A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease
NCT ID: NCT02891226
Last Updated: 2022-08-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
191 participants
INTERVENTIONAL
2016-12-14
2021-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Mirikizumab
Placebo
Period 1 (Weeks 0 -12): Participants received placebo administered intravenously (IV) Q4W.
Placebo
Interventions
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Mirikizumab
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Longwood Research
Huntsville, Alabama, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Valley View Internal Medicine
Garden Grove, California, United States
Ventura Clinical Trials
Ventura, California, United States
Delta Waves Sleep Disorders and Research Center
Colorado Springs, Colorado, United States
Medical Research Center of Connecticut
Hamden, Connecticut, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Wellness Clinical Research
Hialeah Gardens, Florida, United States
University of Miami
Miami, Florida, United States
Vista Health Research
Miami, Florida, United States
Clinical Neuroscience Solutions Inc
Orlando, Florida, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Indiana University Health
Indianapolis, Indiana, United States
Robley Rex VAMC
Louisville, Kentucky, United States
Health Quest Medical Care
Owensboro, Kentucky, United States
Delta Research Partners LLC
Monroe, Louisiana, United States
Louisiana Research Center
Shreveport, Louisiana, United States
MedStar Health Research Institute
Rosedale, Maryland, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, United States
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, United States
Washington University Medical School
St Louis, Missouri, United States
St. Louis Center for Clinical Research
St Louis, Missouri, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Carolina Digestive Diseases
Greenville, North Carolina, United States
Consultants For Clinical Research
Cincinnati, Ohio, United States
University Hospitals Health Center
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Healthcare Research Consultant
Tulsa, Oklahoma, United States
Ocean State Clinical Research Partners
Lincoln, Rhode Island, United States
Gastro One
Germantown, Tennessee, United States
Advanced Gastroenterology
Union City, Tennessee, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
Hermann Drive Surgical Hospital
Houston, Texas, United States
Digestive Health Associates of Texas
Richardson, Texas, United States
San Antonio Gastroenterology
San Antonio, Texas, United States
Care Access Research - Salt Lake City
Salt Lake City, Utah, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Ballarat Health Services - Base Hospital
Ballarat, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Hospital Universitaire Erasme Brussel
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Sudbury Endoscopy Centre
Greater Sudbury, Ontario, Canada
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, Czech Republic, Czechia
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Gregar s.r.o.
Olomouc, , Czechia
Fakultni Nemocnice v Motole
Prague, , Czechia
Thomayerova Nemocnice
Praha 4 - Krc, , Czechia
Krajska nemocnice T. Bati a.s.
Zlín, , Czechia
Obudai Egeszsegugyi Centrum Kft
Budapest, , Hungary
Javorszky Odon Hospital
Vác, , Hungary
Toho University School of Medicine, Sakura Hospital
Sakura-shi, Chiba, Japan
Kitakyushu Municipal Medical Center
Kitakyusyu-shi, Fukoka, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, Hokkaido, Japan
Sameshima Hospital
Kagoshima, Kagoshima-ken, Japan
Gokeikai Ofuna Chuo Hospital
Kamakura-shi, Kanagawa, Japan
Takagi Clinic
Sendai, Miyagi, Japan
Kinshukai Infusion Clinic
Osaka, Osaka, Japan
Tokyo Medical And Dental University Hospital
Bunkyo-ku, Tokyo, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
JHCO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, Japan
Toyama Prefectural Central Hospital
Toyama, Toyama, Japan
Fukuoka University Hospital
Fukuoka, , Japan
St Elisabeth Ziekenhuis
Tilburg, North Brabant, Netherlands
Academisch Medisch Centrum
Amsterdam, , Netherlands
Radboud Universitair Medisch Centrum Nijmegen
Nijmegen, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Szpital Uniwersytecki nr 2 im. dr J. Biziela
Bydgoszcz, , Poland
KO-MED Centra Kliniczne Lublin II
Lublin, , Poland
SOLUMED Centrum Medyczne
Poznan, , Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, , Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, , Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw, , Poland
Melita Medical Sp. Z O. O.
Wroclaw, , Poland
SC Pelican SRL
Oradea, Bihor County, Romania
SC Med Life SA
Bucharest, , Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, , Romania
Novosibirsk State Medical University
Novosibirsk, , Russia
FSBI Scientific Research Inst. of Physyology and Basic Medic
Novosibirsk, , Russia
Ultramed
Omsk, , Russia
City Clinical Hospital # 2 n.a. Fedor Khristoforovich Gral
Perm, , Russia
Private Medical Institution Evromedservis
Pushkin, , Russia
Baltic Medicine
Saint Petersburg, , Russia
City Hospital of Saint Martyr Elizabeth
Saint Petersburg, , Russia
LLC Scientific Research Centre EKO-Bezopasnost
Saint Petersburg, , Russia
Medical Institute REAVIZ
Samara, , Russia
NonState Healthcare Institution Central Clinical Hospital
Samara, , Russia
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, , Russia
Universitätsspital Zürich
Zurich, , Switzerland
Kyiv Municipal Clinical Hospital #1
Kyiv, , Ukraine
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
Kyiv, , Ukraine
Lviv Regional Central Hospital
Lviv, , Ukraine
Odesa Regional Clinical Hospital
Odesa, , Ukraine
A. Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, , Ukraine
Vinnitsa City Clinical Hospital #1
Vinnytsia, , Ukraine
SRI of Invalid Rehabil.,Educ.Scient.Med.Complex
Vinnytsia, , Ukraine
City Clinical Hospital #6
Zaporizhzhia, , Ukraine
CI City Hospital #1
Zaporizhzhia, , Ukraine
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Countries
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References
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Magro F, Protic M, De Hertogh G, Chan LS, Pollack P, Jairath V, Carlier H, Hon E, Feagan BG, Harpaz N, Pai R, Reinisch W. Effects of Mirikizumab on Histologic Resolution of Crohn's Disease in a Randomized Controlled Phase 2 Trial. Clin Gastroenterol Hepatol. 2024 Sep;22(9):1878-1888.e10. doi: 10.1016/j.cgh.2023.11.010. Epub 2023 Nov 20.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease (SERENITY)
Other Identifiers
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I6T-MC-AMAG
Identifier Type: OTHER
Identifier Source: secondary_id
2016-002204-84
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16492
Identifier Type: -
Identifier Source: org_study_id
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