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

Official title

A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease

Overview

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.

Interventions

• Drug Guselkumab
  Guselkumab will be administered subcutaneously.
• Drug Guselkumab
  Guselkumab will be administered intravenously.

Primary outcome measures

• Percentage of Participants with Clinical Remission at Week 52 [Time frame: Week 52]
• Percentage of Participants Who Achieve Endoscopic Response at Week 52 [Time frame: Week 52]

Secondary outcome measures (12)

• Percentage of Participants with Clinical Response at Week 12 [Time frame: Week 12]
• Percentage of Participants with Clinical Response at Week 52 [Time frame: Week 52]
• Percentage of Participants with Clinical Remission at Week 12 [Time frame: Week 12]
• Percentage of Participants with Endoscopic Remission at Week 52 [Time frame: Week 52]
• Percentage of Participants with Corticosteroid-free Remission at Week 52 [Time frame: Week 52]
• Percentage of Participants with Sustained Clinical Remission at Weeks 12, 24, and 52 [Time frame: Weeks 12, 24, and 52]
• Percentage of Participants with Clinical remission by Patient-Reported Outcome (PRO-2) [Time frame: Week 12 and/or Week 52]
• Serum Concentration of Guselkumab During Induction Phase [Time frame: From Week 0 to Week 12]
• Trough Plasma Concentration (Ctrough) of Guselkumab During Maintenance Phase [Time frame: At Weeks 16, 24, 36, 48 and 52]
• Change from Baseline in Body Weight at Weeks 12, 24, and 52 [Time frame: Baseline, Weeks 12, 24, and 52]
• Change from Baseline in Body Weight Percentiles at Weeks 12, 24, and 52 [Time frame: Baseline, Weeks 12, 24, and 52]
• Change from Baseline in Body Weight z-scores at Weeks 12, 24, and 52 [Time frame: Baseline, Weeks 12, 24, and 52]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 14 centers

• Cedars Sinai Medical Center — Los Angeles
• Connecticut Children's Medical Center — Hartford
• Emory University — Atlanta
• Children's Center for Digestive Health Care — Atlanta
• Riley Hospital for Children — Indianapolis
• Boston Childrens Hospital — Boston
• Goryeb Children's Hospital — Morristown
• Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center — New York
• … and 6 more centers

Japan · 12 centers

• Hirosaki University Hospital — Hirosaki
• Kagoshima University Hospital — Kagoshima
• Tsujinaka Hospital Kashiwanoha — Kashiwa-shi
• Kobe University Hospital — Kobe
• Saga University Hospital — Saga
• Miyagi Childrens Hospital — Sendai
• National Center for Child Health and Development — Setagaya Ku
• Juntendo University Hospital — Tokyo
• … and 4 more centers

Brazil · 7 centers

• Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro — Campinas
• Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro — Curitiba
• Universidade Federal de Goias - Hospital das Clinicas da UFG — Goiânia
• Hospital De Clinicas De Porto Alegre — Porto Alegre
• Irmandade Santa Casa de Misericordia de Porto Alegre — Porto Alegre
• Centro de Ciencias e Saude da Universidade Federal do Espirito Santo-Nucleo de Doencas Inf — Vitória
• INTEGRAL Pesquisa e Ensino — Votuporanga

Israel · 6 centers

• Soroka University Medical Center — Beersheba
• Shamir Medical Center Assaf Harofeh — Be’er Ya‘aqov
• Shaare Zedek Medical Center — Jerusalem
• Hadassah Medical Center — Jerusalem
• Schneider Children's Medical Center — Petah Tikva
• Kaplan Medical Center — Rehovot

Italy · 6 centers

• A.O. Santi Antonio e Biagio e Cesare Arrigo — Alessandria
• Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) — Bergamo
• Ospedale Bellaria, U.O.Cardiologia Az. USL di Bologna — Bologna
• Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer — Florence
• Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittor — Milan
• AOU Policlinico Umberto I — Roma

United Kingdom · 6 centers

• Royal Hospital for Sick Children — Glasgow
• … and 5 more centers

South Korea · 5 centers

• Inje University Haeundae Paik Hospital — Busan
• Kyungpook National University Chilgok Hospital — Daegu
• Seoul National University Hospital — Seoul
• Samsung Medical Center — Seoul
• Severance Hospital Yonsei University Health System — Seoul

Belgium · 4 centers

• Universitair Ziekenhuis Brussel — Brussels
• Cliniques Universitaires Saint Luc — Brussels
• Universitair Ziekenhuis Gent — Ghent
• UZ Leuven — Leuven

France · 4 centers

• CHU Amiens-Hopital Nord — Amiens
• Hôpital Jeanne de FLANDRE, CHRU LILLE — Lille
• Hôpital Necker - Enfants Malades — Paris
• Hôpital Robert Debré — Paris

Norway · 4 centers

• Akershus Universitetssykehus HF — Nordbyhagen
• Oslo University Hospital — Oslo
• Universitetssykehuset Nord-Norge HF — Tromsø
• St. Olavs Hospital — Trondheim

Australia · 3 centers

• Perth Children's Hospital — Nedlands
• Mater Hospital Brisbane — South Brisbane
• The Children's Hospital at Westmead — Westmead

Canada · 3 centers

• Iwk Health Centre — Halifax
• London Health Sciences Centre Victoria Hospital — London
• Hospital For Sick Children — Toronto

Poland · 3 centers

• Korczowski Bartosz Gabinet Lekarski — Rzeszów
• WIP Warsaw IBD Point Profesor Kierkus — Warsaw
• Instytut Pomnik Centrum Zdrowia — Warsaw

Portugal · 3 centers

• Hospital de Braga — Braga
• Centro Hospitalar de Lisboa Norte Hospital Santa Maria — Lisbon
• Centro Hospitalar de Sao Joao E.P.E. — Porto

Spain · 3 centers

• Hosp Reina Sofia — Córdoba
• Corporacio Sanitari Parc Tauli — Sabadell
• Hosp. Univ. I Politecni La Fe — Valencia

Austria · 1 center

• AKH - Medizinische Universitat Wien — Vienna

Netherlands · 1 center

• Erasmus Medisch Centrum — Rotterdam

Identifiers

NCT: NCT05923073 · CR109212 · CNTO1959PBCRD3007 · 2021-006282-37 · 2023-504735-41-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗