CompletedNCT02891226SERENITYUpdated Aug 30, 2022Results posted

A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease

A Phase 2 interventional study of Mirikizumab and Placebo in Crohn's Disease, sponsored by Eli Lilly and Company. Completed at 108 sites in 14 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-08-30.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 191
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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

Conditions studied

Crohn's Disease

Browse trials for

Crohn Disease 1,880

Keywords

inflammatory bowel disease
IL-23
biologic

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 191 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Active Crohn's Disease (CD) as determined by the SES-CD, and participant reported stool frequency and abdominal pain.
Inadequate response or failure to tolerate at least one of the following: aminosalicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of CD.

Exclusion criteria

Exclusion Criteria:

Have complications of CD such as strictures, stenoses, or any other manifestation for which surgery might be indicated, or that could confound the evaluation of efficacy.
Diagnosis of conditions affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome.
Have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior to screening.
Are unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject's safety or confound data interpretation.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 191 participants (actual)

Study arms

Experimental
Mirikizumab
Period 1 (Weeks 0 -12): 200 Milligram (mg), 600 mg, and 1000 mg mirikizumab administered intravenously (IV) every 4 Weeks (Q4W). Period 2 (Weeks 12 - 52): 200 mg, 600 mg, and 1000 mg mirikizumab administered IV Q4W; 300 mg mirikizumab administered subcutaneously (SC) Q4W; 1000 mg mirikizumab administered IV Q4W for non-improvers in period 1; and 1000 mg mirikizumab administered IV Q4W for participants on placebo during period 1. Period 3 (Weeks 52 - 208): 300 mg mirikizumab administered SC Q4W.
Drug: Mirikizumab
Placebo comparator
Placebo
Period 1 (Weeks 0 -12): Participants received placebo administered intravenously (IV) Q4W.
Drug: Placebo

Interventions

DrugMirikizumab
Also known as: LY3074828
DrugPlacebo

What researchers measure

Primary outcomes

Percentage of Participants Achieving Endoscopic Response at Week 12
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.
Time frame: Week 12

Secondary outcomes

Percentage of Participants Achieving Endoscopic Remission at Week 12
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.
Time frame: Week 12
Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12
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.
Time frame: Week 12
Mean Change From Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score at Week 12
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.
Time frame: Baseline, Week 12
Mean of Patient Global Rating - Change (PGRC) Crohn's Disease Score at Week 12
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."
Time frame: Baseline, Week 12
Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
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.
Time frame: Baseline, Week 12
Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
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.
Time frame: Baseline, Week 12
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
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.
Time frame: Baseline, Week 12
Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab
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.
Time frame: 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
Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab
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.
Time frame: 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

Results

Posted Feb 28, 2022

Participant flow

Period 1 (Weeks 0 to 12)

Participant flow — Period 1 (Weeks 0 to 12)
Milestone	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
Withdrew: Adverse event	4	1	3	0
Withdrew: Lost to follow-up	1	1	0	0
Withdrew: Withdrawal by subject	0	0	0	2
Withdrew: Enrollment failure	0	0	1	0
Withdrew: Sponsor decision	0	0	0	1
Withdrew: Lack of efficacy	0	0	0	1

Period 2 (Weeks 12 to 52)

Participant flow — Period 2 (Weeks 12 to 52)
Milestone	Period 2: 200 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)	Period 2: 600 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)	Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)	Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W (Period 1 Mirikizumab Improvers)	Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Non-improvers)	Period 2: 1000 mg Mirkizumab IV Q4W (Period 1 Placebo)
Started	9	9	23	46	30	59
Completed	8	8	20	41	24	42
Not completed	1	1	3	5	6	17
Withdrew: Adverse event	0	0	1	1	3	7
Withdrew: Lost to follow-up	0	1	0	0	0	1
Withdrew: Withdrawal by subject	0	0	1	2	1	6
Withdrew: Pi decision due to lack of efficacy	1	0	0	0	0	0
Withdrew: Pi and sponsor decision due to subject safety	0	0	1	0	0	0
Withdrew: Lack of efficacy	0	0	0	1	1	1
Withdrew: Pi decision due to lack of efficacy	0	0	0	1	0	0
Withdrew: Endoscopic procedure was not evaluated	0	0	0	0	1	0
Withdrew: Lack of efficacy and withdrew from study	0	0	0	0	0	1
Withdrew: Sponsor decision	0	0	0	0	0	1

Period 3 (Weeks 52 to 208)

Participant flow — Period 3 (Weeks 52 to 208)
Milestone	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 1 Mirikizumab Improvers)	Period 2: 600 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)	Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)	Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W (Period 1 Mirikizumab Improvers)	Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Non-improvers)	Period 2: 1000 mg Mirkizumab IV Q4W (Period 1 Placebo)	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 (Period 1 Mirikizumab Improvers)	Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Non-improvers)	Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (Placebo in Period 1)	Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3
Started	0	0	0	0	0	0	0	0	0	0	137	0	0	0	0	0
Completed	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Not completed	0	0	0	0	0	0	0	0	0	0	137	0	0	0	0	0
Withdrew: Adverse event	0	0	0	0	0	0	0	0	0	0	5	0	0	0	0	0
Withdrew: Lost to follow-up	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Withdrew: Withdrawal by subject	0	0	0	0	0	0	0	0	0	0	14	0	0	0	0	0
Withdrew: Roll over to amax	0	0	0	0	0	0	0	0	0	0	108	0	0	0	0	0
Withdrew: Decided to not participate in extension period (week 104-208)	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0
Withdrew: Lack of efficacy	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0
Withdrew: Pi decision as subject not responding to study drug	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0
Withdrew: Non-compliance with study visit schedule	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0

Follow-up Period

Participant flow — Follow-up Period
Milestone	Follow-up Period: 200 mg Mirikizumab IV Q4W in Period 2	Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Improvers)	Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Non-improvers)	Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (Placebo in Period 1)	Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3
Started	1	2	1	1	3
Completed	0	2	1	0	2
Not completed	1	0	0	1	1
Withdrew: Withdrawal by subject	1	0	0	1	1

Outcome measures

PrimaryPercentage of Participants Achieving Endoscopic Response at Week 12

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.

Time frame:: Week 12
Reported as:: Number · percentage of participants

Percentage of Participants Achieving Endoscopic Response at Week 12
percentage of participants	Placebo IV Q4W	200 mg Mirikizumab IV Q4W	600 mg Mirikizumab IV Q4W	1000 mg Mirikizumab IV Q4W
Percentage of Participants Achieving Endoscopic Response at Week 12	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)

Statistical analysis

Placebo IV Q4W vs 200 mg Mirikizumab IV Q4W · Regression, Logistic · p = 0.079 · Odds ratio (or): 2.75 · 90% CI 1.07 to 7.08
Placebo IV Q4W vs 600 mg Mirikizumab IV Q4W · Regression, Logistic · p = 0.003 · Odds ratio (or): 4.92 · 90% CI 2.01 to 12.07
Placebo IV Q4W vs 1000 mg Mirikizumab IV Q4W · Regression, Logistic · p = <0.001 · Odds ratio (or): 6.14 · 90% CI 2.81 to 13.42

SecondaryPercentage of Participants Achieving Endoscopic Remission at Week 12

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.

Time frame:: Week 12
Reported as:: Number · percentage of participants

Percentage of Participants Achieving Endoscopic Remission at Week 12
percentage of participants	Placebo IV Q4W	200 mg Mirikizumab IV Q4W	600 mg Mirikizumab IV Q4W	1000 mg Mirikizumab IV Q4W
Percentage of Participants Achieving Endoscopic Remission at Week 12	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)

Statistical analysis

Placebo IV Q4W vs 200 mg Mirikizumab IV Q4W · Regression, Logistic · p = 0.241 · Odds ratio (or): 4.31 · 90% CI 0.55 to 33.58
Placebo IV Q4W vs 600 mg Mirikizumab IV Q4W · Regression, Logistic · p = 0.032 · Odds ratio (or): 11.16 · 90% CI 1.76 to 70.64
Placebo IV Q4W vs 1000 mg Mirikizumab IV Q4W · Regression, Logistic · p = 0.009 · Odds ratio (or): 16.04 · 90% CI 2.82 to 91.32

SecondaryPercentage of Participants Achieving Patient Reported Outcome Remission at Week 12

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.

Time frame:: Week 12
Reported as:: Number · percentage of participants

Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12
percentage of participants	Placebo IV Q4W	200 mg Mirikizumab IV Q4W	600 mg Mirikizumab IV Q4W	1000 mg Mirikizumab IV Q4W
Percentage of Participants Achieving Patient Reported Outcome Remission at Week 12	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)

Statistical analysis

Placebo IV Q4W vs 200 mg Mirikizumab IV Q4W · Regression, Logistic · p = 0.330 · Odds ratio (or): 2.0 · 90% CI 0.62 to 6.45
Placebo IV Q4W vs 600 mg Mirikizumab IV Q4W · Regression, Logistic · p = 0.006 · Odds ratio (or): 5.72 · 90% CI 2.02 to 16.21
Placebo IV Q4W vs 1000 mg Mirikizumab IV Q4W · Regression, Logistic · p = 0.029 · Odds ratio (or): 3.52 · 90% CI 1.37 to 9.07

SecondaryMean Change From Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score at Week 12

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.

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · score on a scale

Mean Change From Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score at Week 12
score on a scale	Placebo IV Q4W	200 mg Mirikizumab IV Q4W	600 mg Mirikizumab IV Q4W	1000 mg Mirikizumab IV Q4W
Mean Change From Baseline on the Patient Global Rating - Severity (PGRS) Crohn's Disease Score at Week 12	-0.44 ± 0.132	-1.08 ± 0.194	-1.27 ± 0.189	-0.98 ± 0.134

Statistical analysis

Placebo IV Q4W vs 200 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = 0.007 · Ls mean difference (final values): -0.64 · 90% CI -1.03 to -0.25
Placebo IV Q4W vs 600 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = <0.001 · Ls mean difference (final values): -0.83 · 90% CI -1.21 to -0.45
Placebo IV Q4W vs 1000 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = 0.005 · Ls mean difference (final values): -0.53 · 90% CI -0.84 to -0.22

SecondaryMean of Patient Global Rating - Change (PGRC) Crohn's Disease Score at Week 12

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."

Time frame:: Baseline, Week 12
Reported as:: Mean · score on a scale

Mean of Patient Global Rating - Change (PGRC) Crohn's Disease Score at Week 12
score on a scale	Placebo IV Q4W	200 mg Mirikizumab IV Q4W	600 mg Mirikizumab IV Q4W	1000 mg Mirikizumab IV Q4W
Mean of Patient Global Rating - Change (PGRC) Crohn's Disease Score at Week 12	3.6 ± 1.11	2.8 ± 1.26	2.6 ± 0.97	2.5 ± 0.89

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

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.

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · score on a scale

Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
score on a scale	Placebo IV Q4W	200 mg Mirikizumab IV Q4W	600 mg Mirikizumab IV Q4W	1000 mg Mirikizumab IV Q4W
Mean Change From Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12	17.11 ± 3.725	41.16 ± 5.311	46.57 ± 5.244	42.35 ± 3.770

Statistical analysis

Placebo IV Q4W vs 200 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = <0.001 · Ls mean difference (final values): 24.05 · 90% CI 13.53 to 34.56
Placebo IV Q4W vs 600 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = <0.001 · Ls mean difference (final values): 29.46 · 90% CI 18.84 to 40.08
Placebo IV Q4W vs 1000 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = <0.001 · Ls mean difference (final values): 25.24 · 90% CI 16.67 to 33.82

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

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.

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · score on a scale

Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
score on a scale	Placebo IV Q4W	200 mg Mirikizumab IV Q4W	600 mg Mirikizumab IV Q4W	1000 mg Mirikizumab IV Q4W
Mean Change From Baseline on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12	2.90 ± 1.209	10.81 ± 1.728	9.09 ± 1.721	9.62 ± 1.223

Statistical analysis

Placebo IV Q4W vs 200 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = <0.001 · Ls mean difference (final values): 7.91 · 90% CI 4.48 to 11.34
Placebo IV Q4W vs 600 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = 0.004 · Ls mean difference (final values): 6.20 · 90% CI 2.72 to 9.67
Placebo IV Q4W vs 1000 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = <0.001 · Ls mean difference (final values): 6.73 · 90% CI 3.94 to 9.51

SecondaryMean 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

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.

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · score on a scale

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
score on a scale	Placebo IV Q4W	200 mg Mirikizumab IV Q4W	600 mg Mirikizumab IV Q4W	1000 mg Mirikizumab IV Q4W
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

Statistical analysis

Placebo IV Q4W vs 200 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = 0.008 · Ls mean difference (final values): 5.14 · 90% CI 1.95 to 8.32
Placebo IV Q4W vs 600 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = 0.033 · Ls mean difference (final values): 4.18 · 90% CI 0.96 to 7.41
Placebo IV Q4W vs 1000 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = 0.021 · Ls mean difference (final values): 3.71 · 90% CI 1.08 to 6.34
Placebo IV Q4W vs 200 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = 0.229 · Ls mean difference (final values): 1.59 · 90% CI -0.59 to 3.77
Placebo IV Q4W vs 600 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = <0.001 · Ls mean difference (final values): 4.91 · 90% CI 2.67 to 7.14
Placebo IV Q4W vs 1000 mg Mirikizumab IV Q4W · Mixed Models Analysis · p = 0.001 · Ls mean difference (final values): 3.60 · 90% CI 1.81 to 5.38

SecondaryPopulation Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab

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.

Time frame:: 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
Reported as:: Geometric mean · Liters per Hour (L/h)

Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab
Liters per Hour (L/h)	Mirikizumab IV Q4W
Population Pharmacokinetics (PopPK): Mean Population Clearance of Mirikizumab	0.0225 ± 30

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

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.

Time frame:: 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
Reported as:: Geometric mean · Liters (L)

Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab
Liters (L)	Mirikizumab IV Q4W
Population Pharmacokinetics (PopPK): Mean Population Volume of Distribution of Mirikizumab	5.05 ± 18

Adverse events

Collected over Baseline Up To 208 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Period 1: Placebo Intravenous (IV) Every 4 Weeks (Q4W)	0/64 (0%)	7/64 (10.9%)	24/64 (37.5%)
Period 1: 200 Milligram (mg) Mirikizumab IV Q4W	0/31 (0%)	0/31 (0%)	11/31 (35.5%)
Period 1: 600 mg Mirikizumab IV Q4W	0/32 (0%)	3/32 (9.4%)	12/32 (37.5%)
Period 1: 1000 mg Mirikizumab IV Q4W	0/64 (0%)	2/64 (3.1%)	27/64 (42.2%)
Period 2: 200 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)	0/9 (0%)	0/9 (0%)	7/9 (77.8%)
Period 2: 600 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)	0/9 (0%)	0/9 (0%)	5/9 (55.6%)
Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)	0/23 (0%)	0/23 (0%)	14/23 (60.9%)
Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W (Period 1 Mirikizumab Improvers)	0/46 (0%)	2/46 (4.3%)	30/46 (65.2%)
Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Non-improvers)	0/30 (0%)	3/30 (10%)	16/30 (53.3%)
Period 2: 1000 mg Mirkizumab IV Q4W (Period 1 Placebo)	0/59 (0%)	9/59 (15.3%)	30/59 (50.8%)
Period 3: 300 mg Mirikizumab SC Q4W	0/136 (0%)	15/136 (11%)	89/136 (65.4%)
Follow-up Period: 200 mg Mirikizumab IV Q4W in Period 2	0/1 (0%)	0/1 (0%)	0/1 (0%)
Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Improvers)	0/2 (0%)	0/2 (0%)	1/2 (50%)
Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Non-improvers)	0/1 (0%)	0/1 (0%)	1/1 (100%)
Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (Placebo in Period 1)	0/1 (0%)	0/1 (0%)	0/1 (0%)
Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3	0/3 (0%)	0/3 (0%)	0/3 (0%)

Most frequent serious events

Showing 10 of 37

Most frequent serious events
Event	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 1 Mirikizumab Improvers)	Period 2: 600 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)	Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)	Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W (Period 1 Mirikizumab Improvers)	Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Non-improvers)	Period 2: 1000 mg Mirkizumab IV Q4W (Period 1 Placebo)	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 (Period 1 Mirikizumab Improvers)	Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Non-improvers)	Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (Placebo in Period 1)	Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3
Maternal exposure during pregnancyInjury, poisoning and procedural complications	0/36	0/14	0/18	0/30	0/4	0/4	0/12	0/23	1/13	0/33	0/61	0/1	—	0/1	0/1	0/1
Abortion spontaneousPregnancy, puerperium and perinatal conditions	0/36	0/14	0/18	0/30	0/4	0/4	0/12	0/23	1/13	0/33	0/61	0/1	—	0/1	0/1	0/1
Crohn's diseaseGastrointestinal disorders	3/64	0/31	1/32	0/64	0/9	0/9	0/23	1/46	1/30	1/59	2/136	0/1	0/2	0/1	0/1	0/3
Anaphylactic reactionImmune system disorders	0/64	0/31	0/32	0/64	0/9	0/9	0/23	0/46	0/30	2/59	0/136	0/1	0/2	0/1	0/1	0/3
PneumoniaInfections and infestations	0/64	0/31	0/32	0/64	0/9	0/9	0/23	0/46	1/30	0/59	0/136	0/1	0/2	0/1	0/1	0/3
Large intestinal stenosisGastrointestinal disorders	0/64	0/31	1/32	0/64	0/9	0/9	0/23	0/46	0/30	0/59	0/136	0/1	0/2	0/1	0/1	0/3
Large intestine perforationGastrointestinal disorders	0/64	0/31	1/32	0/64	0/9	0/9	0/23	0/46	0/30	0/59	0/136	0/1	0/2	0/1	0/1	0/3
Non-cardiac chest painGeneral disorders	0/64	0/31	1/32	0/64	0/9	0/9	0/23	0/46	0/30	1/59	0/136	0/1	0/2	0/1	0/1	0/3
Paternal exposure during pregnancyInjury, poisoning and procedural complications	0/28	0/17	0/14	0/34	0/5	0/5	0/11	0/23	0/17	0/26	2/75	—	0/2	—	—	0/2
Ileal perforationGastrointestinal disorders	0/64	0/31	0/32	0/64	0/9	0/9	0/23	1/46	0/30	0/59	0/136	0/1	0/2	0/1	0/1	0/3

Most frequent other events

Showing 10 of 51

Most frequent other events
Event	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 1 Mirikizumab Improvers)	Period 2: 600 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)	Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Improvers)	Period 2: 300mg Mirikizumab Subcutaneous (SC) Q4W (Period 1 Mirikizumab Improvers)	Period 2: 1000 mg Mirikizumab IV Q4W (Period 1 Mirikizumab Non-improvers)	Period 2: 1000 mg Mirkizumab IV Q4W (Period 1 Placebo)	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 (Period 1 Mirikizumab Improvers)	Follow-up Period: 1000 mg Mirikizumab IV Q4W in Period 2 (Period 1 Mirikizumab Non-improvers)	Follow-up Period: 1000 mg Mirkizumab IV Q4W in Period 2 (Placebo in Period 1)	Follow-up Period: 300 mg Mirikizumab SC Q4W in Period 3
Crohn's diseaseGastrointestinal disorders	6/64	0/31	0/32	0/64	0/9	0/9	1/23	3/46	0/30	1/59	8/136	0/1	0/2	1/1	0/1	0/3
Respiratory tract infection viralInfections and infestations	1/64	1/31	0/32	0/64	0/9	0/9	0/23	1/46	0/30	1/59	2/136	0/1	0/2	1/1	0/1	0/3
Vitamin d deficiencyMetabolism and nutrition disorders	0/64	0/31	0/32	0/64	0/9	0/9	0/23	0/46	2/30	0/59	0/136	0/1	1/2	0/1	0/1	0/3
Vulvovaginal mycotic infectionInfections and infestations	1/36	0/14	0/18	0/30	0/4	1/4	0/12	0/23	0/13	2/33	2/61	0/1	—	0/1	0/1	0/1
NasopharyngitisInfections and infestations	1/64	0/31	2/32	4/64	0/9	0/9	2/23	6/46	3/30	4/59	25/136	0/1	0/2	0/1	0/1	0/3
Injection site reactionGeneral disorders	0/64	0/31	0/32	0/64	0/9	1/9	0/23	3/46	0/30	1/59	18/136	0/1	0/2	0/1	0/1	0/3
ArthralgiaMusculoskeletal and connective tissue disorders	3/64	1/31	1/32	3/64	1/9	1/9	1/23	6/46	1/30	3/59	8/136	0/1	0/2	0/1	0/1	0/3
HeadacheNervous system disorders	2/64	2/31	2/32	7/64	0/9	0/9	3/23	4/46	3/30	4/59	16/136	0/1	0/2	0/1	0/1	0/3
AnaemiaBlood and lymphatic system disorders	1/64	2/31	1/32	2/64	1/9	0/9	1/23	2/46	2/30	5/59	7/136	0/1	0/2	0/1	0/1	0/3
HypothyroidismEndocrine disorders	0/64	0/31	0/32	0/64	0/9	1/9	0/23	0/46	0/30	0/59	1/136	0/1	0/2	0/1	0/1	0/3

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(years)	Placebo IV Q4W	200 mg Mirikizumab IV Q4W	600 mg Mirikizumab IV Q4W	1000 mg Mirikizumab IV Q4W	Total
Mean	39.00 ± 13.04	38.10 ± 11.80	40.40 ± 13.33	37.70 ± 13.11	38.70 ± 12.70

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo IV Q4W	200 mg Mirikizumab IV Q4W	600 mg Mirikizumab IV Q4W	1000 mg Mirikizumab IV Q4W	Total
Female	36	14	18	30	98
Male	28	17	14	34	93

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo IV Q4W	200 mg Mirikizumab IV Q4W	600 mg Mirikizumab IV Q4W	1000 mg Mirikizumab IV Q4W	Total
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)
Race (NIH/OMB)(Participants)	Placebo IV Q4W	200 mg Mirikizumab IV Q4W	600 mg Mirikizumab IV Q4W	1000 mg Mirikizumab IV Q4W	Total
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
Region of Enrollment(Participants)	Placebo IV Q4W	200 mg Mirikizumab IV Q4W	600 mg Mirikizumab IV Q4W	1000 mg Mirikizumab IV Q4W	Total
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

Study locations

108 sites

Longwood Research
Huntsville, Alabama 35801, United States
Del Sol Research Management, LLC
Tucson, Arizona 85710, United States
Valley View Internal Medicine
Garden Grove, California 92843, United States
Ventura Clinical Trials
Ventura, California 93003, United States
Delta Waves Sleep Disorders and Research Center
Colorado Springs, Colorado 80918, United States
Medical Research Center of Connecticut
Hamden, Connecticut 06518, United States
Clinical Research of West Florida
Clearwater, Florida 33765, United States
Wellness Clinical Research
Hialeah Gardens, Florida 33012, United States
University of Miami
Miami, Florida 33136, United States
Vista Health Research
Miami, Florida 33176, United States
Clinical Neuroscience Solutions Inc
Orlando, Florida 32801, United States
Digestive Healthcare of Georgia
Atlanta, Georgia 30309, United States
Columbus Regional Research Institute
Columbus, Georgia 31904, United States
Indiana University Health
Indianapolis, Indiana 46202, United States
Robley Rex VAMC
Louisville, Kentucky 40206, United States
Health Quest Medical Care
Owensboro, Kentucky 42303, United States
Delta Research Partners LLC
Monroe, Louisiana 71201, United States
Louisiana Research Center
Shreveport, Louisiana 71105, United States
MedStar Health Research Institute
Rosedale, Maryland 21237, United States
University of Michigan Health Systems
Ann Arbor, Michigan 48109, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan 48197, United States
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota 55446, United States
Washington University Medical School
Saint Louis, Missouri 63110, United States
St. Louis Center for Clinical Research
Saint Louis, Missouri 63128, United States
Las Vegas Medical Research
Las Vegas, Nevada 89113, United States
Holy Name Medical Center
Teaneck, New Jersey 07666, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York 11021, United States
Columbia University Medical Center
New York, New York 10032, United States
University of North Carolina
Chapel Hill, North Carolina 27599, United States
Carolina Digestive Diseases
Greenville, North Carolina 27834, United States
Consultants For Clinical Research
Cincinnati, Ohio 45219, United States
University Hospitals Health Center
Cleveland, Ohio 44106, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104, United States
Healthcare Research Consultant
Tulsa, Oklahoma 74135, United States
Ocean State Clinical Research Partners
Lincoln, Rhode Island 02865, United States
Gastro One
Germantown, Tennessee 38138, United States
Advanced Gastroenterology
Union City, Tennessee 38261, United States
Texas Clinical Research Institute, LLC
Arlington, Texas 76012, United States
Hermann Drive Surgical Hospital
Houston, Texas 77004, United States
Digestive Health Associates of Texas
Richardson, Texas 75082, United States
San Antonio Gastroenterology
San Antonio, Texas 78229, United States
Care Access Research - Salt Lake City
Salt Lake City, Utah 84124, United States
Virginia Mason Medical Center
Seattle, Washington 98101, United States
University of Washington Medical Center
Seattle, Washington 98195-6424, United States
Princess Alexandra Hospital
Woolloongabba, Queensland 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia 5000, Australia
Ballarat Health Services - Base Hospital
Ballarat, Victoria 3350, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria 3065, Australia
Hospital Universitaire Erasme Brussel
Brussel, 1070, Belgium
Universitair Ziekenhuis Gent
Gent, 9000, Belgium
Sudbury Endoscopy Centre
Sudbury, Ontario P3C 5K6, Canada
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Usti nad Labem, Czech Republic 40113, Czechia
Hepato-gastroenterologie HK, s.r.o.
Hradec Kralove, 50012, Czechia
Gregar s.r.o.
Olomouc, 779 00, Czechia
Thomayerova Nemocnice
Praha 4 - Krc, 140 59, Czechia
Fakultni Nemocnice v Motole
Praha 5, 150 06, Czechia
Krajska nemocnice T. Bati a.s.
Zlin, 76275, Czechia
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Javorszky Odon Hospital
Vac, 2600, Hungary
Toho University School of Medicine, Sakura Hospital
Sakura-shi, Chiba-Ken 285 8471, Japan
Kitakyushu Municipal Medical Center
Kitakyusyu-shi, Fukoka 802-0077, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka-Ken 818 8502, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo-shi, Hokkaido 060 0033, Japan
Sameshima Hospital
Kagoshima-shi, Kagoshima 892-0846, Japan
Gokeikai Ofuna Chuo Hospital
Kamakura-shi, Kanagawa 247-0056, Japan
Takagi Clinic
Sendai-shi, Miyagi-Ken 981 3213, Japan
Kinshukai Infusion Clinic
Osaka-shi, Osaka-Fu 530-0011, Japan
Tokyo Medical And Dental University Hospital
Bunkyo-ku, Tokyo 113-8519, Japan
Kyorin University Hospital
Mitaka, Tokyo 181-8611, Japan
JHCO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo 169-0073, Japan
Toyama Prefectural Central Hospital
Toyama-Shi, Toyama 930-8550, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
St Elisabeth Ziekenhuis
Tilburg, Noord Brabant 5022 GC, Netherlands
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
Radboud Universitair Medisch Centrum Nijmegen
Nijmegen, 6525, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 CE, Netherlands
Szpital Uniwersytecki nr 2 im. dr J. Biziela
Bydgoszcz, 85-168, Poland
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362, Poland
SOLUMED Centrum Medyczne
Poznan, 60-529, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszow, 35-302, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warszawa, 00-632, Poland
Melita Medical Sp. Z O. O.
Wroclaw, 50-449, Poland
SC Pelican SRL
Oradea, Bihor 410469, Romania
SC Med Life SA
Bucuresti, 010719, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timisoara, 300002, Romania
Novosibirsk State Medical University
Novosibirsk, 630091, Russian Federation
FSBI Scientific Research Inst. of Physyology and Basic Medic
Novosibirsk, 630117, Russian Federation
Ultramed
Omsk, 644024, Russian Federation
City Clinical Hospital # 2 n.a. Fedor Khristoforovich Gral
Perm, 614068, Russian Federation
Private Medical Institution Evromedservis
Pushkin, 196603, Russian Federation
Medical Institute REAVIZ
Samara, 443001, Russian Federation
NonState Healthcare Institution Central Clinical Hospital
Samara, 443041, Russian Federation
Baltic Medicine
St. Petersburg, 194356, Russian Federation
City Hospital of Saint Martyr Elizabeth
St. Petersburg, 195257, Russian Federation
LLC Scientific Research Centre EKO-Bezopasnost
St. Petersburg, 196143, Russian Federation
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, 432063, Russian Federation
Universitätsspital Zürich
Zürich, 8091, Switzerland
Kyiv Municipal Clinical Hospital #1
Kyiv, 02091, Ukraine
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
Kyiv, 04107, Ukraine

Showing the first 100 of 108 sites across 14 countries.

References and documents

Publications

Sands BE, Peyrin-Biroulet L, Kierkus J, Higgins PDR, Fischer M, Jairath V, Hirai F, D'Haens G, Belin RM, Miller D, Gomez-Valderas E, Naegeli AN, Tuttle JL, Pollack PF, Sandborn WJ. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn's Disease. Gastroenterology. 2022 Feb;162(2):495-508. doi: 10.1053/j.gastro.2021.10.050. Epub 2021 Nov 5. PubMed 34748774 ↗

Study documents

Study protocol · Jul 11, 2018
Statistical analysis plan · Mar 16, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02891226
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Sep 7, 2016
Start date: Dec 14, 2016
Primary completion: Dec 11, 2018
Completion: Feb 5, 2021
Results posted: Feb 28, 2022
Last update: Aug 30, 2022

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease

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