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Clinical Trial Results:
A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)

Summary
EudraCT number	2016-002204-84
Trial protocol	GB CZ HU AT NL PL BE
Global end of trial date	05 Feb 2021

Results information
Results version number	v2(current)
This version publication date	15 Sep 2022
First version publication date	18 Feb 2022
Other versions	v1
Version creation reason	Correction of full data set resolving 2 advisory ct.gov comments and update EU record for same changes (Adjusting risk numbers for gender specific events in AE section and updating estimation parameter of statistical analysis for outcomes 4, 6, 7 and 8).

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

I6T-MC-AMAG

ISRCTN number

US NCT number

NCT02891226

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 16492

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

05 Feb 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

05 Feb 2021

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn’s Disease.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

14 Dec 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 4

Country: Number of subjects enrolled

Belgium: 6

Country: Number of subjects enrolled

Czechia: 10

Country: Number of subjects enrolled

Hungary: 7

Country: Number of subjects enrolled

Japan: 18

Country: Number of subjects enrolled

Netherlands: 7

Country: Number of subjects enrolled

Poland: 24

Country: Number of subjects enrolled

Romania: 5

Country: Number of subjects enrolled

Russian Federation: 14

Country: Number of subjects enrolled

Ukraine: 19

Country: Number of subjects enrolled

United Kingdom: 1

Country: Number of subjects enrolled

United States: 76

Worldwide total number of subjects

191

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

184

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Recruitment additional details: From Study treatment, 5 participants entered into follow-up period at week 52 and 3 participants entered the follow-up period in period 3 and they were followed up for safety and these 3 participants voluntarily discontinued from the follow-up period.

Screening details

Not Applicable.

Period 1 title

Period 1 (Weeks 0 to 12)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)

Arm description

Participants received placebo administered intravenously (IV) Q4W.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received placebo administered IV Q4W.

Period 1: 200 milligram (mg) Mirikizumab IV Q4W

Arm description

Participants received 200 mg mirikizumab administered IV Q4W.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

LY3074828

Other name

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received 200 mg mirikizumab administered IV Q4W.

Period 1: 600 mg Mirikizumab IV Q4W

Arm description

Participants received 600 mg mirikizumab administered IV Q4W.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

LY3074828

Other name

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received 600 mg mirikizumab administered IV Q4W.

Period 1: 1000 mg Mirikizumab IV Q4W

Arm description

Participants received 1000 mg mirikizumab administered IV Q4W.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

LY3074828

Other name

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received 1000 mg mirikizumab administered IV Q4W.

Number of subjects in period 1	Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)	Period 1: 200 milligram (mg) Mirikizumab IV Q4W	Period 1: 600 mg Mirikizumab IV Q4W	Period 1: 1000 mg Mirikizumab IV Q4W
Started	64	31	32	64
Received at least 1 Dose of Study Drug	64	31	32	64
Completed	59	29	28	60
Not completed	5	2	4	4
Consent withdrawn by subject	-	-	-	1
Adverse event, non-fatal	4	1	3	-
Enrollment Failure	-	-	1	-
Sponsor Decision	-	-	-	1
Lost to follow-up	1	1	-	-
Lack of efficacy	-	-	-	2

Period 2 title

Period 2 (Weeks 12 to 52)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Period 2: 200 mg Mirikizumab IV Q4W

Arm description

Participants received 200 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

LY3074828

Other name

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received 200 mg mirikizumab administered IV Q4W.

Period 2: 600 mg Mirikizumab IV Q4W

Arm description

Participants received 600 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

LY3074828

Other name

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received 600 mg mirikizumab administered IV Q4W.

Period 2: 1000 mg Mirikizumab IV Q4W

Arm description

Participants received 1000 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

LY3074828

Other name

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants received 1000 mg mirikizumab administered IV Q4W. Group does not include participants who did not improve on mirikizumab in period 1 or who were on placebo in period 1.

Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W

Arm description

Participants received 300 mg mirikizumab administered SC Q4W. Participants improved on any mirikizumab dose in Period 1.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

LY3074828

Other name

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received 300 mg mirikizumab administered SC Q4W.

Period 2:1000 mg Mirikizumab IV Q4W(No Improvement in Period1)

Arm description

Participants who did not improve in period 1 on mirikizumab received 1000 mg mirikizumab administered IV Q4W.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

LY3074828

Other name

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants who did not improve in period 1 on mirikizumab received 1000 mg mirikizumab administered IV Q4W.

Period 2: 1000 mg Mirkizumab IV Q4W (Placebo in Period 1)

Arm description

Participants who received placebo in period 1 received 1000 mg mirikizumab administered IV Q4W.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

LY3074828

Other name

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Participants who received placebo in period 1 received 1000 mg mirikizumab administered IV Q4W.

Number of subjects in period 2	Period 2: 200 mg Mirikizumab IV Q4W	Period 2: 600 mg Mirikizumab IV Q4W	Period 2: 1000 mg Mirikizumab IV Q4W	Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W	Period 2:1000 mg Mirikizumab IV Q4W(No Improvement in Period1)	Period 2: 1000 mg Mirkizumab IV Q4W (Placebo in Period 1)
Started	9	9	23	46	30	59
Completed	8	8	20	41	24	42
Not completed	1	1	3	5	6	17
Adverse event, serious fatal	-	-	1	-	-	-
Consent withdrawn by subject	-	-	1	2	1	6
Adverse event, non-fatal	-	-	-	1	3	7
Endoscopic Procedure was not Evaluated	-	-	-	-	1	-
PI and Sponsor Decision due to Subject Safety	-	-	1	-	-	-
Lack of Efficacy and Withdrew from Study	-	-	-	-	-	1
Sponsor Decision	-	-	-	-	-	1
Lost to follow-up	-	1	-	-	-	1
PI decision due to Lack of Efficacy	1	-	-	-	-	-
Lack of efficacy	-	-	-	2	1	1

Period 3 title

Period 3 (Weeks 52 to 208)

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Period 3: 300 mg Mirikizumab SC Q4W

Arm description

Participants received 300 mg mirikizumab administered SC Q4W.

Arm type

Experimental

Investigational medicinal product name

Mirikizumab

Investigational medicinal product code

LY3074828

Other name

Pharmaceutical forms

Concentrate for solution for injection/infusion

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received 300 mg mirikizumab administered SC Q4W.

Number of subjects in period 3 ^[1]	Period 3: 300 mg Mirikizumab SC Q4W
Started	137
Completed	0
Not completed	137
Consent withdrawn by subject	14
Non-Compliance With Study Visit Schedule	2
Not Participated in Extension Period(Week 104-208)	2
Adverse event, non-fatal	5
PI Decision as Subject Non response to Study Drug	2
Roll over to AMAX	108
Lost to follow-up	1
Lack of efficacy	3

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Participants were assigned to this arm during period 3.

Baseline characteristics

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Reporting group title

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)

Reporting group description

Participants received placebo administered intravenously (IV) Q4W.

Reporting group title

Period 1: 200 milligram (mg) Mirikizumab IV Q4W

Reporting group description

Participants received 200 mg mirikizumab administered IV Q4W.

Reporting group title

Period 1: 600 mg Mirikizumab IV Q4W

Reporting group description

Participants received 600 mg mirikizumab administered IV Q4W.

Reporting group title

Period 1: 1000 mg Mirikizumab IV Q4W

Reporting group description

Participants received 1000 mg mirikizumab administered IV Q4W.

Reporting group values	Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)	Period 1: 200 milligram (mg) Mirikizumab IV Q4W	Period 1: 600 mg Mirikizumab IV Q4W	Period 1: 1000 mg Mirikizumab IV Q4W	Total
Number of subjects	64	31	32	64	191
Age categorical
Units: Subjects
Age continuous
All randomized participants.
Units: years
arithmetic mean (standard deviation)	39.00 ( 13.04 )	38.10 ( 11.80 )	40.40 ( 13.33 )	37.70 ( 13.11 )	-
Gender categorical
All randomized participants.
Units: Subjects
Female	36	14	18	30	98
Male	28	17	14	34	93
Ethnicity (NIH/OMB)
All randomized participants.
Units: Subjects
Hispanic or Latino	4	0	2	2	8
Not Hispanic or Latino	53	27	26	54	160
Unknown or Not Reported	7	4	4	8	23
Race (NIH/OMB)
All randomized participants.
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0
Asian	7	1	4	8	20
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	2	2	3	4	11
White	55	28	24	52	159
More than one race	0	0	1	0	1
Unknown or Not Reported	0	0	0	0	0
Region of Enrollment
All randomized participants.
Units: Subjects
Australia	3	0	0	1	4
Belgium	0	1	1	4	6
Czechia	4	1	0	5	10
Hungary	3	1	0	3	7
Japan	6	1	4	7	18
Netherlands	2	3	0	2	7
Poland	6	6	3	9	24
Romania	0	0	1	4	5
Russia	6	3	2	3	14
Ukraine	4	5	4	6	19
United Kingdom	1	0	0	0	1
United States	29	10	17	20	76

End points

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Reporting group title

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)

Reporting group description

Participants received placebo administered intravenously (IV) Q4W.

Reporting group title

Period 1: 200 milligram (mg) Mirikizumab IV Q4W

Reporting group description

Participants received 200 mg mirikizumab administered IV Q4W.

Reporting group title

Period 1: 600 mg Mirikizumab IV Q4W

Reporting group description

Participants received 600 mg mirikizumab administered IV Q4W.

Reporting group title

Period 1: 1000 mg Mirikizumab IV Q4W

Reporting group description

Participants received 1000 mg mirikizumab administered IV Q4W.

Reporting group title

Period 2: 200 mg Mirikizumab IV Q4W

Reporting group description

Participants received 200 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.

Reporting group title

Period 2: 600 mg Mirikizumab IV Q4W

Reporting group description

Participants received 600 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.

Reporting group title

Period 2: 1000 mg Mirikizumab IV Q4W

Reporting group description

Participants received 1000 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.

Reporting group title

Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W

Reporting group description

Participants received 300 mg mirikizumab administered SC Q4W. Participants improved on any mirikizumab dose in Period 1.

Reporting group title

Period 2:1000 mg Mirikizumab IV Q4W(No Improvement in Period1)

Reporting group description

Participants who did not improve in period 1 on mirikizumab received 1000 mg mirikizumab administered IV Q4W.

Reporting group title

Period 2: 1000 mg Mirkizumab IV Q4W (Placebo in Period 1)

Reporting group description

Participants who received placebo in period 1 received 1000 mg mirikizumab administered IV Q4W.

Reporting group title

Period 3: 300 mg Mirikizumab SC Q4W

Reporting group description

Participants received 300 mg mirikizumab administered SC Q4W.

Subject analysis set title

Mirikizumab IV Q4W

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants received 200 mg, 600 mg, 1000 mg mirikizumab administered IV Q4W.

Primary: Percentage of Participants Achieving Endoscopic Response at Week 12

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End point title

Percentage of Participants Achieving Endoscopic Response at Week 12

End point description

Endoscopic response defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12. The SES-CD evaluates 4 endoscopic variables: presence and size of ulcers, proportion of surface covered by ulcers, proportion of surface affected by disease, and presence and severity of stenosis. The total SES-CD calculated as sum of 4 variables for 5 bowel segments: (ileum;right,transverse,and left colon;and rectum): presence and size of ulcers (none = score 0; diameter 0.1-0.5 cm = score 1; 0.5-2 cm = score 2; >2 cm = score 3); extent of ulcerated surface (none = 0; <10% = 1;10-30% = 2;>30% = 3);extent of affected surface (none = 0; <50% = 1;50-75% = 2;>75% =3); and presence and type of narrowings (none=0; single, can be passed=1; multiple,can be passed=2; cannot be passed=3). Total SES-CD scores range from 0 to 56, with higher scores indicating more severe disease.

End point type

Primary

End point timeframe

Week 12

End point values	Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)	Period 1: 200 milligram (mg) Mirikizumab IV Q4W	Period 1: 600 mg Mirikizumab IV Q4W	Period 1: 1000 mg Mirikizumab IV Q4W
Number of subjects analysed	64 ^[1]	31 ^[2]	32 ^[3]	64 ^[4]
Units: percentage of participants
number (confidence interval 90%)	10.9 (4.5 to 17.4)	25.8 (12.9 to 38.7)	37.5 (23.4 to 51.6)	43.8 (33.6 to 53.9)

Notes
[1] - All randomized participants.
[2] - All randomized participants.
[3] - All randomized participants.
[4] - All randomized participants.

Statistical analysis 1

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 200 milligram (mg) Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.079

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

2.75

Confidence interval

level

90%

sides

2-sided

lower limit

1.07

upper limit

7.08

Statistical analysis 2

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 600 mg Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

4.92

Confidence interval

level

90%

sides

2-sided

lower limit

2.01

upper limit

12.07

Statistical analysis 3

Comparison groups

Period 1: 1000 mg Mirikizumab IV Q4W v Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

6.14

Confidence interval

level

90%

sides

2-sided

lower limit

2.81

upper limit

13.42

Secondary: Percentage of Participants Achieving Endoscopic Remission at Week 12

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End point title

Percentage of Participants Achieving Endoscopic Remission at Week 12

End point description

Endoscopic remission defined as SES-CD of <4 ileal-colonic or <2 for isolated ileal disease, and no subscore >1 at week 12. The SES-CD evaluates 4 endoscopic variables: presence and size of ulcers, proportion of surface covered by ulcers, proportion of surface affected by disease, and presence and severity of stenosis. The total SES-CD is calculated as the sum of the 4 variables for the 5 bowel segments: (ileum; right, transverse, and left colon; and rectum): presence and size of ulcers (none = score 0; diameter 0.1-0.5 cm = score 1; 0.5-2 cm = score 2; greater than (>) 2 cm = score 3); extent of ulcerated surface (none = 0; less than (<) 10% = 1; 10-30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50-75% = 2; >75% = 3); and presence and type of narrowings (none=0; single, can be passed=1; multiple, can be passed=2; cannot be passed=3). Total SES-CD scores range from 0 to 56, with higher scores indicating more severe disease.

End point type

Secondary

End point timeframe

Week 12

End point values	Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)	Period 1: 200 milligram (mg) Mirikizumab IV Q4W	Period 1: 600 mg Mirikizumab IV Q4W	Period 1: 1000 mg Mirikizumab IV Q4W
Number of subjects analysed	64 ^[5]	31 ^[6]	32 ^[7]	64 ^[8]
Units: percentage of participants
number (confidence interval 90%)	1.6 (0.0 to 4.1)	6.5 (0.0 to 13.7)	15.6 (5.1 to 26.2)	20.3 (12.0 to 28.6)

Notes
[5] - All randomized participants.
[6] - All randomized participants.
[7] - All randomized participants.
[8] - All randomized participants.

Statistical analysis 1

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 200 milligram (mg) Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.241

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

4.31

Confidence interval

level

90%

sides

2-sided

lower limit

0.55

upper limit

33.58

Statistical analysis 2

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 600 mg Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.032

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

11.16

Confidence interval

level

90%

sides

2-sided

lower limit

1.76

upper limit

70.64

Statistical analysis 3

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 1000 mg Mirikizumab IV Q4W

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.009

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

16.04

Confidence interval

level

90%

sides

2-sided

lower limit

2.82

upper limit

91.32

Secondary: Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12

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End point title

Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12

End point description

PRO remission is defined as stool frequency (SF) ≤2.5 and abdominal pain (AP) ≤1 and no worse than baseline at week 12. SF captures the number of liquid or very soft stools. AP score is classified as 0=none, 1=mild, 2=moderate, 3=severe.

End point type

Secondary

End point timeframe

Week 12

End point values	Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)	Period 1: 200 milligram (mg) Mirikizumab IV Q4W	Period 1: 600 mg Mirikizumab IV Q4W	Period 1: 1000 mg Mirikizumab IV Q4W
Number of subjects analysed	64 ^[9]	31 ^[10]	32 ^[11]	64 ^[12]
Units: percentage of participants
number (confidence interval 90%)	6.3 (1.3 to 11.2)	12.9 (3.0 to 22.8)	28.1 (15.1 to 41.2)	21.9 (13.4 to 30.4)

Notes
[9] - All randomized participants.
[10] - All randomized participants.
[11] - All randomized participants.
[12] - All randomized participants.

Statistical analysis 1

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 200 milligram (mg) Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.33

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

0.62

upper limit

6.45

Statistical analysis 2

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 600 mg Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

5.72

Confidence interval

level

90%

sides

2-sided

lower limit

2.02

upper limit

16.21

Statistical analysis 3

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 1000 mg Mirikizumab IV Q4W

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.029

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

3.52

Confidence interval

level

90%

sides

2-sided

lower limit

1.37

upper limit

9.07

Secondary: Mean Change From Baseline on the Patient Global Rating – Severity (PGRS) Crohn’s Disease Score at Week 12

Top of page

End point title

Mean Change From Baseline on the Patient Global Rating – Severity (PGRS) Crohn’s Disease Score at Week 12

End point description

The PGRS is a 1-item patient-rated questionnaire designed to assess the participant's rating of their disease symptom severity over the past 24 hours. Responses are graded on a 6-point scale in which a score of 1 indicates the subject has no symptoms (that is, "none") and a score of 6 indicates that the participant's symptom are "very severe." Least Squares Mean (LS Mean) was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)	Period 1: 200 milligram (mg) Mirikizumab IV Q4W	Period 1: 600 mg Mirikizumab IV Q4W	Period 1: 1000 mg Mirikizumab IV Q4W
Number of subjects analysed	58 ^[13]	26 ^[14]	29 ^[15]	56 ^[16]
Units: score on a scale
least squares mean (standard error)	-0.44 ( 0.132 )	-1.08 ( 0.194 )	-1.27 ( 0.189 )	-0.98 ( 0.134 )

Notes
[13] - All randomized participants who had a baseline and at least one post-baseline PGRS value.
[14] - All randomized participants who had a baseline and at least one post-baseline PGRS value.
[15] - All randomized participants who had a baseline and at least one post-baseline PGRS value.
[16] - All randomized participants who had a baseline and at least one post-baseline PGRS value.

Statistical analysis 1

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 200 milligram (mg) Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.007

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.64

Confidence interval

level

90%

sides

2-sided

lower limit

-1.03

upper limit

-0.25

Variability estimate

Standard error of the mean

Dispersion value

0.234

Statistical analysis 2

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 600 mg Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.83

Confidence interval

level

90%

sides

2-sided

lower limit

-1.21

upper limit

-0.45

Variability estimate

Standard error of the mean

Dispersion value

0.23

Statistical analysis 3

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 1000 mg Mirikizumab IV Q4W

Number of subjects included in analysis

114

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.005

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

-0.53

Confidence interval

level

90%

sides

2-sided

lower limit

-0.84

upper limit

-0.22

Variability estimate

Standard error of the mean

Dispersion value

0.188

Secondary: Mean of Patient Global Rating – Change (PGRC) Crohn’s Disease Score at Week 12

Top of page

End point title

Mean of Patient Global Rating – Change (PGRC) Crohn’s Disease Score at Week 12

End point description

The PGRC scale is a patient-rated instrument designed to assess the participant's rating of change in their symptom(s). Responses are graded on a 7-point Likert scale in which a score of 1 indicates that the participant's symptom is "very much better," a score of 4 indicates that the participant's symptom has experienced "no change," and a score of 7 indicates that the participant's symptom is "very much worse."

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)	Period 1: 200 milligram (mg) Mirikizumab IV Q4W	Period 1: 600 mg Mirikizumab IV Q4W	Period 1: 1000 mg Mirikizumab IV Q4W
Number of subjects analysed	56 ^[17]	29 ^[18]	27 ^[19]	57 ^[20]
Units: score on a scale
arithmetic mean (standard deviation)	3.6 ( 1.11 )	2.8 ( 1.26 )	2.6 ( 0.97 )	2.5 ( 0.89 )

Notes
[17] - All randomized participants who had a baseline and at least one post-baseline PGRC value.
[18] - All randomized participants who had a baseline and at least one post-baseline PGRC value.
[19] - All randomized participants who had a baseline and at least one post-baseline PGRC value.
[20] - All randomized participants who had a baseline and at least one post-baseline PGRC value.

No statistical analyses for this end point

Secondary: Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12

Top of page

End point title

Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12

End point description

The IBDQ is a 32-item self-administered questionnaire. The IBDQ has 4 dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). 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. LS Mean was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)	Period 1: 200 milligram (mg) Mirikizumab IV Q4W	Period 1: 600 mg Mirikizumab IV Q4W	Period 1: 1000 mg Mirikizumab IV Q4W
Number of subjects analysed	56 ^[21]	29 ^[22]	28 ^[23]	57 ^[24]
Units: score on a scale
least squares mean (standard error)	17.11 ( 3.725 )	41.16 ( 5.311 )	46.57 ( 5.244 )	42.35 ( 3.770 )

Notes
[21] - All randomized participants who had a baseline and at least one post-baseline IBDQ value.
[22] - All randomized participants who had a baseline and at least one post-baseline IBDQ value.
[23] - All randomized participants who had a baseline and at least one post-baseline IBDQ value.
[24] - All randomized participants who had a baseline and at least one post-baseline IBDQ value.

Statistical analysis 1

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 200 milligram (mg) Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

24.05

Confidence interval

level

90%

sides

2-sided

lower limit

13.53

upper limit

34.56

Variability estimate

Standard error of the mean

Dispersion value

6.358

Statistical analysis 2

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 600 mg Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

29.46

Confidence interval

level

90%

sides

2-sided

lower limit

18.84

upper limit

40.08

Variability estimate

Standard error of the mean

Dispersion value

6.421

Statistical analysis 3

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 1000 mg Mirikizumab IV Q4W

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

25.24

Confidence interval

level

90%

sides

2-sided

lower limit

16.67

upper limit

33.82

Variability estimate

Standard error of the mean

Dispersion value

5.185

Secondary: Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12

Top of page

End point title

Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12

End point description

The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0-4 associated with a range over "Not at all" to "Very much" for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue. LS Mean was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)	Period 1: 200 milligram (mg) Mirikizumab IV Q4W	Period 1: 600 mg Mirikizumab IV Q4W	Period 1: 1000 mg Mirikizumab IV Q4W
Number of subjects analysed	56 ^[25]	29 ^[26]	28 ^[27]	57 ^[28]
Units: score on a scale
least squares mean (standard error)	2.90 ( 1.209 )	10.81 ( 1.728 )	9.09 ( 1.721 )	9.62 ( 1.223 )

Notes
[25] - All randomized participants who had a baseline and at least one post-baseline FACIT-F value.
[26] - All randomized participants who had a baseline and at least one post-baseline FACIT-F value.
[27] - All randomized participants who had a baseline and at least one post-baseline FACIT-F value.
[28] - All randomized participants who had a baseline and at least one post-baseline FACIT-F value.

Statistical analysis 1

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 200 milligram (mg) Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

7.91

Confidence interval

level

90%

sides

2-sided

lower limit

4.48

upper limit

11.34

Variability estimate

Standard error of the mean

Dispersion value

2.072

Statistical analysis 2

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 600 mg Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

6.2

Confidence interval

level

90%

sides

2-sided

lower limit

2.72

upper limit

9.67

Variability estimate

Standard error of the mean

Dispersion value

2.102

Statistical analysis 3

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 1000 mg Mirikizumab IV Q4W

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

6.73

Confidence interval

level

90%

sides

2-sided

lower limit

3.94

upper limit

9.51

Variability estimate

Standard error of the mean

Dispersion value

1.686

Secondary: Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 12

Top of page

End point title

Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 12

End point description

The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains:physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing individual items and transforming scores into a 0 to 100 scale with higher scores indicating better health status or functioning. LS Mean was calculated using Mixed Model for Repeated Measures (MMRM) model with treatment, geographic region, geographic region, prior biologic CD therapy use (prior biologic experience versus prior biologic naive), baseline score, visit, and the interaction of treatment-by-visit and baseline-by-visit as fixed factors.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W)	Period 1: 200 milligram (mg) Mirikizumab IV Q4W	Period 1: 600 mg Mirikizumab IV Q4W	Period 1: 1000 mg Mirikizumab IV Q4W
Number of subjects analysed	56 ^[29]	29 ^[30]	28 ^[31]	57 ^[32]
Units: Baseline, Week 12
least squares mean (standard error)
MCS	2.34 ( 1.133 )	7.47 ( 1.602 )	6.52 ( 1.592 )	6.05 ( 1.152 )
PCS	3.11 ( 0.774 )	4.70 ( 1.096 )	8.01 ( 1.108 )	6.70 ( 0.787 )

Notes
[29] - All randomized participants who had a baseline and at least one post-baseline PCS and MCS value.
[30] - All randomized participants who had a baseline and at least one post-baseline PCS and MCS value.
[31] - All randomized participants who had a baseline and at least one post-baseline PCS and MCS value.
[32] - All randomized participants who had a baseline and at least one post-baseline PCS and MCS value.

Statistical analysis 1: MCS

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 200 milligram (mg) Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

5.14

Confidence interval

level

90%

sides

2-sided

lower limit

1.95

upper limit

8.32

Variability estimate

Standard error of the mean

Dispersion value

1.927

Statistical analysis 2: MCS

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 600 mg Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.033

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

4.18

Confidence interval

level

90%

sides

2-sided

lower limit

0.96

upper limit

7.41

Variability estimate

Standard error of the mean

Dispersion value

1.951

Statistical analysis 3: MCS

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 1000 mg Mirikizumab IV Q4W

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.021

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

3.71

Confidence interval

level

90%

sides

2-sided

lower limit

1.08

upper limit

6.34

Variability estimate

Standard error of the mean

Dispersion value

1.589

Statistical analysis 4: PCS

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 200 milligram (mg) Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.229

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

1.59

Confidence interval

level

90%

sides

2-sided

lower limit

-0.59

upper limit

3.77

Variability estimate

Standard error of the mean

Dispersion value

1.319

Statistical analysis 5: PCS

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 600 mg Mirikizumab IV Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

4.91

Confidence interval

level

90%

sides

2-sided

lower limit

2.67

upper limit

7.14

Variability estimate

Standard error of the mean

Dispersion value

1.349

Statistical analysis 6: PCS

Comparison groups

Period 1: Placebo Intravenous (IV) every 4 weeks (Q4W) v Period 1: 1000 mg Mirikizumab IV Q4W

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001

Method

Mixed models analysis

Parameter type

LS Mean difference (Final Values)

Point estimate

3.6

Confidence interval

level

90%

sides

2-sided

lower limit

1.81

upper limit

5.38

Variability estimate

Standard error of the mean

Dispersion value

1.078

Secondary: Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab

Top of page

End point title

Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab

End point description

Population mean (between-subject coefficient variance [CV %]) apparent clearance. Clearance is estimated based on concentration data collected in the time frame of 0-208 weeks.

End point type

Secondary

End point timeframe

Week 0, 4, 8: Predose, end of infusion; Week 2; 4; 6; 8, 11-12; 12-13; 16; 20; 24; 28; 36; 44; 52; 60; 68; 76; 84; 92; 104; 108; 112; 120; 128; 136; 144; 156; 164; 172; 180; 188; 196 and 208 weeks post infusion

End point values	Mirikizumab IV Q4W
Number of subjects analysed	186 ^[33]
Units: Liters per Hour (L/h)
geometric mean (geometric coefficient of variation)	0.0225 ( 30 )

Notes
[33] - All randomized participants who received at least one dose of study drug and had evaluable PK data.

No statistical analyses for this end point

Secondary: Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab

Top of page

End point title

Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab

End point description

Population mean (between-subject coefficient variance [CV %]) apparent volume of distribution. Volume of distribution is estimated based on concentration data collected in the time frame of 0-208 weeks.

End point type

Secondary

End point timeframe

End point values	Mirikizumab IV Q4W
Number of subjects analysed	186 ^[34]
Units: Liters (L)
geometric mean (geometric coefficient of variation)	5.05 ( 18 )

Notes
[34] - All randomized participants who received at least one dose of study drug and had evaluable PK data.

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Baseline Up To 208 Weeks

Adverse event reporting additional description

All randomized participants who received at least 1 dose of study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

23.0

Reporting group title

Period 1: Placebo Intravenous (IV) Every 4 Weeks (Q4W)

Reporting group description

Participants received placebo administered intravenously (IV) Q4W.

Reporting group title

Period 1: 200 Milligram (mg) Mirikizumab IV Q4W

Reporting group description

Participants received 200 mg mirikizumab administered IV Q4W.

Reporting group title

Period 1: 600 mg Mirikizumab IV Q4W

Reporting group description

Participants received 600 mg mirikizumab administered IV Q4W.

Reporting group title

Period 1: 1000 mg Mirikizumab IV Q4W

Reporting group description

Participants received 1000 mg mirikizumab administered IV Q4W.

Reporting group title

Period 2: 200 mg Mirikizumab IV Q4W

Reporting group description

Participants received 200 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.

Reporting group title

Period 2: 1000 mg Mirikizumab IV Q4W

Reporting group description

Participants received 1000 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.

Reporting group title

Period 2: 600 mg Mirikizumab IV Q4W

Reporting group description

Participants received 600 mg mirikizumab administered IV Q4W. Participants improved on the same mirikizumab dose in Period 1.

Reporting group title

Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W

Reporting group description

Participants received 300 mg mirikizumab administered SC Q4W. Participants improved on any mirikizumab dose in Period 1.

Reporting group title

Period 2: 1000 mg Mirikizumab IV Q4W (NI)

Reporting group description

Participants who did not improve in Period 1 on mirikizumab (any dose) received 1000 mg mirikizumab administered IV Q4W.

Reporting group title

Period 2: 1000 mg Mirkizumab IV Q4W (PBO)

Reporting group description

Participants who received placebo in period 1 received 1000 mg mirikizumab administered IV Q4W.

Reporting group title

Period 3: 300 mg Mirikizumab SC Q4W

Reporting group description

Participants received 300 mg mirikizumab administered SC Q4W.

Reporting group title

Follow-up Period: 200 mg Mirikizumab IV Q4W in Period 2

Reporting group description

Participants did not receive drug during the follow-up period. Group includes participants who received 200 mg mirikizumab IV Q4W during period 2.

Reporting group title

Follow-up Period:1000 mg Mirikizumab IV Q4W in Period 2 (Impv)

Reporting group description

Participants did not receive drug during the follow-up period. Group includes participants who received 1000 mg mirikizumab IV Q4W during period 2 after improving on the same dose in Period 1. Impv = Improvers.

Reporting group title

Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (NI)

Reporting group description

Participants did not receive drug during the follow-up period. Group includes participants who did not improve in period 1, and received 1000 mg mirikizumab IV Q4W during period 2.

Reporting group title

Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (PBO)

Reporting group description

Participants did not receive drug during the follow-up period. Group includes participants who received placebo (PBO) in period 1 and 1000 mg mirikizumab administered IV Q4W.

Reporting group title

Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3

Reporting group description

Participants did not receive drug during the follow-up period. Group includes participants who received 300 mg mirikizumab administered SC Q4W during period 3.

Period 1: Placebo Intravenous (IV) Every 4 Weeks (Q4W)

Period 1: 200 Milligram (mg) Mirikizumab IV Q4W

Period 1: 600 mg Mirikizumab IV Q4W

Period 1: 1000 mg Mirikizumab IV Q4W

Period 2: 200 mg Mirikizumab IV Q4W

Period 2: 1000 mg Mirikizumab IV Q4W

Period 2: 600 mg Mirikizumab IV Q4W

Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W

Period 2: 1000 mg Mirikizumab IV Q4W (NI)

Period 2: 1000 mg Mirkizumab IV Q4W (PBO)

Period 3: 300 mg Mirikizumab SC Q4W

Follow-up Period: 200 mg Mirikizumab IV Q4W in Period 2

Follow-up Period:1000 mg Mirikizumab IV Q4W in Period 2 (Impv)

Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (NI)

Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (PBO)

Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3

Total subjects affected by serious adverse events

subjects affected / exposed

7 / 64 (10.94%)

0 / 31 (0.00%)

3 / 32 (9.38%)

2 / 64 (3.13%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

2 / 46 (4.35%)

3 / 30 (10.00%)

9 / 59 (15.25%)

15 / 136 (11.03%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

gastrointestinal tract adenoma

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

1 / 136 (0.74%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

deep vein thrombosis

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

1 / 136 (0.74%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pregnancy, puerperium and perinatal conditions

abortion spontaneous

Additional description: Follow-up Period:1000 mg Mirikizumab IV Q4W in Period 2 (Impv) = Subjects exposed number = 0. However, due to EudraCT database constraint we have included all the participants for this arm.

alternative dictionary used: MedDRA 23.0

subjects affected / exposed ^[1]

0 / 36 (0.00%)

0 / 14 (0.00%)

0 / 18 (0.00%)

0 / 30 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 4 (0.00%)

0 / 23 (0.00%)

1 / 13 (7.69%)

0 / 33 (0.00%)

0 / 61 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

malaise

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

1 / 64 (1.56%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

non-cardiac chest pain

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

1 / 32 (3.13%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

1 / 59 (1.69%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pyrexia

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

1 / 64 (1.56%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

1 / 136 (0.74%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune system disorders

anaphylactic reaction

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

2 / 59 (3.39%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

infusion related hypersensitivity reaction

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

1 / 59 (1.69%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

pulmonary embolism

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

1 / 136 (0.74%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Investigations

blood potassium decreased

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

1 / 64 (1.56%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

concussion

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

1 / 136 (0.74%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

intestinal anastomosis complication

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

1 / 59 (1.69%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

maternal exposure during pregnancy

alternative dictionary used: MedDRA 23.0

subjects affected / exposed ^[2]

0 / 36 (0.00%)

0 / 14 (0.00%)

0 / 18 (0.00%)

0 / 30 (0.00%)

0 / 4 (0.00%)

0 / 12 (0.00%)

0 / 4 (0.00%)

0 / 23 (0.00%)

1 / 13 (7.69%)

0 / 33 (0.00%)

0 / 61 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

paternal exposure during pregnancy

Additional description: Follow-up Period:200 mg Mirikizumab IV Q4W in Period 2;1000 mg Mirikizumab IV Q4W in Period 2 (NI);1000 mg Mirkizumab IV Q4W in Period 2 (PBO)=Subjects exposed number=0.However,due to EudraCT database constraint we have included all the participants

alternative dictionary used: MedDRA 23.0

subjects affected / exposed ^[3]

0 / 28 (0.00%)

0 / 17 (0.00%)

0 / 14 (0.00%)

0 / 34 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 5 (0.00%)

0 / 23 (0.00%)

0 / 17 (0.00%)

0 / 26 (0.00%)

2 / 75 (2.67%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

cardiac failure

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

1 / 136 (0.74%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

abdominal pain

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

1 / 64 (1.56%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

crohn's disease

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

3 / 64 (4.69%)

0 / 31 (0.00%)

1 / 32 (3.13%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

1 / 46 (2.17%)

1 / 30 (3.33%)

1 / 59 (1.69%)

2 / 136 (1.47%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 3

0 / 0

0 / 1

0 / 0

0 / 1

1 / 1

0 / 1

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

ileal perforation

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

1 / 46 (2.17%)

0 / 30 (0.00%)

0 / 59 (0.00%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ileal stenosis

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

1 / 136 (0.74%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ileus

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

1 / 136 (0.74%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

intestinal obstruction

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

1 / 59 (1.69%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

intestinal perforation

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

1 / 136 (0.74%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

large intestinal stenosis

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

1 / 32 (3.13%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

large intestine perforation

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

1 / 32 (3.13%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

lower gastrointestinal haemorrhage

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

1 / 136 (0.74%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pneumatosis intestinalis

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

1 / 64 (1.56%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

small intestinal stenosis

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

1 / 136 (0.74%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

renal colic

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

1 / 136 (0.74%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

back pain

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

1 / 64 (1.56%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

osteoarthritis

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

1 / 59 (1.69%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

rotator cuff syndrome

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

0 / 59 (0.00%)

1 / 136 (0.74%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

clostridium difficile infection

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

0 / 30 (0.00%)

1 / 59 (1.69%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

peritonitis

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

1 / 46 (2.17%)

0 / 30 (0.00%)

0 / 59 (0.00%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pneumonia

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

0 / 46 (0.00%)

1 / 30 (3.33%)

0 / 59 (0.00%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

pyelonephritis

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

1 / 46 (2.17%)

0 / 30 (0.00%)

0 / 59 (0.00%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

dehydration

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

1 / 46 (2.17%)

0 / 30 (0.00%)

0 / 59 (0.00%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

hypokalaemia

alternative dictionary used: MedDRA 23.0

subjects affected / exposed

0 / 64 (0.00%)

0 / 31 (0.00%)

0 / 32 (0.00%)

0 / 64 (0.00%)

0 / 9 (0.00%)

0 / 23 (0.00%)

0 / 9 (0.00%)

1 / 46 (2.17%)

0 / 30 (0.00%)

0 / 59 (0.00%)

0 / 136 (0.00%)

0 / 1 (0.00%)

0 / 2 (0.00%)

0 / 1 (0.00%)

0 / 3 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Period 1: Placebo Intravenous (IV) Every 4 Weeks (Q4W)	Period 1: 200 Milligram (mg) Mirikizumab IV Q4W	Period 1: 600 mg Mirikizumab IV Q4W	Period 1: 1000 mg Mirikizumab IV Q4W	Period 2: 200 mg Mirikizumab IV Q4W	Period 2: 1000 mg Mirikizumab IV Q4W	Period 2: 600 mg Mirikizumab IV Q4W	Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W	Period 2: 1000 mg Mirikizumab IV Q4W (NI)	Period 2: 1000 mg Mirkizumab IV Q4W (PBO)	Period 3: 300 mg Mirikizumab SC Q4W	Follow-up Period: 200 mg Mirikizumab IV Q4W in Period 2	Follow-up Period:1000 mg Mirikizumab IV Q4W in Period 2 (Impv)	Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (NI)	Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (PBO)	Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3
Total subjects affected by non serious adverse events
subjects affected / exposed	24 / 64 (37.50%)	11 / 31 (35.48%)	12 / 32 (37.50%)	27 / 64 (42.19%)	7 / 9 (77.78%)	14 / 23 (60.87%)	5 / 9 (55.56%)	30 / 46 (65.22%)	16 / 30 (53.33%)	30 / 59 (50.85%)	89 / 136 (65.44%)	0 / 1 (0.00%)	1 / 2 (50.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
Vascular disorders
hypertension
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	1 / 31 (3.23%)	0 / 32 (0.00%)	2 / 64 (3.13%)	0 / 9 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	3 / 46 (6.52%)	0 / 30 (0.00%)	2 / 59 (3.39%)	11 / 136 (8.09%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	2	0	0	0	3	0	2	12	0	0	0	0	0
General disorders and administration site conditions
fatigue
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	3 / 64 (4.69%)	0 / 31 (0.00%)	0 / 32 (0.00%)	1 / 64 (1.56%)	0 / 9 (0.00%)	1 / 23 (4.35%)	0 / 9 (0.00%)	1 / 46 (2.17%)	0 / 30 (0.00%)	4 / 59 (6.78%)	7 / 136 (5.15%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	3	0	0	1	0	1	0	1	0	4	7	0	0	0	0	0
infusion site reaction
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	1 / 9 (11.11%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 46 (0.00%)	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 136 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0
injection site pain
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	1 / 23 (4.35%)	1 / 9 (11.11%)	4 / 46 (8.70%)	1 / 30 (3.33%)	3 / 59 (5.08%)	8 / 136 (5.88%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	1	15	64	7	16	162	0	0	0	0	0
injection site reaction
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	3 / 46 (6.52%)	0 / 30 (0.00%)	1 / 59 (1.69%)	18 / 136 (13.24%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	4	4	0	2	114	0	0	0	0	0
pyrexia
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	1 / 64 (1.56%)	0 / 31 (0.00%)	3 / 32 (9.38%)	1 / 64 (1.56%)	1 / 9 (11.11%)	0 / 23 (0.00%)	0 / 9 (0.00%)	2 / 46 (4.35%)	2 / 30 (6.67%)	1 / 59 (1.69%)	6 / 136 (4.41%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	3	1	1	0	0	2	2	1	6	0	0	0	0	0
Reproductive system and breast disorders
endometrial hyperplasia
Additional description: Follow-up Period:1000 mg Mirikizumab IV Q4W in Period 2 (Impv) = Subjects exposed number = 0. However, due to EudraCT database constraint we have included all the participants for this arm.
alternative dictionary used: MedDRA 23.0
subjects affected / exposed ^[4]	0 / 36 (0.00%)	0 / 14 (0.00%)	0 / 18 (0.00%)	0 / 30 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 4 (0.00%)	0 / 23 (0.00%)	0 / 13 (0.00%)	0 / 33 (0.00%)	0 / 61 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
endometriosis
Additional description: Follow-up Period:1000 mg Mirikizumab IV Q4W in Period 2 (Impv) = Subjects exposed number = 0. However, due to EudraCT database constraint we have included all the participants for this arm.
alternative dictionary used: MedDRA 23.0
subjects affected / exposed ^[5]	0 / 36 (0.00%)	0 / 14 (0.00%)	0 / 18 (0.00%)	0 / 30 (0.00%)	0 / 4 (0.00%)	1 / 12 (8.33%)	0 / 4 (0.00%)	0 / 23 (0.00%)	0 / 13 (0.00%)	0 / 33 (0.00%)	0 / 61 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	1 / 64 (1.56%)	0 / 9 (0.00%)	2 / 23 (8.70%)	0 / 9 (0.00%)	1 / 46 (2.17%)	0 / 30 (0.00%)	0 / 59 (0.00%)	3 / 136 (2.21%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	1	0	2	0	1	0	0	3	0	0	0	0	0
sinus congestion
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	2 / 32 (6.25%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 46 (0.00%)	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 136 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Psychiatric disorders
anxiety
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	1 / 64 (1.56%)	1 / 31 (3.23%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	0 / 46 (0.00%)	0 / 30 (0.00%)	2 / 59 (3.39%)	2 / 136 (1.47%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	1	0	0	0	0	1	0	0	3	2	0	0	0	0	0
depression
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	1 / 46 (2.17%)	0 / 30 (0.00%)	1 / 59 (1.69%)	1 / 136 (0.74%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	1	1	0	0	0	0	0
insomnia
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	1 / 31 (3.23%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	2 / 46 (4.35%)	1 / 30 (3.33%)	0 / 59 (0.00%)	2 / 136 (1.47%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	0	0	1	2	1	0	2	0	0	0	0	0
irritability
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	0 / 46 (0.00%)	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 136 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
panic attack
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	0 / 46 (0.00%)	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 136 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Investigations
alanine aminotransferase increased
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	2 / 31 (6.45%)	0 / 32 (0.00%)	1 / 64 (1.56%)	0 / 9 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	3 / 46 (6.52%)	0 / 30 (0.00%)	2 / 59 (3.39%)	8 / 136 (5.88%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	0	1	0	0	0	3	0	2	10	0	0	0	0	0
aspartate aminotransferase increased
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	2 / 31 (6.45%)	0 / 32 (0.00%)	1 / 64 (1.56%)	0 / 9 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	2 / 46 (4.35%)	0 / 30 (0.00%)	1 / 59 (1.69%)	3 / 136 (2.21%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	0	1	0	0	0	2	0	1	3	0	0	0	0	0
blood creatine phosphokinase increased
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	1 / 46 (2.17%)	1 / 30 (3.33%)	2 / 59 (3.39%)	7 / 136 (5.15%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	2	7	0	0	0	0	0
weight increased
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	1 / 31 (3.23%)	3 / 32 (9.38%)	3 / 64 (4.69%)	1 / 9 (11.11%)	1 / 23 (4.35%)	0 / 9 (0.00%)	2 / 46 (4.35%)	1 / 30 (3.33%)	2 / 59 (3.39%)	5 / 136 (3.68%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	3	3	1	1	0	3	1	4	5	0	0	0	0	0
Injury, poisoning and procedural complications
skin laceration
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	0 / 46 (0.00%)	1 / 30 (3.33%)	0 / 59 (0.00%)	1 / 136 (0.74%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	1	0	1	0	0	0	0	0
Nervous system disorders
headache
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	2 / 64 (3.13%)	2 / 31 (6.45%)	2 / 32 (6.25%)	7 / 64 (10.94%)	0 / 9 (0.00%)	3 / 23 (13.04%)	0 / 9 (0.00%)	4 / 46 (8.70%)	3 / 30 (10.00%)	4 / 59 (6.78%)	16 / 136 (11.76%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	2	3	7	0	4	0	4	4	4	30	0	0	0	0	0
hypoaesthesia
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	1 / 64 (1.56%)	0 / 9 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	1 / 46 (2.17%)	0 / 30 (0.00%)	3 / 59 (5.08%)	1 / 136 (0.74%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	1	0	0	0	1	0	3	1	0	0	0	0	0
Blood and lymphatic system disorders
anaemia
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	1 / 64 (1.56%)	2 / 31 (6.45%)	1 / 32 (3.13%)	2 / 64 (3.13%)	1 / 9 (11.11%)	1 / 23 (4.35%)	0 / 9 (0.00%)	2 / 46 (4.35%)	2 / 30 (6.67%)	5 / 59 (8.47%)	7 / 136 (5.15%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	2	1	2	1	2	0	2	2	6	8	0	0	0	0	0
Eye disorders
lacrimation increased
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	1 / 23 (4.35%)	1 / 9 (11.11%)	0 / 46 (0.00%)	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 136 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0
Gastrointestinal disorders
abdominal distension
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	2 / 32 (6.25%)	1 / 64 (1.56%)	0 / 9 (0.00%)	1 / 23 (4.35%)	0 / 9 (0.00%)	3 / 46 (6.52%)	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 136 (0.74%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	2	1	0	1	0	3	0	0	1	0	0	0	0	0
abdominal pain
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	1 / 64 (1.56%)	0 / 31 (0.00%)	1 / 32 (3.13%)	0 / 64 (0.00%)	1 / 9 (11.11%)	2 / 23 (8.70%)	0 / 9 (0.00%)	3 / 46 (6.52%)	0 / 30 (0.00%)	3 / 59 (5.08%)	8 / 136 (5.88%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	1	0	1	2	0	3	0	3	10	0	0	0	0	0
anal incontinence
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	0 / 46 (0.00%)	0 / 30 (0.00%)	0 / 59 (0.00%)	2 / 136 (1.47%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	2	0	0	0	0	0
crohn's disease
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	6 / 64 (9.38%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	1 / 23 (4.35%)	0 / 9 (0.00%)	3 / 46 (6.52%)	0 / 30 (0.00%)	1 / 59 (1.69%)	8 / 136 (5.88%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	7	0	0	0	0	1	0	3	0	1	10	0	0	1	0	0
diarrhoea
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	1 / 64 (1.56%)	1 / 31 (3.23%)	0 / 32 (0.00%)	2 / 64 (3.13%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	3 / 46 (6.52%)	1 / 30 (3.33%)	0 / 59 (0.00%)	6 / 136 (4.41%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	1	0	2	0	0	1	3	1	0	7	0	0	0	0	0
flatulence
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	1 / 64 (1.56%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	0 / 46 (0.00%)	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 136 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0
haemorrhoids
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	1 / 64 (1.56%)	1 / 31 (3.23%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	1 / 46 (2.17%)	1 / 30 (3.33%)	1 / 59 (1.69%)	1 / 136 (0.74%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	1	0	0	0	0	1	1	1	1	1	0	0	0	0	0
intestinal obstruction
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	0 / 46 (0.00%)	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 136 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
nausea
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	2 / 64 (3.13%)	0 / 31 (0.00%)	2 / 32 (6.25%)	2 / 64 (3.13%)	0 / 9 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 46 (0.00%)	1 / 30 (3.33%)	3 / 59 (5.08%)	6 / 136 (4.41%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	0	2	2	0	0	0	0	2	3	8	0	0	0	0	0
rectal polyp
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	1 / 9 (11.11%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 46 (0.00%)	0 / 30 (0.00%)	1 / 59 (1.69%)	0 / 136 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0
Endocrine disorders
hypothyroidism
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	0 / 46 (0.00%)	0 / 30 (0.00%)	0 / 59 (0.00%)	1 / 136 (0.74%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	3 / 64 (4.69%)	1 / 31 (3.23%)	1 / 32 (3.13%)	3 / 64 (4.69%)	1 / 9 (11.11%)	1 / 23 (4.35%)	1 / 9 (11.11%)	6 / 46 (13.04%)	1 / 30 (3.33%)	3 / 59 (5.08%)	8 / 136 (5.88%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	3	1	1	3	1	1	1	6	1	4	9	0	0	0	0	0
joint stiffness
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	0 / 46 (0.00%)	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 136 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
myalgia
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	1 / 31 (3.23%)	0 / 32 (0.00%)	0 / 64 (0.00%)	1 / 9 (11.11%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 46 (0.00%)	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 136 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Infections and infestations
cystitis
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	2 / 31 (6.45%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 46 (0.00%)	0 / 30 (0.00%)	0 / 59 (0.00%)	2 / 136 (1.47%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	2	0	0	0	0	0
epididymitis
Additional description: Follow-up Period:200 mg Mirikizumab IV Q4W in Period 2;1000 mg Mirikizumab IV Q4W in Period 2 (NI);1000 mg Mirkizumab IV Q4W in Period 2 (PBO)=Subjects exposed number=0.However,due to EudraCT database constraint we have included all the participants
alternative dictionary used: MedDRA 23.0
subjects affected / exposed ^[6]	0 / 28 (0.00%)	0 / 17 (0.00%)	0 / 14 (0.00%)	0 / 34 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 23 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 75 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0
erysipelas
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	1 / 9 (11.11%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 46 (0.00%)	0 / 30 (0.00%)	1 / 59 (1.69%)	1 / 136 (0.74%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	1	0	0	0	0	0
gastroenteritis viral
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	1 / 9 (11.11%)	1 / 23 (4.35%)	1 / 9 (11.11%)	0 / 46 (0.00%)	1 / 30 (3.33%)	1 / 59 (1.69%)	1 / 136 (0.74%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	1	1	1	0	1	1	1	0	0	0	0	0
human anaplasmosis
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	0 / 46 (0.00%)	0 / 30 (0.00%)	0 / 59 (0.00%)	0 / 136 (0.00%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
influenza
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	1 / 32 (3.13%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	1 / 46 (2.17%)	1 / 30 (3.33%)	1 / 59 (1.69%)	5 / 136 (3.68%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	1	0	0	0	1	1	1	1	5	0	0	0	0	0
nasopharyngitis
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	1 / 64 (1.56%)	0 / 31 (0.00%)	2 / 32 (6.25%)	4 / 64 (6.25%)	0 / 9 (0.00%)	2 / 23 (8.70%)	0 / 9 (0.00%)	6 / 46 (13.04%)	3 / 30 (10.00%)	4 / 59 (6.78%)	25 / 136 (18.38%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	2	4	0	2	0	7	3	6	33	0	0	0	0	0
respiratory tract infection viral
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	1 / 64 (1.56%)	1 / 31 (3.23%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	1 / 46 (2.17%)	0 / 30 (0.00%)	1 / 59 (1.69%)	2 / 136 (1.47%)	0 / 1 (0.00%)	0 / 2 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	1	0	0	0	0	0	1	0	1	2	0	0	1	0	0
sinusitis
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	1 / 64 (1.56%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	1 / 46 (2.17%)	1 / 30 (3.33%)	3 / 59 (5.08%)	5 / 136 (3.68%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	1	3	8	0	0	0	0	0
upper respiratory tract infection
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	2 / 64 (3.13%)	1 / 31 (3.23%)	0 / 32 (0.00%)	2 / 64 (3.13%)	1 / 9 (11.11%)	1 / 23 (4.35%)	0 / 9 (0.00%)	3 / 46 (6.52%)	2 / 30 (6.67%)	3 / 59 (5.08%)	14 / 136 (10.29%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	2	1	0	2	1	1	0	4	2	3	18	0	0	0	0	0
urinary tract infection
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	1 / 64 (1.56%)	1 / 31 (3.23%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	1 / 46 (2.17%)	1 / 30 (3.33%)	3 / 59 (5.08%)	1 / 136 (0.74%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	1	1	0	0	0	0	0	1	1	3	1	0	0	0	0	0
vulvovaginal mycotic infection
Additional description: Follow-up Period:1000 mg Mirikizumab IV Q4W in Period 2 (Impv) = Subjects exposed number = 0. However, due to EudraCT database constraint we have included all the participants for this arm.
alternative dictionary used: MedDRA 23.0
subjects affected / exposed ^[7]	1 / 36 (2.78%)	0 / 14 (0.00%)	0 / 18 (0.00%)	0 / 30 (0.00%)	0 / 4 (0.00%)	0 / 12 (0.00%)	1 / 4 (25.00%)	0 / 23 (0.00%)	0 / 13 (0.00%)	2 / 33 (6.06%)	2 / 61 (3.28%)	0 / 1 (0.00%)	0 / 2 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	1	0	0	2	2	0	0	0	0	0
Metabolism and nutrition disorders
vitamin d deficiency
alternative dictionary used: MedDRA 23.0
subjects affected / exposed	0 / 64 (0.00%)	0 / 31 (0.00%)	0 / 32 (0.00%)	0 / 64 (0.00%)	0 / 9 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 46 (0.00%)	2 / 30 (6.67%)	0 / 59 (0.00%)	0 / 136 (0.00%)	0 / 1 (0.00%)	1 / 2 (50.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)	0 / 3 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	1	0	0	0

Notes
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

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Were there any global substantial amendments to the protocol? Yes

21 Jul 2016

- Added, modified or deleted major secondary and other secondary objectives and endpoints; - Updated power calculations and window for schedule of activities; - Clarification of the participant for whom follicle-stimulating hormone (FSH) should be performed; - Clarification to be consistent with management of hypersensitivity and infusion-related event section; - Clarification of definition of normal stool frequency for the modified Mayo score to participants entering the study; -Clarification of inclusion and exclusion criteria; - Clarification of safety criteria for drug discontinuation.

21 Nov 2017

-Increased duration of all IV study drug administration to 2 hours; - Addition of a 1-hour post infusion observation period to allow adequate evaluation of potential hypersensitivity or infusion related reactions; Clarification added that patients who experience serious adverse reactions and clarification comment and correction on schedule of activities; - Clarification added that the intent of the treatment regimens is to keep the dosing within the visit windows and as close to every 4 weeks as possible.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Achieving Endoscopic Response at Week 12

Primary: Percentage of Participants Achieving Endoscopic Response at Week 12

Secondary: Percentage of Participants Achieving Endoscopic Remission at Week 12

Secondary: Percentage of Participants Achieving Endoscopic Remission at Week 12

Secondary: Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12

Secondary: Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12

Secondary: Mean Change From Baseline on the Patient Global Rating – Severity (PGRS) Crohn’s Disease Score at Week 12

Secondary: Mean Change From Baseline on the Patient Global Rating – Severity (PGRS) Crohn’s Disease Score at Week 12

Secondary: Mean of Patient Global Rating – Change (PGRC) Crohn’s Disease Score at Week 12

Secondary: Mean of Patient Global Rating – Change (PGRC) Crohn’s Disease Score at Week 12

Secondary: Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12

Secondary: Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12

Secondary: Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12

Secondary: Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12

Secondary: Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 12

Secondary: Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 12

Secondary: Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab

Secondary: Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab

Secondary: Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab

Secondary: Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Achieving Endoscopic Response at Week 12

Primary: Percentage of Participants Achieving Endoscopic Response at Week 12

Secondary: Percentage of Participants Achieving Endoscopic Remission at Week 12

Secondary: Percentage of Participants Achieving Endoscopic Remission at Week 12

Secondary: Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12

Secondary: Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12

Secondary: Mean Change From Baseline on the Patient Global Rating – Severity (PGRS) Crohn’s Disease Score at Week 12

Secondary: Mean Change From Baseline on the Patient Global Rating – Severity (PGRS) Crohn’s Disease Score at Week 12

Secondary: Mean of Patient Global Rating – Change (PGRC) Crohn’s Disease Score at Week 12

Secondary: Mean of Patient Global Rating – Change (PGRC) Crohn’s Disease Score at Week 12

Secondary: Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12

Secondary: Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12

Secondary: Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12

Secondary: Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12

Secondary: Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 12

Secondary: Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 12

Secondary: Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab

Secondary: Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab

Secondary: Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab

Secondary: Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY)