A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
Who is this study for? Patients with moderately to severely active Crohn's disease
What treatments are being studied? Guselkumab
Status: Active_not_recruiting
Location: See all (339) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of Crohn's disease (CD) of at least 3 months in duration
• Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
• Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Locations
United States
Alabama
Digestive Health Specialists of the Southeast
Dothan
Arkansas
Central Arkansas Veterans Healthcare System
Little Rock
Moore Clinical Trials, LLC
Little Rock
Arizona
Advanced Gastro P.C
Chandler
Reliance Research
Scottsdale
California
Om Research LLC
Lancaster
United Gastroenterologists
Los Alamitos
Paul Wallace MD
Los Angeles
Clinnova Research
Orange
Digestive System Healthcare
Pasadena
Clinical Applications Laboratories, Inc
San Diego
Northshore Gastroenterology Research, LLC
San Diego
Santa Maria Gastroenterology
Santa Maria
Clinical Research of California
Walnut Creek
Colorado
Amel Med LLC Research
Grand Junction
Connecticut
Western Connecticut Health Network/Danbury Hospital
Danbury
Florida
Gastroenterology Associates of SW Florida
Clearwater
Pioneer Research Solutions Inc.
Coconut Creek
Omega Research Consultants
Debary
Harmony Medical Research Institute, Inc.
Hialeah
Central Florida Gastro Research
Kissimmee
Community Research Foundation, Inc.
Miami
Gastroenterology Group Of Naples
Naples
Center for Digestive Health
Orlando
Central Florida Internists
Orlando
Synergy Clinical Research
St. Petersburg
Georgia
Agile Clinical Research Trials, LLC
Atlanta
Atlanta Gastroenterology Specialists, PC
Atlanta
Atlanta Center For Gastroenterology
Decatur
Gastroenterolgy Associates of Central GA
Macon
Gastroenterology Consultants
Roswell
Idaho
USF Asthma, Allergy, Immunology Clinical Research Unit
Boise
Grand Teton Research Group, PLLC
Idaho Falls
Illinois
Lemah Creek Clinical Research
Oakbrook Terrace
Kansas
University of Kansas Medical Center
Kansas City
BVL Clinical Research
Leawood
Cotton O'Neil Digestive Health Center
Topeka
Kentucky
Tri-State Gastroenterology Assoc
Crestview Hills
Louisiana
Tandem Clinical Research
Marrero
Massachusetts
Digestive Health Specialists PC
Chelmsford
FC Research, LLC
South Dartmouth
Maryland
Institute for Digestive Health and Liver Disease
Baltimore
Woodholme Gastroenterology Associates
Glen Burnie
Michigan
Clinical Research Institute of Michigan, LLC
Chesterfield
Detroit Clinical Research Center
Livonia
Mississippi
University of Mississippi Medical Center
Jackson
North Carolina
Carolinas Medical Center
Charlotte
Onsite Clinical Solutions
Charlotte
Carolina Research
Greenville
Gastroenterology Associates of the Piedmont, P.A.
Winston-salem
New York
SUNY Downstate Medical Center
Brooklyn
Smart Medical Research
Jackson Heights
Crystal Run Healthcare LLP
Middletown
New York Gastroenterology Associates
New York
DiGiovanna Institute for Medical Education & Research
North Massapequa
A1 Clinical Network
Queens
Ohio
Central Ohio Endoscopy Center LLC
Columbus
Dayton Gastroenterology, Inc
Dayton
Great Lakes Gastroenterology
Mentor
Oklahoma
Central Sooner Research
Oklahoma City
Integris Baptist Office
Oklahoma City
Oklahoma University Health Science Center
Oklahoma City
Essential Medical Research
Tulsa
Oregon
The Oregon Clinic
Portland
Pennsylvania
Frontier Clinical Research
Smithfield
South Carolina
Gastroenterology Associates P.A.
Greenville
Carolina Health Specialists
Myrtle Beach
Texas
West Texas Clinical Research
Lubbock
Victoria Gastroenterology
Richmond
Gastroenterology Clinic Of San Antonio P A
San Antonio
Wellness Clinical Research
San Antonio
Texas Digestive Disease Consultants
Southlake
Digestive Health Specialists of Tyler
Tyler
Utah
Care Access Research- Salt Lake City
Salt Lake City
Virginia
Burke Internal Medicine and Research
Burke
Gastroenterology Associates of Tidewater
Chesapeake
Other Locations
Australia
Monash Health, Monash Medical Centre
Clayton
Coral Sea Clinical Research Institute
North Mackay
Belgium
OLV Ziekenhuis Aalst
Aalst
CHU Saint-Pierre
Brussels
Hopital Erasme
Brussels
Universitair Ziekenhuis Gent
Ghent
Algemeen Ziekenhuis Delta
Roeselare
Bosnia and Herzegovina
University hospital Clinical centre Banja Luka
Banja Luka
Clinical Center University of Sarajevo
Sarajevo
Polyclinic Dr. Al-Tawil
Sarajevo
General Hospital Tesanj
Tešanj
Plava poliklinika Tuzla
Tuzla
Cantonal Hospital Zenica
Zenica
Brazil
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu
CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
Brasília
Chronos Clinica Medica Ltda
Brasília
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas
CDC - Centro Digestivo de Curitiba
Curitiba
Universidade Federal Do Ceara
Fortaleza
Centro de Estudos Clínicos do Interior Paulista - CECIP
Jaú
Cliged
Macaé
Liga Norte Riograndense Contra O Cancer
Natal
Instituto Mederi de Pesquisa e Saude
Passo Fundo
Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles
Porto Alegre
Associacao Hospitalar Moinhos de Vento
Porto Alegre
Hospital das Clinicas de Porto Alegre
Porto Alegre
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre
Hospital das Clinicas - Universidade Federal de Pernambuco
Recife
SER - Servicos Especializados em Reumatologia da Bahia
Salvador
Universidade Federal da Bahia - Hospital Professor Edgard Santos
Salvador
Pesquisare Saude
Santo André
Irmandade da Santa Casa da Misericórdia de Santos
Santos
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo Do Campo
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José Do Rio Preto
Kaiser Hospta
São José Do Rio Preto
BR TRIALS Ensaios Clinicos e Consultoria Ltda
São Paulo
Hepatogastro
São Paulo
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
São Paulo
Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui
Teresina
Integral Centro de Pesquisas Clinicas
Votuporanga
Canada
London Health Sciences Centre
London
North Bay Dermatology Centre
North Bay
China
The Affiliated Hospital of Bengbu Medical College
Bengbu
The second Xiangya Hospital of Central South University
Changsha
Xiangya Hospital Central South University
Changsha
Changzhou No 2 Peoples Hospital
Changzhou
West China Hospital Sichuan University
Chengdu
Chongqing Medical University
Chongqing
The First People's Hospital of Foshan
Foshan
The First Affiliated Hospital of Fujian Medical University
Fuzhou
First Affiliated Hospital of Gannan Medical University
Ganzhou
Guangdong Provincial People's Hospital
Guangzhou
Guangzhou First Municipal People's Hospital
Guangzhou
Guangzhou Medical University
Guangzhou
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou
The First Affiliated Hospital of Anhui Medical University
Hefei
The First Affiliated Hospital of NanChang University
Nanchang
Nanjing 1st Hospital
Nanjing
Nanjing Drum Tower Hospital
Nanjing
The First Hospital of Quanzhou
Quanzhou
Huashan Hospital Fudan University
Shanghai
Shanghai East Hospital
Shanghai
Shengjing Hospital Of China Medical University
Shenyang
The first affiliated hospital of suzhou University
Suzhou
Wuxi People s Hospital
Wuxi
Yangzhou First People's Hospital
Yangzhou
ZhuZhou Central Hospital
Zhuzhou
Croatia
Opca bolnica Bjelovar
Bjelovar
University Hospital Center Split
Split
Opca bolnica Zadar
Zadar
Poliklinika Solmed
Zagreb
Denmark
Sydvestjysk Sygehus
Esbjerg
Nordsjaellands Hospital - Hillerod
Hilleroed
France
Centre Hospitalier de la Cote Basque
Bayonne
CHRU Besancon Hopital Jean Minjoz
Besançon
Hopital Louis Mourier
Colombes
CHU de Nantes hotel Dieu
Nantes
CHU de Nice Hopital de l Archet
Nice
Hôpital Bichat
Paris
Hospices Civils de Lyon HCL
Pierre-bénite
Hôpital Robert Debré
Reims
CHU Saint Etienne Hopital Nord
Saint-priest-en-jarez
CHRU Strasbourg
Strasbourg
CHU Rangueil
Toulouse
Germany
Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center
Berlin
DRK Kliniken Westend
Berlin
Krankenhaus Waldfriede Mitte
Berlin
Staedtisches Klinikum Braunschweig
Braunschweig
Evangelisches Krankenhaus Kalk
Cologne
Medizinisches Versorgungszentrum (MVZ) Dachau
Dachau
MVZ Sanaklinikum Duisburg
Duisburg
BSF Studiengesellschaft
Halle
Medizinische Hochschule Hannover
Hanover
Praxisgemeinschaft Jerichow
Jerichow
Gastroenterologische Spezialpraxis - Berlin-Karlshorst
Karlshorst
Universitaetsklinikum Mannheim
Mannheim
Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
Nordhausen
Hungary
Egyesített Szent István és Szent László Kórház
Budapest
Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
Budapest
Mh Egészségügyi Központ
Budapest
Obudai Egeszsegugyi Centrum Kft
Budapest
Pannónia Magánorvosi Centrum Kft
Budapest
Semmelweis Egyetem
Budapest
Pest Megyei Flor Ferenc Korhaz
Kistarcsa
Mohacsi Korhaz
Mohács
Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika
Pécs
Markusovszky Egyetemi Oktatokorhaz
Szombathely
Israel
Haemek Medical Center
Afula
Soroka University Medical Center
Beersheba
The Chaim Sheba Medical Center
Ramat Gan
Kaplan Medical Center
Rehovot
Assaf Harofeh Medical Center
Tzrifin
Italy
Policlinico Sant'Orsola Malpighi
Bologna
Istituto Clinico Humanitas Rozzano, IRCCS
Milan
Policlinico Universitario Agostino Gemelli
Roma
Università Campus Biomedico di Roma
Roma
Japan
Juntendo University Hospital
Bunkyō City
Ginza central clinic
Chūōku
Fukui Prefectural Hospital
Fukui-ken
Fukuoka University Hospital
Fukuoka
Japanese Red Cross Fukuoka Hospital
Fukuoka
National Hospital Organization Fukuyama Medical Center
Fukuyama
Gamagori City Hospital
Gamagōri
Gunma University Hospital
Gunma
Hachinohe City Hospital
Hachinohe
Hamamatsu University Hospital
Hamamatsu
Matsuda Hospital
Hamamatsu
National Hospital Organization Mito Medical Center
Higashi-ibaraki
Kure Kyosai Hospital
Hiroshima
National Hospital Organization Shikoku Cancer Center
Iizuka-shi
Kagoshima IBD Gastroenterology Clinic
Kagoshima
Kagoshima University Hospital
Kagoshima
Tsujinaka Hospital Kashiwanoha
Kashiwa
Kyushu Rosai Hospital
Kitakyushu
Kobe University Hospital
Kobe
Yamanashi Prefectural Central Hospital
Kofu
Dokkyo Medical University Saitama Medical Center
Koshigaya
Hidaka Coloproctologic Clinic
Kurume
Japanese Red Cross Kyoto Daini Hospital
Kyoto
University Hospital Kyoto Prefectural University of Medicine
Kyoto
Iwate Medical University Hospital
Morioka
Nagasaki University Hospital
Nagasaki
Yokoyama IBD Clinic
Nagoya
University of the Ryukyus Hospital
Nakagami-gun
Niigata University Medical And Dental Hospital
Niigata
Nishinomiya Municipal Central Hospital
Nishinomiya
Oita Red Cross Hospital
Ōita
Japanese Red Cross Osaka Hospital
Osaka
Kinshukai Infusion Clinic
Osaka
National Hospital Organization Osaka National Hospital
Osaka
Osaka General Medical Center
Osaka
Shiga University of Medical Science Hospital
Ōtsu
Sapporo Higashi Tokushukai Hospital
Sapporo
Takagi Clinic
Sendai
National Hospital Organization Shizuoka Medical Center
Sunto-gun
Tokyo Medical University Hospital
Tokyo
Toyota Kosei Hospital
Toyota
Yokohama City University Medical Center
Yokohama
Jordan
Abdali Hospital
Amman
Istiklal Hospital
Amman
Khalidi Hospital and Medical Center
Amman
The Speciality Hospital (TSH) / Advanced Clinical Center
Amman
Irbid Specialty Hospital
Irbid
King Abdullah University Hospital
Irbid
Lithuania
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
Kaunas
Vilnius University Hospital Santaros Klinikos, Public Institution
Vilnius
Malaysia
Hospital Sultanah Aminah
Johor Bharu
Hospital University Sains Malaysia
Kota Bharu
Hospital Raja Permaisuri Bainun
Kota Kinabalu
University Malaya Medical Centre
Kuala Lumpur
Hospital Tengku Ampuan Afzan
Kuantan
Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam
Sint Franciscus Gasthuis
Rotterdam
Elisabeth-TweeSteden Ziekenhuis
Tilburg
New Zealand
Christchurch Hospital
Christchurch
Dunedin Hospital
Dunedin
Poland
Gastromed Kralisz Romatowski Stachurska Sp. j.
Bialystok
10 Wojskowy Szpital Kliniczny z Poliklinika, SP ZOZ
Bydgoszcz
Centrum Medyczne Lukamed
Chojnice
Sahlgrenska University Hospital
Chrzanów
Private Practice - Dr. Krzysztof Cymerman
Gdynia
Centrum Medyczne Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j.
Grudziądz
Centrum Medyczne Plejady
Krakow
Centrum Medyczne ProMiMed
Krakow
Malopolskie Centrum Kliniczne
Krakow
AmiCare Centrum Medyczne
Lodz
Centrum Medyczne Med Gastr
Lodz
IP Clinic Sp. z o.o.
Lodz
ETG Lublin
Lublin
Niepubliczny Zaklad Opieki Zdrowotnej
Lublin
Allmedica
Nowy Targ
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn
Twoja Przychodnia
Opole
Centrum Medyczne
Piotrkow Trybunalski
EMC Instytut Medyczny SA PL CERTUS
Poznan
Synexus Polska Sp z o o
Poznan
Twoja Przychodnia
Poznan
Centrum Medyczne Medyk
Rzeszów
Centrum Medyczne Promed
Skorzewo
Endoskopia Sp z o.o.
Sopot
Kiepury Clinic
Sosnowiec
KO Med Centrum Medyczne
Straszów
Sonomed Sp. z o.o.
Szczecin
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin
GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
Torun
H-T Centrum Medyczne Endoterapia
Tychy
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw
Centrum Zdrowia Matki Dziecka i Mlodziezy
Warsaw
Endoterapia
Warsaw
Gabinety Lekarskie Bodyclinic
Warsaw
IBD Point Profesor Kierkus
Warsaw
Medical Concierge Centrum Medyczne
Warsaw
NZOZ Vivamed
Warsaw
Centrum Zdrowia Tuchow
Wierzchosławice
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
Włocławek
Centrum Medyczne Melita Medical
Wroclaw
Melita Medical Sp. z o.o.
Wroclaw
Przychodnia Vistamed
Wroclaw
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
Wroclaw
ETG Zamosc
Zamość
Republic of Korea
DongA Medical Center
Busan
Inje University Haeundae Paik Hospital
Busan
Kosin University Gospel Hospital
Busan
Kyungpook National University Chilgok Hospital
Busan
Yeungnam University Medical Center
Daegu
The Catholic University of Korea Seoul St.Mary's Hospital
Daejeon
Kyung Hee University Hospital
Dongdaemun-gu
Dongguk University Ilsan Hospital
Goyang-si
Chonnam National University Hospital
Gwangju
CHA Bundang Medical Center, CHA University
Gyeonggi-do
The Catholic university of Korea, St. Vincent's Hospital
Gyeonggi-do
Kangbuk Samsung Hospital
Seoul
Samsung Medical Center
Seoul
The Catholic University of Korea Seoul St Mary s Hospital
Seoul
Yonsei University College of Medicine
Seoul
Ajou University Hospital
Suwon
Wonju Christian Hospital
Wŏnju
Ewha Womans University Mokdong Hospital
Yangch’ŏn-gu
Slovakia
FNsP F.D.R. Banska Bystrica
Banská Bystrica
ENDOMED s.r.o
Košice
GASTRO I. s.r.o.
Prešov
Spain
Hosp. de Cabuenes
Gijón
Hosp. Gral. Juan Ramon Jimenez
Huelva
Hosp. Gral. Juan Ramon Jimenez
Huelva
Hosp. Univ. Infanta Leonor
Madrid
Hosp. Virgen Macarena
Seville
Hosp. Alvaro Cunqueiro
Vigo
Hosp. de La Marina Baixa
Villajoyosa
Taiwan
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaoshiung
China Medical University Hospital
Taichung
National Taiwan University Hospital, Division of Infectious Diseases
Taipei
Taipei Medical University
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan District
Turkey
Ankara Numune Egitim ve Arastirma Hastanesi
Ankara
Gazi University Medical Faculty
Ankara
Hacettepe University Hospital
Ankara
Acibadem Fulya Hospital
Istanbul
Ege Universitesi Tip Fakultesi
Izmir
Mersin University Medical Faculty
Mersin
Ondokuz Mayis University
Samsun
Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi
Zonguldak
Time Frame
Start Date: 2022-01-19
Completion Date: 2028-10-30
Participants
Target number of participants: 350
Treatments
Experimental: Group 1: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.
Experimental: Group 2: Guselkumab
Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.
Placebo_comparator: Group 3: Placebo
Participants will receive placebo injection subcutaneously.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC