Phase
Condition
Crohn's Disease
Colic
Ulcerative Colitis
Treatment
Guselkumab
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have a documented diagnosis of Crohn's disease (CD) confirmed by endoscopic,histologic, and/or radiologic studies prior to resection or by tissue obtained atresection
Have undergone an ileocolonic surgical resection (that is, an intestinal resectionwith an ileocolonic anastomosis) for CD prior to the baseline visit with thefollowing criteria: (a)Have no known active CD anywhere in the gastrointestinal (GI)tract, including the findings at surgery. (b)Be able to undergo randomization nolater than 49 days after surgery, and at least 10 days after surgery (or 8 daysafter resumption of bowel activity, example, in case of postoperative ileus) (c)Ileocolonic resection was not for the purpose of removing known dysplasia. (d) Ifileocolonic resection is the participant's first resection for Crohn's, and occursgreater than (>) 10 years since the diagnosis of CD and only fibrostenoticstricturing is present, then length of stricture must be > 10 centimeter (cm)
Have a baseline Crohn's Disease Activity Index (CDAI) less than (<) 200
A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) test result during screening and anegative urine pregnancy test at week 0, prior to randomization
A woman must agree not to donate eggs (ova, oocytes) or freeze for future use forthe purposes of assisted reproduction during the study and for a period of 12 weeksafter the last administration of study intervention
Exclusion
Exclusion Criteria:
Has complications of CD, such as symptomatic strictures or stenoses, short bowelsyndrome, a draining (that is, functioning) stoma or ostomy, or any othermanifestation, that might be anticipated to require surgery, could preclude the useof the CDAI to assess response to therapy, or would possibly confound the ability toassess the effect of treatment with guselkumab
Currently has or is suspected to have an abscess. Recent cutaneous and perianalabscesses are not exclusionary if drained and adequately treated at least 3 weeksbefore baseline, or 8 weeks before baseline for intra-abdominal abscesses, providedthat there is no anticipated need for any further surgery
Have had any active perianal disease within 3 months of screening (except skin tags)or have had any draining fistula within 3 months of screening unless the fistula wasremoved at the index surgery
Evidence of a herpes zoster infection within 8 weeks before the first dose of studyintervention
Has a history of severe, progressive, or uncontrolled renal, genitourinary,hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic,psychiatric, or metabolic disturbances, or signs and symptoms thereof
Study Design
Connect with a study center
Medizinische Universität Graz
Graz, 8036
AustriaSite Not Available
Medizinische Universität Innsbruck
Innsbruck, 6020
AustriaSite Not Available
Universitätsklinikum Salzburg - Landeskrankenhaus
Salzburg, 5020
AustriaSite Not Available
Akh Wien
Wien, 1090
AustriaSite Not Available
Hopital Erasme
Bruxelles, 1070
BelgiumSite Not Available
AZ Maria Middelares
Gent, 9000
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
University of Calgary
Calgary, Alberta T2N 4N1
CanadaSite Not Available
Nova Scotia Health Authority
Halifax, Nova Scotia B3H 2Y9
CanadaSite Not Available
Mount Sinai Hospital-Toronto
Toronto, Ontario M5G 1X5
CanadaSite Not Available
Toronto Digestive Disease Associates Inc
Vaughan, Ontario L4L 4Y7
CanadaSite Not Available
McGill University Health Centre
Montreal, Quebec H3G 1A4
CanadaSite Not Available
Covenant Health/Grey Nuns hospital
Edmonton, T6K 4B2
CanadaSite Not Available
NH Hospital, a.s.
Horovice, 268 31
CzechiaSite Not Available
Hepato-gastroenterologie HK, s.r.o.
Hradec Kralove, 500 12
CzechiaSite Not Available
ISCARE a.s.
Praha 9, 190 00
CzechiaSite Not Available
CHRU Besançon -Hôpital Jean Minjoz
Besançon Cedex, 25000
FranceSite Not Available
CHRU Montpellier - Hopital Saint-Eloi
Montpellier Cedex 5, 34295
FranceSite Not Available
CHU de Nice Hopital de l Archet
Nice, 6202
FranceSite Not Available
Hopital Saint-Louis
Paris, 75010
FranceSite Not Available
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
FranceSite Not Available
CHU de Reims
Reims, 51100
FranceSite Not Available
CHU de Nancy - Hôpital de Brabois
Vandoeuvre-les-Nancy, 54511
FranceSite Not Available
Klinikum Augsburg
Augsburg, 86156
GermanySite Not Available
Krankenhaus Waldfriede Mitte
Berlin, 14163
GermanySite Not Available
Universitätsklinikum Erlangen Medizinische Klinik I
Erlangen, 91054
GermanySite Not Available
Universitaetsklinikum Frankfurt
Frankfurt, 60590
GermanySite Not Available
Universitatsklinikum Freiburg
Freiburg, 79110
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover, 30625
GermanySite Not Available
Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd
Heidelberg, 69115
GermanySite Not Available
Universitätsklinikum Jena
Jena, 07747
GermanySite Not Available
Staedtisches Klinikum Lueneburg
Lueneburg, 21339
GermanySite Not Available
Universitatsklinikum Mannheim
Mannheim, 68167
GermanySite Not Available
Klinikum rechts der Isar der TU Munchen
München, 81675
GermanySite Not Available
Medius Klinik Nürtingen
Nurtingen, 72622
GermanySite Not Available
Siloah St. Trudpert Klinikum
Pforzheim, 75179
GermanySite Not Available
Universitätsklinikum Ulm
Ulm, 89070
GermanySite Not Available
Semmelweis Egyetem
Budapest, H-1088
HungarySite Not Available
Policlinico di Bari Ospedale Giovanni XXIII
Bari, 70124
ItalySite Not Available
Università degli studi di Bologna
Bologna, 40138
ItalySite Not Available
AOU Policlinico G.Martino
Messina, 98125
ItalySite Not Available
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, 20122
ItalySite Not Available
Ospedale Sacro Cuore Don Calabria
Negrar Ve, 37024
ItalySite Not Available
A.O.R Villa Sofia Cervello
Palermo, 90146
ItalySite Not Available
Universita Campus Bio Medico[UOC Gastroenterologia]
Roma, 00128
ItalySite Not Available
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
ItalySite Not Available
IRCCS Policlinico San Donato
San Donato Milanese (MI), 20097
ItalySite Not Available
Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
ItalySite Not Available
Dong-A University Hospital
Busan, 49201
Korea, Republic ofSite Not Available
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
Yonsei University Wonju Severance Christian Hospital
Wonju, Gangwon-do, 26426
Korea, Republic ofSite Not Available
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX
NetherlandsSite Not Available
Sint Franciscus Gasthuis
Rotterdam, 3045 PM
NetherlandsSite Not Available
Stichting Zuyderland Medisch Centrum
Sittard-Geleen, 6162 BG
NetherlandsSite Not Available
Elisabeth-TweeSteden Ziekenhuis
Tilburg, 5022 GC
NetherlandsSite Not Available
UMC Utrecht
Utrecht, 3584 CX
NetherlandsSite Not Available
Centrum Medyczne Medyk
Rzeszow, 35-326
PolandSite Not Available
H-T Centrum Medyczne Endoterapia
Tychy, 43-100
PolandSite Not Available
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
Warszawa, 02-781
PolandSite Not Available
WIP Warsaw IBD Point Profesor Kierkus
Warszawa, 00-728
PolandSite Not Available
Melita Medical Sp. z o.o.
Wroclaw, 50-449
PolandSite Not Available
University Clinical Hospital Center Dr Dragisa Misovic- Dedi
Belgrade, 11040
SerbiaSite Not Available
Clinical Hospital Center Bezanijska Kosa
Zemun, 11080
SerbiaSite Not Available
Hosp. Gral. Univ. de Alicante
Alicante, 0-3010
SpainSite Not Available
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
SpainSite Not Available
Hosp. Reina Sofia
Cordoba, 14004
SpainSite Not Available
Hosp. Arquitecto Marcide
El Ferrol, 15405
SpainSite Not Available
Hosp. Univ. de La Princesa
Madrid, 28006
SpainSite Not Available
Hosp. Univ. Central de Asturias
Oviedo, 33011
SpainSite Not Available
Hosp. de Navarra
Pamplona, 31008
SpainSite Not Available
Hosp. Clinico Univ. de Santiago
Santiago De Compostela, 15706
SpainSite Not Available
Hosp. Clinico Univ. De Valencia
Valencia, 46010
SpainSite Not Available
Hosp. Univ. Miguel Servet
Zaragoza, 50009
SpainSite Not Available
Royal Victoria Hospital
Belfast, BT12 6BA
United KingdomSite Not Available
Fairfield General Hospital
Bury, BL9 7TD
United KingdomSite Not Available
London North West University Healthcare NHS Trust
Harrow, HA1 3UJ
United KingdomSite Not Available
Guy's and St Thomas' Hospital
London, SE1 7EH
United KingdomSite Not Available
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
United KingdomSite Not Available
Southampton University Hospitals NHS Trust
Southampton, SO16 6YD
United KingdomSite Not Available
Medical Associates Research Group, Inc.
San Diego, California 92123
United StatesSite Not Available
University of California, San Francisco
San Francisco, California 94115
United StatesSite Not Available
University of Colorado Denver Anschultz Medical Campus
Aurora, Colorado 80045
United StatesSite Not Available
Medical Research Center of Connecticut
Hamden, Connecticut 06518
United StatesSite Not Available
Gastroenterology Group Of Naples
Naples, Florida 34102
United StatesSite Not Available
Gastroenterolgy Associates of Central GA
Macon, Georgia 31201
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
Digestive Health Center of Louisiana
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Louisiana Research Center, LLC
Shreveport, Louisiana 71105
United StatesSite Not Available
Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
United StatesSite Not Available
Brigham & Women's Hospital
Chestnut Hill, Massachusetts 02467
United StatesSite Not Available
University of Michigan Health Systems
Ann Arbor, Michigan 48109
United StatesSite Not Available
Huron Gastroenterology Associates Center for Digestive Care
Ypsilanti, Michigan 48197
United StatesSite Not Available
NYU Langone Medical Center
New Hyde Park, New York 11042
United StatesSite Not Available
Rush University Medical Center
New York, New York 60612
United StatesSite Not Available
Smart Medical Research
Queens Village, New York 11427
United StatesSite Not Available
Asheville Gastroenterology Associates
Asheville, North Carolina 28801
United StatesSite Not Available
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Gastro Health Ohio
Cincinnati, Ohio 45219
United StatesSite Not Available
Greater Cincinnati Gastroenterology Association, Inc.
Cincinnati, Ohio 45219
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
University of Miami/Sylvester Cancer Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Texas Digestive Consultants of South Texas dba Texas Digestive Specialists
Brownsville, Texas 78526
United StatesSite Not Available
Baylor University Medical Center
Dallas, Texas 75246
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
Gastroenterology Research of San Antonio
San Antonio, Texas 78212
United StatesSite Not Available
Southern Star Research Institute, LLC
San Antonio, Texas 78229
United StatesSite Not Available
Center For Digestive Disease
Shenandoah, Texas 77384
United StatesSite Not Available
Texas Digestive Disease Consultants
Southlake, Texas 76092
United StatesSite Not Available
Texas Gastroenterology Associates - Research
Spring, Texas 77386
United StatesSite Not Available
Tyler Research Institute, LLC
Tyler, Texas 75701
United StatesSite Not Available
Velocity Clinical Research
Riverton, Utah 84065
United StatesSite Not Available
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia 24014-1372
United StatesSite Not Available
Swedish Medical Center-First Hill Campus
Issaquah, Washington 98029
United StatesSite Not Available
Digestive Health Specialists
Tacoma, Washington 98405
United StatesSite Not Available
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