A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease (MACARONI-23)
Last Updated April 23, 2025
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CR109212
OVERVIEW
-
Sexes Eligible for Study
all -
Age
years -
Phase
phase 33 -
Sites
Sites -
Status
Recruiting
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.
CONDITIONS
- Crohn's Disease
ELIGIBILITY
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 ac
DETAILS
LOCATIONS
Locations in:
United States, France, Italy, Japan, Norway, Poland, Spain, United Kingdom, Belgium, Austria, Brazil, Israel, South Korea, Netherlands, Portugal
| Country (15) | City or Province (63) | Status |
| United States | Atlanta Emory University |
RECRUITING
|
| United States | Atlanta Children's Center for Digestive Health Care |
RECRUITING
|
| United States | Indianapolis Riley Hospital for Children |
RECRUITING
|
| United States | New York Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center |
RECRUITING
|
| France | Lille Hôpital Jeanne de FLANDRE, CHRU LILLE |
RECRUITING
|
| Italy | Firenze Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer |
RECRUITING
|
| Italy | Roma AOU Policlinico Umberto I |
RECRUITING
|
| Japan | Hirosaki Hirosaki University Hospital |
RECRUITING
|
| Japan | Kashiwa-shi Tsujinaka Hospital Kashiwanoha |
RECRUITING
|
| Japan | Saga Saga University Hospital |
RECRUITING
|
| Japan | Sendai Miyagi Children's Hospital |
RECRUITING
|
| Japan | Setagaya Ku National Center for Child Health and Development |
RECRUITING
|
| Japan | Tokyo Juntendo University Hospital |
RECRUITING
|
| Japan | Yokohama-shi Yokohama City University Medical Center |
RECRUITING
|
| Norway | Nordbyhagen Akershus Universitetssykehus HF |
RECRUITING
|
| Norway | Oslo Oslo University Hospital |
RECRUITING
|
| Norway | Tromsø Universitetssykehuset Nord-Norge HF |
RECRUITING
|
| Norway | Trondheim St. Olavs Hospital |
RECRUITING
|
| Poland | Rzeszow Korczowski Bartosz Gabinet Lekarski |
RECRUITING
|
| Spain | Valencia Hosp. Univ. I Politecni La Fe |
RECRUITING
|
| United Kingdom | Sheffield Sheffield Children's Hospital |
RECRUITING
|
| Belgium | Gent Universitair Ziekenhuis Gent |
RECRUITING
|
| United States | Hartford Connecticut Children's Medical Center |
RECRUITING
|
| United States | New York Columbia University Medical Center |
RECRUITING
|
| United States | Philadelphia Children's Hospital of Philadelphia |
RECRUITING
|
| United States | Colchester University of Vermont Medical Center |
RECRUITING
|
| Austria | Vienna AKH - Medizinische Universitat Wien |
RECRUITING
|
| Belgium | Brussels Universitair Ziekenhuis Brussel |
RECRUITING
|
| Belgium | Bruxelles Cliniques Universitaires Saint Luc |
RECRUITING
|
| Brazil | Campinas Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro |
RECRUITING
|
| Brazil | Curitiba Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro |
RECRUITING
|
| Brazil | Goiania Universidade Federal de Goias - Hospital das Clinicas da UFG |
RECRUITING
|
| Brazil | Porto Alegre Irmandade Santa Casa de Misericordia de Porto Alegre |
RECRUITING
|
| Brazil | Vitória Centro de Ciências e Saúde da Universidade Federal do Espirito Santo-Núcleo de Doenças Infecciosas |
RECRUITING
|
| Brazil | Votuporanga INTEGRAL Pesquisa e Ensino |
RECRUITING
|
| France | Amiens Cedex 1 CHU Amiens-Hopital Nord |
RECRUITING
|
| France | Paris cedex 15 Hôpital Necker - Enfants Malades |
RECRUITING
|
| France | Paris Hôpital Robert Debré |
RECRUITING
|
| Israel | Be Er Ya Akov Shamir Medical Center Assaf Harofeh |
RECRUITING
|
| Israel | Beersheba Soroka University Medical Center |
RECRUITING
|
| Israel | Jerusalem Shaare Zedek Medical Center |
RECRUITING
|
| Israel | Jerusalem Hadassah Medical Center |
RECRUITING
|
| Israel | Petach-Tikva Schneider Children's Medical Center |
RECRUITING
|
| Italy | Bergamo Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) |
RECRUITING
|
| Italy | Bologna Ospedale Bellaria, U.O.Cardiologia Az. USL di Bologna |
RECRUITING
|
| Italy | Milano Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi |
RECRUITING
|
| South Korea | Busan Inje University Haeundae Paik Hospital |
RECRUITING
|
| South Korea | Daegu Kyungpook National University Chilgok Hospital |
RECRUITING
|
| South Korea | Seoul Seoul National University Hospital |
RECRUITING
|
| South Korea | Seoul Samsung Medical Center |
RECRUITING
|
| South Korea | Seoul Severance Hospital Yonsei University Health System |
RECRUITING
|
| Netherlands | Rotterdam Erasmus Medisch Centrum |
RECRUITING
|
| Poland | Warszawa WIP Warsaw IBD Point Profesor Kierkus |
RECRUITING
|
| Poland | Warszawa Instytut Pomnik Centrum Zdrowia |
RECRUITING
|
| Portugal | Braga Hospital de Braga |
RECRUITING
|
| Portugal | Lisboa Centro Hospitalar de Lisboa Norte Hospital Santa Maria |
RECRUITING
|
| Portugal | Porto Centro Hospitalar de Sao Joao E.P.E. |
RECRUITING
|
| Spain | Córdoba Hosp Reina Sofia |
RECRUITING
|
| Spain | Sabadell Corporacio Sanitari Parc Tauli |
RECRUITING
|
| United Kingdom | Glasgow Royal Hospital for Sick Children |
RECRUITING
|
| United Kingdom | London Great Ormond Street Hospital |
RECRUITING
|
| United Kingdom | Manchester Royal Manchester Children's Hospital |
RECRUITING
|
| United Kingdom | Oxford John Radcliffe Hospital |
RECRUITING
|
Geo Locations
33.749, -84.38798
33.749, -84.38798
39.76838, -86.15804
40.71427, -74.00597
50.63297, 3.05858
43.77925, 11.24626
41.89193, 12.51133
40.59306, 140.4725
35.86224, 139.97732
33.23333, 130.3
38.26667, 140.86667
35.64825, 139.65376
35.6895, 139.69171
35.43333, 139.65
59.9306759, 10.9917067
59.91273, 10.74609
69.6489, 18.95508
63.43049, 10.39506
50.04132, 21.99901
39.46975, -0.37739
53.38297, -1.4659
51.05, 3.71667
41.76371, -72.68509
40.71427, -74.00597
39.95233, -75.16379
44.54394, -73.14791
48.20849, 16.37208
50.85045, 4.34878
50.85045, 4.34878
-22.90556, -47.06083
-25.42778, -49.27306
-16.67861, -49.25389
-30.03306, -51.23
-20.31944, -40.33778
-20.42278, -49.97278
49.9, 2.3
48.85341, 2.3488
48.85341, 2.3488
31.943507, 34.83904
31.25181, 34.7913
31.76904, 35.21633
31.76904, 35.21633
32.08707, 34.88747
45.69601, 9.66721
44.49381, 11.33875
45.46427, 9.18951
35.10278, 129.04028
35.87028, 128.59111
37.566, 126.9784
37.566, 126.9784
37.566, 126.9784
51.9225, 4.47917
52.22977, 21.01178
52.22977, 21.01178
41.55032, -8.42005
38.71667, -9.13333
41.14961, -8.61099
37.89155, -4.77275
41.54329, 2.10942
55.86515, -4.25763
51.50853, -0.12574
53.48095, -2.23743
51.75222, -1.25596
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5
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