A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
Recruiting · NCT05923073 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
2 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 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)
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
Where it is running
60 locations listed across 11 US states.
- Cedars Sinai Medical Center - Los Angeles, California, United States
- Connecticut Children's Medical Center - Hartford, Connecticut, United States
- Emory University - Atlanta, Georgia, United States
- Children's Center for Digestive Health Care - Atlanta, Georgia, United States
- Riley Hospital for Children - Indianapolis, Indiana, United States
- Boston Childrens Hospital - Boston, Massachusetts, United States
- Goryeb Children's Hospital - Morristown, New Jersey, United States
- Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center - New York, New York, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Columbia University Medical Center - New York, New York, United States
- The Children's Medical Center of Dayton - Dayton, Ohio, United States
- Children's Hospital of Philadelphia - Philadelphia, Pennsylvania, United States
- Cook Childrens Medical Center - Fort Worth, Texas, United States
- University of Vermont Medical Center - Colchester, Vermont, United States
- A.O. Santi Antonio e Biagio e Cesare Arrigo - Alessandria, Italy
- CHU Amiens-Hopital Nord - Amiens, France
- Soroka University Medical Center - Beersheba, Israel
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) - Bergamo, Italy
- Shamir Medical Center Assaf Harofeh - Be’er Ya‘aqov, Israel
- Ospedale Bellaria, U.O.Cardiologia Az. USL di Bologna - Bologna, Italy
- Hospital de Braga - Braga, Portugal
- Universitair Ziekenhuis Brussel - Brussels, Belgium
- Cliniques Universitaires Saint Luc - Brussels, Belgium
- Inje University Haeundae Paik Hospital - Busan, South Korea
- Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro - Campinas, Brazil
- Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro - Curitiba, Brazil
- Hosp Reina Sofia - Córdoba, Spain
- Kyungpook National University Chilgok Hospital - Daegu, South Korea
- Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer - Florence, Italy
- Universitair Ziekenhuis Gent - Ghent, Belgium
- Royal Hospital for Sick Children - Glasgow, United Kingdom
- Universidade Federal de Goias - Hospital das Clinicas da UFG - Goiânia, Brazil
- Hirosaki University Hospital - Hirosaki, Japan
- Shaare Zedek Medical Center - Jerusalem, Israel
- Hadassah Medical Center - Jerusalem, Israel
- Kagoshima University Hospital - Kagoshima, Japan
- Tsujinaka Hospital Kashiwanoha - Kashiwa-shi, Japan
- Kobe University Hospital - Kobe, Japan
- UZ Leuven - Leuven, Belgium
- Hôpital Jeanne de FLANDRE, CHRU LILLE - Lille, France
- Centro Hospitalar de Lisboa Norte Hospital Santa Maria - Lisbon, Portugal
- Great Ormond Street Hospital - London, United Kingdom
- Nowgen Centre, Research and Innovation - Manchester, United Kingdom
- Royal Manchester Children's Hospital - Manchester, United Kingdom
- Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi - Milan, Italy
- Perth Children's Hospital - Nedlands, Australia
- Akershus Universitetssykehus HF - Nordbyhagen, Norway
- Oslo University Hospital - Oslo, Norway
- John Radcliffe Hospital - Oxford, United Kingdom
- Hôpital Necker - Enfants Malades - Paris, France
- Hôpital Robert Debré - Paris, France
- Schneider Children's Medical Center - Petah Tikva, Israel
- Centro Hospitalar de Sao Joao E.P.E. - Porto, Portugal
- Hospital De Clinicas De Porto Alegre - Porto Alegre, Brazil
- Irmandade Santa Casa de Misericordia de Porto Alegre - Porto Alegre, Brazil
- Kaplan Medical Center - Rehovot, Israel
- AOU Policlinico Umberto I - Roma, Italy
- Erasmus Medisch Centrum - Rotterdam, Netherlands
- Korczowski Bartosz Gabinet Lekarski - Rzeszów, Poland
- Corporacio Sanitari Parc Tauli - Sabadell, Spain
Showing 60 of 85 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →