A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis

Primary Outcome Measures

1. Change From Baseline in Bowel Urgency Severity Urgency Numeric Rating Scale (UNRS)
   The UNRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicate more severe urgency. Baseline Observation Carried Forward (BOCF) endpoint was defined as the baseline value for participants discontinued during acute phase and defined as the last non-missing observation in the treatment phase for all other randomized participants.

Secondary Outcome Measures

1. Change From Baseline in Bowel Urgency Frequency (BUF)
   BUF is participant reported single item measure of the number of urgent bowel movements reported in the past 24 hours.
2. Percentage of Participants Achieving Clinically Meaningful Improvement in BUF
   This outcome measures the percentage of participants who experience a clinically meaningful reduction in the frequency of bowel urgency episodes from baseline to the 12 week treatment period. Results for this outcome will be reported during final results posting.
3. Percentage of Participants With Stool Deferral Time (SDT) Intervals at Week 12
   The SDT is a participant-reported single item measure of the average duration a patient could delay defecation in the past 24 hours. The shortest weekly SDT is used for analysis of SDT in minutes by taking the shortest response (i.e. minimum value) available over the past 7 days, where no urgency is treated as the largest value. The SDT categories were:\<1 min, ≥1 min to \<2 min, ≥2 min to \<5 min, ≥5 min to \<15 min, and ≥15 min or no urgency. No urgency indicates participant's selected "Did not feel urge to have a bowel movement in the past 24 hours" for all available days in 7-day period.
4. Percentage of Participants Achieving Clinically Meaningful Improvement of SDT
   This outcome measures the percentage of participants who demonstrate a clinically meaningful improvement in SDT. Results for this outcome will be reported during final results posting.
5. Percentage of Participants Achieving Both Clinical Remission, Based on the Modified Mayo Score (MMS) and a Rounded Urgency Numeric Rating Scale (UNRS) Score of ≤1
   Clinical remission based on MMS is defined as Stool Frequency (SF) sub score (range 0-3, higher is worse) = 0, or SF = 1 with a ≥1- point decrease from baseline, and 1. Rectal Bleeding (RB) sub score (range 0-3, higher is worse) = 0, and 2. Endoscopic sub score (ES) (range 0-3, higher is worse) = 0 or 1 (excluding friability). UNRS measures bowel urgency severity (range 0 to 10; Higher scores indicate more severe urgency) This outcome assesses the proportion of participants who achieved both a clinical response, as defined by an MMS, and an improvement of ≥3 points from baseline in a UNRS score at Week 12.
6. Percentage of Participants Achieving Both Clinical Response, Based on the Modified Mayo Score (MMS) and a Rounded Urgency Numeric Rating Scale (UNRS) Score ≥3 Points of Improvement From Baseline
   Clinical response based on MMS is defined as: 1. A change in the MMS of ≤ -2 points and ≤ -30% change from baseline, and 2. A change of ≤-1 point in the RB subscore (range 0-3, higher is worse) from baseline or a RB score of 0 or 1. UNRS measures bowel urgency severity (range 0 to 10; Higher scores indicate more severe urgency) This outcome measures the percentage of participants achieving both, clinical response, based on the MMS, and a UNRS score of ≥3 points of improvement from baseline at 12 weeks.
7. Pairwise Correlations Between the Urgency Numeric Rating Scale (UNRS), Baseline in Bowel Urgency Frequency (BUF), Stool Deferral Time (SDT) and Absorbent Product Use (APU) Measures
   UNRS measures bowel urgency severity (range 0 to 10; Higher scores indicate more severe urgency). BUF measures the number of urgent bowel movements reported in the past 24 hours. SDT measures the average duration a patient could delay defecation in the past 24 hours. APU is a single item to assess participant's need to wear an adult diaper, pad or protection because of bowel urgency. This outcome evaluates the pairwise correlations among four bowel urgency-related measures above.
8. Pairwise Correlations Between Change From Baseline in Urgency Numeric Rating Scale (UNRS), Baseline in Bowel Urgency Frequency (BUF), Stool Deferral Time (SDT) and Absorbent Product Use (APU) Measures
   UNRS measures bowel urgency severity (range 0 to 10; Higher scores indicate more severe urgency). BUF measures the number of urgent bowel movements reported in the past 24 hours. SDT measures the average duration a patient could delay defecation in the past 24 hours. APU is a single item to assess participant's need to wear an adult diaper, pad or protection because of bowel urgency. This outcome evaluates the pairwise correlations between the change in correlations among four bowel urgency-related measures above.
9. Correlation Between Urgency Numeric Rating Scale (UNRS), Baseline in Bowel Urgency Frequency (BUF),Stool Deferral Time (SDT) and Absorbent Product Use (APU) Measures,With Quality of Life (QoL)/Functional Outcome Measures and UC Symptom Measures
   This outcome evaluates correlations between UNRS, BUF, SDT, APU, and patient-reported outcomes (PROs) related to quality of life (QoL), functional outcomes, and UC symptoms. QoL is assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ), a 32-item patient-completed tool with four domains: bowel (score range 10-70), systemic (5-35), emotional (12-84), and social (5-35). Each item is rated on a 7-point Likert scale (1 = very severe problem,7 = not a problem at all); The total IBDQ score is calculated by summing the scores from all four domains and total score range is 32-224 (Higher = better QoL). Functional outcomes measures: Work Productivity and Activity Impairment (WPAI) questionnaire (four scores derived: absenteeism, presenteeism, productivity loss, activity impairment; each score 0-100%, higher = greater impairment) and Generalized Anxiety Disorder-7 (GAD-7; total score range 0-21, higher = more severe anxiety)... (Continued below due to character constraint)
10. Correlation Between Change From Baseline in Urgency Numeric Rating Scale (UNRS), Baseline in Bowel Urgency Frequency (BUF), Stool Deferral Time (SDT) and Absorbent Product Use (APU) Measures, With QoL/Functional Outcome Measures and UC Symptom Measures
    This outcome evaluates correlations between change from baseline in UNRS, BUF, SDT, APU, and PROs related to quality of life (QoL), functional outcomes, and UC symptoms. QoL is assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ), a 32-item patient-completed tool with four domains: bowel (score range 10-70), systemic (5-35), emotional (12-84), and social (5-35). Each item is rated on a 7-point Likert scale (1 = very severe problem, 7 = not a problem at all); The total IBDQ score is calculated by summing the scores from all four domains and total score range is 32-224 (Higher = better QoL). Functional outcomes measures: Work Productivity and Activity Impairment (WPAI) questionnaire (four scores derived: absenteeism, presenteeism, productivity loss, activity impairment; each score 0-100%, higher = greater impairment) and Generalized Anxiety Disorder-7 (GAD-7;total score range 0-21, higher = more severe anxiety)... (Continued below due to character constraint)