The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC). Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
252
Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)
The mMS is a composite score reported by participants and physician and is comprised of the following 3 subscores: Stool Frequency (SF); Rectal Bleeding (RB), and Endoscopic Subscore (ES). Clinical remission (mMS) is defined as: * SF subscore = 0 or 1 and no greater than baseline * RB subscore = 0 * Centrally read ES = 0 or 1; score of 1 modified to exclude friability
Time frame: Week 12
Percentage of Participants Who Achieve Clinical Response with mMS
Time frame: Week 12
Percentage of Participants Who Achieve Endoscopic Improvement
Time frame: Week 12
Percentage of Participants Who Achieve Symptomatic Remission
Time frame: Week 12
Percentage of Participants Who Achieve Clinical Remission with mMS
Time frame: Week 24
Percentage of Participants Who Achieve Clinical Response with mMS
Time frame: Week 24
Percentage of Participants Who Achieve Clinical Remission with mMS
Time frame: Week 48
Percentage of Participants Who Achieve Clinical Response with mMS
Time frame: Week 48
Percentage of Participants Who Achieve Clinical Remission with mMS + Physician's Global Assessment (PGA)
Time frame: Week 48
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Percentage of Participants Who Achieve Clinical Response with mMS + PGA
Time frame: Week 48