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.
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.
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
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There are 81 Locations for this study
Phoenix Arizona, 85016, United States
Little Rock Arkansas, 72202, United States
Los Angeles California, 90048, United States
San Francisco California, 94143, United States
Hartford Connecticut, 06106, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Indianapolis Indiana, 46202, United States
Boston Massachusetts, 02115, United States
Royal Oak Michigan, 48073, United States
New York New York, 10021, United States
New York New York, 10029, United States
Chapel Hill North Carolina, 27514, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19104, United States
Columbia South Carolina, 29203, United States
Knoxville Tennessee, 37916, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Colchester Vermont, 05446, United States
Milwaukee Wisconsin, 53226, United States
Nedlands , 6009, Australia
North Adelaide , 5006, Australia
South Brisbane , 4101, Australia
Vienna , 1090, Austria
Brussels , 1090, Belgium
Brussel , 1200, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Campinas , 13060, Brazil
Curitiba , 80.25, Brazil
Goiânia , 74605, Brazil
Porto Alegre , 90035, Brazil
Ribeirao Preto , 14098, Brazil
Vitória , 29040, Brazil
Vancouver British Columbia, V6H 3, Canada
Halifax Nova Scotia, B3K 6, Canada
London Ontario, N6A 5, Canada
Toronto Ontario, M5G 1, Canada
Praha 5 , 150 0, Czechia
Amiens Cedex 1 , 80054, France
Lille , 59037, France
Paris cedex 15 , 75015, France
Paris , 75019, France
Be'er Ya'akov , 70300, Israel
Beersheba , 84101, Israel
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Jerusalem , 91240, Israel
Petach-Tikva , 49202, Israel
Bergamo , 24127, Italy
Bologna , 40124, Italy
Roma , 00165, Italy
Roma , 161, Italy
Daegu , 41404, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Rotterdam , 3015 , Netherlands
Nordbyhagen , 1474, Norway
Oslo , 424, Norway
Tromsø , 9038, Norway
Trondheim , 7030, Norway
Krakow , 30-66, Poland
Rzeszow , 35-30, Poland
Szczecin , 71-43, Poland
Warszawa , 00-63, Poland
Warszawa , 00-72, Poland
Braga , 4710-, Portugal
Lisboa , 1649-, Portugal
Porto , 4200-, Portugal
Córdoba , 14004, Spain
Madrid , 28009, Spain
Madrid , 28046, Spain
Sabadell , 8208, Spain
Valencia , 46026, Spain
Bern , 3010, Switzerland
Zürich , 8032, Switzerland
Denmark Hill , SE5 9, United Kingdom
Glasgow , G51 4, United Kingdom
Manchester , M13 9, United Kingdom
Manchester , M13 9, United Kingdom
Sheffield , S1 0 , United Kingdom
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