Multiple Sclerosis Clinical Trial

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn’s Disease

Summary

The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.

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Full Description

Participants screened in the MACARONI-23 platform study could be randomized to guselkumab to participate in this intervention specific arm of the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index [PCDAI] score greater than [>] 30)
Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (>=) 6 (or >=4 for participants with isolated ileal disease) during screening into this study
Participants must have a prior or current CD medication history that includes either inadequate response, loss of response to or failure to tolerate current treatment immunomodulators or with oral or intravenously (IV) corticosteroids or have received biologic therapy/JAK inhibitor for the treatment of CD and have a documented history of inadequate response, loss of response (LOR), or intolerance to the biologic therapy/JAK inhibitor

Exclusion Criteria:

Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery.
Participants must not have an abscess
Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

120

Study ID:

NCT05923073

Recruitment Status:

Not yet recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 81 Locations for this study

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Phoenix Children's Hospital
Phoenix Arizona, 85016, United States
Arkansas Childrens Hospital Research Institute
Little Rock Arkansas, 72202, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
University of California San Francisco
San Francisco California, 94143, United States
Connecticut Children's Medical Center
Hartford Connecticut, 06106, United States
Emory University
Atlanta Georgia, 30322, United States
Children's Center for Digestive Health Care
Atlanta Georgia, 30342, United States
Riley Hospital for Children
Indianapolis Indiana, 46202, United States
Boston Children's Hospital
Boston Massachusetts, 02115, United States
The Retina Inst. William Beaumont Hospital
Royal Oak Michigan, 48073, United States
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
New York New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27514, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
Palmetto Pediatric Gastroenterology & Nutrition
Columbia South Carolina, 29203, United States
East Tennessee Children's Hospital
Knoxville Tennessee, 37916, United States
Cook Childrens Medical Center
Fort Worth Texas, 76104, United States
Texas Children's Hospital
Houston Texas, 77030, United States
University of Vermont Medical Center
Colchester Vermont, 05446, United States
Children's Hospital of Wisconsin
Milwaukee Wisconsin, 53226, United States
Perth Children's Hospital
Nedlands , 6009, Australia
Women's and Children's Hospital
North Adelaide , 5006, Australia
Mater Hospital Brisbane
South Brisbane , 4101, Australia
AKH - Medizinische Universität Wien
Vienna , 1090, Austria
Universitair Ziekenhuis Brussel
Brussels , 1090, Belgium
Cliniques Universitaires Saint-Luc
Brussel , 1200, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
UZ Leuven
Leuven , 3000, Belgium
Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
Campinas , 13060, Brazil
Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro
Curitiba , 80.25, Brazil
Universidade Federal de Goias - Hospital das Clinicas da UFG
Goiânia , 74605, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre , 90035, Brazil
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
Ribeirao Preto , 14098, Brazil
Centro de Ciências e Saúde da Universidade Federal do Espirito Santo-Núcleo de Doenças Infecciosas
Vitória , 29040, Brazil
British Columbia Children's Hospital
Vancouver British Columbia, V6H 3, Canada
Iwk Health Centre
Halifax Nova Scotia, B3K 6, Canada
London Health Sciences Centre - Victoria Hospital
London Ontario, N6A 5, Canada
Hospital For Sick Children
Toronto Ontario, M5G 1, Canada
Fakultni nemocnice v Motole
Praha 5 , 150 0, Czechia
CHU Amiens-Hopital Nord
Amiens Cedex 1 , 80054, France
Hôpital Jeanne de FLANDRE, CHRU LILLE
Lille , 59037, France
Hôpital Necker - Enfants Malades
Paris cedex 15 , 75015, France
Hôpital Robert Debré
Paris , 75019, France
Shamir Medical Center (Assaf Harofeh)
Be'er Ya'akov , 70300, Israel
Soroka University Medical Center
Beersheba , 84101, Israel
Rambam Health Care Campus
Haifa , 31096, Israel
Shaare Zedek Medical Center
Jerusalem , 91031, Israel
Hadassah Medical Center
Jerusalem , 91240, Israel
Schneider Children's Medical Center
Petach-Tikva , 49202, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo , 24127, Italy
Ospedale Bellaria, U.O.Cardiologia Az. USL di Bologna
Bologna , 40124, Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Roma , 00165, Italy
AOU Policlinico Umberto I
Roma , 161, Italy
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 120-7, Korea, Republic of
Erasmus Medisch Centrum
Rotterdam , 3015 , Netherlands
Akershus Universitetssykehus HF
Nordbyhagen , 1474, Norway
Oslo University Hospital
Oslo , 424, Norway
Universitetssykehuset Nord-Norge HF
Tromsø , 9038, Norway
St. Olavs Hospital
Trondheim , 7030, Norway
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow , 30-66, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszow , 35-30, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin , 71-43, Poland
Centrum Zdrowia MDM
Warszawa , 00-63, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warszawa , 00-72, Poland
Hospital de Braga
Braga , 4710-, Portugal
Centro Hospitalar de Lisboa Norte - Hospital Santa Maria
Lisboa , 1649-, Portugal
Centro Hospitalar de São João, E.P.E.
Porto , 4200-, Portugal
Hosp. Reina Sofia
Córdoba , 14004, Spain
Hosp. Infantil Univ. Niño Jesus
Madrid , 28009, Spain
Hosp. Univ. de La Paz
Madrid , 28046, Spain
Corporacio Sanitari Parc Tauli
Sabadell , 8208, Spain
Hosp. Univ. I Politecni La Fe
Valencia , 46026, Spain
INSELSPITAL, Universitätsspital Bern
Bern , 3010, Switzerland
Kinderspital Zürich
Zürich , 8032, Switzerland
King's College Hospital
Denmark Hill , SE5 9, United Kingdom
Royal Hospital for Sick Children
Glasgow , G51 4, United Kingdom
Nowgen Centre, Research and Innovation
Manchester , M13 9, United Kingdom
Royal Manchester Children's Hospital
Manchester , M13 9, United Kingdom
Sheffield Children's Hospital
Sheffield , S1 0 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

120

Study ID:

NCT05923073

Recruitment Status:

Not yet recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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