Trial Outcomes & Findings for A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis (NCT NCT05767021)

Last Updated: 2025-10-28

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

172 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2025-10-28

Participant Flow

Current results reporting analysis is only for the primary outcome data per Primary completion date (August 9, 2024) and final results will be presented at the time of reporting the final results, i.e., no later than September 2026.

Participant milestones

Participant milestones
Measure	300 mg Mirikizumab Participants received 300 milligram (mg) mirikizumab every 4 weeks (Q4W) at week 0, 4, and 8 administered intravenously (IV).
Overall Study STARTED	172
Overall Study Received at Least One Dose of Study Drug	172
Overall Study COMPLETED	155
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	300 mg Mirikizumab Participants received 300 milligram (mg) mirikizumab every 4 weeks (Q4W) at week 0, 4, and 8 administered intravenously (IV).
Overall Study Adverse Event	2
Overall Study Protocol Deviation	1
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1
Overall Study Lack of Efficacy	11
Overall Study Assigned Treatment by Mistake	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	300 mg Mirikizumab n=172 Participants Participants received 300 mg mirikizumab Q4W at week 0, 4, and 8 administered IV.
Age, Continuous	41.10 years STANDARD_DEVIATION 14.352 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	151 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	150 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Region of Enrollment Hungary	7 Participants n=5 Participants
Region of Enrollment United States	33 Participants n=5 Participants
Region of Enrollment Czechia	18 Participants n=5 Participants
Region of Enrollment Poland	50 Participants n=5 Participants
Region of Enrollment Italy	32 Participants n=5 Participants
Region of Enrollment United Kingdom	6 Participants n=5 Participants
Region of Enrollment Slovakia	10 Participants n=5 Participants
Region of Enrollment France	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol) with a non-missing baseline and BOCF endpoint.

Outcome measures

Outcome measures
Measure	300 mg Mirikizumab n=172 Participants Participants received 300 mg mirikizumab Q4W at week 0, 4, and 8 administered IV.
Change From Baseline in Bowel Urgency Severity Urgency Numeric Rating Scale (UNRS)	-3.25 score on a scale Interval -3.63 to -2.87

SECONDARY outcome

Timeframe: Baseline, Week 12

BUF is participant reported single item measure of the number of urgent bowel movements reported in the past 24 hours.

Outcome measures

Outcome measures
Measure	300 mg Mirikizumab n=172 Participants Participants received 300 mg mirikizumab Q4W at week 0, 4, and 8 administered IV.
Change From Baseline in Bowel Urgency Frequency (BUF)	-3.83 counts of urgent bowel movements/day Interval -4.33 to -3.33

SECONDARY outcome

Timeframe: Baseline to Week 12

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	300 mg Mirikizumab n=172 Participants Participants received 300 mg mirikizumab Q4W at week 0, 4, and 8 administered IV.
Percentage of Participants With Stool Deferral Time (SDT) Intervals at Week 12 <1 min	8.7 percentage of participants
Percentage of Participants With Stool Deferral Time (SDT) Intervals at Week 12 >=1 to <2 min	21.5 percentage of participants
Percentage of Participants With Stool Deferral Time (SDT) Intervals at Week 12 >=2 to <5 min	30.2 percentage of participants
Percentage of Participants With Stool Deferral Time (SDT) Intervals at Week 12 >=5 to <15 min	23.8 percentage of participants
Percentage of Participants With Stool Deferral Time (SDT) Intervals at Week 12 >=15 min or no urgency	15.7 percentage of participants

SECONDARY outcome

Timeframe: Week 12

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12

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.

Outcome measures

Outcome measures
Measure	300 mg Mirikizumab n=172 Participants Participants received 300 mg mirikizumab Q4W at week 0, 4, and 8 administered IV.
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	5.23 percentage of participants

SECONDARY outcome

Timeframe: Week 12

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.

Outcome measures

Outcome measures
Measure	300 mg Mirikizumab n=172 Participants Participants received 300 mg mirikizumab Q4W at week 0, 4, and 8 administered IV.
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	44.19 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: All enrolled participants who received at least one dose of study drug and had evaluable data for this outcome (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol).

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.

Outcome measures

Outcome measures
Measure	300 mg Mirikizumab n=160 Participants Participants received 300 mg mirikizumab Q4W at week 0, 4, and 8 administered IV.
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 Correlation between UNRS and BUF	0.68 Spearman Correlation Coefficient Interval 0.58 to 0.75
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 Correlation between SDT and APU	-0.37 Spearman Correlation Coefficient Interval -0.49 to -0.22
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 Correlation between UNRS and SDT	-0.50 Spearman Correlation Coefficient Interval -0.61 to -0.37
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 Correlation between UNRS and APU	0.37 Spearman Correlation Coefficient Interval 0.22 to 0.5
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 Correlation between BUF and SDT	-0.47 Spearman Correlation Coefficient Interval -0.58 to -0.34
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 Correlation between BUF and APU	0.45 Spearman Correlation Coefficient Interval 0.31 to 0.56

SECONDARY outcome

Timeframe: Baseline, Week 12

Outcome measures

Outcome measures
Measure	300 mg Mirikizumab n=160 Participants Participants received 300 mg mirikizumab Q4W at week 0, 4, and 8 administered IV.
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 Correlation between UNRS and BUF	0.49 Spearman Correlation Coefficient Interval 0.36 to 0.6
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 Correlation between UNRS and SDT	-0.48 Spearman Correlation Coefficient Interval -0.59 to -0.35
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 Correlation between UNRS and APU	0.17 Spearman Correlation Coefficient Interval 0.01 to 0.32
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 Correlation between BUF and SDT	-0.27 Spearman Correlation Coefficient Interval -0.41 to -0.12
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 Correlation between BUF and APU	0.16 Spearman Correlation Coefficient Interval 0.0 to 0.31
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 Correlation between SDT and APU	0.07 Spearman Correlation Coefficient Interval -0.09 to 0.23

SECONDARY outcome

Timeframe: Baseline to Week 12 UC symptom measures:Patient Global Rating of Severity (PGR-S)(1-6),Patient Global Impression of Change (PGI-C)(1-7),Mayo SF/RB (0-3),Abdominal pain/fatigue NRS (0-10),nocturnal stool frequency;higher=worse severity for all 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)

Outcome measures

Outcome measures
Measure	300 mg Mirikizumab n=160 Participants Participants received 300 mg mirikizumab Q4W at week 0, 4, and 8 administered IV.
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 BUF: Nocturnal Stool	0.62 Spearman Correlation Coefficient Interval 0.51 to 0.7
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 SDT: PGR-S	-0.44 Spearman Correlation Coefficient Interval -0.56 to -0.31
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 SDT:Absolute SF	-0.30 Spearman Correlation Coefficient Interval -0.43 to -0.15
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 SDT: Mayo RB	-0.22 Spearman Correlation Coefficient Interval -0.36 to -0.07
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 SDT: Abdominal Pain NRS	-0.44 Spearman Correlation Coefficient Interval -0.55 to -0.3
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 SDT: Fatigue NRS	-0.30 Spearman Correlation Coefficient Interval -0.43 to -0.15
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 SDT: Nocturnal Stool	-0.33 Spearman Correlation Coefficient Interval -0.46 to -0.19
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 SDT: PGI-C	-0.29 Spearman Correlation Coefficient Interval -0.43 to -0.14
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 APU: PGR-S	0.39 Spearman Correlation Coefficient Interval 0.25 to 0.52
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 APU: PGI-C	0.35 Spearman Correlation Coefficient Interval 0.2 to 0.48
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 APU: Mayo SF	0.44 Spearman Correlation Coefficient Interval 0.3 to 0.55
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 APU: Mayo RB	0.22 Spearman Correlation Coefficient Interval 0.06 to 0.36
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 APU: Abdominal Pain NRS	0.23 Spearman Correlation Coefficient Interval 0.07 to 0.37
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 APU: Fatigue NRS	0.29 Spearman Correlation Coefficient Interval 0.14 to 0.43
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 UNRS-IBDQ: IBDQ Total score	-0.55 Spearman Correlation Coefficient Interval -0.65 to -0.42
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 BUF-IBDQ: IBDQ Total score	-0.60 Spearman Correlation Coefficient Interval -0.69 to -0.48
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 SDT-APU for BU	-0.37 Spearman Correlation Coefficient Interval -0.49 to -0.22
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 BUF: PGI-C	0.45 Spearman Correlation Coefficient Interval 0.31 to 0.56
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 BUF: Mayo SF	0.53 Spearman Correlation Coefficient Interval 0.4 to 0.63
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 BUF: Mayo RB	0.22 Spearman Correlation Coefficient Interval 0.07 to 0.36
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 BUF: Abdominal Pain NRS	0.55 Spearman Correlation Coefficient Interval 0.43 to 0.65
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 UNRS-IBDQ: Bowel symptoms	-0.48 Spearman Correlation Coefficient Interval -0.6 to -0.35
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 UNRS-IBDQ: Systemic symptoms	-0.50 Spearman Correlation Coefficient Interval -0.61 to -0.37
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 UNRS-IBDQ: Emotional function	-0.51 Spearman Correlation Coefficient Interval -0.62 to -0.38
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 UNRS-IBDQ: Social function	-0.49 Spearman Correlation Coefficient Interval -0.61 to -0.36
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 UNRS-WPAI: Work Productivity Loss Score	0.40 Spearman Correlation Coefficient Interval 0.21 to 0.55
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 UNRS-WPAI: Absenteeism Score	0.28 Spearman Correlation Coefficient Interval 0.1 to 0.45
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 UNRS-WPAI: Presenteeism Score	0.39 Spearman Correlation Coefficient Interval 0.21 to 0.55
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 UNRS-WPAI: Activity Impairment Score	0.54 Spearman Correlation Coefficient Interval 0.41 to 0.64
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 UNRS-Generalize Anxiety Disorder-7 Score	0.36 Spearman Correlation Coefficient Interval 0.21 to 0.49
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 BUF-IBDQ: Bowel symptoms	-0.57 Spearman Correlation Coefficient Interval -0.67 to -0.45
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 BUF-IBDQ: Systemic symptoms	-0.57 Spearman Correlation Coefficient Interval -0.67 to -0.45
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 BUF-IBDQ: Emotional function	-0.51 Spearman Correlation Coefficient Interval -0.62 to -0.37
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 BUF-IBDQ: Social function	-0.58 Spearman Correlation Coefficient Interval -0.68 to -0.46
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 BUF-WPAI: Work Productivity Loss Score	0.50 Spearman Correlation Coefficient Interval 0.33 to 0.63
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 BUF-WPAI: Absenteeism Score	0.27 Spearman Correlation Coefficient Interval 0.08 to 0.43
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 BUF-WPAI: Presenteeism Score	0.50 Spearman Correlation Coefficient Interval 0.33 to 0.63
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 BUF-WPAI: Activity Impairment Score	0.60 Spearman Correlation Coefficient Interval 0.48 to 0.69
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 BUF-Generalize Anxiety Disorder-7 Score	0.35 Spearman Correlation Coefficient Interval 0.2 to 0.48
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 SDT-IBDQ: IBDQ Total score	0.37 Spearman Correlation Coefficient Interval 0.22 to 0.5
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 SDT-IBDQ: Bowel symptoms	0.36 Spearman Correlation Coefficient Interval 0.21 to 0.49
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 SDT-IBDQ: Systemic symptoms	0.34 Spearman Correlation Coefficient Interval 0.19 to 0.48
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 SDT-IBDQ: Emotional function	0.32 Spearman Correlation Coefficient Interval 0.16 to 0.46
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 SDT-IBDQ: Social function	0.34 Spearman Correlation Coefficient Interval 0.19 to 0.48
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 SDT-WPAI: UC Work Productivity Loss Score	-0.29 Spearman Correlation Coefficient Interval -0.46 to -0.1
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 SDT-WPAI: UC Absenteeism Score	-0.18 Spearman Correlation Coefficient Interval -0.36 to 0.01
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 SDT-WPAI: UC Presenteeism Score	-0.30 Spearman Correlation Coefficient Interval -0.47 to -0.11
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 SDT-WPAI: UC Activity Impairment Score	-0.29 Spearman Correlation Coefficient Interval -0.43 to -0.14
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 SDT-Generalize Anxiety Disorder-7 Score	-0.26 Spearman Correlation Coefficient Interval -0.4 to -0.11
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 APU-IBDQ: IBDQ Total score	-0.51 Spearman Correlation Coefficient Interval -0.62 to -0.38
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 APU-IBDQ: Bowel symptoms	-0.46 Spearman Correlation Coefficient Interval -0.58 to -0.32
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 APU-IBDQ: Systemic symptoms	-0.43 Spearman Correlation Coefficient Interval -0.56 to -0.29
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 APU-IBDQ: Emotional function	-0.45 Spearman Correlation Coefficient Interval -0.57 to -0.3
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 APU-IBDQ: Social function	-0.54 Spearman Correlation Coefficient Interval -0.64 to -0.41
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 APU-WPAI: Work Productivity Loss Score	0.43 Spearman Correlation Coefficient Interval 0.25 to 0.58
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 APU-WPAI: Absenteeism Score	0.22 Spearman Correlation Coefficient Interval 0.03 to 0.4
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 APU-WPAI: Presenteeism Score	0.41 Spearman Correlation Coefficient Interval 0.22 to 0.56
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 APU-WPAI: Activity Impairment Score	0.48 Spearman Correlation Coefficient Interval 0.34 to 0.59
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 APU-Generalize Anxiety Disorder-7 Score	0.25 Spearman Correlation Coefficient Interval 0.09 to 0.39
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 UNRS: PGR-S	0.64 Spearman Correlation Coefficient Interval 0.54 to 0.72
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 UNRS: PGI-C	0.45 Spearman Correlation Coefficient Interval 0.31 to 0.56
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 UNRS: Mayo SF	0.35 Spearman Correlation Coefficient Interval 0.2 to 0.48
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 UNRS: Mayo RB	0.21 Spearman Correlation Coefficient Interval 0.05 to 0.35
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 UNRS: Abdominal Pain NRS	0.62 Spearman Correlation Coefficient Interval 0.51 to 0.7
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 UNRS: Fatigue NRS	0.58 Spearman Correlation Coefficient Interval 0.47 to 0.67
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 UNRS: Nocturnal Stool	0.49 Spearman Correlation Coefficient Interval 0.36 to 0.59
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 BUF: PGR-S	0.65 Spearman Correlation Coefficient Interval 0.56 to 0.73
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 APU: Nocturnal Stool	0.50 Spearman Correlation Coefficient Interval 0.37 to 0.61
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 BUF: Fatigue NRS	0.49 Spearman Correlation Coefficient Interval 0.36 to 0.6
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 SDT: Mayo SF	-0.28 Spearman Correlation Coefficient Interval -0.41 to -0.13

SECONDARY outcome

Timeframe: Baseline, Week 12 UC symptom measures:Patient Global Rating of Severity (PGR-S)(1-6),Patient Global Impression of Change (PGI-C)(1-7),Mayo SF/RB (0-3),Abdominal pain/fatigue NRS (0-10),nocturnal stool frequency; higher=worse severity for all 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)

Outcome measures

Outcome measures
Measure	300 mg Mirikizumab n=160 Participants Participants received 300 mg mirikizumab Q4W at week 0, 4, and 8 administered IV.
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 UNRS-IBDQ: IBDQ Total score	-0.546 Spearman Correlation Coefficient Interval -0.654 to -0.414
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 UNRS-IBDQ: Bowel symptoms	-0.522 Spearman Correlation Coefficient Interval -0.634 to -0.385
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 UNRS-IBDQ: Systemic symptoms	-0.473 Spearman Correlation Coefficient Interval -0.594 to -0.329
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 UNRS-IBDQ: Emotional function	-0.485 Spearman Correlation Coefficient Interval -0.604 to -0.342
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 UNRS-IBDQ: Social function	-0.454 Spearman Correlation Coefficient Interval -0.578 to -0.307
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 UNRS-WPAI: Work Productivity Loss Score	0.488 Spearman Correlation Coefficient Interval 0.286 to 0.645
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 UNRS-WPAI: Absenteeism Score	0.092 Spearman Correlation Coefficient Interval -0.108 to 0.285
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 UNRS-WPAI: Presenteeism Score	0.509 Spearman Correlation Coefficient Interval 0.312 to 0.661
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 UNRS-WPAI: Activity Impairment Score	0.451 Spearman Correlation Coefficient Interval 0.309 to 0.571
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 UNRS-Generalize Anxiety Disorder-7 Score	0.179 Spearman Correlation Coefficient Interval 0.015 to 0.331
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 BUF-IBDQ: IBDQ Total score	-0.399 Spearman Correlation Coefficient Interval -0.532 to -0.245
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 BUF-IBDQ: Bowel symptoms	-0.380 Spearman Correlation Coefficient Interval -0.515 to -0.223
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 BUF-IBDQ: Systemic symptoms	-0.353 Spearman Correlation Coefficient Interval -0.492 to -0.194
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 BUF-IBDQ: Emotional function	-0.278 Spearman Correlation Coefficient Interval -0.427 to -0.113
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 BUF-IBDQ: Social function	-0.378 Spearman Correlation Coefficient Interval -0.514 to -0.222
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 BUF-WPAI: Work Productivity Loss Score	0.275 Spearman Correlation Coefficient Interval 0.044 to 0.475
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 BUF-WPAI: Absenteeism Score	0.150 Spearman Correlation Coefficient Interval -0.051 to 0.338
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 BUF-WPAI: Presenteeism Score	0.275 Spearman Correlation Coefficient Interval 0.045 to 0.475
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 BUF-WPAI: Activity Impairment Score	0.356 Spearman Correlation Coefficient Interval 0.203 to 0.489
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 BUF-WPAI: Generalize Anxiety Disorder-7 Score	0.130 Spearman Correlation Coefficient Interval -0.034 to 0.287
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 SDT-IBDQ: IBDQ Total score	0.22 Spearman Correlation Coefficient Interval 0.05 to 0.38
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 SDT-IBDQ: Bowel symptoms	0.26 Spearman Correlation Coefficient Interval 0.1 to 0.41
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 SDT-IBDQ: Systemic symptoms	0.18 Spearman Correlation Coefficient Interval 0.01 to 0.34
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 SDT-IBDQ: Emotional function	0.16 Spearman Correlation Coefficient Interval -0.01 to 0.32
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 SDT-IBDQ: Social function	0.15 Spearman Correlation Coefficient Interval -0.02 to 0.31
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 SDT-WPAI: UC Work Productivity Loss Score	-0.14 Spearman Correlation Coefficient Interval -0.36 to 0.09
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 SDT-WPAI: UC Absenteeism Score	0.03 Spearman Correlation Coefficient Interval -0.17 to 0.22
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 SDT-WPAI: UC Presenteeism Score	-0.17 Spearman Correlation Coefficient Interval -0.38 to -0.06
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 SDT-WPAI: UC Activity Impairment Score	-0.17 Spearman Correlation Coefficient Interval -0.32 to 0.0
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 SDT-Generalize Anxiety Disorder-7 Score	0.03 Spearman Correlation Coefficient Interval -0.14 to 0.19
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 SDT- APU for BU	0.07 Spearman Correlation Coefficient Interval -0.09 to 0.23
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 APU-IBDQ: IBDQ Total score	-0.290 Spearman Correlation Coefficient Interval -0.436 to -0.126
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 APU-IBDQ: Bowel symptoms	-0.240 Spearman Correlation Coefficient Interval -0.392 to -0.073
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 APU-IBDQ: Systemic symptoms	-0.160 Spearman Correlation Coefficient Interval -0.319 to 0.01
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 APU-IBDQ: Emotional function	-0.258 Spearman Correlation Coefficient Interval -0.409 to -0.093
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 APU-IBDQ: Social function	-0.321 Spearman Correlation Coefficient Interval -0.464 to -0.16
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 APU-WPAI: Work Productivity Loss Score	0.040 Spearman Correlation Coefficient Interval -0.194 to 0.269
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 APU-WPAI: Absenteeism Score	-0.031 Spearman Correlation Coefficient Interval -0.228 to 0.169
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 APU-WPAI: Presenteeism Score	0.030 Spearman Correlation Coefficient Interval -0.204 to 0.259
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 APU-WPAI: Activity Impairment Score	0.153 Spearman Correlation Coefficient Interval -0.01 to 0.308
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 APU-WPAI: Generalize Anxiety Disorder-7 Score	0.139 Spearman Correlation Coefficient Interval -0.025 to 0.294
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 UNRS: PGR-S	0.672 Spearman Correlation Coefficient Interval 0.575 to 0.748
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 UNRS: Mayo SF	0.478 Spearman Correlation Coefficient Interval 0.348 to 0.589
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 UNRS: Mayo RB	0.368 Spearman Correlation Coefficient Interval 0.225 to 0.494
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 UNRS: Abdominal Pain NRS	0.667 Spearman Correlation Coefficient Interval 0.57 to 0.744
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 UNRS: Fatigue NRS	0.601 Spearman Correlation Coefficient Interval 0.491 to 0.691
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 UNRS: Nocturnal Stool	0.191 Spearman Correlation Coefficient Interval 0.036 to 0.335
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 BUF: PGR-S	0.502 Spearman Correlation Coefficient Interval 0.375 to 0.609
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 BUF: Mayo SF	0.477 Spearman Correlation Coefficient Interval 0.346 to 0.587
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 BUF: Mayo RB	0.351 Spearman Correlation Coefficient Interval 0.207 to 0.48
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 BUF: Abdominal Pain NRS	0.399 Spearman Correlation Coefficient Interval 0.258 to 0.521
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 BUF: Fatigue NRS	0.404 Spearman Correlation Coefficient Interval 0.264 to 0.525
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 BUF: Nocturnal Stool	0.579 Spearman Correlation Coefficient Interval 0.464 to 0.672
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 SDT: PGR-S	-0.44 Spearman Correlation Coefficient Interval -0.55 to -0.3
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 SDT: Absolute SF	-0.23 Spearman Correlation Coefficient Interval -0.37 to -0.08
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 SDT: Mayo SF	-0.35 Spearman Correlation Coefficient Interval -0.48 to -0.21
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 SDT: Mayo RB	-0.22 Spearman Correlation Coefficient Interval -0.37 to -0.07
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 SDT: Abdominal Pain NRS	-0.39 Spearman Correlation Coefficient Interval -0.52 to -0.25
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 SDT: Fatigue NRS	-0.30 Spearman Correlation Coefficient Interval -0.43 to -0.15
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 SDT: Nocturnal Stool	-0.07 Spearman Correlation Coefficient Interval -0.22 to 0.09
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 APU: PGR-S	0.047 Spearman Correlation Coefficient Interval -0.114 to 0.206
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 APU: Mayo SF	0.177 Spearman Correlation Coefficient Interval 0.018 to 0.327
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 APU: Mayo RB	0.120 Spearman Correlation Coefficient Interval -0.041 to 0.274
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 APU: Abdominal Pain NRS	0.168 Spearman Correlation Coefficient Interval 0.008 to 0.319
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 APU: Fatigue NRS	0.154 Spearman Correlation Coefficient Interval -0.007 to 0.306
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 APU: Nocturnal Stool	0.115 Spearman Correlation Coefficient Interval -0.047 to 0.27

Adverse Events

300 mg Mirikizumab

Serious events: 5 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	300 mg Mirikizumab n=172 participants at risk Participants received 300 mg mirikizumab Q4W at week 0, 4, and 8 administered IV.
Blood and lymphatic system disorders Any event	0.58% 1/172 • Number of events 1 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Blood and lymphatic system disorders Anaemia	0.58% 1/172 • Number of events 1 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Gastrointestinal disorders Any event	0.58% 1/172 • Number of events 1 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Gastrointestinal disorders Colitis ulcerative	0.58% 1/172 • Number of events 1 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Infections and infestations Any event	0.58% 1/172 • Number of events 1 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Infections and infestations Joint abscess	0.58% 1/172 • Number of events 1 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Respiratory, thoracic and mediastinal disorders Any event	0.58% 1/172 • Number of events 1 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.58% 1/172 • Number of events 1 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Vascular disorders Any event	0.58% 1/172 • Number of events 1 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Vascular disorders Deep vein thrombosis	0.58% 1/172 • Number of events 1 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)

Other adverse events

Other adverse events
Measure	300 mg Mirikizumab n=172 participants at risk Participants received 300 mg mirikizumab Q4W at week 0, 4, and 8 administered IV.
Gastrointestinal disorders Any event	5.8% 10/172 • Number of events 11 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Gastrointestinal disorders Abdominal distension	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Blood and lymphatic system disorders Any event	2.3% 4/172 • Number of events 4 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Blood and lymphatic system disorders Anaemia	2.3% 4/172 • Number of events 4 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Cardiac disorders Any event	1.7% 3/172 • Number of events 3 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Cardiac disorders Tachycardia	1.7% 3/172 • Number of events 3 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Gastrointestinal disorders Colitis ulcerative	1.7% 3/172 • Number of events 3 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Gastrointestinal disorders Diarrhoea	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Gastrointestinal disorders Haemorrhoids	1.7% 3/172 • Number of events 4 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
General disorders Any event	7.0% 12/172 • Number of events 13 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
General disorders Asthenia	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
General disorders Fatigue	2.9% 5/172 • Number of events 5 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
General disorders Infusion site reaction	1.7% 3/172 • Number of events 3 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
General disorders Pyrexia	1.7% 3/172 • Number of events 3 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Hepatobiliary disorders Any event	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Hepatobiliary disorders Hepatic steatosis	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Infections and infestations Any event	6.4% 11/172 • Number of events 11 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Infections and infestations Covid-19	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Infections and infestations Upper respiratory tract infection	4.1% 7/172 • Number of events 7 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Infections and infestations Viral infection	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Metabolism and nutrition disorders Any event	3.5% 6/172 • Number of events 6 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Metabolism and nutrition disorders Hypercholesterolaemia	2.3% 4/172 • Number of events 4 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Metabolism and nutrition disorders Hyperglycaemia	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Musculoskeletal and connective tissue disorders Any event	2.3% 4/172 • Number of events 4 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Musculoskeletal and connective tissue disorders Arthralgia	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Musculoskeletal and connective tissue disorders Back pain	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Nervous system disorders Any event	3.5% 6/172 • Number of events 7 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Nervous system disorders Dizziness	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Nervous system disorders Headache	2.3% 4/172 • Number of events 5 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Psychiatric disorders Any event	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Psychiatric disorders Insomnia	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Respiratory, thoracic and mediastinal disorders Any event	2.3% 4/172 • Number of events 6 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Respiratory, thoracic and mediastinal disorders Cough	2.3% 4/172 • Number of events 4 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Skin and subcutaneous tissue disorders Any event	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)
Skin and subcutaneous tissue disorders Rash	1.2% 2/172 • Number of events 2 • Baseline Up to Week 12 All enrolled participants who received at least one dose of study drug (regardless of whether the participant does not receive the correct treatment or otherwise does not follow the protocol)

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 08005455979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60