A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

May 12, 2026 updated by: Eli Lilly and Company

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1328

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, X5016KEH
        • Hospital Privado Centro Medico de Cordoba SA
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1027AAP
        • Centro de Investigaciones Metabólicas (CINME)
      • Ciudad Autonoma de Buenos Air, Buenos Aires, Argentina, C1128AAF
        • Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
      • Quilmes, Buenos Aires, Argentina, B1878DVC
        • Cer Instituto Medico
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DEJ
        • Fundacion de Estudios Clinicos
    • Tucumán Province
      • SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL
        • Centro de Investigaciones Medicas Tucuman
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • C.I.C.E. 9 de Julio
  • Australia
    • Essex
      • Harlow, Essex, Australia, CM20 1QX
        • Princess Alexandra Hospital
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Coastal Digestive Health
      • South Brisbane, Queensland, Australia, 4101
        • Mater University Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital Outpatients
      • Malvern, Victoria, Australia, 3144
        • Melbourne Gastrointestinal Investigation Unit (MGIU)
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
  • Austria
      • Innsbruck, Austria, 6020
        • Medizinische Universitat Innsbruck
      • Salzburg, Austria, 5020
        • Universitätsklinikum Salzburg
      • Vienna, Austria, 1090
        • Medical University of Vienna
  • Belgium
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Universitair Ziekenhuis Gent
    • Wallonne, Région
      • Tournai, Wallonne, Région, Belgium, 7500
        • Centre Hospitalier de Wallonie Picarde - Site Notre Dame
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5R 1W2
        • West Edmonton Diabetes Center
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GI Research Institute
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • The Gordon and Leslie Diamond Health Care Centre
      • Victoria, British Columbia, Canada, V8V 3M9
        • PerCuro Clinical Research
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Victoria Hospital
      • London, Ontario, Canada, N6A 5G1
        • University of Western Ontario
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Centre de santé et de services sociaux Champlain-Charles-Le Moyne
      • Montreal, Quebec, Canada, H1T 2M4
        • Hopital Maisonneure-Rosemount
      • Montreal, Quebec, Canada, H3G 1A4
        • Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC
  • China
      • Wuhan, China, 430030
        • Tongji Hospital of Tongji University
    • Anhui
      • Hefei, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, Anhui, China, 230000
        • Anhui Provincial Hospital
    • Changsha City
      • Kaifu District, Changsha City, China, 410008
        • Xiangya Hospital Central South University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400037
        • The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
      • Chongqing, Chongqing Municipality, China, 400038
        • The First Hospital Affiliated to AMU (Southwest Hospital)
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated hospital, Sun Yat-sen University
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • The Affiliated Drum Tower Hospital of Nanjing University
      • Nanjing, Jiangsu, China, 210029
        • Zhongda Hospital Southeast University
      • Nanjing, Jiangsu, China, 211106
        • Nanjing Medical University - Nanjing Jiangning Hospital
    • Jiangxi
      • Pingxiang, Jiangxi, China, 337055
        • Jiangxi Pingxiang People's Hospital
    • Jilin
      • Jilin, Jilin, China, 132011
        • Jilin Central General Hospital
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital
      • Jinan, Shandong, China, 250014
        • Qilu Hospital of Shandong University
      • Liaocheng, Shandong, China, 252000
        • Liaocheng People's Hospital
      • Qingdao, Shandong, China, 266000
        • The Affiliated Hospital of Qingdao University
      • Taian, Shandong, China, 271000
        • Taian City Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Shanghai Jiaotong University School of Medicine Ruijin Hospital
      • Shanghai, Shanghai Municipality, China, 200127
        • Renji Hospital Affliated to Shanghai Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
    • Yunnan
      • Kunming, Yunnan, China, 650034
        • The First People's Hospital of Yunnan Province
      • Kunming, Yunnan, China, 650032
        • Kunming Medical College Affiliated First Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital
      • Hangzhou, Zhejiang, China, 310003
        • First Affiliated Hosp of College of Med, Zhejiang University
      • Hangzhou, Zhejiang, China, 310000
        • The Second Affiliated Hospital of Zhejiang University School of Med
      • Wenzhou, Zhejiang, China, 325027
        • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
  • Czechia
      • Brno, Czechia, 65691
        • Fakultni nemocnice u sv. Anny v Brne
      • Olomouc, Czechia, 779
        • PreventaMed, s.r.o.
      • Prague, Czechia, 19000
        • ISCARE Clinical Centre
    • Brno-město
      • Brno, Brno-město, Czechia, 636 00
        • Vojenska nemocnice Brno
    • Hl. M. Praha
      • Prague, Hl. M. Praha, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
    • Hradec Králové
      • Hradec Králové, Hradec Králové, Czechia, 500 12
        • Hepato-Gastroenterologie HK
    • Olomouc Region
      • Olomouc, Olomouc Region, Czechia, 779 00
        • MUDr. Gregar, s.r.o.
    • Plzeň-město
      • Pilsen, Plzeň-město, Czechia, 301 00
        • A-Shine
    • Praha 8
      • Prague, Praha 8, Czechia, 186 00
        • MEDIENDO
  • Denmark
      • Herlev, Denmark, 2730
        • Herlev and Gentofte Hospital
      • Køge, Denmark, 4600
        • Zealand University Hospital Køge
  • France
      • Chambray-lès-Tours, France, 37170
        • CHU Tours - Hôpital Trousseau
      • Marseille, France, 13915
        • Assistance Publique Hôpitaux de Marseille - Hôpital Nord
      • Montpellier, France, 34295
        • CHRU de Montpellier-Hopital St Eloi
      • Nice, France, 06200
        • Hopital L'Archet 2
      • Pessac, France, 33604
        • CHU Bordeaux - Hôpital Haut-Lévêque
      • Reims, France, 51092
        • Robert Debré Hospital
      • Saint-Priest-en-Jarez, France, 42270
        • CHU de Saint Etienne Hopital Nord
      • Vandœuvre-lès-Nancy, France, 54500
        • CHRU Nancy Brabois - Hôpital d'Enfants
    • Bas Rhin
      • Strasbourg, Bas Rhin, France, 67098
        • Hopital de Hautepierre - Service d'Hépatogastroentérolgie
    • Cedex 10
      • Paris, Cedex 10, France, 75475
        • Hopital Saint-Louis
    • Nord
      • Lille, Nord, France, 59037
        • CHU Lille - Hôpital Claude Huriez
    • Paris
      • Clichy, Paris, France, 92110
        • Hôpital Beaujon
    • Pyrénées-Atlantiques
      • Pau, Pyrénées-Atlantiques, France, 64046
        • Centre Hospitalier de Pau
    • Rhone
      • Pierre-Bénite, Rhone, France, 69495
        • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
    • Somme
      • Amiens, Somme, France, 80480
        • CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro
  • Germany
      • Berlin, Germany, 14163
        • Krankenhaus Waldfriede
      • Berlin, Germany, 12203
        • Charité Campus Virchow-Klinikum
      • Brandenburg, Germany, 14770
        • Städtisches Klinikum Brandenburg
      • Hamburg, Germany, 20251
        • HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
      • Weyhe, Germany, 28844
        • Internistische Praxisgemeinschaft
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Medizinische Hochschule Hanover
    • Rhineland-Palatinate
      • Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67067
        • Gemeinschaftspraxis Dr. Peter Uebel
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06108
        • Studiengesellschaft BSF Unternehmergesellschaft
      • Halle, Saxony-Anhalt, Germany, 06120
        • Universitatsklinikum Halle
  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem
      • Budapest, Hungary, 1036
        • Óbudai Egészségügyi Centrum
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Miskolc, Hungary, 3526
        • Endomedix Diagnosztikai Központ - Miskolc
      • Mosonmagyaróvár, Hungary, 9200
        • Karolina Korhaz-Rendelointezet
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
      • Szekszárd, Hungary, 7100
        • CLINFAN Szolgáltató Kft
    • EU
      • Balatonfüred, EU, Hungary, 8230
        • DRC Gyogyszervizsgalo Kozpont Kft.
    • Pest County
      • Vác, Pest County, Hungary, 2600
        • Javorszky Odon Korhaz
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500058
        • Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
    • Gujarat
      • Gandhinagar, Gujarat, India, 382428
        • Apollo Research and Innovations, Apollo Hospitals International Ltd
      • Rajkot, Gujarat, India, 360005
        • Shree Giriraj Multispeciality Hospital
      • Surat, Gujarat, India, 395002
        • Nirmal Hospital Pvt Ltd.
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • M S Ramaiah Medical College and Hospitals
      • Bangalore, Karnataka, India, 560 002
        • Bangalore Medical College and Research Institute
    • Maharashtra
      • Nagpur, Maharashtra, India, 440010
        • Midas Multispeciality Hospital Pvt.Ltd.
      • Pune, Maharashtra, India, 411 001
        • Poona Medical Foundation. Ruby Hall Clinic
      • Wardha, Maharashtra, India, 442004
        • Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110 025
        • Escorts Heart Institute and Research Centre Ltd
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College and Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
        • SR Kalla Memorial Gastro & General Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500003
        • Gandhi Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • King George Medical University
  • Ireland
      • Dublin, Ireland, D9
        • Beaumont Hospital, Dublin
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center - Pediatric Outpatient Clinic
      • Nahariya, Israel, 2210001
        • Galilee Medical Center Department of Internal Medicine A
      • Rehovot, Israel, 7610001
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
      • Ẕerifin, Israel, 70300
        • King Fahad Medical City
    • Jerusalem
      • Bait Vagan, Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
  • Italy
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Catanzaro, Italy, 88100
        • Azienda ospedaliero-universitaria Mater Domini
      • Genova, Italy, 16132
        • Azienda Ospedaliero Universitaria San Martino
      • Milan, Italy, 20122
        • Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
      • Modena, Italy, 41124
        • Azienda Ospedaliera Universitaria Policlinico de Modena
      • Pisa, Italy, 56124
        • Azienda Ospedaliera Universitaria Pisana
      • Roma, Italy, 00168
        • Policlinico Gemelli - Università Cattolica del Sacro Cuore
      • Torino, Italy, 10128
        • Ospedale Mauriziano Umberto I
      • Udine, Italy, 33100
        • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia
    • Milano
      • Rho, Milano, Italy, 20017
        • Presidio di Rho
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas
      • San Donato Milanese, Milano, Italy, 20097
        • Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia
    • Roma
      • Rome, Roma, Italy, 00157
        • Ospedale Sandro Pertini
      • Torre, Roma, Italy, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Japan
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Kagoshima, Japan, 892-0846
        • Sameshima Hospital
      • Kyoto, Japan, 612-8555
        • National Hospital Organization Kyoto Medical Center
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Saitama, Japan, 336-0963
        • Tokitokai Tokito Clinic
      • Toyama, Japan, 930-0975
        • Toyama Prefectural Central Hospital
    • Aichi-ken
      • Nagakute-shi, Aichi-ken, Japan, 480-1195
        • Aichi Medical University Hospital
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Fujita Health University
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8545
        • National Hospital Organization Hirosaki National Hospital
    • Chiba
      • Sakura, Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center
    • Fukoka
      • Kitakyusyu-shi, Fukoka, Japan, 802-0077
        • Kitakyushu Municipal Medical Center
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-8502
        • Fukuoka University Chikushi Hospital
      • Kurume-shi, Fukuoka, Japan, 839 0809
        • Hidaka Coloproctology Clinic
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Gunma University Hospital
      • Takasaki, Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Centar
    • HigaShiibaraki-Gun
      • Ibaraki-machi, HigaShiibaraki-Gun, Japan, 311 3193
        • NHO Mito Medical Center
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 070-8610
        • Asahikawa City Hospital
      • Sapporo, Hokkaido, Japan, 065-0033
        • Sapporo Higashi Tokushukai Hospital
      • Sapporo, Hokkaido, Japan, 004 0041
        • Tokushukai Sapporo Tokushukai Hospital
      • Sapporo, Hokkaido, Japan, 060 0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650 0015
        • Aoyama Clinic GI Endoscopy & IBD Center
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Japan, 760-8557
        • Kagawa Prefectural Central Hospital
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-0056
        • Ofuna Central Hospital
      • Kawasaki, Kanagawa, Japan, 210-0013
        • Kawasaki Municipal Hospital
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
      • Yokohama, Kanagawa, Japan, 234-0032
        • Showa University Northern Yokohama Hospital
      • Yokohama, Kanagawa, Japan, 226 0025
        • Sankikai Yokohama Shin midori General Hospital
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 860-0012
        • Kumamoto University Hospital
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Mie University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 981 3213
        • Takagi Clinic - Sendai
    • Niigata
      • Nagaoka-shi, Niigata, Japan, 940-8653
        • Nagaoka Chuo General Hospital
    • Oita Prefecture
      • Ōita, Oita Prefecture, Japan, 870 0823
        • Ishida Clinic of IBD and Gastroenterology
    • Osaka
      • Fujiidera, Osaka, Japan, 583-0027
        • Sai Gastroenterologist Proctology
      • Osaka, Osaka, Japan, 530 0011
        • Infusion Clinic
      • Osaka, Osaka, Japan, 540 0006
        • NHO Osaka National Hospital
    • Saga-ken
      • Saga, Saga-ken, Japan, 840-8571
        • Saga-Ken Medical Center Koseikan
    • Saitama
      • Kumagaya-shi, Saitama, Japan, 360-8567
        • Kumagaya General Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 4328061
        • Matsuda Hospital
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Bunkyō, Tokyo, Japan, 113-8519
        • Tokyo Medical and Dental University Hospital
      • Koto-ku, Tokyo, Japan, 135 8577
        • Showa University Koto Toyosu Hospital
      • Minato-Ku, Tokyo, Japan, 108 8642
        • Kitasato University Kitasato Institute Hospital
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin University Hospital
      • Shinjuku-ku, Tokyo, Japan, 169-0073
        • JHCO Tokyo Yamate Medical Center
    • Tokyo-To
      • Chiyoda-ku, Tokyo-To, Japan, 101-8643
        • Mitsui Memorial Hospital
      • Shinjuku-ku, Tokyo-To, Japan, 162 8655
        • Center Hospital of the National Center for Global Health and Medicine
  • Latvia
      • Riga, Latvia, 1079
        • Digestive Diseases Center "Gastro"
      • Riga, Latvia, LV-1038
        • Riga Eastern Clinical University Hospital
    • Riga
      • Riga, Riga, Latvia, LV-1002
        • Pauls Stradins Clinical Univeristy Hospital
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Hospital of Lithuanian University of Health Sciences Kaunas
      • Klaipėda, Lithuania, 92288
        • Klaipeda Seamen's Hospital
      • Klaipėda, Lithuania, 92231
        • Republic Hospital of Klaipeda
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital Santariskiu Clinics
    • Panevėžys
      • Panevezys, Panevėžys, Lithuania, LT-35144
        • Respublikine Panevezio ligonine
  • Malaysia
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Universiti Sains Malaysia
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
    • Selangor
      • Ampang, Selangor, Malaysia, 68000
        • Hospital Ampang
  • Mexico
      • Chihuahua City, Mexico, 31203
        • Scientia Investigacion Clinica S.C.
      • Veracruz, Mexico, 91900
        • Sociedad de Metabolismo y Corazon
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45030
        • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
    • Mexico City
      • Mexico City, Mexico City, Mexico, 07020
        • Centro de Investigación Clínica Acelerada
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80230
        • Centro Para el Desarrollo de la Medicina y de Asistencia Medica S.C
  • Netherlands
      • Uden, Netherlands, 5406 PT
        • Bernhoven Ziekenhuis
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht, Dept. of Internal Medicine, MDL
    • North Brabant
      • Tilburg, North Brabant, Netherlands, 5022 GC
        • St Elisabeth Ziekenhuis
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Amsterdam UMC, locatie AMC
  • Poland
      • Katowice, Poland, 40-660
        • All-Medicus
      • Olsztyn, Poland, 10-561
        • Wojewodzki Specjalistyczny Szpital w Olsztynie
      • Szczecin, Poland, 71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Torun, Poland, 87-100
        • Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii
      • Warsaw, Poland, 00-728
        • Warsaw IBD Point Profesor Kierkus
      • Warsaw, Poland, 00635
        • Centrum Zdrowia MDM
      • Warsaw, Poland, 01-697
        • Centrum Medyczne NeuroProtect
      • Wroclaw, Poland, 52-210
        • PlanetMed Sp.z o.o.
      • Zamość, Poland, 22-400
        • ETG Zamosc
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
        • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-506
        • Topolowa Medicenter
      • Nowy Targ, Lesser Poland Voivodeship, Poland, 34-400
        • Medicenter Nowy Targ
      • Wadowice, Lesser Poland Voivodeship, Poland, 34-100
        • NZOZ Formed
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-114
        • LexMedica
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-954
        • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
      • Lublin, Lublin Voivodeship, Poland, 20-582
        • ZOZ Gastromed
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 03-580
        • NZOZ Vivamed
    • Silesian Voivodeship
      • Będzin, Silesian Voivodeship, Poland, 42-500
        • Promedica Dental Clinic
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-685
        • SONOMED Centrum Medyczne
    • Świętokrzyskie Voivodeship
      • Straszów, Świętokrzyskie Voivodeship, Poland, 28-200
        • KO-Med Centrum Medyczne
  • Romania
      • Bucharest, Romania, 022328
        • Institutul Clinic Fundeni
      • Bucharest, Romania, 020125
        • Spitalul Clinic Colentina
      • Bucharest, Romania, 010719
        • MedLife Grivita
      • Bucharest, Romania, 031864
        • Hifu Terramed Conformal SRL
      • Oradea, Romania, 410469
        • Spital Pelican Oradea
    • Bucharest
      • Bucharest, Bucharest, Romania, 030463
        • CCBR Clinical Research
  • Russia
      • Barnaul, Russia, 656043
        • Multidisciplinary Medical Clinic "Anthurium"
      • Cherepovets, Russia, 162600
        • Medical and Sanitary Division of Severstal
      • Izhevsk, Russia, 426061
        • Alliance Biomedical URAL Group
      • Kaliningrad, Russia, 236035
        • Clinical Trials Center of Medical Institute
      • Kazan', Russia, 420064
        • State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan
      • Kemerovo, Russia, 650066
        • SIH Kemerovo Regional Clinical Hosptial
      • Moscow, Russia, 125367
        • Medical rehabilitation center
      • Novosibirsk, Russia, 630005
        • LLC "Medicine Center SibNovoMed"
      • Omsk, Russia, 644024
        • Clinical Diagnostic Center Ultramed
      • Saint Petersburg, Russia, 191104
        • City Mariinskaya Hospital
      • Saint Petersburg, Russia, 195067
        • Pokrovskaya Municipal Hospital
      • Saint Petersburg, Russia, 195271
        • Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways
      • Saint Petersburg, Russia, 197022
        • Saint Petersburg State Medical University n.a. Pavlov I.P.
      • Saint Petersburg, Russia, 197110
        • SBIH City Clinical Hospital #31
      • Samara, Russia, 443001
        • Medical Institute REAVIZ
      • Stavropol, Russia, 355018
        • Stavropol State Medical University
      • Yaroslavl, Russia, 150030
        • Yaroslavl Municipal HI Clinical Hospital #8
      • Yekaterinburg, Russia, 620109
        • LLC MA New Hospital
    • Irkutsk Oblast
      • Irkutsk, Irkutsk Oblast, Russia, 664079
        • Scientific Centre of Reconstructive and Restorative Surgery
    • Kareliya, Respublika
      • Petrozavodsk, Kareliya, Respublika, Russia, 185019
        • Karelia Republican Hospital V.A. Baranova
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603126
        • Nizhny Novgorod Regional Hospital N.A. Semashko
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603140
        • Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
    • Novosibirsk Oblast
      • Novosibirsk, Novosibirsk Oblast, Russia, 630007
        • Novosibirski Gastrocenter
    • Rostov Oblast
      • Rostov-on-Don, Rostov Oblast, Russia, 344091
        • Rostov State Medical University
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 196143
        • Scientific research center ECO-security
  • Serbia
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac Gastroenterohepatology Clinic
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Clinical Hospital Center Zvezdara
    • NAP
      • Belgrade, NAP, Serbia, 11080
        • University Medical Center "Bezanijska kosa"
    • Vojvodina
      • Sombor, Vojvodina, Serbia, 25000
        • Regional Hospital Dr Radivoj Simonovic Sombor
      • Sremska Mitrovica, Vojvodina, Serbia, 22000
        • Sremska Mitrovica Health Centre
      • Zrenjanin, Vojvodina, Serbia, 23000
        • General Hospital "Djordje Joanovic"
  • Slovakia
      • Banská Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica
      • Bratislava, Slovakia, 82007
        • Univerzitna nemocnica Bratislava
    • Nitra Region
      • Nitra, Nitra Region, Slovakia, 949 01
        • KM Management
    • Presov
      • Prešov, Presov, Slovakia, 080 01
        • Gastro
      • Vranov N. Toplou, Presov, Slovakia, 093 01
        • Endomed, s.r.o.
  • South Korea
      • Busan, South Korea, 48108
        • Inje University Haeundae Paik Hospital
      • Daegu, South Korea, 42415
        • Yeungnam Univeristy Medical Center
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26426
        • Severance Hospital, Yonsei University Health System
    • Korea
      • Seoul, Korea, South Korea, 02447
        • Kyung Hee University Hospital
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, South Korea, 49201
        • Dong-A University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
        • Asan Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03181
        • Kangbuk Samsung Hospital
    • Taejǒn-Kwangyǒkshi
      • Daejeon, Taejǒn-Kwangyǒkshi, South Korea, 34943
        • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Spain
      • A Coruña, Spain, 15006
        • Complexo Hospitalario Universitario A Coruña, CHUAC
      • Alicante, Spain, 3004
        • Instituto de Ciencias Médicas
      • Girona, Spain, 17007
        • Hospital Universitari de Girona
      • Huelva, Spain, 21005
        • Hospital Universitario Juan Ramon Jimenez
      • Las Palmas de Gran Canaria, Spain, 35010
        • Hospital de Gran Canaria Dr. Negrín
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Oviedo, Spain, 3306
        • Hospital Universitario Central de Asturias
    • Andalusia
      • Seville, Andalusia, Spain, 41013
        • Hospital Universitario Virgen del Rocio
    • Baleares Islands
      • Palma de Mallorca, Baleares Islands, Spain, 07120
        • Hospital Universitari Son Espases
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital De Fuenlabrada
    • Valencia
      • Sagunto, Valencia, Spain, 46520
        • Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital Bern
      • Sankt Gallen, Switzerland, 9007
        • Kantonsspital St.Gallen
      • Zurich, Switzerland, 8091
        • Universitatsspital Zurich
    • Canton of Bern
      • Bern, Canton of Bern, Switzerland, 3012
        • Gastroenterologische Praxis Balsiger, Seibold & Partner
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 10002
        • Health management center
  • Turkey (Türkiye)
    • Antalya
      • Kocaeli, Antalya, Turkey (Türkiye), 7100
        • Antalya Egitim ve Arastırma Hastanesi
    • Istanbul
      • Kadıköy, Istanbul, Turkey (Türkiye), 34734
        • Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
    • Kocaeli
      • İzmit, Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli University Medical Faculty Hospital
    • Mersin
      • Yenişehir, Mersin, Turkey (Türkiye), 33110
        • Mersin University Medical Faculty
    • Turkey
      • Izmir, Turkey, Turkey (Türkiye), 35100
        • Ege Universitesi Hastanesi
  • Ukraine
      • Kharkiv, Ukraine, 61039
        • GI L.T. Malaya TI Namsu
      • Kharkiv, Ukraine, 61002
        • Kharkiv City Student Hospital
      • Kropyvnytskyi, Ukraine, 25006
        • Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
      • Kyiv, Ukraine, 02091
        • Kyiv Municipal Clinical Hospital #1
      • Kyiv, Ukraine, 04107
        • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
      • Kyiv, Ukraine, 04078
        • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
      • Odesa, Ukraine, 65000
        • Communal Enterprise "Odesa Regional Clinical Hospital"
      • Uzhhorod, Ukraine, 88000
        • A. Novak Transcarpathian Regional Clinical Hospital
      • Vinnytsia, Ukraine, 21029
        • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
      • Vinnytsia, Ukraine, 21005
        • Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
      • Vinnytsia, Ukraine, 21009
        • MCIC MC LLC Health Clinic
      • Vinnytsia, Ukraine, 21018
        • M.I. Pyrogov Regional Clinical Hospital
      • Zaporizhzhia, Ukraine, 69104
        • Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76008
        • Ivano-Frankivsk Regional Clinical Hospital
    • Kharkivs’ka Oblast’
      • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61037
        • City Clinical Hospital No. 2
    • Kherson Oblast
      • Kherson, Kherson Oblast, Ukraine, 73000
        • Kherson City Clinical Hospital
    • Kyiv Oblast
      • Kiev, Kyiv Oblast, Ukraine, 4050
        • Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79000
        • Lviv Railway Clinical Hospital
      • Lviv, Lviv Oblast, Ukraine, 79000
        • Lviv Regional Endocrinology Dispensary
      • Lviv, Lviv Oblast, Ukraine, 79000
        • Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
    • Poltava Oblast
      • Poltava, Poltava Oblast, Ukraine, 36000
        • Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
    • Zaporizhzhia Oblast
      • Zaporizhia, Zaporizhzhia Oblast, Ukraine, 69076
        • Diaservis - Medical and Diagnostic Center
  • United Kingdom
    • Essex
      • Romford, Essex, United Kingdom, RM7 0AG
        • Queens Hospital
    • Great Britain
      • Bury, Great Britain, United Kingdom, BL9 7TD
        • Fairfield General Hospital
    • London
      • Great Maze Pond, London, United Kingdom, SE1 9RT
        • St Thomas' Hospital
    • Surrey
      • London, Surrey, United Kingdom, E11 1NR
        • Whipps Cross University Hospital
    • Swansea [Abertawe Gb-ata]
      • Swansea, Swansea [Abertawe Gb-ata], United Kingdom, SA6 6SG
        • Morriston Hospital
    • Vinnytsia
      • Leeds, Vinnytsia, United Kingdom, LS9 7TF
        • St James's University Hospital
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists of the Southeast
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Dcr-Pi, Pc
      • Phoenix, Arizona, United States, 85008
        • Maricopa Integrated Health System
      • Tempe, Arizona, United States, 85284
        • Physicians Research Group
    • California
      • Arcadia, California, United States, 91006
        • Valley Gastroenterology
      • Berkeley, California, United States, 94705
        • Care Access Research
      • Lancaster, California, United States, 93534
        • Om Research, LLC
      • Northridge, California, United States, 91324
        • California Medical Research Associates
      • San Diego, California, United States, 92103
        • Clinical Applications Laboratories, Inc.
      • San Francisco, California, United States, 94158
        • UCSF Medical Center at Mission Bay
    • Florida
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Research Center
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research, LLC
      • Kissimmee, Florida, United States, 34741
        • SIH Research, LLC
      • Miami, Florida, United States, 33134
        • Research Associates of South Florida, LLC
      • Miami Lakes, Florida, United States, 33016
        • Wellness Clinical Research
      • Orlando, Florida, United States, 32818
        • Clintheory Healthcare
      • Orlando, Florida, United States, 32803
        • Center for Interventional Endoscopy
      • Pensacola, Florida, United States, 32503
        • Gastroenterology Associates of Pensacola, PA
      • Zephyrhills, Florida, United States, 33542-7505
        • Florida Medical Clinic LLC
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Digestive Healthcare of Georgia
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Grand Teton Research Group
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center, Digestive Health
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Texas Digestive Disease Consultants
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners LLC
      • New Orleans, Louisiana, United States, 70125
        • Nola Research Works, LLC
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
      • Novi, Michigan, United States, 48377
        • Henry Ford Health System
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan, P.L.C.
      • Ypsilanti, Michigan, United States, 48197
        • Huron Gastroenterology Associates
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39206
        • Care Access Research LLC
      • Tupelo, Mississippi, United States, 38801
        • Digestive Health Specialists
    • New York
      • Great Neck, New York, United States, 11021
        • Northwell Health
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Center for Inflammatory Bowel Disease
      • Greenville, North Carolina, United States, 27834
        • Carolina Digestive Diseases and Endoscopy Center
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research
      • Poland, Ohio, United States, 44514
        • Care Access - Youngstown
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Central Sooner Research
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Digestive Disease Associates
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Midwest Medical Care
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Hixson, Tennessee, United States, 37343
        • Galen Medical Group
    • Texas
      • Garland, Texas, United States, 75044
        • Digestive Health Associates of Texas
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77030
        • Houston Methodist Research Ins
      • San Antonio, Texas, United States, 78229
        • Southern Star Research Institute, LLC
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Research of San Antonio
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consultants
    • Utah
      • Ogden, Utah, United States, 84403
        • Care Access Research LLC - Salt Lake City
    • Virginia
      • Leesburg, Virginia, United States, 20176
        • Emeritas Research Group
      • Reston, Virginia, United States, 20191
        • The Gastroenterology Group, P.C.
      • Roanoke, Virginia, United States, 24016
        • Carilion Clinic
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Wisconsin Center for Advanced Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
  • Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
  • If female, must meet the contraception requirements.

Exclusion Criteria:

  • Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
  • Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
  • Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
  • Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
  • Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
  • Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Maintenance Period: Miri Induction Responder (IR) - Placebo (PBO) Subcutaneous (SC)
Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.
Drug: Placebo SC
Administered SC
Experimental: Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Drug: Mirikizumab SC
Administered SC
Other Names:
  • LY3074828
Experimental: Maintenance Period: PBO IR - PBO SC
Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Drug: Placebo SC
Administered SC
Experimental: Maintenance Period: Miri IR - PBO SC - ME2 Cohort
Participants in the ME2 Cohort who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.
Drug: Placebo SC
Administered SC
Experimental: Maintenance Period: Miri IR - 200 mg Miri SC - ME2 Cohort
Participants in the ME2 Cohort who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Drug: Mirikizumab SC
Administered SC
Other Names:
  • LY3074828
Experimental: Maintenance Period: PBO IR - PBO SC - ME2 Cohort
Participants in the ME2 Cohort who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Drug: Mirikizumab IV
Administered IV
Other Names:
  • LY3074828
Drug: Placebo SC
Administered SC
Experimental: Loss of Response (LOR) Rescue Period: LOR Cohort-300 mg Miri IV
Participants who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.
Drug: Mirikizumab IV
Administered IV
Other Names:
  • LY3074828
Experimental: LOR Rescue Period: LOR Cohort-300 mg Miri IV - ME2 Cohort
Participants in the ME2 Cohort who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.
Drug: Mirikizumab IV
Administered IV
Other Names:
  • LY3074828
Experimental: Extended Induction: Induction Nonresponders - 300mg Miri IV
Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.
Drug: Mirikizumab IV
Administered IV
Other Names:
  • LY3074828
Experimental: Extended Induction: Induction Nonresponders - 300mg Miri IV - ME2 Cohort
Participants in the ME2 Cohort who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.
Drug: Mirikizumab IV
Administered IV
Other Names:
  • LY3074828
Experimental: Open Label Maintenance: Delayed Responders - 200 mg Miri SC
Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).
Drug: Mirikizumab SC
Administered SC
Other Names:
  • LY3074828
Experimental: Open Label Maintenance: Delayed Responders - 200 mg Miri SC - ME2 Cohort
Participants in the ME2 Cohort who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).
Drug: Mirikizumab SC
Administered SC
Other Names:
  • LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders)
Time Frame: Week 40

Clinical remission at week 40 is defined as achieving a 9-point modified Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability).

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 central reading of colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).

Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of mirikizumab and who had a correctly measured Modified Mayo Score at baseline. Participants were analyzed according to the treatment arm to which they were randomized, regardless of the treatment actually received.
Week 40

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Clearance of Mirikizumab
Time Frame: Predose: Weeks 0, 4, 12, 24 and 40
Clearance of mirikizumab was evaluated.
Predose: Weeks 0, 4, 12, 24 and 40
Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders)
Time Frame: Week 40
Endoscopic remission at week 40 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 40. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
Week 40
Percentage of Participants With Histologic Remission at Week 40 (Mirikizumab Induction Responders)
Time Frame: Week 40
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).
Week 40
Percentage of Participants in Symptomatic Remission at Week 40 (Mirikizumab Induction Responders)
Time Frame: Week 40

Symptomatic remission at week 40 is defined as a Mayo score 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).
Week 40
Percentage of Participants in Endoscopic Response at Week 40 (Mirikizumab Induction Responders)
Time Frame: Week 40
Endoscopic response at week 40 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.
Week 40
Percentage of Participants in Clinical Response at Week 40 (Mirikizumab Induction Responders)
Time Frame: Week 40
Clinical response at week 40 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).
Week 40
Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Mirikizumab Induction Responders)
Time Frame: Induction Baseline, Week 40
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. 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), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other).
Induction Baseline, Week 40
Change From Baseline to Week 40 in Fecal Calprotectin (Mirikizumab Induction Responders)
Time Frame: Induction Baseline, Week 40
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 ANCOVA model for post-baseline measures: The ANCOVA model includes treatment, baseline value, prior biologic or tofacitinib failure (yes/no), corticosteroid use (yes/no) at AMAN baseline, region (North America/Europe/Other), Clinical Remission status (yes/no) at AMAN Week 12.
Induction Baseline, Week 40
Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) (Mirikizumab Induction Responders)
Time Frame: Induction Baseline, Week 40
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), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other).
Induction Baseline, Week 40
Percentage of Participants Hospitalized for Ulcerative Colitis (UC) (Mirikizumab Induction Responders)
Time Frame: Week 40
Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with >=24 hours stay were recorded.
Week 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2018

Primary Completion (Actual)

November 3, 2021

Study Completion (Actual)

February 17, 2025

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

May 10, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16823
  • I6T-MC-AMBG (Other Identifier: Eli Lilly and Company)
  • 2017-003238-96 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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