Ulcerative ColitisPhase 2NCT02589665

A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis

A Phase 2 study testing Mirikizumab in people with Ulcerative Colitis, run by Eli Lilly and Company at 76 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Ulcerative Colitis
What is being tested?: Mirikizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 249 participants
Where: 76 sitesin 16 countries
Study dates: 9 Dec 2015to 7 May 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an endoscopic subscore ≥2 within 14 days before the first dose of study treatment (note: a partial Mayo score of at least 4 and other eligibility criteria must have been met before endoscopy is performed as a study procedure)
Have evidence of UC extending proximal to the rectum (≥15 centimeters [cm] of involved colon)
Up-to-date colorectal cancer surveillance (performed according to local standard), for subjects with family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor
Participants must either: be naive to biologic therapy (eg, tumor necrosis factor [TNF] antagonists or vedolizumab) and have at least 1 of the following: inadequate response or failure to tolerate current treatment with oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) OR have received treatment with 1 or more biologic agents (eg, TNF antagonists or vedolizumab) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment

Who cannot join

Have been diagnosed with indeterminate colitis, proctitis (distal disease involving the rectum only; less than 15 cm from the anal verge) or Crohn's Disease
Have had surgery for treatment of UC or are likely to require surgery for UC during the study
Have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 30 days of screening

Trial locations and contacts

76 sites in 16 countries.

Country

City, postcode or hospital

76 sites in 16 countries

Japan18 sites

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Bunkyō City, 113-8519
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Chūōku, 060-0033
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Kagoshima, 892-0846
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Kamakura-shi, 247-0056
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Kasugai-shi, 487-0031
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Kawasaki, 210-0013
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Mitaka, 181-8611
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Nishinomiya, 663-8501
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Ōita, 870-0033
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Osaka, 530-0011
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Saga, 840-8571
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Sakura, 285-8741
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Shinjuku-ku, 169-0073
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Takasaki, 370-0829
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Toyama, 930-8550
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Toyota-shi, 470-1219
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Tsu, 514-8507
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Yokohama, 220-0045

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United States11 sites

University of Michigan
Ann Arbor, Michigan, 48109
Carolinas Healthcare System
Charlotte, North Carolina, 28204
University of Chicago Medical Center
Chicago, Illinois, 60637
Precision Research Institute, LLC
Chula Vista, California, 91910
Borland Groover Clinic
Jacksonville, Florida, 32256 6004
University of California - San Diego
La Jolla, California, 92093
Delta Research Partners LLC
Monroe, Louisiana, 71201
Columbia University Medical Center
New York, New York, 10032
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, 55446
Inland Empire Liver Foundation
Rialto, California, 92377
Care Access Research - Salt Lake City
Salt Lake City, Utah, 84124

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Poland11 sites

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Bydgoszcz, 85-168
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Elblag, 82-300
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Katowice, 40 660
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Krakow, 31009
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Lublin, 20-582
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Rzeszów, 35-068
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Sopot, 81-756
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Warsaw, 03 580
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Warsaw, 03-580
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Wroclaw, 53 114
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Wroclaw, 53114

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Czechia6 sites

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Hradec Králové, 50012
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Prague, 140 21
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Prague, 14021
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Prague, 14059
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Prague, 17004
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Praha 4 Kralove, 14059

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Canada5 sites

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Calgary, T2N 2T9
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Calgary, t2n2z6
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Montreal, H1T 2M4
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Montreal, H3A 1A1
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Montreal, H3G 1A4

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France5 sites

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Clichy, 92110
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Montpellier, 34295
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Nice, 06202
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Saint-Priest-en-Jarez, 42270
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Vandœuvre-lès-Nancy, 54511

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Hungary5 sites

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Békéscsaba, 5600
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Budapest, 1125
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Szeged, 6720
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Szekszárd, 7100
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Vác, 2600

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Australia4 sites

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Concord, 2139
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Fitzroy, 3065
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South Brisbane, 4101
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Woolloongabba, 4102

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Belgium2 sites

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Ghent, 9000
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Leuven, 3000

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Lithuania2 sites

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Kaunas, LT-50009
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Vilnius, 08661

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United Kingdom2 sites

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Oxford, OX3 9DU
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Winchester, S022 5DG

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Denmark1 site

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Svendborg, 5700

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Georgia1 site

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Tbilisi, 0112

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Moldova1 site

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Chisinau, MD2025

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Netherlands1 site

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Amsterdam, 1105 AZ

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Romania1 site

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Bucharest, 020125

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About this study

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis

Conditions: Ulcerative Colitis
Being tested: Mirikizumab, Placebo
Keywords: IL-23 antibody
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MirikizumabDrug
Also called LY3074828
PlaceboDrug

Study groups in NCT02589665
Study group	Role	What they receive
50 mg Mirikizumab IV Q4W (Induction)	Experimental	50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period. Receives: Drug: Mirikizumab
200 mg Mirikizumab IV Q4W (induction)	Experimental	200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period. Receives: Drug: Mirikizumab
600 mg Mirikizumab IV Q4W (Induction)	Experimental	600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period. Receives: Drug: Mirikizumab
Placebo IV Q4W (Induction)	Placebo comparator	Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Receives: Drug: Placebo
200 mg Mirikizumab SC Q4W (Maintenance)	Experimental	Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period. Receives: Drug: Mirikizumab
200 mg Mirikizumab SC Q12W (Maintenance)	Experimental	Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period. Receives: Drug: Mirikizumab
Placebo SC Q4W (Maintenance)	Placebo comparator	Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period. Receives: Drug: Placebo
600mg Mirikizumab IV Q4W Extension Open-Label	Experimental	Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label. Receives: Drug: Mirikizumab
1000mg Mirikizumab IV Q4W Extension Open-Label	Experimental	Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label. Receives: Drug: Mirikizumab
200mg Mirikizumab SC Q4W Extension Open-Label	Experimental	Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label Receives: Drug: Mirikizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Induction Period: Percentage of Participants With Clinical Remission at Week 12
Clinical remission at week 12 is a defined as achieving a 9-pt Mayo subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1, excluding 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) to 3 (blood only passed);
- Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration);
- Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from 0 (normal) to 3 (severe disease).
The total score ranges from 0 to 9 points, with higher scores representing more severe disease.
Measured: Week 12

Secondary outcomes (12)

Induction Period: Percentage of Participants With Clinical Response at Week 12
Clinical response at week 12 is defined as a decrease in the 9-point Mayo subscores (rectal bleeding, stool frequency and the endoscopic findings) inclusive of >= 2 points and >=35% from baseline with either a decrease of rectal bleeding subscore of >=1 or rectal bleeding subscore of 0 or 1.
The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four 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) to 3 (blood only passed);
- Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The total score ranges from 0 to 9 points, with higher scores representing more severe disease.
Measured: Week 12
Induction Period: Percentage of Participants With Endoscopic Remission at Week 12
Endoscopic remission at week 12 is defined as achieving a Mayo endoscopic score of 0 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 total score ranges from 0 to 3 points, with higher scores representing more severe disease.
Measured: Week 12
Maintenance Period: Percentage of Participants With Endoscopic Remission at Week 52
Endoscopic remission at week 52 is defined as achieving a Mayo endoscopic subscore of 0 at Week 52. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration);
The total score ranges from 0 to 3 points, with higher scores representing more severe disease.
Measured: Week 52
Induction Period: Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
The IBDQ is a 32-item subject-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. LS Mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, Week 12
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, with higher values representing a better outcome [(Raw score) - min{raw score}] / (max {raw score} - min{raw score}) x 100]. LS Mean was calculated using Mixed effect Model Repeat Measurement (MMRM) model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, Week 12
Induction Period: Change From Baseline to Week 12 in Patient's Global Impressions of Severity (PGI-S) Score
PGI-S is a 1-item subject-rated questionnaire designed to assess the subject's impression of their disease symptoms at baseline (Guy 1976; Yalcin and Bump 2003). Responses are graded on a 7-point scale in which a score of 1 indicates that the subject's symptom(s) are "normal," a score of 2 indicates that the subject feels "borderline ill," a score of 3 indicates that the subject feels "mildly ill," a score of 4 indicates that the subject(s) feel "moderately ill," and scores of 5, 6, and 7 indicate that the subject feels "markedly ill," "severely ill," and "extremely ill," respectively. LS Mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment*Time (Type III sum of squares).
Measured: Baseline, Week 12
Induction Period: Patient's Global Impressions of Improvement (PGI-I) Score at Week 12
PGI-I scale is a subject-rated instrument designed to assess the subject's impression of change in their symptom(s) (Guy 1976; Yalcin and Bump 2003). Responses are graded on a 7-point Likert scale in which a score of 1 indicates that the subject's symptom(s) is "very much better," a score of 4 indicates that the subject's symptom(s) has experienced "no change," and a score of 7 indicates that the subject's symptom(s) is "very much worse."
Measured: Week 12
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, Tau) of Mirikizumab
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, tau) of Mirikizumab
Measured: Induction Period: Day (D) 1, D15 ± 2d, D29 ± 2d, D43 ± 2d, D57 ± 2d, D78-85; Maintenance Period: D85-92,D113± 7d,D141± 7d,D169± 7d,D225 ±7d,D281 ±7d,D337 ±7d,D393± 7d,D448± 7d,D504± 7d,D560± 7d,D616± 7d,D672± 7d,D728± 7d,D784± 7d,D840± 7d
Induction Period: Percentage of Participants With Symptomatic Remission at Week 12
Symptomatic remission is defined as a stool frequency score of 0 or 1 and a rectal bleeding score of 0.
- Stool Frequency Subscore is 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 is based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed).
The total score ranges from 0 to 1 points, with higher scores representing more severe disease.
The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.
Measured: Week 12
Maintenance Period: Percentage of Participants With Symptomatic Remission at Week 52
Symptomatic remission is defined as a stool frequency score of 0 or 1 and a rectal bleeding score of 0.
- Stool Frequency Subscore , based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal);
- Rectal Bleeding Subscore , based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed);
- Endoscopy Subscore , based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration);
- Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from zero (normal) to 3 (severe disease).
The total score ranges from 0 to 1 points, with higher scores representing more severe disease.
The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.
Measured: Week 52
Induction Period: Percentage of Participants With Endoscopic Improvement at Week 12
Endoscopic Improvement defined as achieving an endoscopic findings subscore of 0 or 1. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.
Measured: Week 12
Maintenance Period: Percentage of Participants With Endoscopic Improvement at Week 52
Endoscopic Improvement defined as achieving an endoscopic findings subscore of 0 or 1. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 20157 May 2019

First posted28 Oct 2015 (estimated)
Study start9 Dec 2015
Primary completion19 Dec 2017
Study completion7 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 249 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02589665
Sponsor's protocol ID: 15829
Other IDs: I6T-MC-AMAC, 2015-003123-57, 2015
Status last verified: Jun 2020
First submitted: 27 Oct 2015
Last updated: 17 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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.

Publications

Friedrich S, Chua L, Adams DH, Crandall W, Zhang XC. Mirikizumab Exposure-Response Relationships in Patients with Moderately-to-Severely Active Ulcerative Colitis in Randomized Phase II and III Studies. Clin Pharmacol Ther. 2024 Aug;116(2):435-447. doi: 10.1002/cpt.3305. Epub 2024 May 26.
PubMed 38797892
Chua L, Friedrich S, Zhang XC. Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. Clin Pharmacokinet. 2023 Oct;62(10):1479-1491. doi: 10.1007/s40262-023-01281-z. Epub 2023 Aug 23.
PubMed 37610533
Johnson T, Steere B, Zhang P, Zang Y, Higgs R, Milch C, Reinisch W, Panes J, Huang K, D'Haens G, Krishnan V. Mirikizumab-Induced Transcriptome Changes in Ulcerative Colitis Patient Biopsies at Week 12 Are Maintained Through Week 52. Clin Transl Gastroenterol. 2023 Nov 1;14(11):e00630. doi: 10.14309/ctg.0000000000000630.
PubMed 37594044
Steere B, Schmitz J, Powell N, Higgs R, Gottlieb K, Liu Y, Jia B, Tuttle JL, Sandborn WJ, Sands BE, D'Haens G, Reinisch W, Krishnan V. Mirikizumab Regulates Genes Involved in Ulcerative Colitis Disease Activity and Anti-TNF Resistance: Results From a Phase 2 Study. Clin Transl Gastroenterol. 2023 Jul 1;14(7):e00578. doi: 10.14309/ctg.0000000000000578.
PubMed 36881820
Dubinsky MC, Panaccione R, Lewis JD, Sands BE, Hibi T, Lee SD, Naegeli AN, Shan M, Green LA, Morris N, Arora V, Bleakman AP, Belin R, Travis S. Impact of Bowel Urgency on Quality of Life and Clinical Outcomes in Patients With Ulcerative Colitis. Crohns Colitis 360. 2022 Jun 3;4(3):otac016. doi: 10.1093/crocol/otac016. eCollection 2022 Jul.
PubMed 36777426
Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Hibi T, D'Haens GR, Tuttle JL, Krueger K, Friedrich S, Durante M, Arora V, Naegeli AN, Schmitz J, Feagan BG. Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):105-115.e14. doi: 10.1016/j.cgh.2020.09.028. Epub 2020 Sep 18.
PubMed 32950748
Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Feagan BG, Hibi T, Tuttle JL, Klekotka P, Friedrich S, Durante M, Morgan-Cox M, Laskowski J, Schmitz J, D'Haens GR. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):537-549.e10. doi: 10.1053/j.gastro.2019.08.043. Epub 2019 Sep 4.
PubMed 31493397

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
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Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease

All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis
ClinicalTrials.gov ID: NCT02589665
Acronym / sponsor ID: 15829
Conditions: Ulcerative Colitis
Keywords: IL-23 antibody
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 249 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 9 Dec 2015 (actual)
Primary completion: 19 Dec 2017 (actual)
Study completion: 7 May 2019 (actual)
First posted: 28 Oct 2015 (estimated)
Results: Posted 29 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
50 mg Mirikizumab IV Q4W (Induction)	Experimental	Drug: Mirikizumab50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
200 mg Mirikizumab IV Q4W (induction)	Experimental	Drug: Mirikizumab200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
600 mg Mirikizumab IV Q4W (Induction)	Experimental	Drug: Mirikizumab600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
Placebo IV Q4W (Induction)	Placebo comparator	Drug: PlaceboPlacebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
200 mg Mirikizumab SC Q4W (Maintenance)	Experimental	Drug: MirikizumabInduction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
200 mg Mirikizumab SC Q12W (Maintenance)	Experimental	Drug: MirikizumabInduction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
Placebo SC Q4W (Maintenance)	Placebo comparator	Drug: PlaceboInduction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.
600mg Mirikizumab IV Q4W Extension Open-Label	Experimental	Drug: MirikizumabInduction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
1000mg Mirikizumab IV Q4W Extension Open-Label	Experimental	Drug: MirikizumabInduction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
200mg Mirikizumab SC Q4W Extension Open-Label	Experimental	Drug: MirikizumabExtension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an endoscopic subscore ≥2 within 14 days before the first dose of study treatment (note: a partial Mayo score of at least 4 and other eligibility criteria must have been met before endoscopy is performed as a study procedure)
Have evidence of UC extending proximal to the rectum (≥15 centimeters [cm] of involved colon)
Up-to-date colorectal cancer surveillance (performed according to local standard), for subjects with family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor
Participants must either: be naive to biologic therapy (eg, tumor necrosis factor [TNF] antagonists or vedolizumab) and have at least 1 of the following: inadequate response or failure to tolerate current treatment with oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) OR have received treatment with 1 or more biologic agents (eg, TNF antagonists or vedolizumab) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment

Key exclusion criteria (3 listed)

Have been diagnosed with indeterminate colitis, proctitis (distal disease involving the rectum only; less than 15 cm from the anal verge) or Crohn's Disease
Have had surgery for treatment of UC or are likely to require surgery for UC during the study
Have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 30 days of screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MirikizumabAlso: LY3074828	Drug	1000mg Mirikizumab IV Q4W Extension Open-Label, 200 mg Mirikizumab IV Q4W (induction), 200 mg Mirikizumab SC Q12W (Maintenance), 200 mg Mirikizumab SC Q4W (Maintenance), 200mg Mirikizumab SC Q4W Extension Open-Label, 50 mg Mirikizumab IV Q4W (Induction), 600 mg Mirikizumab IV Q4W (Induction), 600mg Mirikizumab IV Q4W Extension Open-Label
Placebo	Drug	Placebo IV Q4W (Induction), Placebo SC Q4W (Maintenance)

Primary outcome

Induction Period: Percentage of Participants With Clinical Remission at Week 12
Time frame: Week 12
Clinical remission at week 12 is a defined as achieving a 9-pt Mayo subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1, excluding 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) to 3 (blood only passed); * Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); * Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from 0 (normal) to 3 (severe disease). The total score ranges from 0 to 9 points, with higher scores representing more severe disease.

12 secondary outcomes

Induction Period: Percentage of Participants With Clinical Response at Week 12
Time frame: Week 12
Induction Period: Percentage of Participants With Endoscopic Remission at Week 12
Time frame: Week 12
Maintenance Period: Percentage of Participants With Endoscopic Remission at Week 52
Time frame: Week 52
Induction Period: Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Time frame: Baseline, Week 12
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
Time frame: Baseline, Week 12
Induction Period: Change From Baseline to Week 12 in Patient's Global Impressions of Severity (PGI-S) Score
Time frame: Baseline, Week 12
Induction Period: Patient's Global Impressions of Improvement (PGI-I) Score at Week 12
Time frame: Week 12
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, Tau) of Mirikizumab
Time frame: Induction Period: Day (D) 1, D15 ± 2d, D29 ± 2d, D43 ± 2d, D57 ± 2d, D78-85; Maintenance Period: D85-92,D113± 7d,D141± 7d,D169± 7d,D225 ±7d,D281 ±7d,D337 ±7d,D393± 7d,D448± 7d,D504± 7d,D560± 7d,D616± 7d,D672± 7d,D728± 7d,D784± 7d,D840± 7d
Induction Period: Percentage of Participants With Symptomatic Remission at Week 12
Time frame: Week 12
Maintenance Period: Percentage of Participants With Symptomatic Remission at Week 52
Time frame: Week 52
Induction Period: Percentage of Participants With Endoscopic Improvement at Week 12
Time frame: Week 12
Maintenance Period: Percentage of Participants With Endoscopic Improvement at Week 52
Time frame: Week 52

Results and safety

Results posted to the registry on 29 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Induction: Placebo IV Q4W	63	60
Induction: 50 mg Mirikizumab IV Q4W	63	61
Induction: 200 mg Mirikizumab IV Q4W	62	60
Induction: 600 mg Mirikizumab IV Q4W	61	57
Maintenance: Placebo SC Q4W	0	0
Maintenance: 200 mg Mirikizumab SC Q4W	0	0
Maintenance: 200 mg Mirikizumab SC Q12W	0	0
Induction Extension: 600mg Mirikizumab IV Q4W	0	0
Induction Extension: 1000mg Mirikizumab IV Q4W	0	0
Maintenance Extension: 200mg Mirikizumab SC Q4W	0	0

Primary outcome: Induction Period: Percentage of Participants With Clinical Remission at Week 12

Time frame: Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo IV Q4W n = 63	50 mg Mirikizumab IV Q4W n = 63	200 mg Mirikizumab IV Q4W n = 62	600 mg Mirikizumab IV Q4W n = 61
Value	4.8 (0.0 to 10.0)	15.9 (6.8 to 24.9)	22.6 (12.2 to 33.0)	11.5 (3.5 to 19.5)

Placebo IV Q4W vs 600 mg Mirikizumab IV Q4W: Odds Ratio (OR): 2.93 (95% CI 0.70 to 12.27)
Placebo IV Q4W vs 200 mg Mirikizumab IV Q4W: Odds Ratio (OR): 7.22 (95% CI 1.88 to 27.65)
Placebo IV Q4W vs 50 mg Mirikizumab IV Q4W: Odds Ratio (OR): 3.61 (95% CI 0.92 to 14.17)

Population analysed: Induction Period: All randomized participants.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To 39 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Induction: Placebo IV Q4W	2 of 63 (3.2%)	18 of 63 (28.6%)	0 of 63
Induction: 50 mg Mirikizumab Administered Every 4 Weeks (Q4W)	0 of 63 (0%)	14 of 63 (22.2%)	0 of 63
Induction: 200 mg Mirikizumab IV Q4W	2 of 62 (3.2%)	8 of 62 (12.9%)	0 of 62
Induction: 600 mg Mirikizumab IV Q4W	3 of 60 (5%)	14 of 60 (23.3%)	0 of 60
Maintenance: Placebo SC Q4W	2 of 13 (15.4%)	11 of 13 (84.6%)	0 of 13
Maintenance: 200 mg Mirikizumab SC Q4W	2 of 47 (4.3%)	27 of 47 (57.4%)	0 of 47
Maintenance: 200 mg Mirikizumab SC Q12W	1 of 46 (2.2%)	30 of 46 (65.2%)	0 of 46
Induction Extension: 600mg Mirikizumab IV Q4W	1 of 32 (3.1%)	9 of 32 (28.1%)	0 of 32
Induction Extension:1000mg Mirikizumab IV Q4W	5 of 96 (5.2%)	8 of 96 (8.3%)	0 of 96
Maintenance Extension: 200mg Mirikizumab SC Q4W	3 of 68 (4.4%)	30 of 68 (44.1%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38797892Friedrich S, Chua L, Adams DH, Crandall W, Zhang XC. Mirikizumab Exposure-Response Relationships in Patients with Moderately-to-Severely Active Ulcerative Colitis in Randomized Phase II and III Studies. Clin Pharmacol Ther. 2024 Aug;116(2):435-447. doi: 10.1002/cpt.3305. Epub 2024 May 26.
Derived from this study: PubMed 37610533Chua L, Friedrich S, Zhang XC. Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. Clin Pharmacokinet. 2023 Oct;62(10):1479-1491. doi: 10.1007/s40262-023-01281-z. Epub 2023 Aug 23.
Derived from this study: PubMed 37594044Johnson T, Steere B, Zhang P, Zang Y, Higgs R, Milch C, Reinisch W, Panes J, Huang K, D'Haens G, Krishnan V. Mirikizumab-Induced Transcriptome Changes in Ulcerative Colitis Patient Biopsies at Week 12 Are Maintained Through Week 52. Clin Transl Gastroenterol. 2023 Nov 1;14(11):e00630. doi: 10.14309/ctg.0000000000000630.
Derived from this study: PubMed 36881820Steere B, Schmitz J, Powell N, Higgs R, Gottlieb K, Liu Y, Jia B, Tuttle JL, Sandborn WJ, Sands BE, D'Haens G, Reinisch W, Krishnan V. Mirikizumab Regulates Genes Involved in Ulcerative Colitis Disease Activity and Anti-TNF Resistance: Results From a Phase 2 Study. Clin Transl Gastroenterol. 2023 Jul 1;14(7):e00578. doi: 10.14309/ctg.0000000000000578.
Derived from this study: PubMed 36777426Dubinsky MC, Panaccione R, Lewis JD, Sands BE, Hibi T, Lee SD, Naegeli AN, Shan M, Green LA, Morris N, Arora V, Bleakman AP, Belin R, Travis S. Impact of Bowel Urgency on Quality of Life and Clinical Outcomes in Patients With Ulcerative Colitis. Crohns Colitis 360. 2022 Jun 3;4(3):otac016. doi: 10.1093/crocol/otac016. eCollection 2022 Jul.
Derived from this study: PubMed 32950748Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Hibi T, D'Haens GR, Tuttle JL, Krueger K, Friedrich S, Durante M, Arora V, Naegeli AN, Schmitz J, Feagan BG. Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):105-115.e14. doi: 10.1016/j.cgh.2020.09.028. Epub 2020 Sep 18.
Derived from this study: PubMed 31493397Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Feagan BG, Hibi T, Tuttle JL, Klekotka P, Friedrich S, Durante M, Morgan-Cox M, Laskowski J, Schmitz J, D'Haens GR. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):537-549.e10. doi: 10.1053/j.gastro.2019.08.043. Epub 2019 Sep 4.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

76 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mirikizumab in people with Ulcerative Colitis, run by Eli Lilly and Company at 76 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Japan, United States, Poland, Czechia, Canada and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Induction Period: Percentage of Participants With Clinical Remission at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02589665, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.