A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

Last updated: April 25, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Terminated

Phase

3

Condition

Crohn's Disease

Colic

Ulcerative Colitis

Treatment

Guselkumab

Placebo

Clinical Study ID

NCT05784129
CR109292
CNTO1959CRD3007
2022-002389-33
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the effectiveness of guselkumab treatment compared with placebo (an inactive substance with no medicine) in preventing recurrence of Crohn's disease in participants after surgery.

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

Total Participants: 4
Treatment Group(s): 2
Primary Treatment: Guselkumab
Phase: 3
Study Start date:
February 21, 2023
Estimated Completion Date:
October 10, 2023

Connect with a study center

  • Medizinische Universität Graz

    Graz, 8036
    Austria

    Site Not Available

  • Medizinische Universität Innsbruck

    Innsbruck, 6020
    Austria

    Site Not Available

  • Universitätsklinikum Salzburg - Landeskrankenhaus

    Salzburg, 5020
    Austria

    Site Not Available

  • Akh Wien

    Wien, 1090
    Austria

    Site Not Available

  • Hopital Erasme

    Bruxelles, 1070
    Belgium

    Site Not Available

  • AZ Maria Middelares

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • University of Calgary

    Calgary, Alberta T2N 4N1
    Canada

    Site Not Available

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • Mount Sinai Hospital-Toronto

    Toronto, Ontario M5G 1X5
    Canada

    Site Not Available

  • Toronto Digestive Disease Associates Inc

    Vaughan, Ontario L4L 4Y7
    Canada

    Site Not Available

  • McGill University Health Centre

    Montreal, Quebec H3G 1A4
    Canada

    Site Not Available

  • Covenant Health/Grey Nuns hospital

    Edmonton, T6K 4B2
    Canada

    Site Not Available

  • NH Hospital, a.s.

    Horovice, 268 31
    Czechia

    Site Not Available

  • Hepato-gastroenterologie HK, s.r.o.

    Hradec Kralove, 500 12
    Czechia

    Site Not Available

  • ISCARE a.s.

    Praha 9, 190 00
    Czechia

    Site Not Available

  • CHRU Besançon -Hôpital Jean Minjoz

    Besançon Cedex, 25000
    France

    Site Not Available

  • CHRU Montpellier - Hopital Saint-Eloi

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • CHU de Nice Hopital de l Archet

    Nice, 6202
    France

    Site Not Available

  • Hopital Saint-Louis

    Paris, 75010
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495
    France

    Site Not Available

  • CHU de Reims

    Reims, 51100
    France

    Site Not Available

  • CHU de Nancy - Hôpital de Brabois

    Vandoeuvre-les-Nancy, 54511
    France

    Site Not Available

  • Klinikum Augsburg

    Augsburg, 86156
    Germany

    Site Not Available

  • Krankenhaus Waldfriede Mitte

    Berlin, 14163
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen Medizinische Klinik I

    Erlangen, 91054
    Germany

    Site Not Available

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60590
    Germany

    Site Not Available

  • Universitatsklinikum Freiburg

    Freiburg, 79110
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd

    Heidelberg, 69115
    Germany

    Site Not Available

  • Universitätsklinikum Jena

    Jena, 07747
    Germany

    Site Not Available

  • Staedtisches Klinikum Lueneburg

    Lueneburg, 21339
    Germany

    Site Not Available

  • Universitatsklinikum Mannheim

    Mannheim, 68167
    Germany

    Site Not Available

  • Klinikum rechts der Isar der TU Munchen

    München, 81675
    Germany

    Site Not Available

  • Medius Klinik Nürtingen

    Nurtingen, 72622
    Germany

    Site Not Available

  • Siloah St. Trudpert Klinikum

    Pforzheim, 75179
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, 89070
    Germany

    Site Not Available

  • Semmelweis Egyetem

    Budapest, H-1088
    Hungary

    Site Not Available

  • Policlinico di Bari Ospedale Giovanni XXIII

    Bari, 70124
    Italy

    Site Not Available

  • Università degli studi di Bologna

    Bologna, 40138
    Italy

    Site Not Available

  • AOU Policlinico G.Martino

    Messina, 98125
    Italy

    Site Not Available

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Site Not Available

  • Ospedale Sacro Cuore Don Calabria

    Negrar Ve, 37024
    Italy

    Site Not Available

  • A.O.R Villa Sofia Cervello

    Palermo, 90146
    Italy

    Site Not Available

  • Universita Campus Bio Medico[UOC Gastroenterologia]

    Roma, 00128
    Italy

    Site Not Available

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • IRCCS Policlinico San Donato

    San Donato Milanese (MI), 20097
    Italy

    Site Not Available

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • Dong-A University Hospital

    Busan, 49201
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Yonsei University Wonju Severance Christian Hospital

    Wonju, Gangwon-do, 26426
    Korea, Republic of

    Site Not Available

  • Academisch Medisch Centrum Universiteit van Amsterdam

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Sint Franciscus Gasthuis

    Rotterdam, 3045 PM
    Netherlands

    Site Not Available

  • Stichting Zuyderland Medisch Centrum

    Sittard-Geleen, 6162 BG
    Netherlands

    Site Not Available

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg, 5022 GC
    Netherlands

    Site Not Available

  • UMC Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Centrum Medyczne Medyk

    Rzeszow, 35-326
    Poland

    Site Not Available

  • H-T Centrum Medyczne Endoterapia

    Tychy, 43-100
    Poland

    Site Not Available

  • Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie

    Warszawa, 02-781
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkus

    Warszawa, 00-728
    Poland

    Site Not Available

  • Melita Medical Sp. z o.o.

    Wroclaw, 50-449
    Poland

    Site Not Available

  • University Clinical Hospital Center Dr Dragisa Misovic- Dedi

    Belgrade, 11040
    Serbia

    Site Not Available

  • Clinical Hospital Center Bezanijska Kosa

    Zemun, 11080
    Serbia

    Site Not Available

  • Hosp. Gral. Univ. de Alicante

    Alicante, 0-3010
    Spain

    Site Not Available

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916
    Spain

    Site Not Available

  • Hosp. Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hosp. Arquitecto Marcide

    El Ferrol, 15405
    Spain

    Site Not Available

  • Hosp. Univ. de La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Hosp. Univ. Central de Asturias

    Oviedo, 33011
    Spain

    Site Not Available

  • Hosp. de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Santiago

    Santiago De Compostela, 15706
    Spain

    Site Not Available

  • Hosp. Clinico Univ. De Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hosp. Univ. Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

  • Royal Victoria Hospital

    Belfast, BT12 6BA
    United Kingdom

    Site Not Available

  • Fairfield General Hospital

    Bury, BL9 7TD
    United Kingdom

    Site Not Available

  • London North West University Healthcare NHS Trust

    Harrow, HA1 3UJ
    United Kingdom

    Site Not Available

  • Guy's and St Thomas' Hospital

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Southampton University Hospitals NHS Trust

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Medical Associates Research Group, Inc.

    San Diego, California 92123
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94115
    United States

    Site Not Available

  • University of Colorado Denver Anschultz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Medical Research Center of Connecticut

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • Gastroenterology Group Of Naples

    Naples, Florida 34102
    United States

    Site Not Available

  • Gastroenterolgy Associates of Central GA

    Macon, Georgia 31201
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Digestive Health Center of Louisiana

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Louisiana Research Center, LLC

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Brigham & Women's Hospital

    Chestnut Hill, Massachusetts 02467
    United States

    Site Not Available

  • University of Michigan Health Systems

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Huron Gastroenterology Associates Center for Digestive Care

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • NYU Langone Medical Center

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Rush University Medical Center

    New York, New York 60612
    United States

    Site Not Available

  • Smart Medical Research

    Queens Village, New York 11427
    United States

    Site Not Available

  • Asheville Gastroenterology Associates

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Gastro Health Ohio

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Greater Cincinnati Gastroenterology Association, Inc.

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University of Miami/Sylvester Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Texas Digestive Consultants of South Texas dba Texas Digestive Specialists

    Brownsville, Texas 78526
    United States

    Site Not Available

  • Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Gastroenterology Research of San Antonio

    San Antonio, Texas 78212
    United States

    Site Not Available

  • Southern Star Research Institute, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Center For Digestive Disease

    Shenandoah, Texas 77384
    United States

    Site Not Available

  • Texas Digestive Disease Consultants

    Southlake, Texas 76092
    United States

    Site Not Available

  • Texas Gastroenterology Associates - Research

    Spring, Texas 77386
    United States

    Site Not Available

  • Tyler Research Institute, LLC

    Tyler, Texas 75701
    United States

    Site Not Available

  • Velocity Clinical Research

    Riverton, Utah 84065
    United States

    Site Not Available

  • Gastroenterology Consultants of Southwest Virginia

    Roanoke, Virginia 24014-1372
    United States

    Site Not Available

  • Swedish Medical Center-First Hill Campus

    Issaquah, Washington 98029
    United States

    Site Not Available

  • Digestive Health Specialists

    Tacoma, Washington 98405
    United States

    Site Not Available

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