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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Guselkumab will be administered subcutaneously.
Guselkumab will be administered intravenously.
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 (\<=) 10.
Time frame: Week 52
Percentage of Participants Who Achieve Endoscopic Response at 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.
Time frame: Week 52
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 \<30.
Time frame: Week 12
Percentage of Participants with Clinical Response at 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.
Time frame: Week 52
Percentage of Participants with Clinical Remission at Week 12
Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is defined as PCDAI score \<=10.
Time frame: Week 12
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 \<=4 and at least a 2-point reduction from baseline and no subscore \>1.
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Cedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGConnecticut Children's Medical Center
Hartford, Connecticut, United States
COMPLETEDEmory University
Atlanta, Georgia, United States
RECRUITINGChildren's Center for Digestive Health Care
Atlanta, Georgia, United States
RECRUITINGRiley Hospital for Children
Indianapolis, Indiana, United States
COMPLETEDBoston Childrens Hospital
Boston, Massachusetts, United States
RECRUITINGGoryeb Children's Hospital
Morristown, New Jersey, United States
RECRUITINGWeill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
New York, New York, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGColumbia University Medical Center
New York, New York, United States
COMPLETED...and 75 more locations
Time frame: Week 52
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 \<=10 at Week 52 and not receiving corticosteroids for at least 90 days before Week 52.
Time frame: Week 52
Percentage of Participants with Sustained Clinical Remission at 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.
Time frame: Weeks 12, 24, and 52
Percentage of Participants with Clinical remission by Patient-Reported Outcome (PRO-2)
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.
Time frame: Week 12 and/or Week 52
Serum Concentration of Guselkumab During Induction Phase
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.
Time frame: From Week 0 to Week 12
Trough Plasma Concentration (Ctrough) of Guselkumab During Maintenance Phase
Ctrough is defined as the serum concentration of guselkumab immediately prior (pre-dose) to the next drug administration.
Time frame: At Weeks 16, 24, 36, 48 and 52
Change from Baseline in Body Weight at Weeks 12, 24, and 52
Change from baseline in body weight at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Change from Baseline in Body Weight Percentiles at Weeks 12, 24, and 52
Change from baseline in body weight percentiles at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Change from Baseline in Body Weight z-scores at Weeks 12, 24, and 52
Change from baseline in body weight z-scores at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Change from Baseline in Height at Weeks 12, 24, and 52
Change from baseline in height at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Change from Baseline in Height Percentiles at Weeks 12, 24, and 52
Change from baseline in height percentiles at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Change from Baseline in Height z-scores at Weeks 12, 24, and 52
Change from baseline in height z-scores at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Change from Baseline in Height Velocity at Weeks 12, 24, and 52
Change from baseline in height velocity at Weeks 12, 24, and 52 will be assessed.
Time frame: Baseline, Weeks 12, 24, and 52
Percentage of Participants with Clinical Remission
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.
Time frame: Week 52
Percentage of Participants Who Achieve Endoscopic Response
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.
Time frame: Week 52
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: Up to Week 64