The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
703
Guselkumab will be administered as subcutaneous injection.
Golimumab will be administered as subcutaneous injection.
JNJ-78934804 will be administered subcutaneously as per defined regimen.
Percentage of Participants with Clinical Remission at Week 48
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).
Time frame: Week 48
Percentage of Participants with Endoscopic Response at Week 48
Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the simple endoscopic score for Crohn's disease (SES-CD), as assessed by central endoscopy reading.
Time frame: Week 48
Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48
Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores.
Time frame: Week 48
Percentage of Participants with Endoscopic Remission at Week 48
Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD, as assessed by central endoscopy reading.
Time frame: Week 48
Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 48
Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported.
Time frame: Week 48
Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).
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Placebo will be administered as subcutaneous injection.
University of Alabama Liver Center
Birmingham, Alabama, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Moore Clinical Trials, LLC
Little Rock, Arkansas, United States
Om Research LLC
Apple Valley, California, United States
Valley Gastroenterology Medical Group
Arcadia, California, United States
Southern California Research Center
Coronado, California, United States
Desert Gastroenterology Associates
Lancaster, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
...and 446 more locations
Time frame: Week 48
Secondary Comparison: Percentage of Participants with Endoscopic Response at Week 48
Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the SES-CD, as assessed by central endoscopy reading.
Time frame: Week 48
Percentage of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Time frame: Up to Week 48
Percentage of Participants with Serious Adverse Events (SAEs)
A SAE 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; is medically important.
Time frame: Up to Week 48
Clinical Laboratory Parameters Over Time
Clinical laboratory parameters over time will be reported.
Time frame: Up to Week 48
Vital Sign Parameters Over Time
Vital sign parameters over time will be reported.
Time frame: Up to Week 48
Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score
The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Worsening of suicidal ideation is defined as an increase in severity of suicidal ideation from baseline.
Time frame: Up to Week 48
Serum Concentrations of Guselkumab Over Time
Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method.
Time frame: Up to Week 48
Serum Concentrations of Golimumab Over Time
Serum concentrations of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of golimumab using a validated, specific, and sensitive method.
Time frame: Up to Week 48
Percentage of Participants with Antibodies to Guselkumab
Percentage of participants with antibodies to guselkumab will be reported.
Time frame: Up to Week 48
Titers of Antibodies to Guselkumab
Titers of antibodies to guselkumab will be reported.
Time frame: Up to Week 48
Percentage of Participants with Antibodies to Golimumab
Percentage of participants with antibodies to golimumab will be reported.
Time frame: Up to Week 48
Titers of Antibodies to Golimumab
Titers of antibodies to golimumab will be reported.
Time frame: Up to Week 48
Percentage of Participants with Neutralizing Antibodies to Guselkumab.
Percentage of participants with neutralizing antibodies to guselkumab will be reported.
Time frame: Up to Week 48
Percentage of Participants with Neutralizing Antibodies to Golimumab
Percentage of participants with neutralizing antibodies to golimumab will be reported.
Time frame: Up to Week 48