A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease

Status: Recruiting
Location: See all (450) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. 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 per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). 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 per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).

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

• Has had a diagnosis of CD at least 3 months before study.

• Has moderately to severely active CD.

• Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.

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

Locations
United States
Alabama
Digestive Health Specialists ( Site 5064)
RECRUITING
Dothan
Arizona
Arizona Arthritis & Rheumatology Research, PC ( Site 5094)
RECRUITING
Phoenix
GI Alliance - Sun City ( Site 5118)
RECRUITING
Sun City
University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)
RECRUITING
Tucson
California
Clinnova Research ( Site 5110)
RECRUITING
Anaheim
Southern California Research Center ( Site 5044)
RECRUITING
Coronado
Om Research LLC ( Site 5038)
RECRUITING
Lancaster
Cedars Sinai Medical Center ( Site 5080)
RECRUITING
Los Angeles
UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)
RECRUITING
Los Angeles
Om Research LLC ( Site 5045)
RECRUITING
Oxnard
Clinical Applications Laboratories ( Site 5123)
RECRUITING
San Diego
Amicis Research Center - Valencia ( Site 5055)
RECRUITING
Valencia
Colorado
University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 5026)
RECRUITING
Aurora
Peak Gastroenterology Associates ( Site 5023)
RECRUITING
Colorado Springs
South Denver Gastroenterology, PC ( Site 5132)
RECRUITING
Englewood
Rocky Mountain Gastroenterology ( Site 5082)
RECRUITING
Lakewood
Connecticut
Medical Research Center of Connecticut ( Site 5005)
RECRUITING
Hamden
Yale University School of Medicine-Digestive Disease ( Site 5019)
RECRUITING
New Haven
Washington, D.c.
Emerson Clinical Research Institute ( Site 5051)
RECRUITING
Washington D.c.
Florida
Gastroenterology Consultants of Clearwater ( Site 5052)
RECRUITING
Clearwater
Nature Coast Clinical Research - Inverness ( Site 5042)
RECRUITING
Inverness
Atlantic Medical Research ( Site 5073)
RECRUITING
Margate
Endoscopic Research Inc ( Site 5061)
RECRUITING
Orlando
Orlando Health-Digestive Health Institute ( Site 5010)
RECRUITING
Orlando
USF Health Carol and Frank Morsani Center for Advanced Healthcare ( Site 5039)
RECRUITING
Tampa
Georgia
Atlanta Center for Gastroenterology ( Site 5035)
RECRUITING
Decatur
Gastroenterology Associates of Central Georgia ( Site 5048)
RECRUITING
Macon
Iowa
Iowa Digestive Disease Center ( Site 5007)
RECRUITING
Clive
Illinois
Eagle Clinical Research ( Site 5089)
RECRUITING
Chicago
University of Chicago Medical Center ( Site 5066)
RECRUITING
Chicago
Endeavor Health ( Site 5018)
RECRUITING
Evanston
GI ALLIANCE - GURNEE ( Site 5003)
RECRUITING
Gurnee
Indiana
Indiana University Health University Hospital ( Site 5022)
RECRUITING
Indianapolis
Kansas
Cotton O'Neil Digestive Health Center ( Site 5033)
RECRUITING
Topeka
Louisiana
Southern Clinical Research ( Site 5095)
RECRUITING
Zachary
Massachusetts
Massachusetts General Hospital-Crohn's and Colitis Center ( Site 5037)
RECRUITING
Boston
Maryland
Walter Reed National Military Medical Center ( Site 5006)
RECRUITING
Bethesda
Michigan
University of Michigan ( Site 5060)
RECRUITING
Ann Arbor
Clinical Research Institute of Michigan, LLC ( Site 5002)
RECRUITING
Clinton Township
Minnesota
Mayo Clinic in Rochester, Minnesota ( Site 5024)
RECRUITING
Rochester
Missouri
Mid-America GI Clinical Research ( Site 5130)
RECRUITING
Kansas City
BVL Research - Kansas ( Site 5099)
RECRUITING
Liberty
Washington University School of Medicine ( Site 5058)
RECRUITING
St Louis
North Carolina
University of North Carolina Medical Center ( Site 5034)
RECRUITING
Chapel Hill
Atrium Health Gastroenterology MMP ( Site 5105)
RECRUITING
Charlotte
Javara - Tryon Medical Partners ( Site 5046)
COMPLETED
Charlotte
New Jersey
HMHN Justice Marie Garibaldi Medical Plaza ( Site 5072)
RECRUITING
Hackensack
New York
Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017)
RECRUITING
Great Neck
Circuit Clinical /Crystal Run Healthcare LLP ( Site 5050)
RECRUITING
Middletown
New York Gastroenterology Associates ( Site 5013)
RECRUITING
New York
NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)
RECRUITING
New York
Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)
RECRUITING
New York
Ohio
Great Lakes Gastroenterology Research, LLC ( Site 5016)
RECRUITING
Mentor
Oklahoma
Digestive Disease Specialists Inc. ( Site 5117)
RECRUITING
Oklahoma City
Pennsylvania
Thomas Jefferson University Hospital ( Site 5133)
RECRUITING
Philadelphia
Frontier Clinical Research, LLC ( Site 5098)
RECRUITING
Uniontown
Rhode Island
University Gastroenterology - Providence - West River Street ( Site 5057)
RECRUITING
Providence
Tennessee
Quality Medical Research ( Site 5114)
RECRUITING
Nashville
Vanderbilt Inflammatory Bowel Disease Clinic ( Site 5049)
RECRUITING
Nashville
Texas
Baylor University Medical Center ( Site 5031)
RECRUITING
Dallas
GI Alliance - Dallas - Gaston Avenue ( Site 5054)
RECRUITING
Dallas
Baylor College of Medicine Medical Center ( Site 5020)
RECRUITING
Houston
Caprock Gastro Research ( Site 5077)
RECRUITING
Lubbock
GI Alliance - Lubbock ( Site 5012)
RECRUITING
Lubbock
GI Alliance: Mansfield ( Site 5015)
RECRUITING
Mansfield
Southern Star Research Institute ( Site 5000)
RECRUITING
San Antonio
GI Alliance - Southlake ( Site 5109)
RECRUITING
Southlake
Tyler Research Institute ( Site 5001)
RECRUITING
Tyler
Virginia
Richmond VA Medical Center ( Site 5021)
RECRUITING
Richmond
Washington
Washington Gastroenterology - Bellevue ( Site 5040)
RECRUITING
Bellevue
Swedish Medical Center ( Site 5112)
RECRUITING
Seattle
Washington Gastroenterology - Tacoma ( Site 5004)
RECRUITING
Tacoma
Other Locations
Australia
Royal Adelaide Hosp - GI Clinical Trials ( Site 3203)
RECRUITING
Adelaide
Mater Misericordiae Limited ( Site 3209)
RECRUITING
Brisbane
Royal Brisbane and Women's Hospital ( Site 3200)
RECRUITING
Brisbane
Monash Health-Gastroenterology ( Site 3206)
RECRUITING
Clayton
Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 3202)
RECRUITING
Concord
The Alfred Hospital-Gastroenterology ( Site 3201)
RECRUITING
Melbourne
Austria
Medizinische Universitaet Innsbruck-Innere Medizin 1 ( 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
AZ Delta vzw-Gastroenterology ( Site 0304)
RECRUITING
Roeselare
Canada
Barrie GI Associates ( Site 0016)
RECRUITING
Barrie
Heritage Medical Research Clinic ( Site 0004)
RECRUITING
Calgary
Gastroenterology and internal medicine research institute ( Site 0009)
RECRUITING
Edmonton
Private Practice - Dr. Bruce Musgrave ( Site 0014)
RECRUITING
Kentville
SIX08 Gastroenterology ( Site 0015)
RECRUITING
Lethbridge
Centre de recherche du CISSS de Chaudière-Appalaches - Hôpital Hôtel Dieu de Levis ( Site 0011)
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 0020)
RECRUITING
Mississauga
Centre Hospitalier de l'Université de Montréal - Gastroenterology ( Site 0013)
RECRUITING
Montreal
Montreal General Hospital ( Site 0003)
RECRUITING
Montreal
Fraser Clinical Trials Inc ( Site 0001)
RECRUITING
New Westminster
ABP Research Services Corp. ( Site 0019)
RECRUITING
Oakville
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 0018)
RECRUITING
Vancouver
Toronto Digestive Disease Associates ( Site 0006)
RECRUITING
Vaughan
Chile
Hospital Clínico Regional Dr. Guillermo Grant Benavente ( Site 2604)
RECRUITING
Concepción
CECIM ( Site 2603)
RECRUITING
Santiago
Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2602)
RECRUITING
Santiago
Espacio Eme ( Site 2608)
RECRUITING
Santiago
FALP-UIDO ( Site 2600)
RECRUITING
Santiago
Hospital hernan henriquez aravena de temuco ( Site 2607)
RECRUITING
Temuco
Centro de Investigaciones Clinicas Vina del Mar ( Site 2606)
RECRUITING
Viña Del Mar
China
Peking University Third Hospital ( Site 3910)
RECRUITING
Beijing
The Second Xiangya Hospital of Central South University-gastroenterology department ( Site 3905)
RECRUITING
Changsha
West China Hospital, Sichuan University ( Site 3929)
RECRUITING
Chengdu
Chongqing General Hospital ( Site 3940)
RECRUITING
Chongqing
Dongguan People's Hospital ( Site 3933)
RECRUITING
Dongguan
The First Affiliated Hospital Of Fujian Medical University ( Site 3916)
RECRUITING
Fuzhou
The First Affiliated Hospital, Sun Yat-sen University ( Site 3901)
RECRUITING
Guangzhou
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 3907)
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-GI Medicine ( Site 3902)
RECRUITING
Hangzhou
Anhui Provincial Hospital ( Site 3922)
RECRUITING
Hefei
Huai'an First People's Hospital ( Site 3948)
RECRUITING
Huaian
Huizhou Municipal Central Hospital ( Site 3915)
RECRUITING
Huizhou
First Affiliated Hospital of Kunming Medical University ( Site 3928)
RECRUITING
Kunming
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 3937)
RECRUITING
Nanjing
Zhongda Hospital Southeast University-Gastroenterology ( Site 3911)
RECRUITING
Nanjing
Huashan Hospital of Fudan University ( Site 3946)
RECRUITING
Shanghai
Ruijin Hospital Shanghai Jiaotong University School of Medicine ( Site 3931)
RECRUITING
Shanghai
Shanghai East Hospital ( Site 3914)
RECRUITING
Shanghai
Yuebei People's Hospital ( Site 3912)
RECRUITING
Shaoguan
Shenzhen Hospital of Southern Medical University ( Site 3932)
RECRUITING
Shenzhen
The University of Hong Kong-Shenzhen Hospital ( Site 3930)
RECRUITING
Shenzhen
The Second Afilliated Hospital of Hebei Medical University ( Site 3913)
RECRUITING
Shijiazhuang
Taihe Hospital ( Site 3944)
RECRUITING
Shiyan
Suining Central Hospital ( Site 3927)
RECRUITING
Suining
Taizhou Hospital of Zhejiang Province ( Site 3936)
RECRUITING
Taizhou
Renmin Hospital of Wuhan University ( Site 3921)
RECRUITING
Wuhan
Wuxi People's Hospital ( Site 3925)
RECRUITING
Wuxi
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 3918)
RECRUITING
Xi'an
The First Affiliated hospital of Xiamen University ( Site 3924)
RECRUITING
Xiamen
Zhongshan Hospital Affiliated to Xiamen University ( Site 3923)
RECRUITING
Xiamen
The Second Affiliated Hospital of Zhengzhou University ( Site 3909)
RECRUITING
Zhengzhou
Affiliated Hospital of Jiangsu University ( Site 3919)
RECRUITING
Zhenjiang
Changzhou No.2 People's Hospital ( Site 3904)
RECRUITING
Zhenjiang
Colombia
Fundacion Santa Fe de Bogota ( Site 2703)
RECRUITING
Bogotá
Clinica Medellin S.A ( Site 2705)
RECRUITING
Medellín
IMAT S.A.S ( Site 2700)
RECRUITING
Montería
Oncologos del Occidente ( Site 2702)
RECRUITING
Pereira
Fundación Valle del Lili ( Site 2704)
RECRUITING
Santiago De Cali
Croatia
Poliklinika Borzan ( Site 0500)
RECRUITING
Osijek
Klinička bolnica Merkur ( Site 0503)
RECRUITING
Zagreb
Klinički bolnički centar Zagreb ( Site 0501)
RECRUITING
Zagreb
Poliklinika Bates ( Site 0504)
RECRUITING
Zagreb
Poliklinika Solmed ( Site 0502)
RECRUITING
Zagreb
Denmark
Herlev and Gentofte Hospital ( Site 5300)
RECRUITING
Copenhagen
Odense Universitetshospital ( Site 5301)
RECRUITING
Odense C
Finland
Pohjois-Karjalan Keskussairaala ( Site 5403)
RECRUITING
Joensuu
Tampereen yliopistollinen sairaala ( Site 5401)
RECRUITING
Tampere
Turku University Hospital ( Site 5402)
RECRUITING
Turku
France
CHU d'Amiens-Picardie - Hôpital Sud ( Site 0709)
RECRUITING
Amiens
CHU Besançon ( Site 0724)
RECRUITING
Besançon
Hopital Beaujon ( Site 0729)
RECRUITING
Clichy
Hopital Henri Mondor ( Site 0730)
RECRUITING
Créteil
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 0708)
RECRUITING
Dijon
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0702)
RECRUITING
Le Kremlin-bicêtre
Hopital Claude Huriez - CHU de Lille ( Site 0715)
RECRUITING
Lille
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0722)
RECRUITING
Marseille
CHU SAINT ELOI ( Site 0701)
RECRUITING
Montpellier
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0705)
RECRUITING
Nantes
CMC Ambroise Paré Hartmann - Institut des MICI ( Site 0723)
RECRUITING
Neuilly-sur-seine
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0711)
RECRUITING
Nice
C.H.U. de Nimes. Hopital Caremeau ( Site 0731)
RECRUITING
Nîmes
Hôpital Saint Antoine ( Site 0721)
RECRUITING
Paris
CHU Bordeaux Haut-Leveque ( Site 0713)
RECRUITING
Pessac
centre hospitalier lyon sud ( Site 0716)
RECRUITING
Pierre-bénite
Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré ( Site 0707)
RECRUITING
Reims
CHU Rangueil ( Site 0710)
RECRUITING
Toulouse
Centre Hospitalier de Valence ( Site 0725)
RECRUITING
Valence
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 0717)
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 0996)
RECRUITING
Berlin
Universitätsklinikum Brandenburg an der Havel ( Site 0903)
RECRUITING
Brandenburg
Evangelisches Krankenhaus Kalk gGmbH ( Site 0986)
RECRUITING
Cologne
Stadtische Kliniken Duisburg, Abtlg. Innere Medizin ( Site 0985)
RECRUITING
Duisburg
Medizinische Hochschule Hannover ( Site 0999)
RECRUITING
Hanover
Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0995)
RECRUITING
Kiel
Universitätsklinikum Leipzig ( Site 0997)
RECRUITING
Leipzig
St. Marien und St. Annastift Krankenhaus ( Site 0987)
RECRUITING
Ludwighafen Am Rhein
Klinikum Lüneburg ( Site 0991)
RECRUITING
Lüneburg
Gastroenterologische Gemeinschaftspraxis Minden ( Site 0998)
RECRUITING
Minden
Klinikum der Universität München Großhadern ( Site 0990)
RECRUITING
München
klinikum rechts der isar der technischen universität münchen ( Site 0989)
RECRUITING
München
Medizinisches Versorgungszentrum Portal 10 ( Site 0988)
RECRUITING
Münster
Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin ( Site 0992)
RECRUITING
Pforzheim
Magen Darm Zentrum Remscheid ( Site 0984)
RECRUITING
Remscheid
Universitätsmedizin Rostock ( Site 0993)
RECRUITING
Rostock
Universitaetsklinikum Ulm. ( Site 0994)
RECRUITING
Ulm
Greece
Evangelismos General Hospital of Athens ( Site 1002)
RECRUITING
Athens
THORACIC GENERAL HOSPITAL OF ATHENS I SOTIRIA-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1004)
RECRUITING
Athens
University General Hospital of Heraklion-GASTROENTEROLOGY & HEPATOLOGY ( Site 1000)
RECRUITING
Heraklion
General Hospital of Nikaia-Piraeus Agios Panteleimon ( Site 1003)
RECRUITING
Nikaia Piraeus
Ippokrateio General Hospital of Thessaloniki ( Site 1001)
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital ( Site 3300)
RECRUITING
Hksar
Hungary
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1105)
RECRUITING
Békéscsaba
Clinexpert Kft.-Clinexpert Budapest ( Site 1108)
RECRUITING
Budapest
Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 1100)
RECRUITING
Budapest
Pannónia Magánorvosi Centrum ( Site 1103)
RECRUITING
Budapest
Semmelweis Egyetem ( Site 1118)
RECRUITING
Budapest
Synexus Magyarorszag Kft. (Budapest DRS) ( Site 1107)
COMPLETED
Budapest
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1117)
RECRUITING
Eger
Gyöngyösi Bugát Pál Kórház ( Site 1111)
RECRUITING
Gyöngyös
Komarom-Esztergom Varmegyei Szent Borbala Korhaz ( Site 1115)
RECRUITING
Tatabánya
VeszLife Magánklinika ( Site 1102)
RECRUITING
Veszprém
Ireland
Beaumont Hospital, Dublin ( Site 5601)
RECRUITING
Dublin
Israel
Emek Medical Center ( Site 1206)
RECRUITING
Afula
Barzilai Medical Center ( Site 1209)
RECRUITING
Ashkelon
Bnai Zion Medical Center ( Site 1203)
RECRUITING
Haifa
Rambam Health Care Campus ( Site 1201)
RECRUITING
Haifa
Edith Wolfson Medical Center ( Site 1204)
RECRUITING
Holon
Shaare Zedek Medical Center ( Site 1208)
RECRUITING
Jerusalem
Meir Medical Center. ( Site 1202)
RECRUITING
Kfar Saba
Rabin Medical Center ( Site 1207)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 1200)
RECRUITING
Ramat Gan
Italy
A.O.U.C. Policlinico di Bari ( Site 1306)
RECRUITING
Bari
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1308)
RECRUITING
Bologna
Azienda Ospedaliera Universitaria Di Messina G. Martino ( Site 1314)
RECRUITING
Messina
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Gastroenterology and Endoscopy Unit ( Site 1304)
RECRUITING
Milan
Ospedale San Raffaele-Gastroenterology and Gastrointestinal Endoscopy ( Site 1300)
RECRUITING
Milan
Policlinico Universitario Monserrato-SC Gastroenterologia ( Site 1313)
RECRUITING
Monserrato
A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 1310)
RECRUITING
Naples
Ospedale Sacro Cuore Don G. Calabria-IBD Unit ( Site 1303)
RECRUITING
Negrar Di Valpolicella
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-U.O.S.D. Malattie Infiammatorie Croniche Intestinali ( Site 1302)
RECRUITING
Palermo
Ospedale Felice Lotti Di Pontedera ( Site 1311)
RECRUITING
Pontedera
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Dipartimento di Medicina Interna e Gas ( Site 1312)
RECRUITING
Roma
Fondazione Policlinico Tor Vergata ( Site 1307)
RECRUITING
Rome
Istituto Clinico Humanitas-IBD center ( Site 1309)
RECRUITING
Rozzano
Ospedale Mauriziano - Gastroenterology Unit ( Site 9000)
RECRUITING
Turin
Japan
Tokatsu Tsujinaka Hospital ( Site 3403)
RECRUITING
Abiko
Institute of Science Tokyo Hospital ( Site 3437)
RECRUITING
Bunkyō
Ginza Central Clinic ( Site 3407)
RECRUITING
Chūō
Fukuoka University Hospital ( Site 3417)
RECRUITING
Fukuoka
National Hospital Organization Fukuyama Medical Center ( Site 3442)
RECRUITING
Fukuyama
University of the Ryukyus Hospital ( Site 3459)
RECRUITING
Ginowan
Hamamatsu University Hospital ( Site 3449)
RECRUITING
Hamamatsu
Matsuda Hospital ( Site 3404)
RECRUITING
Hamamatsu
Kansai Medical University Hospital ( Site 3409)
RECRUITING
Hirakata
Hiroshima University Hospital ( Site 3418)
RECRUITING
Hiroshima
Hitachi General Hospital ( Site 3438)
RECRUITING
Hitachi
Kagoshima IBD Gastroenterology Clinic ( Site 3428)
RECRUITING
Kagoshima
Kagoshima University Hospital ( Site 3425)
RECRUITING
Kagoshima
Gokeikai Ofuna Chuo Hospital ( Site 3412)
RECRUITING
Kamakura
Kanazawa University Hospital ( Site 3436)
RECRUITING
Kanazawa
Tsujinaka Hospital - Kashiwanoha ( Site 3402)
RECRUITING
Kashiwa
Saitama Medical Center ( Site 3452)
RECRUITING
Kawagoe
St. Marianna University Hospital ( Site 3440)
RECRUITING
Kawasaki
Yamanashi Prefectural Central Hospital ( Site 3435)
RECRUITING
Kofu
Kurume University Hospital ( Site 3419)
RECRUITING
Kurume
National Hospital Organization Kyoto Medical Center ( Site 3411)
RECRUITING
Kyoto
University Hospital,Kyoto Prefectural University of Medicine ( Site 3406)
RECRUITING
Kyoto
Gunma University Hospital ( Site 3432)
RECRUITING
Maebashi
Kitasato University Kitasato Institute Hospital ( Site 3458)
RECRUITING
Minato
Kyorin University Hospital ( Site 3443)
RECRUITING
Mitaka
The Jikei University Hospital ( Site 3414)
RECRUITING
Mitato
Iwate Medical University Uchimaru Medical Center ( Site 3457)
RECRUITING
Morioka
Aichi Medical University Hospital ( Site 3429)
RECRUITING
Nagakute
Nagoya City University Hospital ( Site 3446)
RECRUITING
Nagoya
Nagoya University Hospital ( Site 3445)
RECRUITING
Nagoya
Hyogo Medical University Hospital ( Site 3430)
RECRUITING
Nishinomiya
Okayama University Hospital ( Site 3454)
RECRUITING
Okayama
Infusion Clinic ( Site 3408)
RECRUITING
Osaka
National Hospital Organization Osaka National Hospital ( Site 3453)
RECRUITING
Osaka
Saga University Hospital ( Site 3424)
RECRUITING
Saga
Toho University Sakura Medical Center ( Site 3413)
RECRUITING
Sakura
Medical Corporation Sapporo IBD Clinic ( Site 3420)
RECRUITING
Sapporo
Sapporo Medical University Hospital ( Site 3460)
RECRUITING
Sapporo
Sapporo Tokushukai Hospital ( Site 3427)
RECRUITING
Sapporo
Sapporohigashi Tokushukai Hospital ( Site 3441)
RECRUITING
Sapporo
Tohoku University Hospital ( Site 3447)
RECRUITING
Sendai
National Hospital Organization Shizuoka Medical Center ( Site 3401)
RECRUITING
Shimizu
National Center for Global Health and Medicine ( Site 3423)
RECRUITING
Shinjuku
Tokyo Medical University Hospital ( Site 3456)
RECRUITING
Shinjuku
Tokyo Yamate Medical Center ( Site 3415)
RECRUITING
Tokyo
Toyama Prefectural Central Hospital ( Site 3410)
RECRUITING
Toyama
Mie University Hospital ( Site 3405)
RECRUITING
Tsu
Yamagata University Hospital ( Site 3426)
RECRUITING
Yamagata
Matsushima Hospital ( Site 3450)
RECRUITING
Yokohama
Yokohama City University Medical Center ( Site 3439)
RECRUITING
Yokohama
Latvia
SIA M & M Centrs ( Site 5902)
RECRUITING
Ādaži
Pauls Stradins Clinical University Hospital ( Site 5903)
RECRUITING
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Gastroenterology ( Site 6000)
RECRUITING
Kaunas
VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS-Department of Clinical Trials and Pharmacology ( Site 6001)
RECRUITING
Vilnius
Malaysia
Hospital Ampang ( Site 6106)
RECRUITING
Ampang
Hospital Sultanah Aminah ( Site 6104)
RECRUITING
Johor Bahru
Hospital Universiti Sains Malaysia ( Site 6103)
RECRUITING
Kubang Kerian
Sarawak General Hospital ( Site 6102)
RECRUITING
Kuching
University Malaya Medical Centre ( Site 6101)
RECRUITING
Lembah Pantai
Mexico
Scientia Investigacion Clinica S.C. ( Site 3114)
RECRUITING
Chihuahua City
JM Research SC ( Site 3109)
RECRUITING
Cuernavaca
Morales Vargas Centro de Investigacion ( Site 3101)
RECRUITING
León
Medical Care and Research SA de CV-GASTROENTEROLOGY ( Site 3110)
RECRUITING
Mérida
Centro de Investigación y Gastroenterología - S.C. ( Site 3102)
RECRUITING
Mexico City
Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 3104)
RECRUITING
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez-Gastroenterología ( Site 3100)
RECRUITING
Monterrey
Centro de Investigacion Clinica de Oaxaca ( Site 3105)
RECRUITING
Oaxaca City
Servicios de Oncología Médica Integral, S.A de C.V. ( Site 3108)
RECRUITING
San Pedro Garza García
Centro Medico Clinico Quirurgico Especializado en Investigación ( Site 3106)
RECRUITING
Tlajomulco De Zúñiga
Netherlands
Amsterdam UMC, locatie VUmc-IBD Trial Unit ( Site 1500)
RECRUITING
Amsterdam
University Medical Center Groningen ( Site 1506)
RECRUITING
Groningen
Radboudumc ( Site 1505)
RECRUITING
Nijmegen
Erasmus Medisch Centrum ( Site 1504)
RECRUITING
Rotterdam
Franciscus Gasthuis & Vlietland, Locatie Gasthuis ( Site 1503)
RECRUITING
Rotterdam
ETZ Elisabeth ( Site 1501)
RECRUITING
Tilburg
Ziekenhuis Bernhoven ( Site 1508)
RECRUITING
Uden
Universitair Medisch Centrum Utrecht ( Site 1502)
RECRUITING
Utrecht
New Zealand
Aotearoa Clinical Trials ( Site 3501)
RECRUITING
Auckland
Dunedin Hospital ( Site 3505)
RECRUITING
Dunedin
Hutt Valley District Health board HVDHB ( Site 3500)
RECRUITING
Lower Hutt
Peru
Hospital Cayetano Heredia ( Site 3003)
RECRUITING
Lima
Hospital Nacional Edgardo Rebagliati Martins-Aparato Digestivo ( Site 0154)
RECRUITING
Lima
Investigaciones Clínicas / Instituto de Ginecología y Reproducción ( Site 3002)
RECRUITING
Lima
Poland
NZOZ Centrum Medyczne KERmed ( Site 1641)
RECRUITING
Bydgoszcz
M2M ( Site 1630)
RECRUITING
Chorzów
Amicare ( Site 1620)
RECRUITING
Jelenia Góra
Centrum Medyczne Plejady ( Site 1627)
RECRUITING
Krakow
FutureMeds Krakow ( Site 1628)
RECRUITING
Krakow
PROMED P. LACH R. GLOWACKI SP. J. ( Site 1636)
RECRUITING
Krakow
AmiCare Sp. z o.o. Sp. k. ( Site 1608)
RECRUITING
Lodz
Centrum Medyczne Med-Gastr Sp. z o.o. ( Site 1616)
RECRUITING
Lodz
IP Clinic ( Site 1638)
RECRUITING
Lodz
Medrise Sp. z o.o. ( Site 1626)
RECRUITING
Lublin
Allmedica ( Site 1602)
RECRUITING
Nowy Targ
Twoja Przychodnia Opolskie Centrum Medyczne ( Site 1633)
RECRUITING
Opole
Medicome Sp. z o.o ( Site 1635)
RECRUITING
Oświęcim
EMC Instytut Medyczny S.A,Prywatna Lecznica Certus Ambulatoria,Prywatna Lecznica Certus Szpital Nr1 ( Site 1605)
RECRUITING
Poznan
Pratia Poznań ( Site 1603)
RECRUITING
Poznan
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.,Twoja Przychodnia PCM ( Site 1632)
RECRUITING
Poznan
Endoskopia Sp. z.o.o. ( Site 1637)
RECRUITING
Sopot
Sonomed Sp. z o. o. ( Site 1617)
RECRUITING
Szczecin
Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 1612)
RECRUITING
Szczecin
Gastromed Sp. z o. o. ( Site 1619)
RECRUITING
Torun
H-T Centrum Medyczne Endoterapia ( Site 1610)
RECRUITING
Tychy
Centrum Zdrowia MDM ( Site 1618)
RECRUITING
Warsaw
ETG Warszawa ( Site 1629)
RECRUITING
Warsaw
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Gastroenterologii Onkologiczne ( Site 1624)
RECRUITING
Warsaw
Vivamed Sp. z o.o. ( Site 1623)
RECRUITING
Warsaw
WIP Warsaw IBD Point Profesor Kierkuś ( Site 1622)
RECRUITING
Warsaw
EMC Instytut Medyczny SA ( Site 1601)
RECRUITING
Wroclaw
Melita Medical ( Site 1607)
RECRUITING
Wroclaw
Planetmed ( Site 1600)
RECRUITING
Wroclaw
Vistamed & Vertigo Sp. z o.o. ( Site 1621)
RECRUITING
Wroclaw
ETG Zamosc ( Site 1631)
RECRUITING
Zamość
Portugal
Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira ( Site 1704)
RECRUITING
Guimarães
Unidade Local de Saude da Região de Leiria - Hospital Santo André ( Site 1706)
RECRUITING
Leiria
Hospital da Luz Lisboa ( Site 1707)
RECRUITING
Lisbon
Hospital dos Lusíadas Lisboa ( Site 1701)
RECRUITING
Lisbon
Unidade Local de Saude do Algarve - Hospital de Portimão ( Site 1700)
RECRUITING
Portimão
ULSAM - Hospital de Santa Luzia ( Site 1703)
RECRUITING
Viana Do Castelo
Unidade Local de Saude Dão-Lafões - Hospital de São Teotónio ( Site 1702)
RECRUITING
Viseu
Republic of Korea
Dong-A University Hospital ( Site 3601)
RECRUITING
Busan
Yeungnam Univeristy Medical Center ( Site 3610)
RECRUITING
Daegu
The Catholic University of Korea, Daejeon St. Mary's Hospital ( Site 3604)
RECRUITING
Daejeon
Chung-Ang University Hospital ( Site 3606)
RECRUITING
Dongjak-gu
Inje University Haeundae Paik Hospital ( Site 3605)
RECRUITING
Haeundae-gu
Asan Medical Center ( Site 3609)
RECRUITING
Seoul
Kangbuk Samsung Hospital-Internal Medicine ( Site 3612)
RECRUITING
Seoul
Kyung Hee University Hospital ( Site 3611)
RECRUITING
Seoul
Samsung Medical Center ( Site 3613)
RECRUITING
Seoul
Seoul National University Hospital ( Site 3607)
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System-Department of Internal Medicine ( Site 3603)
RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3602)
RECRUITING
Seoul
The Catholic University Of Korea St. Vincent's Hospital-Gastroenterology ( Site 3608)
RECRUITING
Suwon
Wonju Severance Christian Hospital-Internal Medicine ( Site 3600)
RECRUITING
Wŏnju
Romania
Fundeni Clinical Institute-Gastroenterology and Hepatology Center ( Site 1808)
RECRUITING
Bucharest
MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 1806)
RECRUITING
Bucharest
Monza Ares SRL ( Site 1804)
RECRUITING
Bucharest
GastroMed ( Site 1809)
RECRUITING
Cluj-napoca
Spitalul Clinic Judetean Mures-Gastroenterology ( Site 1807)
RECRUITING
Târgu Mureş
ASOCIATIA ONCOHELP ( Site 1805)
RECRUITING
Timișoara
Saudi Arabia
King Abdul Aziz Medical City - AlRiyadh ( Site 5210)
RECRUITING
Riyadh
Serbia
Clinical Hospital Center Dragisa Misovic ( Site 1906)
RECRUITING
Belgrade
Clinical Hospital Center Zvezdara-Gastroenterology and hepatology Department ( Site 1903)
RECRUITING
Belgrade
University Medical Center Bezanijska kosa-Gastroenterology and hepatology ( Site 1900)
RECRUITING
Belgrade
Clinical Center Kragujevac ( Site 1904)
RECRUITING
Kragujevac
General Hospital Djordje Joanovic ( Site 1905)
RECRUITING
Zrenjanin
Singapore
Changi General Hospital ( Site 6203)
RECRUITING
Singapore
Singapore General Hospital ( Site 6202)
RECRUITING
Singapore
Tan Tock Seng Hospital-Gastroenterology and Hepatology ( Site 6201)
RECRUITING
Singapore
Slovakia
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica-Gastroenterologicke oddelenie ( Site 2002)
RECRUITING
Banská Bystrica
Cliniq s.r.o. ( Site 2001)
RECRUITING
Bratislava
KM Management ( Site 2000)
RECRUITING
Nitra
GASTRO I ( Site 2004)
RECRUITING
Prešov
Gastro LM ( Site 2005)
RECRUITING
Prešov
South Africa
Life Kingsbury Hospital ( Site 4000)
RECRUITING
Cape Town
Panorama Medical Centre ( Site 4001)
RECRUITING
Cape Town
Spoke Research ( Site 4003)
RECRUITING
Cape Town
Wits Clinical Research ( Site 4004)
RECRUITING
Johannesburg
Private Practice - Dr. M.N. Rajabally ( Site 4007)
RECRUITING
Plumstead
Wits Clinical Research-Wits Clinical Research Bara ( Site 4005)
RECRUITING
Soweto
Spain
Complejo Hospitalario Universitario de Ferrol ( Site 2114)
RECRUITING
A Coruña
Hospital Germans Trias i Pujol ( Site 2101)
RECRUITING
Badalona
HOSPITAL CLÍNIC DE BARCELONA-ICMDM - Clinical Institute of Digestive and Metabolic Diseases ( Site 2112)
RECRUITING
Barcelona
Hospital Universitario La Paz ( Site 2100)
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro ( Site 2102)
RECRUITING
Majadahonda
Hospital Montecelo. Complexo Hospitalario de Pontevedra ( Site 2107)
RECRUITING
Pontevedra
Hospital Universitario Nuestra Senora de la Candelaria ( Site 2105)
RECRUITING
Santa Cruz De Tenerife
Hospital Universitario de Torrejón ( Site 2108)
RECRUITING
Torrejón De Ardoz
HOSPITAL CLINICO DE VALENCIA-MEDICINA DIGESTIVA ( Site 2103)
RECRUITING
Valencia
Hospital Universitari i Politecnic La Fe ( Site 2111)
RECRUITING
Valencia
Hospital Universitario Miguel Servet ( Site 2104)
RECRUITING
Zaragoza
Sweden
Danderyds Sjukhus ( Site 5501)
RECRUITING
Danderyd
Universitetssjukhuset i Linköping ( Site 5502)
RECRUITING
Linköping
Karolinska Universitetssjukhuset Solna ( Site 5500)
RECRUITING
Stockholm
Switzerland
University Hospital Basel-Gastroenterology and Hepatology ( Site 2204)
RECRUITING
Basel
INTESTO-Gastroenterologische Praxis / Crohn-Colitis Zentrum Bern ( Site 2202)
RECRUITING
Bern
Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 2201)
RECRUITING
Sankt Gallen
UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2200)
RECRUITING
Zurich
Taiwan
National Taiwan University Hospital-Internal Medicine ( Site 3700)
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch ( Site 3701)
RECRUITING
Taoyuan District
National Taiwan University BioMedical Park Hospital ( Site 3702)
RECRUITING
Zhubei
Turkey
Ankara Bilkent Şehir Hastanesi-Gastroenterology ( Site 2301)
RECRUITING
Ankara
ANKARA UNIVERSITY IBNI SINA HOSPITAL-Gastroenterology ( Site 2303)
RECRUITING
Ankara
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2300)
RECRUITING
Ankara
Antalya Egitim ve Arastırma Hastanesi ( Site 2304)
RECRUITING
Antalya
Eskisehir Osmangazi University Faculty of Medicine ( Site 2308)
RECRUITING
Eskişehir
Istanbul Universitesi Cerrahpasa Tip Fakultesi Hastanesi ( Site 2306)
RECRUITING
Istanbul
Marmara Univetsitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2305)
RECRUITING
Istanbul
Ege Universitesi Hastanesi ( Site 2302)
RECRUITING
Izmir
Kocaeli University Medical Faculty Hospital ( Site 2309)
RECRUITING
Kocaeli
Ukraine
Communal non-profit enterprise Regional clinical hospital of Ivano-Frankivsk Regional Council ( Site 5815)
RECRUITING
Ivano-frankivsk
Center of Family Medicine Plus ( Site 5803)
RECRUITING
Kyiv
Dobrobut Medical Center ( Site 5801)
RECRUITING
Kyiv
Medical Center of Limited ( Site 5806)
RECRUITING
Kyiv
Medical Center of Private Enterprise Sygma ( Site 5808)
RECRUITING
Kyiv
Medical Center Universal Clinic Oberig of Limited Liability Company Kapytal ( Site 5800)
RECRUITING
Kyiv
Municipal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council ( Site 5813)
RECRUITING
Lutsk
Communal Non-profit Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital-proctology ( Site 5809)
RECRUITING
Lviv
Clinic of Scientific and Research Institute of Invalid Rehabilitation of VNMU n.a. M.I.Pyrohov ( Site 5812)
RECRUITING
Vinnytsia
Communal Non-Commercial Enterprise Vinnytsia City Clinical -Clinical Therapeutic Department #1 ( Site 5811)
RECRUITING
Vinnytsia
Limited liability company Medical center Health Clinic ( Site 5807)
RECRUITING
Vinnytsia
Municipal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 5814)
RECRUITING
Vinnytsia
United Kingdom
Southmead Hospital ( Site 2403)
RECRUITING
Bristol
Addenbrooke's Hospital ( Site 2400)
RECRUITING
Cambridge
Doncaster Royal Infirmary ( Site 2401)
RECRUITING
Doncaster
Royal Devon & Exeter Hospital ... ( Site 2407)
RECRUITING
Exeter
Huddersfield Royal Infirmary ( Site 2409)
RECRUITING
Huddersfield
University College London Hospital-Clinical Research Facility ( Site 2405)
RECRUITING
London
Whipps Cross University Hospital-Clinical Research Unit ( Site 2404)
RECRUITING
London
The John Radcliffe Hospital ( Site 2406)
RECRUITING
Oxford
Southampton General Hospital ( Site 2402)
RECRUITING
Southampton
Walsall Manor Hospital ( Site 2410)
RECRUITING
West Midlands
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-06-05
Estimated Completion Date: 2029-11-12
Participants
Target number of participants: 1200
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 continue 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 continue 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 continue 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 continue in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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