chicago
GI Alliance - Glenview ( Site 0168)
RECRUITING
Glenview
GI ALLIANCE - GURNEE ( Site 0107)
RECRUITING
Gurnee
Kentucky
University of Louisville Hospital-Clinical Trials Unit ( Site 0165)
RECRUITING
Louisville
Louisiana
Baton Rouge General Medical Center - Bluebonnet ( Site 0112)
RECRUITING
Baton Rouge
Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 0154)
RECRUITING
New Orleans
Massachusetts
Massachusetts General Hospital-Crohn's and Colitis Center ( Site 0132)
RECRUITING
Boston
Maryland
Walter Reed National Military Medical Center ( Site 0121)
RECRUITING
Bethesda
Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 3835)
RECRUITING
Glen Burnie
Michigan
University of Michigan ( Site 0143)
RECRUITING
Ann Arbor
Clinical Research Institute of Michigan, LLC ( Site 0108)
RECRUITING
Clinton Township
Michigan Center of Medical Research (MICHMER) ( Site 3850)
RECRUITING
Farmington Hills
Clinical Research Institute of Michigan, LLC ( Site 0150)
COMPLETED
Troy
Huron Gastroenterology ( Site 3836)
RECRUITING
Ypsilanti
Minnesota
Mayo Clinic in Rochester, Minnesota ( Site 0147)
RECRUITING
Rochester
Missouri
BVL Research - Kansas ( Site 3847)
RECRUITING
Liberty
Washington University School of Medicine ( Site 0129)
RECRUITING
St Louis
North Carolina
University of North Carolina Medical Center ( Site 0140)
RECRUITING
Chapel Hill
Carolina Digestive Diseases and Endoscopy Center ( Site 3809)
COMPLETED
Greenville
New York
Circuit Clinical /Middletown Medical PC ( Site 3831)
COMPLETED
Middletown
Lenox Hill Hospital ( Site 0128)
RECRUITING
New York
New York Gastroenterology Associates ( Site 0159)
RECRUITING
New York
NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 3846)
RECRUITING
New York
Pennsylvania
Hospital of the University of Pennsylvania ( Site 0170)
RECRUITING
Philadelphia
Rhode Island
University Gastroenterology ( Site 0164)
RECRUITING
Providence
South Carolina
Gastroenterology Associates of Orangeburg ( Site 0149)
RECRUITING
Orangeburg
Tennessee
Quality Medical Research ( Site 3807)
RECRUITING
Nashville
Vanderbilt Inflammatory Bowel Disease Clinic ( Site 0131)
RECRUITING
Nashville
Texas
GI Alliance - Garland ( Site 0109)
COMPLETED
Garland
Baylor College of Medicine Medical Center ( Site 3812)
RECRUITING
Houston
Clinical Trial Network ( Site 3819)
RECRUITING
Houston
The University of Texas Health Science Center at Houston-Internal Medicine-Division of Gastroentero ( Site 0144)
RECRUITING
Houston
Caprock Gastro Research ( Site 0101)
RECRUITING
Lubbock
GI Alliance - Lubbock ( Site 0167)
RECRUITING
Lubbock
GI Alliance: Mansfield ( Site 0161)
RECRUITING
Mansfield
CARTA - Clinical Associates In Research Therapeutics Of America ( Site 0122)
RECRUITING
San Antonio
Southern Star Research Institute ( Site 0106)
RECRUITING
San Antonio
GI Alliance - San Marcos ( Site 0130)
RECRUITING
San Marcos
GI Alliance - Southlake ( Site 0104)
RECRUITING
Southlake
Tyler Research Institute ( Site 0105)
RECRUITING
Tyler
Texas Digestive Disease Consultants ( Site 0136)
RECRUITING
Webster
Utah
Velocity Clinical Research, Salt Lake City ( Site 3801)
COMPLETED
West Jordan
Virginia
Richmond VA Medical Center ( Site 3845)
RECRUITING
Richmond
Washington
Washington Gastroenterology - Bellevue ( Site 3844)
RECRUITING
Bellevue
Washington Gastroenterology - Tacoma ( Site 0102)
RECRUITING
Tacoma
Wisconsin
MEDICAL COLLEGE OF WISCONSIN ( Site 0141)
RECRUITING
Milwaukee
Other Locations
Argentina
Centro de Investigaciones Médicas Mar del Plata ( Site 2101)
ACTIVE_NOT_RECRUITING
Mar Del Plata
CER medical Institute-Gastroenterology ( Site 2110)
RECRUITING
Quilmes
Hospital Provincial del Centenario ( Site 2108)
RECRUITING
Rosario
C.I.C.E. 9 de Julio-CICE 9 DE JULIO ( Site 2103)
RECRUITING
San Miguel De Tucumán
Australia
Royal Adelaide Hospital-Gastroenterology/Hepatology ( Site 2504)
RECRUITING
Adelaide
Mater Misericordiae Limited-Gastroenterology ( Site 2506)
RECRUITING
Brisbane
Royal Brisbane and Women's Hospital ( Site 2500)
RECRUITING
Brisbane
Monash Health-Gastroenterology ( Site 2505)
RECRUITING
Clayton
Nepean Hospital-Gastroenterology/Hepatology ( Site 2501)
RECRUITING
Kingswood
St Vincent's Hospital ( Site 2510)
RECRUITING
Melbourne
The Alfred Hospital-Gastroenterology ( Site 2503)
RECRUITING
Melbourne
Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 2508)
RECRUITING
Sydney
Austria
Universitaetsklinik fuer Innere Medizin I Innsbruck ( Site 0200)
RECRUITING
Innsbruck
Uniklinikum Salzburg-Innere Medizin I ( Site 0201)
RECRUITING
Salzburg
Medizinische Universität Wien-Klinik für Innere Medizin III - Abteilung für Gastroenterologie und H ( Site 0202)
RECRUITING
Vienna
Belgium
UZ Gent ( Site 0300)
RECRUITING
Ghent
UZ Leuven-Gastroenterology - Inflammatory Bowel Disease ( Site 0301)
RECRUITING
Leuven
Brazil
L2IP - Instituto de Pesquisas Clínicas ( Site 5104)
RECRUITING
Brasília
Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida - Galileo Pesquisa Clínica ( Site 5100)
RECRUITING
Juiz De Fora
Hospital Moinhos de Vento ( Site 5108)
RECRUITING
Porto Alegre
Centro de Pesquisa Kaiser - CEPEK ( Site 5103)
RECRUITING
São José Do Rio Preto
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 5107)
RECRUITING
São José Do Rio Preto
Bulgaria
Medconsult Pleven ( Site 0410)
RECRUITING
Pleven
DKC V - Plovdiv ( Site 0402)
RECRUITING
Plovdiv
MC Rusemed ( Site 0408)
RECRUITING
Rousse
MHAT Hadzhi Dimitar-Gastroenterology ( Site 0403)
RECRUITING
Sliven
4th MHAT ( Site 0409)
RECRUITING
Sofia
Diagnostic - Consultative Center XX - Sofia EOOD ( Site 0407)
RECRUITING
Sofia
Diagnostic Consultative Center 22 - Sofia ( Site 0401)
RECRUITING
Sofia
Medica Plus Medical Center ( Site 0404)
RECRUITING
Veliko Tarnovo
MC Velingrad 2017 EOOD ( Site 0406)
COMPLETED
Velingrad
Canada
Barrie GI Associates ( Site 0012)
RECRUITING
Barrie
Heritage Medical Research Clinic ( Site 0004)
RECRUITING
Calgary
Gastroenterology and internal medicine research institute ( Site 0010)
RECRUITING
Edmonton
Private Practice - Dr. Bruce Musgrave ( Site 0011)
RECRUITING
Kentville
SIX08 Gastroenterology ( Site 0013)
RECRUITING
Lethbridge
Centre Intégré de Santé et Service Sociaux de Chaudière-Appalaches ( Site 0015)
RECRUITING
Lévis
University Hospital - London Health Sciences Centre ( Site 0002)
RECRUITING
London
Victoria Hospital & Children's Hospital - London Health Sciences Centre ( Site 0007)
RECRUITING
London
West GTA Research Inc. ( Site 0017)
RECRUITING
Mississauga
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0018)
RECRUITING
Montreal
Montreal General Hospital ( Site 0003)
RECRUITING
Montreal
Fraser Clinical Trials Inc. ( Site 0019)
RECRUITING
New Westminster
ABP Research Services Corp. ( Site 0016)
RECRUITING
Ontario
Diex Recherche Quebec ( Site 0008)
RECRUITING
Québec
Toronto Immune & Digestive Health Institute ( Site 0005)
RECRUITING
Toronto
G.I.R.I. GI Research Institute Foundation ( Site 0001)
RECRUITING
Vancouver
Toronto Digestive Disease Associates ( Site 0006)
RECRUITING
Vaughan
Chile
CECIM ( Site 2200)
RECRUITING
Santiago
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 2203)
RECRUITING
Santiago
Clínica Alemana de Santiago ( Site 2209)
RECRUITING
Santiago
Clínica MEDS La Dehesa ( Site 2207)
RECRUITING
Santiago
Clínica Universidad de Los Andes ( Site 2202)
RECRUITING
Santiago
FALP-UIDO ( Site 2208)
RECRUITING
Santiago
Pontificia Universidad Catolica de Chile-CICUC ( Site 2205)
RECRUITING
Santiago
Clinical Research Chile SpA ( Site 2201)
RECRUITING
Valdivia
China
Beijing Friendship Hospital Affiliate of Capital University ( Site 3923)
RECRUITING
Beijing
Beijing Luhe Hospital Capital Medical University ( Site 3911)
RECRUITING
Beijing
Peking University Third Hospital ( Site 3909)
RECRUITING
Beijing
Binzhou Medical University Hospital ( Site 3953)
RECRUITING
Binzhou
The Second Xiangya Hospital of Central South University ( Site 3930)
RECRUITING
Changsha
Changzhou No.2 People's Hospital ( Site 3950)
RECRUITING
Changzhou
West China Hospital, Sichuan University ( Site 3951)
RECRUITING
Chengdu
Chongqing University Three Gorges Hospital ( Site 3928)
RECRUITING
Chongqing
Dongguan People's Hospital-Gastroenterology department ( Site 3944)
RECRUITING
Dongguan
The First Affiliated Hospital Of Fujian Medical University ( Site 3904)
RECRUITING
Fuzhou
Guangzhou Medical University 2nd Hospital ( Site 3908)
RECRUITING
Guangzhou
Southern Medical University Nanfang Hospital-Gastroenterology ( Site 3914)
RECRUITING
Guangzhou
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 3906)
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-GI Medicine ( Site 3916)
RECRUITING
Hangzhou
Anhui Provincial Hospital ( Site 3947)
RECRUITING
Hefei
The First Affiliated Hospital of Anhui Medical University ( Site 3957)
RECRUITING
Hefei
Huizhou Municipal Central Hospital ( Site 3917)
RECRUITING
Huizhou
First Affiliated Hospital of Kunming Medical University ( Site 3925)
RECRUITING
Kunming
The First Affiliated Hospital of Nanchang University ( Site 3926)
RECRUITING
Nanchang
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 3900)
RECRUITING
Nanjing
Zhongda Hospital Southeast University ( Site 3919)
RECRUITING
Nanjing
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 3915)
RECRUITING
Shanghai
Ruijin Hospital Shanghai Jiaotong University School of Medicine-Gastroneterology ( Site 3903)
RECRUITING
Shanghai
Shanghai East Hospital ( Site 3922)
RECRUITING
Shanghai
Yuebei People's Hospital Guangdong ( Site 3948)
RECRUITING
Shaoguan
Shenzhen Hospital of Southern Medical University ( Site 3905)
RECRUITING
Shenzhen
The University of Hong Kong-Shenzhen Hospital ( Site 3955)
RECRUITING
Shenzhen
The Second Hospital of Hebei Medical University ( Site 3934)
RECRUITING
Shijiazhuang
Taihe Hospital ( Site 3941)
RECRUITING
Shiyan
Taian City Central Hospital-gastroenterology department ( Site 3946)
RECRUITING
Taian
Tianjin Medical University General Hospital ( Site 3945)
RECRUITING
Tianjin
The First Teaching Hospital of Xinjiang Medical University. ( Site 3937)
RECRUITING
Ürümqi
Renmin Hospital of Wuhan University ( Site 3912)
RECRUITING
Wuhan
The Central Hospital of Wuhan ( Site 3939)
RECRUITING
Wuhan
Wuxi People's Hospital ( Site 3920)
RECRUITING
Wuxi
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 3929)
RECRUITING
Xi'an
The First Affiliated hospital of Xiamen University-Gastroenterology ( Site 3954)
RECRUITING
Xiamen
The Second Affiliated Hospital of Zhengzhou University ( Site 3935)
RECRUITING
Zhengzhou
Colombia
Clinica de la Costa S.A.S. ( Site 2305)
RECRUITING
Barranquilla
Fundacion Santa Fe de Bogota ( Site 2316)
RECRUITING
Bogota
Clínica las Américas ( Site 2318)
RECRUITING
Medellín
Clinica Medellin S.A ( Site 2317)
RECRUITING
Medellín
Oncologos del Occidente ( Site 2310)
RECRUITING
Pereira
Clinica Somer-Unidad de Investigacion y Docencia ( Site 2303)
RECRUITING
Rionegro
Fundación Valle del Lili ( Site 2307)
RECRUITING
Santiago De Cali
Croatia
Poliklinika Borzan ( Site 0500)
RECRUITING
Osijek
Klinički Bolnički Centar Split ( Site 0503)
RECRUITING
Split
Klinička bolnica Merkur ( Site 0505)
RECRUITING
Zagreb
Klinički bolnički centar Zagreb ( Site 0501)
RECRUITING
Zagreb
Poliklinika Bates ( Site 0504)
RECRUITING
Zagreb
Poliklinika Solmed ( Site 0502)
RECRUITING
Zagreb
Dominican Republic
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 3601)
RECRUITING
Santo Domingo
Finland
Pohjois-Karjalan keskussairaala ( Site 4302)
RECRUITING
Joensuu
Tampereen yliopistollinen sairaala ( Site 4300)
RECRUITING
Tampere
Turku University Hospital ( Site 4301)
RECRUITING
Turku
France
CHU d'Amiens-Picardie - Hôpital Sud-Hepato-gastroentérology ( Site 0712)
RECRUITING
Amiens
CHU Besançon ( Site 0710)
RECRUITING
Besançon
Hopital Beaujon ( Site 0716)
RECRUITING
Clichy
Hopital Henri Mondor ( Site 0717)
RECRUITING
Créteil
Clinique des Cèdres ( Site 0719)
RECRUITING
Échirolles
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0715)
RECRUITING
Le Kremlin-bicêtre
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0714)
RECRUITING
Marseille
CHU SAINT ELOI ( Site 0711)
RECRUITING
Montpellier
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0701)
RECRUITING
Nantes
CMC Ambroise Paré Hartmann - Institut des MICI ( Site 0709)
RECRUITING
Neuilly-sur-seine
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0706)
RECRUITING
Nice
C.H.U. de Nimes. Hopital Caremeau ( Site 0718)
RECRUITING
Nîmes
Hôpital Saint Antoine ( Site 0703)
RECRUITING
Paris
Hôpital Saint-Louis ( Site 0702)
RECRUITING
Paris
CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0700)
RECRUITING
Pessac
centre hospitalier lyon sud ( Site 0707)
RECRUITING
Pierre-bénite
Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré ( Site 0705)
COMPLETED
Reims
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 0708)
RECRUITING
Vandœuvre-lès-nancy
Georgia
LTD High Technology Hospital Medcenter ( Site 0802)
RECRUITING
Batumi
Caraps Medline ( Site 0803)
RECRUITING
Tbilisi
Caucasus Medical Centre ( Site 0801)
RECRUITING
Tbilisi
New Hospitals ( Site 0800)
RECRUITING
Tbilisi
Germany
Charité Campus Virchow-Klinikum ( Site 0906)
RECRUITING
Berlin
Universitätsklinikum Brandenburg an der Havel ( Site 0905)
RECRUITING
Brandenburg
MVZ Dachau ( Site 0918)
RECRUITING
Dachau
Stadtische Kliniken Duisburg, Abtlg. Innere Medizin ( Site 0916)
RECRUITING
Duisburg
Agaplesion Markus Krankenhaus ( Site 0904)
RECRUITING
Frankfurt Am Main
Medizinische Hochschule Hannover ( Site 0913)
RECRUITING
Hanover
Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0903)
RECRUITING
Kiel
Universitätsklinikum Leipzig ( Site 0909)
RECRUITING
Leipzig
St. Marien und St. Annastift Krankenhaus ( Site 0901)
RECRUITING
Ludwighafen Am Rhein
Klinikum Lüneburg ( Site 0908)
RECRUITING
Lüneburg
Gastroenterologische Gemeinschaftspraxis Minden ( Site 0911)
RECRUITING
Minden
Klinikum der Universität München Großhadern-Medizinische Klinik und Poliklinik II ( Site 0907)
RECRUITING
Munich
Medizinisches Versorgungszentrum Portal 10 ( Site 0914)
RECRUITING
Münster
Universitaetsklinikum Ulm. ( Site 0902)
RECRUITING
Ulm
Greece
Evangelismos General Hospital of Athens ( Site 4001)
RECRUITING
Athens
THORACIC GENERAL HOSPITAL OF ATHENS I SOTIRIA-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 4000)
RECRUITING
Athens
University General Hospital of Heraklion-GASTROENTEROLOGY & HEPATOLOGY ( Site 4003)
RECRUITING
Heraklion
General Hospital of Nikaia-Piraeus Agios Panteleimon ( Site 4006)
RECRUITING
Nikaia Piraeus
Ippokrateio General Hospital of Thessaloniki ( Site 4004)
RECRUITING
Thessaloniki
Hungary
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1007)
RECRUITING
Békéscsaba
Pannónia Magánorvosi Centrum ( Site 1004)
RECRUITING
Budapest
Semmelweis Egyetem ( Site 1006)
RECRUITING
Budapest
Synexus Magyarorszag Kft. (Budapest DRS) ( Site 1009)
COMPLETED
Budapest
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1012)
RECRUITING
Eger
Gyöngyösi Bugát Pál Kórház ( Site 1011)
RECRUITING
Gyöngyös
Csőszi Endoszkópos KFT ( Site 1001)
RECRUITING
Kecskemét
Mohácsi Kórház ( Site 1008)
RECRUITING
Mohács
Komarom-Esztergom Varmegyei Szent Borbala Korhaz ( Site 1010)
RECRUITING
Tatabánya
VeszLife Magánklinika ( Site 1002)
RECRUITING
Veszprém
Israel
Emek Medical Center ( Site 1106)
RECRUITING
Afula
Barzilai Medical Center ( Site 1109)
RECRUITING
Ashkelon
Bnai Zion Medical Center ( Site 1103)
RECRUITING
Haifa
Rambam Health Care Campus ( Site 1101)
RECRUITING
Haifa
Edith Wolfson Medical Center ( Site 1104)
RECRUITING
Holon
Shaare Zedek Medical Center ( Site 1108)
RECRUITING
Jerusalem
Meir Medical Center. ( Site 1102)
RECRUITING
Kfar Saba
Rabin Medical Center ( Site 1107)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 1100)
RECRUITING
Ramat Gan
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1208)
RECRUITING
Bologna
ASST Fatebenefratelli Sacco-UOC Gastroenterologia ( Site 1200)
RECRUITING
Milan
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Gastroenterology and Endoscopy Unit ( Site 1202)
RECRUITING
Milan
Ospedale San Raffaele-Gastroenterology and Gastrointestinal Endoscopy ( Site 1205)
RECRUITING
Milan
Policlinico Universitario Monserrato-SC Gastroenterologia ( Site 1207)
RECRUITING
Monserrato
A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 1217)
RECRUITING
Naples
Ospedale Sacro Cuore Don G. Calabria ( Site 1212)
RECRUITING
Negrar
Azienda Ospedale - Università Padova-Surgery Oncology and Gastroenterology ( Site 1211)
RECRUITING
Padua
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-U.O.S.D. Malattie Infiammatorie Croniche Intestinali ( Site 1210)
RECRUITING
Palermo
Fondazione IRCCS Policlinico San Matteo-General Medicine ( Site 1206)
RECRUITING
Pavia
Ospedale Di Circolo-U.O.C. di Gastroenterologia ed Endoscopia Digestiva ( Site 1216)
RECRUITING
Rho
Azienda Ospedaliera San Camillo Forlanini ( Site 1204)
RECRUITING
Rome
Fatebenefratelli Isola Tiberina - Gemelli Isola ( Site 1214)
RECRUITING
Rome
Fondazione Policlinico Tor Vergata ( Site 1209)
RECRUITING
Rome
Istituto Clinico Humanitas-IBD center ( Site 1201)
RECRUITING
Rozzano
IRCCS Casa Sollievo della Sofferenza ( Site 1213)
RECRUITING
San Giovanni Rotondo
Japan
Tokatsu Tsujinaka Hospital ( Site 2832)
RECRUITING
Abiko
Asahikawa City Hospital ( Site 2840)
RECRUITING
Asahikawa
Asahikawa Medical University Hospital ( Site 2815)
RECRUITING
Asahikawa
Institute of Science Tokyo Hospital ( Site 2827)
RECRUITING
Bunkyō
Ginza Central Clinic ( Site 2824)
RECRUITING
Chūō
Sai Gastroenterology/Proctology Clinic ( Site 2814)
RECRUITING
Fujiidera
Fukui Prefectural Hospital ( Site 2844)
RECRUITING
Fukui
Fukuoka University Hospital ( Site 2818)
RECRUITING
Fukuoka
National Hospital Organization Fukuyama Medical Center ( Site 2831)
RECRUITING
Fukuyama
Hamamatsu University Hospital ( Site 2874)
RECRUITING
Hamamatsu
Matsuda Hospital ( Site 2826)
RECRUITING
Hamamatsu
Kansai Medical University Hospital ( Site 2823)
RECRUITING
Hirakata
Hiroshima University Hospital ( Site 2845)
RECRUITING
Hiroshima
Hitachi General Hospital ( Site 2856)
RECRUITING
Hitachi
Kagoshima IBD Gastroenterology Clinic ( Site 2821)
RECRUITING
Kagoshima
Kagoshima University Hospital ( Site 2848)
RECRUITING
Kagoshima
Gokeikai Ofuna Chuo Hospital ( Site 2801)
RECRUITING
Kamakura
Ishikawa Prefectural Central Hospital ( Site 2835)
RECRUITING
Kanazawa
Kanazawa University Hospital ( Site 2839)
RECRUITING
Kanazawa
Tsujinaka Hospital - Kashiwanoha ( Site 2802)
RECRUITING
Kashiwa
St. Marianna University Hospital ( Site 2852)
RECRUITING
Kawasaki
Kitakyushu Municipal Medical Center ( Site 2873)
RECRUITING
Kitakyushu
Yamanashi Prefectural Central Hospital ( Site 2836)
RECRUITING
Kofu
Kurume University Hospital ( Site 2846)
RECRUITING
Kurume
National Hospital Organization Kyoto Medical Center ( Site 2813)
RECRUITING
Kyoto
University Hospital,Kyoto Prefectural University of Medicine ( Site 2819)
RECRUITING
Kyoto
Gunma University Hospital ( Site 2850)
RECRUITING
Maebashi
Ehime Prefectural Central Hospital ( Site 2868)
RECRUITING
Matsuyama
The Jikei University Hospital ( Site 2843)
RECRUITING
Minato
Kitasato University Kitasato Institute Hospital ( Site 2817)
RECRUITING
Minato-ku
Toranomon Hospital ( Site 2828)
RECRUITING
Minato-ku
Kyorin University Hospital ( Site 2804)
RECRUITING
Mitaka-shi
Iwate Medical University Uchimaru Medical Center ( Site 2833)
RECRUITING
Morioka
Aichi Medical University Hospital ( Site 2841)
RECRUITING
Nagakute
Hyogo Medical University Hospital ( Site 2830)
RECRUITING
Nishinomiya
Ishida Clinic of IBD and Gastroenterology ( Site 2820)
RECRUITING
Ōita
Okayama University Hospital ( Site 2870)
RECRUITING
Okayama
Infusion Clinic ( Site 2806)
RECRUITING
Osaka
National Hospital Organization Osaka National Hospital ( Site 2869)
RECRUITING
Osaka
Saga University Hospital ( Site 2812)
RECRUITING
Saga
Tokitokai Tokito Clinic Coloproctology Center ( Site 2811)
RECRUITING
Saitama
Toho University Sakura Medical Center ( Site 2805)
RECRUITING
Sakura
Medical Corporation Sapporo IBD Clinic ( Site 2842)
RECRUITING
Sapporo
Sapporo Medical University Hospital ( Site 2829)
RECRUITING
Sapporo
Sapporo Tokushukai Hospital ( Site 2808)
RECRUITING
Sapporo
Sapporohigashi Tokushukai Hospital ( Site 2860)
RECRUITING
Sapporo
National Hospital Organization Shizuoka Medical Center ( Site 2837)
RECRUITING
Shimizu
NTT Medical Center Tokyo ( Site 2834)
RECRUITING
Shinagawa-ku
Tokyo Yamate Medical Center ( Site 2803)
RECRUITING
Tokyo
Toyama Prefectural Central Hospital ( Site 2807)
RECRUITING
Toyama
Mie University Hospital ( Site 2838)
RECRUITING
Tsu
Yamagata University Hospital ( Site 2849)
RECRUITING
Yamagata
Matsushima Hospital ( Site 2822)
RECRUITING
Yokohama
Yokohama City University Medical Center ( Site 2865)
RECRUITING
Yokohama
Latvia
SIA M & M Centrs ( Site 4502)
RECRUITING
Ādaži
Liepaja Regional Hospital ( Site 4501)
RECRUITING
Liepāja
P.Stradins Clinical University Hospital Center of Gastroenterology Hepatology and Nutrition ( Site 4503)
RECRUITING
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 4600)
RECRUITING
Kaunas
VUL SANTAROS KLINIKOS ( Site 4601)
RECRUITING
Vilnius
Malaysia
Hospital Ampang ( Site 4703)
RECRUITING
Ampang
Hospital Sultanah Aminah ( Site 4702)
RECRUITING
Johor Bahru
Hospital Universiti Sains Malaysia ( Site 4704)
RECRUITING
Kubang Kerian
Hospital Tuanku Jaafar Seremban ( Site 4705)
RECRUITING
Seremban
Mexico
ICARO Investigaciones en Medicina ( Site 2405)
RECRUITING
Chihuahua City
PanAmerican Clinical Research - Guadalajara ( Site 2400)
RECRUITING
Guadalajara
Morales Vargas Centro de Investigacion ( Site 2411)
RECRUITING
León
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 2407)
RECRUITING
Mérida
Centro de Investigación y Gastroenterología - S.C. ( Site 2410)
RECRUITING
Mexico City
Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 2406)
RECRUITING
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 2409)
RECRUITING
Monterrey
Oaxaca Site Management Organization S.C. ( Site 2404)
RECRUITING
Oaxaca City
Centro Medico Clinico Quirurgico Especializado en Investigación ( Site 2403)
RECRUITING
Tlajumulco De Zuniga
Netherlands
Amsterdam UMC, locatie VUmc-IBD Trial Unit ( Site 1400)
RECRUITING
Amsterdam
Onze Lieve Vrouwe Gasthuis ( Site 1405)
RECRUITING
Amsterdam
Deventer Ziekenhuis ( Site 1411)
RECRUITING
Deventer
Radboudumc ( Site 1402)
RECRUITING
Nijmegen
Erasmus Medisch Centrum ( Site 1410)
RECRUITING
Rotterdam
Franciscus Gasthuis & Vlietland, Locatie Gasthuis ( Site 1406)
COMPLETED
Rotterdam
ETZ Elisabeth-Department of Gastroenterology and Hepatology ( Site 1403)
RECRUITING
Tilburg
Ziekenhuis Bernhoven-Researchbureau ( Site 1401)
RECRUITING
Uden
Universitair Medisch Centrum Utrecht ( Site 1404)
COMPLETED
Utrecht
New Zealand
Aotearoa Clinical Trials ( Site 2900)
RECRUITING
Auckland
Waikato Hospital ( Site 2903)
RECRUITING
Hamilton
Hutt Valley District Health board HVDHB ( Site 2902)
RECRUITING
Lower Hutt
Norway
Akershus Universitetssykehus ( Site 4200)
RECRUITING
Lørenskog
Oslo Universitetssykehus Ullevål ( Site 4201)
RECRUITING
Oslo
Poland
M2M Med ( Site 1526)
RECRUITING
Chorzów
Vita Longa Sp. Zoo ( Site 1527)
RECRUITING
Katowice
PROMED P. LACH R. GLOWACKI SP. J. ( Site 1529)
RECRUITING
Krakow
Topolowa Medicenter Ryszawa & Wspolnicy sp.j. ( Site 1500)
RECRUITING
Krakow
AmiCare Centrum Medyczne - Zgierska ( Site 1517)
RECRUITING
Lodz
Med-Gastr Sp. z o.o., sp.k ( Site 1515)
RECRUITING
Lodz
Allmedica ( Site 1508)
RECRUITING
Nowy Targ
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.,Twoja Przychodnia PCM ( Site 1523)
RECRUITING
Poznan
Sonomed Sp. z o. o. ( Site 1516)
RECRUITING
Szczecin
Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 1502)
RECRUITING
Szczecin
Gastromed Sp. z o. o. ( Site 1513)
RECRUITING
Torun
Centrum Zdrowia MDM ( Site 1512)
RECRUITING
Warsaw
ETG Warszawa ( Site 1525)
RECRUITING
Warsaw
Vivamed Sp. z o.o. ( Site 1510)
RECRUITING
Warsaw
WIP Warsaw IBD Point Profesor Kierkuś ( Site 1503)
RECRUITING
Warsaw
EMC Instytut Medyczny SA ( Site 1505)
RECRUITING
Wroclaw
Melita Medical ( Site 1519)
RECRUITING
Wroclaw
Planetmed ( Site 1506)
RECRUITING
Wroclaw
Vistamed & Vertigo Sp. z o.o. ( Site 1528)
RECRUITING
Wroclaw
Portugal
Unidade Local de Saude de Braga - Hospital de Braga ( Site 3300)
RECRUITING
Braga
Hospital dos Lusíadas Lisboa ( Site 3303)
RECRUITING
Lisbon
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3305)
RECRUITING
Lisbon
Unidade Local de Saude Lisboa Ocidental - Hospital Egas Moniz ( Site 3306)
RECRUITING
Lisbon
ULSAM - Hospital de Santa Luzia ( Site 3302)
RECRUITING
Viana Do Castelo
Unidade Local de Saude Dão-Lafões - Hospital de São Teotónio ( Site 3308)
RECRUITING
Viseu
Republic of Korea
Dong-A University Hospital ( Site 3010)
RECRUITING
Busan
Yeungnam University Medical Center ( Site 3004)
RECRUITING
Daegu
The Catholic University of Korea, Daejeon St. Mary's Hospital ( Site 3011)
RECRUITING
Daejeon
Chung-Ang University Hospital ( Site 3008)
RECRUITING
Dongjak-gu
Inje University Haeundae Paik Hospital ( Site 3009)
RECRUITING
Haeundae-gu
Asan Medical Center ( Site 3007)
RECRUITING
Seoul
Kangbuk Samsung Hospital-Internal Medicine ( Site 3002)
RECRUITING
Seoul
Kyung Hee University Hospital ( Site 3013)
RECRUITING
Seoul
Samsung Medical Center ( Site 3001)
RECRUITING
Seoul
Seoul National University Hospital ( Site 3005)
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System-Department of Internal Medicine ( Site 3000)
COMPLETED
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3012)
RECRUITING
Seoul
The Catholic University Of Korea St. Vincent's Hospital-Gastroenterology ( Site 3006)
RECRUITING
Suwon
Wonju Severance Christian Hospital-Internal Medicine ( Site 3003)
RECRUITING
Wŏnju
Romania
Fundeni Clinical Institute-Gastroenterology and Hepatology Center ( Site 1608)
RECRUITING
Bucharest
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 1606)
RECRUITING
Bucharest
S.C. Centrul Medical Medicum SRL-Gastroenterology ( Site 1604)
RECRUITING
Bucharest
GastroMed ( Site 1609)
RECRUITING
Cluj-napoca
Spitalul Clinic Judetean de Urgenta Cluj Napoca-Gastroenterology ( Site 1605)
RECRUITING
Cluj-napoca
Spitalul Clinic Judetean Mures-Gastroenterology ( Site 1607)
RECRUITING
Târgu Mureş
Asociatia Oncohelp ( Site 1610)
RECRUITING
Timișoara
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L-Gastroenterology ( Site 1601)
RECRUITING
Timișoara
Serbia
Clinical Hospital Center Dragisa Misovic ( Site 1708)
RECRUITING
Belgrade
Clinical Hospital Center Zvezdara-Gastroenterology and hepatology Department ( Site 1705)
RECRUITING
Belgrade
University Medical Center Bezanijska kosa-Gastroenterology and hepatology ( Site 1704)
RECRUITING
Belgrade
Clinical Center Kragujevac ( Site 1703)
RECRUITING
Kragujevac
General Hospital Djordje Joanovic ( Site 1707)
RECRUITING
Zrenjanin
Singapore
Singapore General Hospital ( Site 4801)
RECRUITING
Singapore
Tan Tock Seng Hospital-Gastroenterology and Hepatology ( Site 4800)
RECRUITING
Singapore
Slovakia
Cliniq s.r.o. ( Site 1800)
RECRUITING
Bratislava
Breznianske centrum gastroenterologie ( Site 1806)
ACTIVE_NOT_RECRUITING
Brezno
ENDOMED ( Site 1801)
RECRUITING
Košice
KM Management ( Site 1804)
RECRUITING
Nitra
GASTRO I ( Site 1807)
RECRUITING
Prešov
Gastro LM ( Site 1808)
RECRUITING
Prešov
Accout Center ( Site 1805)
RECRUITING
Šahy
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica ( Site 1802)
RECRUITING
Slovakia
South Africa
Life Kingsbury Hospital ( Site 3203)
RECRUITING
Cape Town
Panorama Medical Centre ( Site 3209)
RECRUITING
Cape Town
Private Practice - Dr. M.N. Rajabally ( Site 3213)
RECRUITING
Cape Town
Spoke Research ( Site 3210)
RECRUITING
Cape Town
Wits Clinical Research-Research ( Site 3208)
RECRUITING
Johannesburg
Wits Clinical Research-Wits Clinical Research Bara ( Site 3206)
RECRUITING
Soweto
Spain
Hospital Germans Trias i Pujol ( Site 3413)
RECRUITING
Badalona
Hospital Universitario de Fuenlabrada-Digestive ( Site 3415)
COMPLETED
Fuenlabrada
Hospital Galdakao-Usansolo ( Site 3409)
RECRUITING
Galdakao-usansolo
Fundación Jimenez Diaz ( Site 3420)
RECRUITING
Madrid
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Aparato Digestivo ( Site 3403)
RECRUITING
Madrid
Hospital La Princesa-Gastroenterology ( Site 3411)
RECRUITING
Madrid
Hospital Universitario La Paz-Unidad de Enfermedad Inflamatoria Intestinal ( Site 3402)
RECRUITING
Madrid
Hospital Universitari Mutua Terrassa ( Site 3416)
RECRUITING
Terrassa
Hospital Universitario de Torrejon ( Site 3417)
RECRUITING
Torrejón De Ardoz
HOSPITAL CLINICO DE VALENCIA ( Site 3406)
COMPLETED
Valencia
Hospital Universitari i Politecnic La Fe-Enfermedad Inflamatoria Intestinal ( Site 3405)
RECRUITING
Valencia
Sweden
Danderyds Sjukhus ( Site 4401)
RECRUITING
Danderyd
Universitetssjukhuset i Linköping ( Site 4402)
RECRUITING
Linköping
Karolinska Universitetssjukhuset Solna ( Site 4400)
RECRUITING
Stockholm
Akademiska Sjukhuset ( Site 4403)
RECRUITING
Uppsala
Switzerland
INTESTO-Gastroenterologische Praxis / Crohn-Colitis Zentrum Bern ( Site 1902)
RECRUITING
Bern
Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 1901)
RECRUITING
Sankt Gallen
UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 1900)
RECRUITING
Zurich
Taiwan
Changhua Christian Hospital ( Site 3104)
RECRUITING
Changhua County
China Medical University Hospital ( Site 3100)
RECRUITING
Taichung
National Taiwan University Hospital ( Site 3102)
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch ( Site 3101)
RECRUITING
Taoyuan District
National Taiwan University BioMedical Park Hospital ( Site 3103)
RECRUITING
Zhubei
Turkey
Ankara Bilkent Şehir Hastanesi-Gastroenterology ( Site 3501)
RECRUITING
Ankara
ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 3507)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri ( Site 3500)
RECRUITING
Ankara
Antalya Egitim ve Arastirma Hastanesi ( Site 3508)
RECRUITING
Antalya
Trakya University Medical Faculty Hospital ( Site 3510)
RECRUITING
Edirne
Eskisehir Osmangazi University Faculty of Medicine ( Site 3512)
RECRUITING
Eskişehir
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 3505)
RECRUITING
Istanbul
Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3503)
RECRUITING
Istanbul- Fatih
Kocaeli University Medical Faculty Hospital ( Site 3509)
RECRUITING
Kocaeli
Ukraine
Communal non-profit enterprise Regional clinical hospital of Ivano-Frankivsk Regional Council ( Site 4115)
RECRUITING
Ivano-frankivsk
Center of Family Medicine Plus-Treatment Prevention Unit ( Site 4103)
RECRUITING
Kyiv
Dobrobut Medical Center ( Site 4101)
RECRUITING
Kyiv
Medical Center of Private Enterprise Sygma ( Site 4108)
RECRUITING
Kyiv
Medical Center Universal Clinic Oberig of Limited Liability Company Kapytal ( Site 4100)
RECRUITING
Kyiv
Municipal Enterprise Volyn Regional Clinical Hospital of V-surgery department (abdominal, colopro ( Site 4113)
RECRUITING
Lutsk
Communal Non-profit Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital-proctology ( Site 4109)
RECRUITING
Lviv
Communal Non-Commercial Enterprise Vinnytsia City Clinical -Clinical Therapeutic Department #1 ( Site 4111)
RECRUITING
Vinnytsia
Limited liability company Medical center Health Clinic-Gastroenterology, Hepatology and Endocrino ( Site 4107)
RECRUITING
Vinnytsia
Municipal Nonprofit Enterprise Vinnytsia Regional Clinical -Gastroenterology department ( Site 4114)
RECRUITING
Vinnytsia
United Kingdom
Southmead Hospital ( Site 2004)
RECRUITING
Bristol
Addenbrooke's Hospital ( Site 2005)
RECRUITING
Cambridge
Doncaster Royal Infirmary ( Site 2006)
RECRUITING
Doncaster
Royal Devon & Exeter Hospital-IBD Research Group ( Site 2001)
RECRUITING
Exeter
Huddersfield Royal Infirmary ( Site 2010)
RECRUITING
Huddersfield
St. George's Hospital ( Site 2007)
RECRUITING
London
University College London Hospital-Clinical Research Facility ( Site 2002)
RECRUITING
London
Whipps Cross University Hospital-Clinical Research Unit ( Site 2000)
RECRUITING
London
Southampton General Hospital-Gastroenterology ( Site 2003)
RECRUITING
Southampton
Walsall Manor Hospital ( Site 2009)
RECRUITING
West Midlands
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2023-10-25
Estimated Completion Date: 2029-12-17
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

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