The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
214
Guselkumab Dose 1 will be administered as IV infusion.
Guselkumab Dose 2 will be administered as SC injection.
Golimumab Dose 1 will be administered as SC injection.
Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12
Clinical response was defined as a decrease from baseline in the Mayo score greater than or equal to (\>=) 30 percent (%) and \>=3 points with either a decrease from baseline in the rectal bleeding subscore (RBS) \>=1 or a RBS of 0 or 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.
Time frame: Week 12
Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12
Clinical remission was defined as the Mayo score less than or equal to (\<=) 2 with no individual subscore greater than (\>) 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings) each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.
Time frame: Week 12
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Golimumab Dose 2 will be administered as SC injection.
Placebo will be administered.
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