The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Percentage of Participants in Histologic Remission
Histologic remission based on histology.
Time frame: Week 12
Percentage of Participants in Symptomatic Remission
Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores.
Time frame: Week 52
Percentage of Participants in Clinical Remission
Clinical remission based on MMS.
Time frame: Week 52
Percentage of Participants in Endoscopic Remission
Endoscopic remission based on MMS ES.
Time frame: Week 52
Percentage of Participants with Clinical Response
Clinical response based on MMS.
Time frame: Week 12
Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline)
CS free remission without surgery based on clinical remission, symptomatic remission and no CS use.
Time frame: Week 52
Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline
Percentage of participants with resolution of EIMs among those that had them at baseline.
Time frame: Week 52
Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score
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Administered IV
Administered SC
Change from baseline on the IBDQ score.
Time frame: Baseline, Week 52
Percentage of Participants Undergoing Surgery for UC (Including Colectomy)
Percentage of participants undergoing surgery for UC (including colectomy).
Time frame: Week 52
Percentage of Participants Hospitalized for UC
Percentage of participants hospitalized for UC.
Time frame: Week 52