Trial Outcomes & Findings for A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (NCT NCT03524092)

Last Updated: 2025-10-14

Results Overview

Clinical remission at week 40 is defined as achieving a 9-point modified Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). Stool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); Endoscopy Subscore, based on central reading of colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1177 participants

Primary outcome timeframe

Week 40

Results posted on

2025-10-14

Participant Flow

A total of 1177 Participants enrolled in the study of which 716 participants entered to Blinded Maintenance Period as Induction Responder (IR) and 461 participants entered into open label extended Induction period as Induction Nonresponders.

This study was designed to evaluate the safety and efficacy of mirikizumab (miri) in achieving remission at Week (Wk) 40 in participants who completed the 12-week induction study I6T-MC-AMAN (NCT03518086) as clinical responders to mirikizumab. Results for maximum extended enrollment (ME2) participants will be posted after the study completion.

Participant milestones

Participant milestones
Measure	Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.	Maintenance Period: PBO IR - PBO SC Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.	Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV Participants who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.	Extended Induction: Induction Nonresponders - 300mg Miri IV Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.	Open Label Maintenance: Delayed Responders - 200 mg Miri SC Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).
Blinded Maintenance Period (Wk 0-40) STARTED	192	389	135	0	0	0
Blinded Maintenance Period (Wk 0-40) Received at Least One Dose of Study Drug	192	389	135	0	0	0
Blinded Maintenance Period (Wk 0-40) COMPLETED	119	347	90	0	0	0
Blinded Maintenance Period (Wk 0-40) NOT COMPLETED	73	42	45	0	0	0
Loss of Response Rescue Period STARTED	0	0	0	90	0	0
Loss of Response Rescue Period COMPLETED	0	0	0	81	0	0
Loss of Response Rescue Period NOT COMPLETED	0	0	0	9	0	0
Open Label Extended Induction (Wk 0-12) STARTED	0	0	0	0	461	0
Open Label Extended Induction (Wk 0-12) COMPLETED	0	0	0	0	271	0
Open Label Extended Induction (Wk 0-12) NOT COMPLETED	0	0	0	0	190	0
Open Label Maintenance Period (Wk 12-40) STARTED	0	0	0	0	0	271
Open Label Maintenance Period (Wk 12-40) COMPLETED	0	0	0	0	0	256
Open Label Maintenance Period (Wk 12-40) NOT COMPLETED	0	0	0	0	0	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.	Maintenance Period: PBO IR - PBO SC Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.	Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV Participants who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.	Extended Induction: Induction Nonresponders - 300mg Miri IV Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.	Open Label Maintenance: Delayed Responders - 200 mg Miri SC Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).
Blinded Maintenance Period (Wk 0-40) Adverse Event	16	6	1	0	0	0
Blinded Maintenance Period (Wk 0-40) Lack of Efficacy	8	6	7	0	0	0
Blinded Maintenance Period (Wk 0-40) Lost to Follow-up	0	1	0	0	0	0
Blinded Maintenance Period (Wk 0-40) Physician Decision	0	1	0	0	0	0
Blinded Maintenance Period (Wk 0-40) Pregnancy	0	0	1	0	0	0
Blinded Maintenance Period (Wk 0-40) Protocol Violation	0	1	1	0	0	0
Blinded Maintenance Period (Wk 0-40) Withdrawal by Subject	7	8	6	0	0	0
Blinded Maintenance Period (Wk 0-40) Loss of Response Rescue Period	42	19	29	0	0	0
Loss of Response Rescue Period Adverse Event	0	0	0	2	0	0
Loss of Response Rescue Period Lack of Efficacy	0	0	0	5	0	0
Loss of Response Rescue Period Pregnancy	0	0	0	1	0	0
Loss of Response Rescue Period Withdrawal by Subject	0	0	0	1	0	0
Open Label Extended Induction (Wk 0-12) Adverse Event	0	0	0	0	11	0
Open Label Extended Induction (Wk 0-12) Covid-19 related study disruption	0	0	0	0	4	0
Open Label Extended Induction (Wk 0-12) Lack of Efficacy	0	0	0	0	162	0
Open Label Extended Induction (Wk 0-12) Physician Decision	0	0	0	0	1	0
Open Label Extended Induction (Wk 0-12) Protocol Violation	0	0	0	0	5	0
Open Label Extended Induction (Wk 0-12) Withdrawal by Subject	0	0	0	0	6	0
Open Label Extended Induction (Wk 0-12) Lack of capacity due to lack of staff	0	0	0	0	1	0
Open Label Maintenance Period (Wk 12-40) Adverse Event	0	0	0	0	0	4
Open Label Maintenance Period (Wk 12-40) Covid-19 related study disruption	0	0	0	0	0	1
Open Label Maintenance Period (Wk 12-40) Lack of Efficacy	0	0	0	0	0	9
Open Label Maintenance Period (Wk 12-40) Protocol Violation	0	0	0	0	0	1

Baseline Characteristics

A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Maintenance Period: Miri IR - PBO SC n=192 Participants Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC n=389 Participants Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.	Maintenance Period: PBO IR - PBO SC n=135 Participants Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.	Extended Induction: Induction Nonresponders - 300mg Miri IV n=461 Participants Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.	Total n=1177 Participants Total of all reporting groups
Age, Continuous	41.20 years STANDARD_DEVIATION 12.88 • n=5 Participants	43.30 years STANDARD_DEVIATION 14.13 • n=7 Participants	40.80 years STANDARD_DEVIATION 13.40 • n=5 Participants	43.40 years STANDARD_DEVIATION 13.86 • n=4 Participants	42.70 years STANDARD_DEVIATION 13.77 • n=21 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	160 Participants n=7 Participants	61 Participants n=5 Participants	166 Participants n=4 Participants	465 Participants n=21 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	229 Participants n=7 Participants	74 Participants n=5 Participants	295 Participants n=4 Participants	712 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	12 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants	27 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	33 Participants n=7 Participants	8 Participants n=5 Participants	53 Participants n=4 Participants	112 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	172 Participants n=5 Participants	344 Participants n=7 Participants	125 Participants n=5 Participants	397 Participants n=4 Participants	1038 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants
Race (NIH/OMB) Asian	51 Participants n=5 Participants	93 Participants n=7 Participants	28 Participants n=5 Participants	87 Participants n=4 Participants	259 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) White	138 Participants n=5 Participants	285 Participants n=7 Participants	103 Participants n=5 Participants	358 Participants n=4 Participants	884 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment Argentina	1 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	11 Participants n=21 Participants
Region of Enrollment Australia	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants	12 Participants n=21 Participants
Region of Enrollment Austria	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment Belgium	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=21 Participants
Region of Enrollment Canada	3 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	21 Participants n=4 Participants	31 Participants n=21 Participants
Region of Enrollment China	3 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	15 Participants n=21 Participants
Region of Enrollment Czechia	7 Participants n=5 Participants	19 Participants n=7 Participants	11 Participants n=5 Participants	15 Participants n=4 Participants	52 Participants n=21 Participants
Region of Enrollment Denmark	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Region of Enrollment France	10 Participants n=5 Participants	18 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants	57 Participants n=21 Participants
Region of Enrollment Germany	5 Participants n=5 Participants	13 Participants n=7 Participants	3 Participants n=5 Participants	16 Participants n=4 Participants	37 Participants n=21 Participants
Region of Enrollment Hungary	1 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants	23 Participants n=21 Participants
Region of Enrollment India	18 Participants n=5 Participants	25 Participants n=7 Participants	16 Participants n=5 Participants	13 Participants n=4 Participants	72 Participants n=21 Participants
Region of Enrollment Ireland	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment Israel	3 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	15 Participants n=21 Participants
Region of Enrollment Italy	3 Participants n=5 Participants	12 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants	36 Participants n=21 Participants
Region of Enrollment Japan	25 Participants n=5 Participants	47 Participants n=7 Participants	8 Participants n=5 Participants	43 Participants n=4 Participants	123 Participants n=21 Participants
Region of Enrollment Latvia	8 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	29 Participants n=21 Participants
Region of Enrollment Lithuania	6 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	22 Participants n=21 Participants
Region of Enrollment Malaysia	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment Mexico	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	10 Participants n=21 Participants
Region of Enrollment Netherlands	1 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	10 Participants n=21 Participants
Region of Enrollment Poland	15 Participants n=5 Participants	32 Participants n=7 Participants	13 Participants n=5 Participants	62 Participants n=4 Participants	122 Participants n=21 Participants
Region of Enrollment Romania	4 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants	14 Participants n=21 Participants
Region of Enrollment Russia	19 Participants n=5 Participants	36 Participants n=7 Participants	16 Participants n=5 Participants	29 Participants n=4 Participants	100 Participants n=21 Participants
Region of Enrollment Serbia	1 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	21 Participants n=21 Participants
Region of Enrollment Slovakia	6 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	21 Participants n=21 Participants
Region of Enrollment South Korea	3 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	13 Participants n=4 Participants	25 Participants n=21 Participants
Region of Enrollment Spain	1 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants	20 Participants n=21 Participants
Region of Enrollment Switzerland	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	10 Participants n=21 Participants
Region of Enrollment Taiwan	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment Turkey	0 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment Ukraine	18 Participants n=5 Participants	31 Participants n=7 Participants	16 Participants n=5 Participants	28 Participants n=4 Participants	93 Participants n=21 Participants
Region of Enrollment United Kingdom	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	14 Participants n=21 Participants
Region of Enrollment United States	21 Participants n=5 Participants	45 Participants n=7 Participants	10 Participants n=5 Participants	64 Participants n=4 Participants	140 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 40

Population: Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.

Outcome measures

Outcome measures
Measure	Maintenance Period: Miri IR - PBO SC n=179 Participants Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC n=365 Participants Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Percentage of Participants in Clinical Remission at Week 40	25.1 percentage of participants Interval 18.8 to 31.5	49.9 percentage of participants Interval 44.7 to 55.0

SECONDARY outcome

Timeframe: Week 40

Endoscopic remission at week 40 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 40. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).

Outcome measures

Outcome measures
Measure	Maintenance Period: Miri IR - PBO SC n=179 Participants Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC n=365 Participants Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Percentage of Participants in Endoscopic Remission at Week 40	29.1 percentage of participants Interval 22.4 to 35.7	58.6 percentage of participants Interval 53.6 to 63.7

SECONDARY outcome

Timeframe: Week 40

Histologic remission was assessed using the Geboes histologic scoring system developed for assessment of histologic disease activity in ulcerative colitis. Remission was defined as Geboes histological subscore of 0 for grades: 2b (lamina propria neutrophils), and 3 (neutrophils in epithelium), and 4 (crypt destruction), and 5 (erosion or ulceration).

Outcome measures

Outcome measures
Measure	Maintenance Period: Miri IR - PBO SC n=179 Participants Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC n=365 Participants Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Percentage of Participants With Histologic Remission at Week 40	24.6 percentage of participants Interval 18.3 to 30.9	48.5 percentage of participants Interval 43.4 to 53.6

SECONDARY outcome

Timeframe: Week 40

Symptomatic remission at week 40 is defined as a Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline. Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal). Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed).

Outcome measures

Outcome measures
Measure	Maintenance Period: Miri IR - PBO SC n=179 Participants Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC n=365 Participants Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Percentage of Participants in Symptomatic Remission at Week 40	39.7 percentage of participants Interval 32.5 to 46.8	71.0 percentage of participants Interval 66.3 to 75.6

SECONDARY outcome

Timeframe: Week 40

Endoscopic response at week 40 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.

Outcome measures

Outcome measures
Measure	Maintenance Period: Miri IR - PBO SC n=179 Participants Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC n=365 Participants Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Percentage of Participants in Endoscopic Response at Week 40	40.8 percentage of participants Interval 33.6 to 48.0	72.6 percentage of participants Interval 68.0 to 77.2

SECONDARY outcome

Timeframe: Week 40

Clinical response at week 40 is defined as a decrease in the 9-point modified Mayo score (MMS) \[rectal bleeding, stool frequency and the endoscopic findings\] inclusive of \>= 2 points and \>=30% from baseline with either a decrease of rectal bleeding subscore of \>=1 or rectal bleeding subscore of 0 or 1.The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration).

Outcome measures

Outcome measures
Measure	Maintenance Period: Miri IR - PBO SC n=179 Participants Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC n=365 Participants Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Percentage of Participants in Clinical Response at Week 40	49.2 percentage of participants Interval 41.8 to 56.5	80.3 percentage of participants Interval 76.2 to 84.4

SECONDARY outcome

Timeframe: Induction Baseline, Week 40

Population: Modified Intention-to-treat population (mITT): All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline IBDQ measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.

The IBDQ is a 32-item participant-completed questionnaire that measures 4 aspects of subjects' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function. Responses are graded on a 7-point. Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." Scores range from 32 to 224; a higher score indicates a better quality of life. Least square (LS) Mean was calculated using analysis of covariance (ANCOVA) model for post-baseline measures: The ANCOVA model includes: treatment, baseline value, prior biologic or tofacitinib failure (yes/no), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other).

Outcome measures

Outcome measures
Measure	Maintenance Period: Miri IR - PBO SC n=179 Participants Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC n=365 Participants Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score	24.51 score on a scale Standard Error 2.767	49.75 score on a scale Standard Error 2.102

SECONDARY outcome

Timeframe: Induction Baseline, Week 40

Population: Modified Intention-to-treat population (mITT): All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline fecal calprotectin measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.

Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Least square (LS) Mean was calculated using ANCOVA model for post-baseline measures: The ANCOVA model includes treatment, baseline value, prior biologic or tofacitinib failure (yes/no), corticosteroid use (yes/no) at AMAN baseline, region (North America/Europe/Other), Clinical Remission status (yes/no) at AMAN Week 12.

Outcome measures

Outcome measures
Measure	Maintenance Period: Miri IR - PBO SC n=179 Participants Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC n=365 Participants Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Change From Baseline to Week 40 in Fecal Calprotectin	-1155.82 milligram per kilogram (mg/kg) Standard Error 221.394	-1995.47 milligram per kilogram (mg/kg) Standard Error 172.443

SECONDARY outcome

Timeframe: Induction Baseline, Week 40

Population: Modified Intention-to-treat population (mITT): All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline urgency NRS measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.

The Urgency NRS 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. Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other).

Outcome measures

Outcome measures
Measure	Maintenance Period: Miri IR - PBO SC n=104 Participants Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC n=316 Participants Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)	-2.74 score on a scale Standard Error 0.202	-3.80 score on a scale Standard Error 0.139

SECONDARY outcome

Timeframe: Week 40

Population: Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.

Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with \>=24 hours stay were recorded.

Outcome measures

Outcome measures
Measure	Maintenance Period: Miri IR - PBO SC n=179 Participants Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC n=365 Participants Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Percentage of Participants Hospitalized for Ulcerative Colitis (UC)	1.1 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Predose: Weeks 0, 4, 12, 24 and 40

Population: All randomized participants who received at least one dose of study drug subcutaneously (both induction responders and nonresponders) and had evaluable PK data.

Clearance of mirikizumab was evaluated.

Outcome measures

Outcome measures
Measure	Maintenance Period: Miri IR - PBO SC n=652 Participants Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Pharmacokinetics (PK): Clearance of Mirikizumab	0.0487 Liters per Hour (L/h) Geometric Coefficient of Variation 54	—

Adverse Events

Maintenance Period: Miri IR - PBO SC

Serious events: 15 serious events

Other events: 57 other events

Deaths: 1 deaths

Maintenance Period: Miri IR - 200 mg Miri SC

Serious events: 13 serious events

Other events: 90 other events

Deaths: 0 deaths

Maintenance Period: PBO IR - PBO SC

Serious events: 7 serious events

Other events: 37 other events

Deaths: 0 deaths

Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Extended Induction: Induction Nonresponders - 300mg Miri IV

Serious events: 21 serious events

Other events: 44 other events

Deaths: 0 deaths

Open Label Maintenance: Delayed Responders - 200 mg Miri SC

Serious events: 8 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Maintenance Period: Miri IR - PBO SC n=192 participants at risk Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC n=389 participants at risk Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.	Maintenance Period: PBO IR - PBO SC n=135 participants at risk Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.	Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV n=90 participants at risk Participants who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.	Extended Induction: Induction Nonresponders - 300mg Miri IV n=461 participants at risk Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.	Open Label Maintenance: Delayed Responders - 200 mg Miri SC n=271 participants at risk Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).
Infections and infestations Large intestine infection	0.52% 1/192 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Subcutaneous abscess	0.52% 1/192 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Tonsillitis	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/90 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.43% 2/461 • Number of events 2 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Sepsis	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.37% 1/271 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Acute coronary syndrome	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.37% 1/271 • Number of events 2 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Autoimmune thyroiditis	0.52% 1/192 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Maculopathy	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Retinal detachment	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Colitis	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.37% 1/271 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Colitis ulcerative	3.1% 6/192 • Number of events 6 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/90 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 6/461 • Number of events 6 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.74% 2/271 • Number of events 2 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Ileus	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Inguinal hernia	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Large intestine perforation	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Peptic ulcer	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Pneumoperitoneum	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Rectal haemorrhage	0.52% 1/192 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Rectal polyp	0.52% 1/192 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Anaphylactic reaction	0.52% 1/192 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Appendicitis	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bacillus infection	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cellulitis	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.37% 1/271 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19	0.52% 1/192 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19 pneumonia	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cytomegalovirus colitis	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Diverticulitis	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Escherichia infection	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Gastroenteritis	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Influenza	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.37% 1/271 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Klebsiella infection	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood glucose increased	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypoglycaemia	0.52% 1/192 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/90 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.37% 1/271 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Ischaemic stroke	0.52% 1/192 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Migraine	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Presyncope	0.52% 1/192 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Depression suicidal	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Neurologic somatic symptom disorder	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/90 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 2 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Ureterolithiasis	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Rectocele	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.62% 1/160 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthma	0.52% 1/192 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Colectomy total	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.22% 1/461 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Retinopexy	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.26% 1/389 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Tooth extraction	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/135 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.37% 1/271 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Deep vein thrombosis	0.00% 0/192 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/389 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.74% 1/135 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/461 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/271 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	Maintenance Period: Miri IR - PBO SC n=192 participants at risk Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.	Maintenance Period: Miri IR - 200 mg Miri SC n=389 participants at risk Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.	Maintenance Period: PBO IR - PBO SC n=135 participants at risk Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.	Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV n=90 participants at risk Participants who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.	Extended Induction: Induction Nonresponders - 300mg Miri IV n=461 participants at risk Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.	Open Label Maintenance: Delayed Responders - 200 mg Miri SC n=271 participants at risk Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).
Blood and lymphatic system disorders Anaemia	4.7% 9/192 • Number of events 12 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.1% 8/389 • Number of events 8 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.9% 8/135 • Number of events 11 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 5/90 • Number of events 5 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.5% 7/461 • Number of events 7 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 9/271 • Number of events 9 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Colitis ulcerative	18.2% 35/192 • Number of events 35 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 26/389 • Number of events 30 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.6% 17/135 • Number of events 18 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/90 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.87% 4/461 • Number of events 4 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 10/271 • Number of events 11 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Nasopharyngitis	5.7% 11/192 • Number of events 11 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.2% 28/389 • Number of events 38 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 9/135 • Number of events 12 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.1% 1/90 • Number of events 1 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 15/461 • Number of events 15 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.2% 14/271 • Number of events 15 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	4.2% 8/192 • Number of events 8 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 26/389 • Number of events 27 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.0% 4/135 • Number of events 4 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 3/90 • Number of events 5 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.3% 15/461 • Number of events 15 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 19/271 • Number of events 24 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Headache	1.0% 2/192 • Number of events 5 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.1% 16/389 • Number of events 21 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 5/135 • Number of events 18 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 5/90 • Number of events 5 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.7% 8/461 • Number of events 10 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.8% 13/271 • Number of events 21 • Up To 40 Weeks All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60