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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04033445
Other study ID # CR108657
Secondary ID 2018-004002-25CN
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date September 26, 2019
Est. completion date October 27, 2027

Study information

Verified date June 2024
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).


Description:

UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The study is designed to answer scientific questions pertaining to the efficacy and safety of guselkumab in the treatment of moderately to severely active UC. Overall, the study will evaluate long-term guselkumab treatment. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1064
Est. completion date October 27, 2027
Est. primary completion date September 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Documented diagnosis of ulcerative colitis (UC) - Moderately to severely active UC, defined by modified Mayo score - Demonstrated inadequate response or intolerance to medical therapies specified in the protocol - Screening laboratory test results within the parameters specified in the protocol Exclusion Criteria: - Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease - UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon - Presence of a stoma - Presence or history of a fistula - Receiving prohibited medications and/or treatment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Participants will receive matching placebo IV or SC.
Guselkumab
Participants will receive guselkumab IV or SC.

Locations

Country Name City State
Argentina CEMIC (Centro de Educación Médica e Investigaciones Clínicas) Buenos Aires
Argentina Cer Instituto Medico Buenos Aires
Argentina CINME Centro de Investigaciones Metabolicas Buenos Aires
Argentina Hospital General de Agudos José Maria Ramos Mejía Buenos Aires
Argentina Centro Médico Dra. De Salvo Caba
Argentina Clinica Adventista Belgrano Ciudad De Buenos Aires
Argentina Sanatorio Duarte Quiroz Cordoba
Argentina Hospital de Alta Complejidad en Red 'El Cruce' Florencio Varela
Argentina Centro de Investigaciones Medicas Mar Del Plata Mar Del Plata
Argentina Fundacion de Estudios Clinicos Rosario
Argentina Hospital Provincial del Centenario Rosario
Australia Emeritus Research Camberwell
Australia Monash Health Clayton
Australia Western Health Footscray
Australia Fiona Stanley Hospital Murdoch
Australia Royal Perth Hospital Perth
Australia Mater Hospital South Brisbane
Australia St John of God Subiaco Hospital Subiaco
Australia Princess Alexandra Hospital Woolloongabba
Austria Universitaetsklinikum Salzburg Landeskrankenhaus Salzburg
Belgium AZ Sint-Lucas Brugge
Belgium Hopital Erasme Brussels
Belgium CHU Saint-Pierre Bruxelles
Belgium AZ Maria Middelares Gent
Belgium Universitair Ziekenhuis Gent Gent
Belgium Algemeen Ziekenhuis Jan Palfijn Merksem Merksem
Belgium Algemeen Ziekenhuis Delta Roeselare
Brazil L2IP Instituto de Pesquisas Clinicas Brasilia
Brazil Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro Campinas
Brazil CDC - Centro Digestivo de Curitiba Curitiba
Brazil Eurolatino Pesquisas Medicas Ltda Juiz de Fora
Brazil Instituto Mederi de Pesquisa e Saude Passo Fundo
Brazil Hospital das Clinicas de Porto Alegre Porto Alegre
Brazil NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul Porto Alegre
Brazil Universidade Federal do Rio de Janeiro - Faculdade de Medicina Rio de Janeiro
Brazil CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao Salvador
Brazil BR Trials Sao Paulo
Brazil Onco Star SP Oncologia Ltda Sao Paulo
Brazil CPQuali Pesquisa Clinica LTDA ME São Paulo
Brazil Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui Teresina
Brazil Eurolatino Pesquisas Medicas Ltda Uberlandia
Bulgaria Medical Centre Asklepii OOD Dupnitsa
Bulgaria Medical Center-1-Sevlievo EOOD Sevlievo
Bulgaria 2-nd MHAT Sofia
Bulgaria 4th MHAT - Sofia Sofia
Bulgaria Acibadem City Clinic - Oncology Center Sofia
Bulgaria DCC Convex EOOD Sofia
Bulgaria MHAT 'St. Marina' EAD Varna
Bulgaria MHAT Dr Stefan Cherkezov Veliko Tarnovo
Canada Barrie GI Associates Barrie Ontario
Canada Hopital Maisonneuve-Rosemont Montréal Quebec
Canada Royal University Hospital Saskatoon Saskatchewan
Canada Toronto Immune & Digestive Health Institute Inc. Toronto Ontario
Canada GIRI Gastrointestinal Research Institute Vancouver British Columbia
Canada Health Sciences Centre Winnipeg Manitoba
China Capital Medical University, Beijing Friendship Hospital Beijing
China Peking University Third Hospital Beijing
China China-Japan Union Hospital of Jilin University Changchun
China The second Xiangya Hospital of Central South University Changsha
China The Third Xiangya Hospital of Central Sourth University Changsha
China West China Hospital of Sichuan University Chengdu
China Daping Hospital Chongqing
China The Second Hospital To Dalian Medical University Dalian
China First Affiliated Hospital of Gannan Medical University Ganzhou
China The First Affiliated Hospital Sun Yat sen University Guangzhou
China The Sixth Affiliated Hospital Sun Yat sen University Guangzhou
China Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou
China The First Affiliated Hospital Zhejiang University College of Medicine Hangzhou
China The Second Affiliated Hospital of Zhejiang University Hangzhou
China The 1st affiliated hospital of Anhui Medical University Hefei
China First Affiliated Hospital of Kunming Medical Unversity Kunming City
China The First Affiliated Hospital of NanChang University Nanchang
China Jiangsu Province Hospital Nanjing
China Nanjing Drum Tower Hospital Nanjing
China Zhongda Hospital Southeast University Nanjing
China Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine Shanghai
China Shengjing Hospital Of China Medical University Shenyang
China The first affiliated hospital of suzhou University Suzhou
China The Second Hospital Affiliated To Suzhou University Suzhou
China Tianjin Medical University General Hospital Tianjin
China Tongji Hospital, Tongji Medical College of HUST Wuhan
China Wuhan Union Hospital Wuhan
China Wuxi People s Hospital Wuxi
Czechia Nemocnice Ceske Budejovice a s Ceske Budejovice
Czechia Endohope Havirov s.r.o. Havirov
Czechia Gastroenterologie, s.r.o., Hradec Kralove Hradec Kralova
Czechia MUDr. Gregar s.r.o. Olomouc
Czechia Artroscan s r o Ostrava
Czechia Vitkovicka nemocnice a.s. Ostrava
Czechia AXON Clinical s.r.o. Prague
Czechia Synexus Czech s.r.o. Praha 2
Czechia ResTrial GastroEndo, s.r.o Praha 4
Czechia Nemocnice na Homolce Praha 5
Czechia ISCARE a.s. Praha 9
Czechia Nemocnice Strakonice, a.s. Strakonice
France CHU caen Caen
France Hopital Beaujon Clichy
France CHRU de Lille Hopital Claude Huriez Lille
France Hopital Saint Eloi Montpellier
France CHU de Nice Hopital de l Archet Nice Cedex 3
France Hopital Saint Antoine Paris
France Hopital Haut-Leveque, CMC Magellan Pessac
France Centre Hospitalier Lyon Sud Pierre-Benite
France CHU Saint Etienne Hopital Nord Saint-Priest en Jarez
France Nouvel Hopital Civil Strasbourg
France CHU Rangueil Toulouse
France CHRU Nancy Brabois Vandoeuvre les Nancy
Germany Universitaetsklinikum Charite, Campus Virchow Klinikum Berlin
Germany BSF Studiengesellschaft Halle
Germany Medizinische Hochschule Hannover Hannover
Germany Praxisgemeinschaft Jerichow Jerichow
Germany Staedtisches Klinikum Lueneburg Lueneburg
Germany Zentrum für Gastroenterologie Saar MVZ GmbH Saarbrücken
Germany Universitaetsklinikum Ulm Ulm
Hungary Magyar Honvedseg Egeszsegugyi Kozpont Budapest
Hungary Semmelweis University Budapest
Hungary Semmelweis University Budapest
Hungary Synexus Magyarorszag Kft Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debrecen
Hungary Gyongyosi Bugat Pal Korhaz Gyongyos
Hungary Synexus Magyarorszag Kft Gyula
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvostudomanyi Kar, Belgyogyaszati Klinika Szeged
Ireland Beaumont Hospital Dublin
Ireland St Vincent's University Hospital Dublin 4
Ireland University Hospital Galway - Ireland Galway
Israel Bnai Zion Medical Center Haifa
Israel Rambam Medical Center Haifa
Israel Wolfson Medical Center Holon
Israel Lev Talpiot Clinic Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Galilee Medical Center Naharia
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Italy Policlinico Sant'Orsola Malpighi Bologna
Italy Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milano
Italy Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar Negrar
Italy Azienda Ospedaliera di Padova Padova
Italy Ospedale Villa Sofia-Cervello Palermo
Italy Azienda Ospedaliera G.Salvini Ospedale di Rho RHO
Italy Fondazione Policlinico Gemelli Università Cattolica Roma
Italy Università Campus Biomedico di Roma Roma
Italy Istituto Clinico Humanitas Rozzano, IRCCS Rozzano
Italy Casa Sollievo della Sofferenza, IRCCS San Giovanni Rotondo
Italy AO Ordine Mauriziano Torino
Japan Tokyo Medical and Dental University Hospital Bunkyo Ku
Japan Juntendo University Hospital Urayasu Chiba
Japan Fukuoka University Chikushi Hospital Chikushino
Japan Ehime Prefectural Central Hospital Ehime
Japan Sai Clinic, Gastrointestinal and Protology Divisions Fujiidera-shi
Japan Fukuoka University Hospital Fukuoka
Japan Kitakyushu Municipal Medical Center Fukuoka-ken
Japan Fukushima Medical University Hospital Fukushima
Japan Gifu University Hospital Gifu
Japan Hachinohe City Hospital Hachinohe
Japan Tokai University Hachioji Hospital Hachioji
Japan Hakodate Goryoukaku Hospital Hakodate
Japan Matsunami General Hospital Hashima-gun
Japan Hirosaki University Hospital Hirosaki
Japan National Hospital Organization Hirosaki General Medical Center Hirosaki
Japan Kure Kyosai Hospital Hiroshima
Japan Asahikawa Medical University Hospital Hokkaido
Japan Mito Saiseikai General Hospital Ibaraki
Japan Shimane University Hospital Izumo
Japan Imamura General Hospital Kagoshima
Japan Izuro Imamura Hospital Kagoshima
Japan Kagoshima IBD Gastroenterology Clinic Kagoshima
Japan Sameshima Hospital Kagoshima
Japan Kagoshima University Hospital Kagoshima City
Japan Matsushima Hospital Kanagawa
Japan St Marianna University Hospital Kanagawa
Japan Kanazawa University Hospital Kanazawa
Japan National Hospital Organization Kanazawa Medical Center Kanazawa
Japan Nara Medical University Hospital Kashihara
Japan The Jikei University Kashiwa Hospital Kashiwa
Japan Tsujinaka Hospital Kashiwanoha Kashiwa
Japan Kyushu Rosai Hospital Kitakyushu
Japan Aoyama Naika Clinic Kobe
Japan Kobe University Hospital Kobe
Japan National Hospital Organization Kochi National Hospital Kochi
Japan Yamanashi Prefectural Central Hospital Kofu
Japan Kumagaya General Hospital Kumagaya-shi
Japan National Hospital Organization Kure Medical Center and Chugoku Cancer Center Kure
Japan University Hospital Kyoto Perfectural University of Medicine Kyoto
Japan National Hospital Organization Matsumoto Medical Center Matsumoto
Japan National Hospital Organization Tokyo Medical Center Meguro-ku
Japan Kitasato University Kitasato Institute Hospital Minato-ku
Japan Kyorin University Hospital Mitaka
Japan Takagi Clinic Miyagi
Japan Iwate Medical University Uchimaru Medical Center Morioka
Japan Nagoya City University Hospital Nagoya
Japan Nagoya University Hospital Nagoya
Japan Nagaoka Chuo General Hospital Niigata
Japan Hyogo Medical University Hospital Nishinomiya-shi
Japan Oita Red Cross Hospital Oita
Japan Shinbeppu Hospital Oita
Japan Nakagami Hospital Okinawa
Japan Izumiotsu Municipal Hospital Osaka
Japan Japanese Red Cross Osaka Hospital Osaka
Japan Osaka Metropolitan University Hospital Osaka
Japan Kindai University Hospital Osaka Sayama shi
Japan Osaki Citizen Hospital Osaki
Japan Japan Community Health Care Organization Saitama Medical Center Saitama
Japan Toho University Sakura Medical Center Sakura
Japan Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital Sapporo
Japan Sapporo Higashi Tokushukai Hospital Sapporo
Japan Sapporo IBD Clinic Sapporo
Japan Sapporo Medical University Hospital Sapporo
Japan Sapporo Tokushukai Hospital Sapporo
Japan Tokyo Yamate Medical Center Shinjuku-ku
Japan Matsuda Hospital Shizuoka
Japan Tokyo Metropolitan Bokutoh Hospital Sumida ku
Japan Kagawa Prefectural Central Hospital Takamatsu
Japan Tokushima University Hospital Tokushima
Japan The Jikei University Hospital Tokyo
Japan Mie University Hospital Tsu
Japan Yokkaichi Hazu Medical Center Yokkaichi
Japan Yokohama Municipal Citizens Hospital Yokohama
Japan University of Fukui Hospital Yoshida
Jordan Istishari Hospital Amman
Jordan Jordan University Hospital Amman
Jordan Khalidi Hospital and Medical Center Amman
Jordan Irbid Specialty Hospital Irbid
Jordan King Abdullah University Hospital Irbid
Korea, Republic of Inje University Haeundae Paik Hospital Busan
Korea, Republic of Yeungnam University Hospital Daegu
Korea, Republic of Korea University Ansan Hospital Gyeonggi-do
Korea, Republic of The Catholic university of Korea, St. Vincent's Hospital Gyeonggi-do
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Chung-Ang University Hospital Seoul
Korea, Republic of KyungHee University Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Severance Hospital Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea Seoul St Mary s Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon
Latvia Digestive Diseases Centre GASTRO Riga
Latvia Health Centre 4 Centre of Diagnostics Riga
Latvia Pauls Stradins Clinical University Hospital Riga
Latvia Pauls Stradins Clinical University Hospital Riga
Malaysia Hospital Serdang Kajang
Malaysia Hospital University Sains Malaysia Kelantan
Malaysia Pusat Perubatan Universiti Kebangsaan Malaysia Kuala Lumpur
Malaysia University Malaya Medical Centre Kuala Lumpur
Netherlands Onze Lieve Vrouwe Gasthuis Amsterdam
Netherlands Albert Schweitzer Ziekenhuis Dordrecht
Netherlands Radboudumc Nijmegen
New Zealand Dunedin Hospital Dunedin
New Zealand Auckland City Hospital Grafton
New Zealand Waikato Hospital Hamilton
Poland Gastromed Kralisz Romatowski Stachurska Sp. j. Bialystok
Poland Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy Bydgoszcz
Poland Centrum Medyczne Plejady Krakow
Poland Centrum Medyczne Promed Krakow
Poland Gastromed ZOZ Lublin
Poland Medicome Sp z o.o. Oswiecim
Poland Centrum Medyczne Medyk Rzeszow
Poland Endoskopia Sp z o.o. Sopot
Poland Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin
Poland GASTROMED Sp. z o.o. Torun
Poland Medical Network WIP Warsaw IBD Point Profesor Kierkus Warszawa
Poland Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Warszawa
Poland Wojskowy Instytut Medyczny Warszawa
Poland Melita Medical Sp. z o.o. Wroclaw
Poland Wromedica Wroclaw
Poland ETG Zamosc Zamosc
Portugal Centro Hospitalar e Universitário de Coimbra, EPE Coimbra
Portugal Centro Hospitalar do Porto, EPE Porto
Portugal Chsj - Hosp. Sao Joao Porto
Portugal Centro Hospitalar de Entre o Douro e Vouga, E.P.E Santa Maria da Feira
Portugal Centro Hospitalar de Tondela Viseu, EPE Viseu
Russian Federation Medical Center Meditsinskie Tekhnologii Ekaterinburg
Russian Federation OOO MO New Hospital Ekaterinburg
Russian Federation Immanuel Kant Baltic Federal University Kaliningrad
Russian Federation Road Clinical Hospital at the Nizhny Novgorod Station of the Russian Railways Nizhniy Novgorod
Russian Federation LLC 'Novosibirsk Gastrocentr' Novosibirsk
Russian Federation Medical Center SibNovoMed LLC Novosibirsk
Russian Federation City Clinical Hospital #2 Perm
Russian Federation Rostov State Medical University Rostov-On-Don
Russian Federation All-Russian Center of Emergency and Radiation Medicine MCRS Saint-Petersburg
Russian Federation Eco-safety Ltd Saint-Petersburg
Russian Federation Medical University Reaviz Samara
Russian Federation NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways' Samara
Russian Federation Saratov Regional Clinical Hospital Saratov
Russian Federation International Medical Centre SOGAZ St-Petersburg
Russian Federation City Clinical Hospital # 21 Ufa
Russian Federation GBUZ Respublican Clinical Hospital n.a. GG Kuvatova Ufa
Russian Federation Regional Clinical Hospital Yaroslavl
Serbia Zvezdara University Medical Center Belgrade
Serbia General Hospital 'Dr Radivoj Simonovic' Sombor
Serbia General Hospital 'Djordje Joanovic' Zrenjanin
Slovakia FNsP F.D.R. Banska Bystrica Banska Bystrica
Slovakia Gastroenterology Department GASTROMART s.r.o. Bardejov
Slovakia Cliniq s.r.o. Bratislava
Slovakia Gastroenterology Center ASSIDUO Bratislava
Slovakia ENDOMED s.r.o Kosice
Slovakia GASTRO I. s.r.o. Presov
Slovakia Accout Center, s.r.o., Gastroenterologická ambulancia Sahy
Spain Hosp. Univ. Germans Trias I Pujol Badalona
Spain Hosp Clinic de Barcelona Barcelona
Spain Hosp. Univ. Dr. Josep Trueta Girona
Spain Hosp. Univ. La Paz Madrid
Spain Hosp. Univ. Marques de Valdecilla Santander
Spain Hosp. Ntra. Sra. de Valme Sevilla
Spain Hosp. Virgen Del Rocio Sevilla
Sweden Karolinska Universitetssjukhuset Stockholm
Sweden Uppsala University Uppsala
Taiwan Chang-Hua Christian Hospital Changhua
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
Taiwan Chang-Gung Memorial Hospital, LinKou Branch Taoyuan
Turkey Gazi University Hospital Ankara
Turkey Hacettepe University Hospital Ankara
Turkey Trakya University Medical Faculty Edirne
Turkey Acibadem Kozyatagi Hospital Istanbul
Turkey BAU Medical Park Goztepe Hospital Istanbul
Turkey Istanbul University Cerrahpasa Medical Faculty Istanbul
Turkey Istanbul University Istanbul Medical Faculty Istanbul
Turkey Medicana International Istanbul Istanbul
Turkey Dokuz Eylul University Medical Faculty Izmir
Turkey Ege University Medical Faculty Izmir
Turkey Kocaeli University Medical Faculty Kocaeli
Turkey Mersin University Medical Faculty Hospital Mersin
Ukraine Ivano-Frankivsk Regional Clinical Hospital Ivano-Frankivsk
Ukraine Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov' Kharkiv
Ukraine SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine Kharkiv
Ukraine Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh' Kherson
Ukraine MC PE Sygma Kyiv
Ukraine Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies' Kyiv
Ukraine Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital' Lviv
Ukraine Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway Lviv
Ukraine Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council Odesa
Ukraine Sumy State University, Sumy Regional Clinical Hospital Sumy
Ukraine Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital' Ternopil
Ukraine Medical Center Ltd 'Health Clinic', Department Of General Therapy Vinnytsya
Ukraine Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov Vinnytsya
United Kingdom Glasgow Royal Infirmary Glasgow
United Kingdom Guy's and St Thomas' Hospital London
United Kingdom St George's Hospital London
United States Synexus Clinical Research US Inc Anderson South Carolina
United States Atlanta Gastroenterology Associates Atlanta Georgia
United States Atlanta Gastroenterology Associates Atlanta Georgia
United States Emory Clinic Atlanta Georgia
United States Morehouse School of Medicine Atlanta Georgia
United States Care Access Research, Casper Casper Wyoming
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Erlanger Health System Chattanooga Tennessee
United States Gastroenterology Associates of Tidewater Chesapeake Virginia
United States Clinical Research Institute of Michigan, LLC Chesterfield Michigan
United States University of Chicago Chicago Illinois
United States Peak Gastroenterology Associates Colorado Springs Colorado
United States Synexus Clinical Research US Inc Columbus Ohio
United States Tri-State Gastroenterology Assoc Crestview Hills Kentucky
United States Atlanta Center For Gastroenterology Decatur Georgia
United States Revive Research Institute Farmington Hills Michigan
United States Florida Research Network, LLC Gainesville Florida
United States University of Florida Health Jacksonville Gainesville Florida
United States Infusion Associates Grand Rapids Michigan
United States Harmony Medical Research Institute, Inc. Hialeah Florida
United States Baylor College of Medicine Houston Texas
United States UF Health Jacksonville Gastroenterology Emerson Jacksonville Florida
United States Mid-America Gastro-Intestinal Consultants Kansas City Missouri
United States I.H.S. Health. LLC Kissimmee Florida
United States Om Research LLC Lancaster California
United States Las Vegas Medical Research Las Vegas Nevada
United States UCLA Los Angeles California
United States Caprock Gastro Research Lubbock Texas
United States Gastroenterolgy Associates of Central GA Macon Georgia
United States Columbus Clinical Services LLC Miami Florida
United States Vista Health Research, LLC Miami Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States Care Access Research, Ogden Ogden Utah
United States Digestive Disease Specialists Inc Oklahoma City Oklahoma
United States Gastroenterology Associates of Orangeburg, SC Orangeburg South Carolina
United States Care Access Research, Orlando Orlando Florida
United States Orlando Health Orlando Florida
United States Synexus Clinical Research US Inc Pinellas Park Florida
United States Health Science Research Center Pratt Kansas
United States Duke University Hospital Medical Center Raleigh North Carolina
United States Barnes-jewish Hospital Saint Louis Missouri
United States Care Access Research- Salt Lake City Salt Lake City Utah
United States UW-Harborview Medical Center Seattle Washington
United States Providence Medical Group Spokane Washington
United States Velocity Clinical Research Spokane Spokane Washington
United States Digestive Specialists, Inc Springboro Ohio
United States Baystate Medical Center Springfield Massachusetts
United States Univ. of South Florida Med. Group Tampa Florida
United States Tyler Research Institute, LLC Tyler Texas
United States Northshore Gastroenterology Research, LLC Westlake Ohio
United States US Digestive Health Wyomissing Pennsylvania
United States Care Access Research, Poland Youngstown Ohio

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czechia,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Jordan,  Korea, Republic of,  Latvia,  Malaysia,  Netherlands,  New Zealand,  Poland,  Portugal,  Russian Federation,  Serbia,  Slovakia,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Induction Study 1: Clinical Response at Week 12 Clinical response per modified Mayo score. Week 12
Primary Induction Study 2: Clinical Remission at Week 12 Clinical remission per modified Mayo score. Week 12
Primary Maintenance Study: Clinical Remission at Week 44 Clinical remission per modified Mayo score. Week 44
Secondary Induction Study 1: Clinical Remission at Week 12 Clinical remission per modified Mayo score. Week 12
Secondary Induction Study 1: Symptomatic Remission at Week 12 Symptomatic remission per stool frequency and rectal bleeding subscores. Week 12
Secondary Induction Study 1: Endoscopic Healing at Week 12 Endoscopic healing per endoscopy subscore. Week 12
Secondary Induction Study 1: Histo-Endoscopic Mucosal Healing at Week 12 Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading. Week 12
Secondary Induction Study 1: Endoscopic Normalization at Week 12 Endoscopic normalization per endoscopy subscore. Week 12
Secondary Induction Study 2: Symptomatic Remission at Week 12 Symptomatic remission per stool frequency and rectal bleeding subscores. Week 12
Secondary Induction Study 2: Endoscopic Healing at Week 12 Endoscopic healing per endoscopy subscore. Week 12
Secondary Induction Study 2: Clinical Response at Week 12 Clinical response per modified Mayo score. Week 12
Secondary Induction Study 2: Symptomatic Remission at Week 4 Symptomatic remission per stool frequency and rectal bleeding subscores. Week 4
Secondary Induction Study 2: Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12 IBDQ remission is defined as total IBDQ score greater than or equal to (>=) 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with inflammatory bowel disease (IBD) that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes. Week 12
Secondary Induction Study 2: Histo-Endoscopic Mucosal Healing at Week 12 Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading. Week 12
Secondary Induction Study 2: Fatigue Response at Week 12 Fatigue response is defined as an improvement from induction baseline in patient-reported outcomes measurement information system (PROMIS)-fatigue short form 7a. The PROMIS Fatigue Short Form 7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). PROMIS Fatigue Short Form 7a has a recall period of past 7 days. Week 12
Secondary Induction Study 2: Symptomatic Remission at Week 2 Symptomatic remission per stool frequency and rectal bleeding subscores. Week 2
Secondary Induction Study 2: Endoscopic Normalization at Week 12 Endoscopic normalization per endoscopy subscore. Week 12
Secondary Maintenance Study: Symptomatic Remission at Week 44 Symptomatic remission per stool frequency and rectal bleeding subscores. Week 44
Secondary Maintenance Study: Endoscopic Healing at Week 44 Endoscopic healing per endoscopy subscore. Week 44
Secondary Maintenance Study: Corticosteroid-free Clinical Remission at Week 44 Corticosteroid-free clinical remission per modified Mayo score. Week 44
Secondary Maintenance Study: Clinical Response at Week 44 Clinical response per modified Mayo score. Week 44
Secondary Maintenance Study: Histo-Endoscopic Mucosal Healing at Week 44 Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading. Week 44
Secondary Maintenance Study: IBDQ Remission at Week 44 IBDQ remission is defined as total IBDQ score >= 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes. Week 44
Secondary Maintenance Study: Fatigue Response at Week 44 Fatigue response is defined as an improvement from induction baseline in PROMIS-fatigue short form 7a. The PROMIS Fatigue Short Form 7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). PROMIS Fatigue Short Form 7a has a recall period of past 7 days. Week 44
Secondary Maintenance Study: Clinical Remission at Week 44 Among the Participants Who had Achieved Clinical Remission at Maintenance Baseline Clinical remission per modified Mayo score. Week 44
Secondary Maintenance Study: Endoscopic Normalization at Week 44 Endoscopic normalization per endoscopy subscore. Week 44
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