The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
577
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 based on the modified Mayo subscores.
Time frame: Week 48
Percentage of Participants with Endoscopic Improvement at Week 48
Percentage of participants with endoscopic improvement at Week 48 will be reported. Endoscopic improvement at Week 48 based on the Mayo endoscopic subscore.
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
Percentage of Participants with Symptomatic Remission at Week 48
Percentage of participants with symptomatic remission at Week 48 will be reported. Symptomatic remission at Week 48 based on stool and rectal bleeding symptoms.
Time frame: Week 48
Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48
Percentage of participants with combination of histological remission and endoscopic improvement at Week 48 will be reported. Histologic remission and endoscopic improvement at Week 48 based on the histologic grading and the Mayo endoscopy subscore.
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 based on the modified Mayo subscores will be reported.
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Placebo will be administered as subcutaneous injection.
Valley Gastroenterology Medical Group
Arcadia, California, United States
Southern California Research Center
Coronado, California, United States
Om Research LLC
Lancaster, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Medical Research Center of Connecticut
Hamden, Connecticut, United States
Yale University
New Haven, Connecticut, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
...and 393 more locations
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
Laboratory Parameters Over Time
Laboratory parameters over time will be reported.
Time frame: Up to Week 48
Vital Signs Parameters Over Time
Vital signs 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 was 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 concentration 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