A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
MACARONI-23
A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease
4 other identifiers
interventional
120
16 countries
81
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2024
Typical duration for phase_3
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2023
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedStudy Start
First participant enrolled
March 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 12, 2028
April 13, 2026
April 1, 2026
3.6 years
June 20, 2023
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants with Clinical Remission at Week 52
Percentage of participants with clinical remission at Week 52 will be assessed. Clinical remission is defined as pediatric Crohn's Disease activity index (PCDAI) less than or equal to (\<=) 10.
Week 52
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Percentage of participants who achieve endoscopic response at Week 52 will be assessed. Endoscopic response is defined as greater than or equal to (\>=) 50 percent (%) reduction (global) and greater than (\>) 50% reduction (U.S specific) from simplified endoscopic score-Crohn's Disease (SES-CD) score at baseline.
Week 52
Secondary Outcomes (19)
Percentage of Participants with Clinical Response at Week 12
Week 12
Percentage of Participants with Clinical Response at Week 52
Week 52
Percentage of Participants with Clinical Remission at Week 12
Week 12
Percentage of Participants with Endoscopic Remission at Week 52
Week 52
Percentage of Participants with Corticosteroid-free Remission at Week 52
Week 52
- +14 more secondary outcomes
Study Arms (5)
Open-label induction phase: Guselkumab Intravenously (IV)
EXPERIMENTALParticipants will receive guselkumab dose IV based on their body weight during the 12-week open-label induction phase.
Open-label induction phase: Guselkumab Subcutaneously (SC)
EXPERIMENTALParticipants will receive guselkumab dose SC based on their body weight during the 12-week open-label induction phase.
Double-blind maintenance phase: Guselkumab SC Dose Regimen 1
EXPERIMENTALAt the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their body weight up to Week 48.
Double-blind Maintenance Phase: Guselkumab SC Dose Regimen 2
EXPERIMENTALAt the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their body weight up to Week 48.
Open-label maintenance phase: Guselkumab SC
EXPERIMENTALWeek 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 48.
Interventions
Guselkumab will be administered subcutaneously.
Eligibility Criteria
You may qualify if:
- 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 or equal to \[\>=\] 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) within 1 month of receiving study intervention at Week 0
- Participants must have a history of inadequate response, loss of response, or intolerance to immunomodulators (6-MP, AZA, or MTX), oral or IV corticosteroids, or biologic therapy/JAK inhibitor therapy; OR have a history of corticosteroid dependence; OR have a history of inadequate response to exclusive enteral nutrition (EEN)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (84)
Cedars Sinai Medical Center
Los Angeles, California, 90048, 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, 46202-5225, United States
Boston Childrens Hospital
Boston, Massachusetts, 02115, United States
Goryeb Children's Hospital
Morristown, New Jersey, 07960, United States
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
New York, New York, 10021-5663, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
The Children's Medical Center of Dayton
Dayton, Ohio, 45404, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Cook Childrens Medical Center
Fort Worth, Texas, 76104, United States
University of Vermont Medical Center
Colchester, Vermont, 05446, United States
Perth Children's Hospital
Nedlands, 6009, Australia
Mater Hospital Brisbane
South Brisbane, 4101, Australia
The Children's Hospital at Westmead
Westmead, 2145, Australia
AKH - Medizinische Universitat Wien
Vienna, 1090, Austria
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas, 13060-904, Brazil
Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro
Curitiba, 80250-060, Brazil
Universidade Federal de Goias - Hospital das Clinicas da UFG
Goiânia, 74605-020, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, 90035-007, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90035-074, Brazil
Centro de Ciencias e Saude da Universidade Federal do Espirito Santo-Nucleo de Doencas Infecciosas
Vitória, 29040-091, Brazil
INTEGRAL Pesquisa e Ensino
Votuporanga, 100000, Brazil
Iwk Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
London Health Sciences Centre Victoria Hospital
London, Ontario, N6A 5W9, Canada
Hospital For Sick Children
Toronto, Ontario, M5G 1X8, Canada
CHU Amiens-Hopital Nord
Amiens, 80054, France
Hôpital Jeanne de FLANDRE, CHRU LILLE
Lille, 59037, France
Hôpital Necker - Enfants Malades
Paris, 75015, France
Hôpital Robert Debré
Paris, 75019, France
Soroka University Medical Center
Beersheba, 84101, Israel
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, 70300, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah Medical Center
Jerusalem, 9124001, Israel
Schneider Children's Medical Center
Petah Tikva, 4920235, Israel
Kaplan Medical Center
Rehovot, 761001, 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
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence, 50139, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi
Milan, 20154, Italy
AOU Policlinico Umberto I
Roma, 161, Italy
Hirosaki University Hospital
Hirosaki, 036-8563, Japan
Kagoshima University Hospital
Kagoshima, 890-8544, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, 277-0871, Japan
Kobe University Hospital
Kobe, 650 0017, Japan
Saga University Hospital
Saga, 849-8501, Japan
Miyagi Children's Hospital
Sendai, 989-3126, Japan
National Center for Child Health and Development
Setagaya Ku, 157 8535, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
Mie University Hospital
Tsu, 514 8507, Japan
Yamaguchi University Hospital
Ube, 755-8505, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, 230-8765, Japan
Yokohama City University Medical Center
Yokohama, 232-0024, Japan
Erasmus Medisch Centrum
Rotterdam, 3015 GD, 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
Korczowski Bartosz Gabinet Lekarski
Rzeszów, 35-302, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04 501, Poland
Instytut Pomnik Centrum Zdrowia
Warsaw, 04 730, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Centro Hospitalar de Lisboa Norte Hospital Santa Maria
Lisbon, 1649-035, Portugal
Centro Hospitalar de Sao Joao E.P.E.
Porto, 4200-319, Portugal
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Severance Hospital Yonsei University Health System
Seoul, 120-752, South Korea
Hosp Reina Sofia
Córdoba, 14004, Spain
Corporacio Sanitari Parc Tauli
Sabadell, 8208, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Royal Hospital for Sick Children
Glasgow, G51 4TF, United Kingdom
Great Ormond Street Hospital
London, WC1N 3JH, United Kingdom
Nowgen Centre, Research and Innovation
Manchester, M13 9WL, United Kingdom
Royal Manchester Children's Hospital
Manchester, M13 9WL, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Sheffield Children's Hospital
Sheffield, S10 2TH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2023
First Posted
June 28, 2023
Study Start
March 13, 2024
Primary Completion (Estimated)
October 27, 2027
Study Completion (Estimated)
July 12, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu