A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis
NCT ID: NCT02589665
Last Updated: 2020-06-17
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
249 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-12-09
Study Completion Date
2019-05-07
Brief Summary
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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.
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Detailed Description
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Conditions
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Ulcerative Colitis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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50 mg Mirikizumab IV Q4W (Induction)
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.
Group Type
EXPERIMENTAL
Mirikizumab
Intervention Type
DRUG
200 mg Mirikizumab IV Q4W (induction)
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.
Group Type
EXPERIMENTAL
Mirikizumab
Intervention Type
DRUG
600 mg Mirikizumab IV Q4W (Induction)
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.
Group Type
EXPERIMENTAL
Mirikizumab
Intervention Type
DRUG
Placebo IV Q4W (Induction)
Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
200 mg Mirikizumab SC Q4W (Maintenance)
Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
Group Type
EXPERIMENTAL
Mirikizumab
Intervention Type
DRUG
200 mg Mirikizumab SC Q12W (Maintenance)
Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
Group Type
EXPERIMENTAL
Mirikizumab
Intervention Type
DRUG
Placebo SC Q4W (Maintenance)
Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
600mg Mirikizumab IV Q4W Extension Open-Label
Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
Group Type
EXPERIMENTAL
Mirikizumab
Intervention Type
DRUG
1000mg Mirikizumab IV Q4W Extension Open-Label
Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
Group Type
EXPERIMENTAL
Mirikizumab
Intervention Type
DRUG
200mg Mirikizumab SC Q4W Extension Open-Label
Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label
Group Type
EXPERIMENTAL
Mirikizumab
Intervention Type
DRUG
Interventions
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Mirikizumab
Intervention Type
DRUG
Placebo
Intervention Type
DRUG
Other Intervention Names
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LY3074828
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Precision Research Institute, LLC
Chula Vista, California, United States
Site Status
University of California - San Diego
La Jolla, California, United States
Site Status
Inland Empire Liver Foundation
Rialto, California, United States
Site Status
Borland Groover Clinic
Jacksonville, Florida, United States
Site Status
University of Chicago Medical Center
Chicago, Illinois, United States
Site Status
Delta Research Partners LLC
Monroe, Louisiana, United States
Site Status
University of Michigan
Ann Arbor, Michigan, United States
Site Status
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, United States
Site Status
Columbia University Medical Center
New York, New York, United States
Site Status
Carolinas Healthcare System
Charlotte, North Carolina, United States
Site Status
Care Access Research - Salt Lake City
Salt Lake City, Utah, United States
Site Status
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Concord, , Australia
Site Status
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Fitzroy, , Australia
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South Brisbane, , Australia
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Woolloongabba, , Australia
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Ghent, , Belgium
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Leuven, , Belgium
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Calgary, , Canada
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Calgary, , Canada
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Montreal, , Canada
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Montreal, , Canada
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Montreal, , Canada
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Hradec Králové, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Praha 4 Kralove, , Czechia
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Svendborg, , Denmark
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Clichy, , France
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Montpellier, , France
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Nice, , France
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Saint-Priest-en-Jarez, , France
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Vandœuvre-lès-Nancy, , France
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Tbilisi, , Georgia
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Békéscsaba, , Hungary
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Budapest, , Hungary
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Szeged, , Hungary
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Szekszárd, , Hungary
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Vác, , Hungary
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Bunkyō City, , Japan
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Chūōku, , Japan
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Kagoshima, , Japan
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Kamakura-shi, , Japan
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Kasugai-shi, , Japan
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Kawasaki, , Japan
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Mitaka, , Japan
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Nishinomiya, , Japan
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Osaka, , Japan
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Ōita, , Japan
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Saga, , Japan
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Sakura, , Japan
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Shinjuku-ku, , Japan
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Takasaki, , Japan
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Toyama, , Japan
Site Status
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Toyota-shi, , Japan
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Tsu, , Japan
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Yokohama, , Japan
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Kaunas, , Lithuania
Site Status
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Vilnius, , Lithuania
Site Status
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Chisinau, , Moldova
Site Status
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Amsterdam, , Netherlands
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Bydgoszcz, , Poland
Site Status
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Elblag, , Poland
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Katowice, , Poland
Site Status
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Krakow, , Poland
Site Status
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Lublin, , Poland
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Rzeszów, , Poland
Site Status
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Sopot, , Poland
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Warsaw, , Poland
Site Status
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Warsaw, , Poland
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Wroclaw, , Poland
Site Status
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Wroclaw, , Poland
Site Status
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Bucharest, , Romania
Site Status
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Oxford, , United Kingdom
Site Status
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Winchester, , United Kingdom
Site Status
Countries
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United States
Australia
Belgium
Canada
Czechia
Denmark
France
Georgia
Hungary
Japan
Lithuania
Moldova
Netherlands
Poland
Romania
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
Access external resources that provide additional context or updates about the study.
http://www.lillytrialguide.com/EN-us/studies/colitis/amac
Click here for more information about this study: A Study of LY3074828 in Participants With Moderate to Severe Ulcerative Colitis
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I6T-MC-AMAC
Identifier Type: OTHER
Identifier Source: secondary_id
2015-003123-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15829
Identifier Type: -
Identifier Source: org_study_id
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