Clinical trial NCT05923073: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Pediatric, Inflammatory bowel disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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

Primary outcomes:
measure: Percentage of Participants with Clinical Remission at Week 52
timeFrame: Week 52
measure: Percentage of Participants Who Achieve Endoscopic Response at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants with Clinical Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants with Clinical Response at Week 52
timeFrame: Week 52
measure: Percentage of Participants with Clinical Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieve Endoscopic Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants with Endoscopic Remission at Week 52
timeFrame: Week 52
measure: Percentage of Participants with Corticosteroid-free Remission at Week 52
timeFrame: Week 52
measure: Percentage of Participants with Sustained Clinical Remission at Weeks 12, 24, and 52
timeFrame: Weeks 12, 24, and 52
measure: Percentage of Participants with Clinical remission by Patient-Reported Outcome (PRO-2)
timeFrame: Week 12 and/or Week 52
measure: Serum Concentration of Guselkumab During Induction Phase
timeFrame: From Week 0 to Week 12
measure: Trough Plasma Concentration (Ctrough) of Guselkumab During Maintenance Phase
timeFrame: At Weeks 16, 24, 36, 48 and 52
measure: Change from Baseline in Body Weight at Weeks 12, 24, and 52
timeFrame: Baseline, Weeks 12, 24, and 52
measure: Change from Baseline in Body Weight Percentiles at Weeks 12, 24, and 52
timeFrame: Baseline, Weeks 12, 24, and 52
measure: Change from Baseline in Body Weight z-scores at Weeks 12, 24, and 52
timeFrame: Baseline, Weeks 12, 24, and 52
measure: Change from Baseline in Height at Weeks 12, 24, and 52
timeFrame: Baseline, Weeks 12, 24, and 52
measure: Change from Baseline in Height Percentiles at Weeks 12, 24, and 52
timeFrame: Baseline, Weeks 12, 24, and 52
measure: Change from Baseline in Height z-scores at Weeks 12, 24, and 52
timeFrame: Baseline, Weeks 12, 24, and 52
measure: Change from Baseline in Height Velocity at Weeks 12, 24, and 52
timeFrame: Baseline, Weeks 12, 24, and 52
measure: Percentage of Participants with Clinical Remission
timeFrame: Week 52
measure: Percentage of Participants Who Achieve Endoscopic Response
timeFrame: Week 52
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Children's Center for Digestive Health Care
state: Georgia
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: New York
country: United States
facility: Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Dayton
country: United States
facility: The Children's Medical Center of Dayton
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Fort Worth
country: United States
facility: Cook Childrens Medical Center
state: Texas
city: Colchester
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Vienna
country: Austria
facility: AKH - Medizinische Universitat Wien
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Campinas
country: Brazil
facility: Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
city: Curitiba
country: Brazil
facility: Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro
city: Goiania
country: Brazil
facility: Universidade Federal de Goias - Hospital das Clinicas da UFG
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Vitória
country: Brazil
facility: Centro de Ciências e Saúde da Universidade Federal do Espirito Santo-Núcleo de Doenças Infecciosas
city: Votuporanga
country: Brazil
facility: INTEGRAL Pesquisa e Ensino
city: Amiens Cedex 1
country: France
facility: CHU Amiens-Hopital Nord
city: Lille
country: France
facility: Hôpital Jeanne de FLANDRE, CHRU LILLE
city: Paris cedex 15
country: France
facility: Hôpital Necker - Enfants Malades
city: Paris
country: France
facility: Hôpital Robert Debré
city: Be Er Ya Akov
country: Israel
facility: Shamir Medical Center Assaf Harofeh
city: Beersheba
country: Israel
facility: Soroka University Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petach-Tikva
country: Israel
facility: Schneider Children's Medical Center
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
city: Bologna
country: Italy
facility: Ospedale Bellaria, U.O.Cardiologia Az. USL di Bologna
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Kashiwa-shi
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
city: Saga
country: Japan
facility: Saga University Hospital
city: Sendai
country: Japan
facility: Miyagi Children's Hospital
city: Setagaya Ku
country: Japan
facility: National Center for Child Health and Development
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Yokohama-shi
country: Japan
facility: Yokohama City University Medical Center
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Nordbyhagen
country: Norway
facility: Akershus Universitetssykehus HF
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord-Norge HF
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Rzeszow
country: Poland
facility: Korczowski Bartosz Gabinet Lekarski
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Instytut Pomnik Centrum Zdrowia
city: Braga
country: Portugal
facility: Hospital de Braga
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte Hospital Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao E.P.E.
city: Córdoba
country: Spain
facility: Hosp Reina Sofia
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
city: Manchester
country: United Kingdom
facility: Nowgen Centre, Research and Innovation
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Clinical Trial
role: STUDY_DIRECTOR
References: