The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,064
Participants will receive matching placebo IV or SC.
Participants will receive guselkumab IV or SC.
Induction Study 1: Percentage of Participants With Clinical Response 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.
Time frame: At Week I-12
Induction Study 2: Percentage of Participants With Clinical Remission 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.
Time frame: At Week I-12
Maintenance Study: Percentage of Participants With Clinical Remission 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.
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Om Research LLC
Lancaster, California, United States
UCLA
Los Angeles, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Florida Research Network, LLC
Gainesville, Florida, United States
University of Florida Health Jacksonville
Gainesville, Florida, United States
Harmony Medical Research Institute, Inc.
Hialeah, Florida, United States
UF Health Jacksonville Gastroenterology Emerson
Jacksonville, Florida, United States
I.H.S. Health. LLC
Kissimmee, Florida, United States
Columbus Clinical Services LLC
Miami, Florida, United States
Vista Health Research, LLC
Miami, Florida, United States
...and 381 more locations
Time frame: At Week M-44
Induction Study 1: Percentage of Participants With Clinical Remission at Week I-12
Time frame: At Week I-12
Induction Study 1: Percentage of Participants With Symptomatic Remission at Week I-12
Time frame: At Week I-12
Induction Study 1: Percentage of Participants With Endoscopic Healing at Week I-12
Time frame: At Week I-12
Induction Study 1: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12
Time frame: At Week I-12
Induction Study 1: Percentage of Participants With Endoscopic Normalization at Week I-12
Time frame: At Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-12
Time frame: At Week I-12
Induction Study 2: Percentage of Participants With Endoscopic Healing at Week I-12
Time frame: At Week I-12
Induction Study 2: Percentage of Participants With Clinical Response at Week I-12
Time frame: At Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-4
Time frame: At Week I-4
Induction Study 2: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12
Time frame: At Week I-12
Induction Study 2: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12
Time frame: At Week I-12
Induction Study 2: Percentage of Participants With Fatigue Response at Week I-12
Time frame: At Week I-12
Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-2
Time frame: At Week I-2
Induction Study 2: Percentage of Participants With Endoscopic Normalization at Week I-12
Time frame: At Week I-12
Maintenance Study: Percentage of Participants With Symptomatic Remission at Week M-44
Time frame: At Week M-44
Maintenance Study: Percentage of Participants With Endoscopic Healing at Week M-44
Time frame: At Week M-44
Maintenance Study: Percentage of Participants With Corticosteroid-free Clinical Remission at Week M-44
Time frame: At Week M-44
Maintenance Study: Percentage of Participants With Clinical Response at Week M-44
Time frame: At Week M-44
Maintenance Study: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week M-44
Time frame: At Week M-44
Maintenance Study: Percentage of Participants With IBDQ Remission at Week M-44
Time frame: At Week M-44
Maintenance Study: Percentage of Participants With Fatigue Response at Week M-44
Time frame: At Week M-44
Maintenance Study: Percentage of Participants With Clinical Remission at Week 44 Among the Participants Who Had Achieved Clinical Remission at Maintenance Baseline
Time frame: At Week M-44
Maintenance Study: Percentage of Participants With Endoscopic Normalization at Week M-44
Time frame: At Week M-44