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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05197049
Other study ID # CR109125
Secondary ID 2020-006165-11CN
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 19, 2022
Est. completion date March 31, 2025

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 Crohn's disease.


Description:

Crohn's disease is a chronic, progressive and potentially life-threatening disorder which may affect any part of the gastrointestinal (GI) tract. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody that binds to human interleukin (IL)-23, thereby blocking the binding of extracellular IL-23 to the cell surface IL-23 receptor. This binding results in inhibition of IL-23 mediated intracellular signaling, activation and cytokine production. The purpose of the study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn's disease. The overall study duration is up to 109 weeks.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 350
Est. completion date March 31, 2025
Est. primary completion date July 4, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Current diagnosis of ulcerative colitis or indeterminate colitis - Complications of Crohn's disease that require surgical intervention or confound efficacy assessments - Unstable doses of concomitant Crohn's disease therapy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Guselkumab Dose 1
Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.
Guselkumab Dose 2
Guselkumab (Dose 2) will be administered by SC injection.
Guselkumab Dose 3
Guselkumab (Dose 3) will be administered by SC injection.
Placebo
Placebo will be administered by SC injection.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bosnia and Herzegovina,  Brazil,  Canada,  China,  Croatia,  Czechia,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Jordan,  Korea, Republic of,  Lithuania,  Malaysia,  Netherlands,  New Zealand,  Poland,  Slovakia,  Spain,  Taiwan,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Remission at Week 12 Clinical Remission is based on Crohn's Disease Activity Index (CDAI). Week 12
Primary Endoscopic Response at Week 12 Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). Week 12
Secondary Clinical Remission at Week 24 Clinical Remission is based in CDAI. Week 24
Secondary Patient-reported Outcome (PRO)-2 Remission at Week 12 PRO-2 remission is based on abdominal pain (AP) and stool frequency (SF) score. Week 12
Secondary Clinical Response at Week 12 Clinical response is based on change from baseline in CDAI. Week 12
Secondary Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention Percentage of participants with AEs, SAEs and AEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Up to 109 Weeks
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