Recruiting
Phase 3

Guselkumab

Sponsor:

Janssen Research & Development, LLC

Code:

NCT05923073

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Guselkumab

Guselkumab

Study Details

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.

Conditions

Crohn's Disease

Study ID

NCT05923073

Start date

Mar 13, 2024

Status verified date

Sep, 2026

Completion date

Aug 14, 2028

Anticipated

Primary completion date

Oct 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open-label induction phase: Guselkumab Intravenously (IV)

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

experimental: Open-label induction phase: Guselkumab Subcutaneously (SC)

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

experimental: Double-blind maintenance phase: Guselkumab SC Dose Regimen 1

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.

experimental: Double-blind Maintenance Phase: Guselkumab SC Dose Regimen 2

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.

experimental: Open-label maintenance phase: Guselkumab SC

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.

Interventions

Guselkumab

Guselkumab will be administered subcutaneously.

Guselkumab

Guselkumab will be administered intravenously.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Children's Center for Digestive Health Care

Recruiting

Atlanta, Georgia, United States, 30342

Boston Childrens Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Goryeb Children's Hospital

Recruiting

Morristown, New Jersey, United States, 07960

Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center

Recruiting

New York, New York, United States, 10021-5663

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Cook Childrens Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Hospital For Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • Pediatric, Inflammatory bowel disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.