A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease (MACARONI-23)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Guselkumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05923073

CR109212

2021-006282-37 (EudraCT Number)

2023-504735-41-00 (Registry Identifier)

CNTO1959PBCRD3007 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 5 patient groups

Open-label induction phase: Guselkumab Intravenously (IV)

Experimental group

Description:

Participants will receive guselkumab dose IV based on their body weight during the 12-week open-label induction phase.

Treatment:

Drug: Guselkumab

Drug: Guselkumab

Open-label induction phase: Guselkumab Subcutaneously (SC)

Experimental group

Description:

Participants will receive guselkumab dose SC based on their body weight during the 12-week open-label induction phase.

Treatment:

Drug: Guselkumab

Drug: Guselkumab

Double-blind maintenance phase: Guselkumab SC Dose Regimen 1

Experimental group

Description:

At 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.

Treatment:

Drug: Guselkumab

Drug: Guselkumab

Double-blind Maintenance Phase: Guselkumab SC Dose Regimen 2

Experimental group

Description:

At 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.

Treatment:

Drug: Guselkumab

Drug: Guselkumab

Open-label maintenance phase: Guselkumab SC

Experimental group

Description:

Week 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.

Treatment:

Drug: Guselkumab

Drug: Guselkumab