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An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518086
Recruitment Status : Recruiting
First Posted : May 8, 2018
Results First Posted : February 28, 2022
Last Update Posted : October 27, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: Mirikizumab
Drug: Placebo
Enrollment 1281
Recruitment Details  
Pre-assignment Details Participants were randomized in a 3:1 ratio to 300 milligram (mg) mirikizumab intravenously (IV) every 4 weeks (Q4W) or placebo IV Q4W. Results for maximum extended enrollment (ME2) participants will be posted after the study completion.
Arm/Group Title Placebo IV Q4W 300 mg Mirikizumab IV Q4W Placebo IV Q4W ME2 Cohort 300 mg Mirikizumab IV Q4W ME2 Cohort
Hide Arm/Group Description Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Period Title: Overall Study
Started 322 959 0 0
Received at Least One Dose of Study Drug 321 958 0 0
Completed 285 920 0 0
Not Completed 37 39 0 0
Reason Not Completed
Adverse Event             23             15             0             0
Withdrawal by Subject             8             5             0             0
Lack of Efficacy             5             5             0             0
Protocol Violation             1             5             0             0
Lost to Follow-up             0             3             0             0
Insufficient Diary Data             0             2             0             0
Non- compliance to Protocol             0             1             0             0
COVID-19 Related Study Disruption             0             2             0             0
Site Terminated by Sponsor             0             1             0             0
Arm/Group Title Placebo IV Q4W 300 mg Mirikizumab IV Q4W Total
Hide Arm/Group Description Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 322 959 1281
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 322 participants 959 participants 1281 participants
41.3  (13.78) 42.8  (13.83) 42.4  (13.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 322 participants 959 participants 1281 participants
Female 140 367 507
Male 182 592 774
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 322 participants 959 participants 1281 participants
Hispanic or Latino 9 22 31
Not Hispanic or Latino 27 92 119
Unknown or Not Reported 286 845 1131
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 322 participants 959 participants 1281 participants
American Indian or Alaska Native 2 10 12
Asian 68 224 292
Native Hawaiian or Other Pacific Islander 0 1 1
Black or African American 2 10 12
White 247 704 951
More than one race 2 1 3
Unknown or Not Reported 1 9 10
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 322 participants 959 participants 1281 participants
Argentina 3 8 11
Australia 4 10 14
Austria 2 6 8
Belgium 3 6 9
Canada 11 23 34
China 2 16 18
Croatia 1 1 2
Czechia 20 35 55
Denmark 0 7 7
France 15 49 64
Germany 6 33 39
Hungary 7 16 23
India 21 62 83
Ireland 0 1 1
Israel 3 14 17
Italy 12 25 37
Japan 35 102 137
Latvia 6 24 30
Lithuania 6 16 22
Malaysia 0 6 6
Mexico 2 10 12
Netherlands 2 9 11
Poland 32 104 136
Romania 2 13 15
Russia 28 79 107
Serbia 8 13 21
Slovakia 3 21 24
South Korea 5 23 28
Spain 7 15 22
Switzerland 2 9 11
Taiwan 0 3 3
Turkey 5 6 11
Ukraine 26 68 94
United Kingdom 7 11 18
United States 36 115 151
1.Primary Outcome
Title Percentage of Participants With Clinical Remission at Week 12
Hide Description

Clinical remission at week 12 is defined as achieving a modified Mayo score (MMS) subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability), excluding consideration of Physician's Global Assessment (PGA).

Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).

The confidence interval of 99.875% was chosen to match the significance level.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Arm/Group Title Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Hide Arm/Group Description:
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Overall Number of Participants Analyzed 294 868
Measure Type: Number
Number (99.88% Confidence Interval)
Unit of Measure: percentage of participants
13.3
(6.9 to 19.6)
24.2
(19.5 to 28.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV Q4W, 300 mg Mirikizumab IV Q4W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00006
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.1
Confidence Interval (2-Sided) 99.875%
3.2 to 19.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Clinical Response at Week 12
Hide Description Clinical response at week 12 is defined as a decrease in the 9-point modified Mayo score (MMS) [rectal bleeding, stool frequency and the endoscopic findings] inclusive of >= 2 points and >=30% from baseline with either a decrease of rectal bleeding subscore of >=1 or rectal bleeding subscore of 0 or 1.The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration).The MMS ranges from 0 to 9 points,with higher scores representing more severe disease. The confidence interval of 99.875% was chosen to match the significance level.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Arm/Group Title Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Hide Arm/Group Description:
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Overall Number of Participants Analyzed 294 868
Measure Type: Number
Number (99.88% Confidence Interval)
Unit of Measure: percentage of participants
42.2
(32.9 to 51.5)
63.5
(58.2 to 68.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV Q4W, 300 mg Mirikizumab IV Q4W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 21.4
Confidence Interval (2-Sided) 99.875%
10.8 to 32.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Endoscopic Remission at Week 12
Hide Description

Endoscopic remission at week 12 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 12. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration);

The Mayo endoscopic score ranges from 0 to 3 points, with higher scores representing more severe disease.

The confidence interval of 99.875% was chosen to match the significance level.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Arm/Group Title Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Hide Arm/Group Description:
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Overall Number of Participants Analyzed 294 868
Measure Type: Number
Number (99.88% Confidence Interval)
Unit of Measure: percentage of participants
21.1
(13.4 to 28.8)
36.3
(31.0 to 41.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV Q4W, 300 mg Mirikizumab IV Q4W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 15.4
Confidence Interval (2-Sided) 99.875%
6.3 to 24.5
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Symptomatic Remission at Week 12
Hide Description

Symptomatic remission at week 12 is defined as a Mayo subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline.

Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal).

Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed).

The confidence interval of 99.875% was chosen to match the significance level.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Arm/Group Title Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Hide Arm/Group Description:
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Overall Number of Participants Analyzed 294 868
Measure Type: Number
Number (99.88% Confidence Interval)
Unit of Measure: percentage of participants
27.9
(22.8 to 33.0)
45.5
(42.2 to 48.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV Q4W, 300 mg Mirikizumab IV Q4W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 17.5
Confidence Interval (2-Sided) 99.875%
11.4 to 23.6
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Symptomatic Response at Week 12
Hide Description

Symptomatic response at week 12 is defined as ≥30% decrease from baseline in the sum of stool frequency and rectal bleeding subscores.

Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal).

Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed). The sum of stool frequency and rectal bleeding subscores ranges from 0 to 6.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Arm/Group Title Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Hide Arm/Group Description:
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Overall Number of Participants Analyzed 294 868
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52.4
(46.7 to 58.1)
72.0
(69.0 to 75.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV Q4W, 300 mg Mirikizumab IV Q4W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 20.2
Confidence Interval (2-Sided) 95%
13.8 to 26.6
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Histologic Remission at Week 12
Hide Description Histologic remission was assessed using the Geboes histologic scoring system developed for assessment of histologic disease activity in ulcerative colitis. Remission was defined as Geboes histological subscore of 0 for grades: 2b (lamina propria neutrophils), and 3 (neutrophils in epithelium), and 4 (crypt destruction), and 5 (erosion or ulceration).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Arm/Group Title Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Hide Arm/Group Description:
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Overall Number of Participants Analyzed 294 868
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.6
(11.5 to 19.8)
29.3
(26.2 to 32.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV Q4W, 300 mg Mirikizumab IV Q4W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.7
Confidence Interval (2-Sided) 95%
8.6 to 18.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Endoscopic Response at Week 12
Hide Description

Endoscopic response at week 12 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.

The Mayo endoscopic subscore ranges from 0 to 3 points, with higher scores representing more severe disease.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Arm/Group Title Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Hide Arm/Group Description:
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Overall Number of Participants Analyzed 294 868
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.1
(30.6 to 41.5)
55.4
(52.1 to 58.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV Q4W, 300 mg Mirikizumab IV Q4W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 19.5
Confidence Interval (2-Sided) 95%
13.2 to 25.8
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)
Hide Description The Urgency NRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency).Higher scores indicate more severe urgency. Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes: treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention-to-treat population (mITT): All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline urgency NRS measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Arm/Group Title Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Hide Arm/Group Description:
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Overall Number of Participants Analyzed 294 868
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.63  (0.141) -2.59  (0.083)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV Q4W, 300 mg Mirikizumab IV Q4W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.95
Confidence Interval (2-Sided) 99.875%
-1.47 to -0.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.159
Estimation Comments The confidence interval of 99.875 % was chosen to match the significance level.
9.Secondary Outcome
Title Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Hide Description The IBDQ is a 32-item participant-completed questionnaire that measures 4 aspects of subjects' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function (Guyatt et al. 1989). Responses are graded on a 7-point. Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." Scores range from 32 to 224; a higher score indicates a better quality of life. Least square (LS) Mean was calculated using analysis of covariance (ANCOVA) model for post-baseline measures: The ANCOVA model includes: treatment, baseline value, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention-to-treat population (mITT): All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline IBDQ measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Arm/Group Title Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Hide Arm/Group Description:
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Overall Number of Participants Analyzed 294 868
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
25.21  (1.798) 38.42  (1.108)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV Q4W, 300 mg Mirikizumab IV Q4W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 13.21
Confidence Interval (2-Sided) 95%
9.28 to 17.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.005
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline to Week 12 in Fecal Calprotectin
Hide Description Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes: treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention-to-treat population (mITT): All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline fecal calprotectin measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
Arm/Group Title Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Hide Arm/Group Description:
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Overall Number of Participants Analyzed 206 665
Least Squares Mean (Standard Error)
Unit of Measure: milligram per kilogram (mg/kg)
-939.69  (196.557) -1875.29  (116.138)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo IV Q4W, 300 mg Mirikizumab IV Q4W
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -935.60
Confidence Interval (2-Sided) 95%
-1363.64 to -507.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 218.090
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Pharmacokinetics (PK): Clearance of Mirikizumab
Hide Description Clearance of mirikizumab was evaluated. Clearance is estimated based on concentration data collected in the time frame of 0-12 weeks.
Time Frame Predose on week 0, week 4, week 8 and post dose on week 0, 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data.
Arm/Group Title 300 mg Mirikizumab IV Q4W
Hide Arm/Group Description:
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Overall Number of Participants Analyzed 952
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per Hour (L/h)
0.0224
(38%)
Time Frame Up To 12 Weeks
Adverse Event Reporting Description All randomized participants who received at least one dose of study drug.
 
Arm/Group Title Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Hide Arm/Group Description Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks. 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
All-Cause Mortality
Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Affected / at Risk (%) Affected / at Risk (%)
Total   0/321 (0.00%)      0/958 (0.00%)    
Hide Serious Adverse Events
Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/321 (5.30%)      27/958 (2.82%)    
Blood and lymphatic system disorders     
Anaemia † 1  1/321 (0.31%)  1 1/958 (0.10%)  1
Cardiac disorders     
Acute myocardial infarction † 1  1/321 (0.31%)  1 0/958 (0.00%)  0
Ear and labyrinth disorders     
Vertigo † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Gastrointestinal disorders     
Colitis ulcerative † 1  10/321 (3.12%)  10 8/958 (0.84%)  8
Lower gastrointestinal haemorrhage † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Infections and infestations     
Acute sinusitis † 1  1/321 (0.31%)  1 0/958 (0.00%)  0
Cytomegalovirus colitis † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Gastroenteritis viral † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Intestinal sepsis † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Klebsiella infection † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Pneumonia † 1  0/321 (0.00%)  0 2/958 (0.21%)  2
Sinusitis † 1  1/321 (0.31%)  1 0/958 (0.00%)  0
Viral infection † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Injury, poisoning and procedural complications     
Spinal compression fracture † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Spinal fracture † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Metabolism and nutrition disorders     
Diabetes mellitus † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Malnutrition † 1  1/321 (0.31%)  1 0/958 (0.00%)  0
Type 2 diabetes mellitus † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Musculoskeletal and connective tissue disorders     
Ankylosing spondylitis † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Uterine leiomyoma † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Renal and urinary disorders     
Renal colic † 1  1/321 (0.31%)  1 0/958 (0.00%)  0
Reproductive system and breast disorders     
Ovarian enlargement † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Penile vein thrombosis † 1  1/321 (0.31%)  1 0/958 (0.00%)  0
Vascular disorders     
Arteriosclerosis † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
Deep vein thrombosis † 1  1/321 (0.31%)  1 1/958 (0.10%)  1
Hypertension † 1  0/321 (0.00%)  0 1/958 (0.10%)  1
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo IV Q4W 300 mg Mirikizumab IV Q4W
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/321 (5.61%)      31/958 (3.24%)    
Blood and lymphatic system disorders     
Anaemia † 1  18/321 (5.61%)  18 31/958 (3.24%)  32
1
Term from vocabulary, MedDRA 24.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03518086    
Other Study ID Numbers: 16591
I6T-MC-AMAN ( Other Identifier: Eli Lilly and Company )
2017-003229-14 ( EudraCT Number )
First Submitted: May 4, 2018
First Posted: May 8, 2018
Results First Submitted: January 26, 2022
Results First Posted: February 28, 2022
Last Update Posted: October 27, 2022