Crohn's Disease
Conditions
Interventions
- 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.
- Open-label inducti
Sponsors
Sakamoto Takehiko
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Percentage of Participants with Clinical Remission at 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 (=) 50 percent (%) reduction from simplified endoscopic score-Crohn's Disease (SES-CD) score at baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of Participants with Clinical Response at Week 12: Percentage of participants with clinical response at Week 12 will be assessed. Clinical responder is defined as a decrease from baseline in the PCDAI score of >=12.5 points with a total PCDAI score =12.5 points with a total PCDAI score =50% reduction from SES-CD score at baseline. - Percentage of Participants with Endoscopic Remission at Week 52: Percentage of participants with endoscopic remission at Week 52 will be assessed. Endoscopic remission is defined as SES-CD total score 1. - Percentage of Participants with Corticosteroid-free Remission at Week 52: Percentage of participants with corticosteroid-free remission at Week 52 will be assessed. Corticosteroid-free remission is defined as PCDAI score =50% reduction from SES-CD score at baseline. | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, France, Israel, Italy, Japan, Korea,Republic Of, Netherlands, Norway, Poland, Portugal, Spain, UnitedKingdom Of Great Britain, UnitedStates Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed