RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Guselkumab for Crohn's Disease

This study wants to measure the clinical and endoscopic how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT05923073 · Janssen Research & Development, LLC · enrollment listed as 120

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Guselkumab, or Guselkumab. The registry lists allocation as randomized. This study wants to measure the clinical and endoscopic how well it works 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.

They plan to enroll about 120 people at 85 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Guselkumab, Guselkumab

Primary outcome (registry wording): Percentage of Participants with Clinical Remission at Week 52

Who it is for (from inclusion criteria)

Ages 2 Years to 17 Years
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

Who the registry excludes

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

Public study contact (from the registry)

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

85 listed

Cedars Sinai Medical Center — Los Angeles, California (recruiting)
Connecticut Children's Medical Center — Hartford, Connecticut (recruiting)
Emory University — Atlanta, Georgia (recruiting)
Children's Center for Digestive Health Care — Atlanta, Georgia (recruiting)
Riley Hospital for Children — Indianapolis, Indiana (recruiting)
Boston Childrens Hospital — Boston, Massachusetts (recruiting)
Goryeb Children's Hospital — Morristown, New Jersey (recruiting)
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center — New York, New York (recruiting)
Icahn School of Medicine at Mount Sinai — New York, New York (recruiting)
Columbia University Medical Center — New York, New York (recruiting)
The Children's Medical Center of Dayton — Dayton, Ohio (recruiting)
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania (recruiting)

+ 71 sites outside the US on the same record

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FAQ about this NCT record

Is NCT05923073 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05923073?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05923073?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary