CNTO1959UCO3001: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Induction Study 1: Percentage of Participants With Clinical Response at Week I-12

时间窗: At Week I-12

Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.

Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12

时间窗: At Week I-12

Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.

Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44

时间窗: At Week M-44

Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-1 and IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for randomized arms only.