NCT05923073 · Janssen Research & Development, LLC
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
(MACARONI-23)
What this study is about
The purpose of this study is to evaluate the clinical and endoscopic effectiveness 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.
View original scientific description
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 with clinical remission at Week 52 will be assessed. Clinical remission is defined as pediatric Crohn's Disease activity index (PCDAI) less than or equal to (\<=) 10.
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Time frame: Week 52
Percentage of participants who achieve endoscopic response at Week 52 will be assessed. Endoscopic response is defined as greater than or equal to (\>=) 50 percent (%) reduction (global) and greater than (\>) 50% reduction (U.S specific) from simplified endoscopic score-Crohn's Disease (SES-CD) score at baseline.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
- Hartford, Connecticut
- Atlanta, Georgia
- Indianapolis, Indiana
- Boston, Massachusetts
- Morristown, New Jersey
- New York, New York
- Dayton, Ohio
- Philadelphia, Pennsylvania
- Fort Worth, Texas
- Colchester, Vermont
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations