Crohn's Disease
Conditions
Keywords
Pediatric, Inflammatory bowel disease
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.
Interventions
DRUGGuselkumab
Guselkumab will be administered subcutaneously.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve Endoscopic Response at Week 52 | 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. |
| Percentage of Participants with Clinical Remission at Week 52 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Height Percentiles at Weeks 12, 24, and 52 | Baseline, Weeks 12, 24, and 52 | Change from baseline in height percentiles at Weeks 12, 24, and 52 will be assessed. |
| Change from Baseline in Height z-scores at Weeks 12, 24, and 52 | Baseline, Weeks 12, 24, and 52 | Change from baseline in height z-scores at Weeks 12, 24, and 52 will be assessed. |
| Change from Baseline in Height Velocity at Weeks 12, 24, and 52 | Baseline, Weeks 12, 24, and 52 | Change from baseline in height velocity at Weeks 12, 24, and 52 will be assessed. |
| Percentage of Participants with Clinical Remission | Week 52 | Percentage of participants with clinical remission who were assigned to guselkumab dose regimen 1 and did not receive rescue therapy at Week 52 will be assessed. Clinical remission is defined as PCDAI score \<=10. |
| Percentage of Participants with Clinical Response at Week 12 | 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 \<30. |
| Percentage of Participants with Clinical Response at Week 52 | Week 52 | Percentage of participants with clinical response at Week 52 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 \<30. |
| Percentage of Participants with Clinical Remission at Week 12 | Week 12 | Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is defined as PCDAI score \<=10. |
| Percentage of Participants with Endoscopic Remission at Week 52 | Week 52 | Percentage of participants with endoscopic remission at Week 52 will be assessed. Endoscopic remission is defined as SES-CD total score \<=4 and at least a 2-point reduction from baseline and no subscore \>1. |
| Percentage of Participants with Corticosteroid-free Remission at Week 52 | Week 52 | Percentage of participants with corticosteroid-free remission at Week 52 will be assessed. Corticosteroid-free remission is defined as PCDAI score \<=10 at Week 52 and not receiving corticosteroids for at least 90 days before Week 52. |
| Percentage of Participants with Sustained Clinical Remission at Weeks 12, 24, and 52 | Weeks 12, 24, and 52 | Percentage of participants with sustained clinical remission at Weeks 12, 24, and 52 will be assessed. Sustained clinical remission is defined as PCDAI \<=10 at Weeks 12, 24, and 52. |
| Percentage of Participants with Clinical remission by Patient-Reported Outcome (PRO-2) | Week 12 and/or Week 52 | Percentage of participants with clinical remission by PRO-2 will be assessed. Clinical remission by PRO-2 is defined as stool frequency (SF) \<=3 and abdominal pain (AP) \<=1 and no worsening of SF and AP from baseline. |
| Serum Concentration of Guselkumab During Induction Phase | From Week 0 to Week 12 | Serum concentrations of guselkumab will be assessed. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive immunoassay method. |
| Trough Plasma Concentration (Ctrough) of Guselkumab During Maintenance Phase | At Weeks 16, 24, 36, 48 and 52 | Ctrough is defined as the serum concentration of guselkumab immediately prior (pre-dose) to the next drug administration. |
| Change from Baseline in Body Weight at Weeks 12, 24, and 52 | Baseline, Weeks 12, 24, and 52 | Change from baseline in body weight at Weeks 12, 24, and 52 will be assessed. |
| Change from Baseline in Body Weight Percentiles at Weeks 12, 24, and 52 | Baseline, Weeks 12, 24, and 52 | Change from baseline in body weight percentiles at Weeks 12, 24, and 52 will be assessed. |
| Change from Baseline in Body Weight z-scores at Weeks 12, 24, and 52 | Baseline, Weeks 12, 24, and 52 | Change from baseline in body weight z-scores at Weeks 12, 24, and 52 will be assessed. |
| Percentage of Participants Who Achieve Endoscopic Response | Week 52 | Percentage of participants who achieve endoscopic response who were assigned to q4w maintenance therapy and did not receive rescue therapy at Week 52 will be assessed. Endoscopic response is defined as \>=50% reduction (global) and \>50% reduction (U.S specific) from SES-CD score at baseline. |
| Change from Baseline in Height at Weeks 12, 24, and 52 | Baseline, Weeks 12, 24, and 52 | Change from baseline in height at Weeks 12, 24, and 52 will be assessed. |
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 64 | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important. |
Countries
Australia, Austria, Belgium, Brazil, Canada, France, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORClinical Trial
Janssen Research & Development, LLC
Outcome results
None listed