Ulcerative ColitisPhase 3LUCENT 2NCT03524092
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study testing Mirikizumab SC and Mirikizumab IV in people with Ulcerative Colitis, run by Eli Lilly and Company at 385 sites in 34 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Mirikizumab SC and Mirikizumab IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,328 participants
- Where
- 385 sitesin 34 countries
- Study dates
- 19 Oct 2018to 17 Feb 2025
- Phase
- Phase 3
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
385 sites in 34 countries.
385 sites in 34 countries
United States57 sites
Valley Gastroenterology
Arcadia, California, 91006
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
Texas Digestive Disease Consultants
Baton Rouge, Louisiana, 70809
Care Access Research
Berkeley, California, 94705
University of North Carolina Center for Inflammatory Bowel Disease
Chapel Hill, North Carolina, 27599
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305
NorthShore University HealthSystem
Evanston, Illinois, 60201
Digestive Health Associates of Texas
Garland, Texas, 75044
Gastro One
Germantown, Tennessee, 38138
Northwell Health
Great Neck, New York, 11021
Carolina Digestive Diseases and Endoscopy Center
Greenville, North Carolina, 27834
Direct Helpers Research Center
Hialeah, Florida, 33012
Galen Medical Group
Hixson, Tennessee, 37343
Houston Methodist Research Ins
Houston, Texas, 77030
Biopharma Informatic, LLC
Houston, Texas, 77043
Grand Teton Research Group
Idaho Falls, Idaho, 83404
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Nature Coast Clinical Research, LLC
Inverness, Florida, 34452
Care Access Research LLC
Jackson, Mississippi, 39206
SIH Research, LLC
Kissimmee, Florida, 34741
Om Research, LLC
Lancaster, California, 93534
Emeritas Research Group
Leesburg, Virginia, 20176
Dcr-Pi, Pc
Litchfield Park, Arizona, 85340
Research Associates of South Florida, LLC
Miami, Florida, 33134
Wellness Clinical Research
Miami Lakes, Florida, 33016
Paramount Medical Research
Middleburg Heights, Ohio, 44130
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Delta Research Partners LLC
Monroe, Louisiana, 71201
Nola Research Works, LLC
New Orleans, Louisiana, 70125
Weill Cornell Medical College
New York, New York, 10021
Central Sooner Research
Norman, Oklahoma, 73071
California Medical Research Associates
Northridge, California, 91324
Henry Ford Health System
Novi, Michigan, 48377
Care Access Research LLC - Salt Lake City
Ogden, Utah, 84403
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Center for Interventional Endoscopy
Orlando, Florida, 32803
Clintheory Healthcare
Orlando, Florida, 32818
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, 32503
Maricopa Integrated Health System
Phoenix, Arizona, 85008
MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
Plymouth, Minnesota, 55446
Care Access - Youngstown
Poland, Ohio, 44514
The Gastroenterology Group, P.C.
Reston, Virginia, 20191
Carilion Clinic
Roanoke, Virginia, 24016
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229
Southern Star Research Institute, LLC
San Antonio, Texas, 78229
Clinical Applications Laboratories, Inc.
San Diego, California, 92103
UCSF Medical Center at Mission Bay
San Francisco, California, 94158
Midwest Medical Care
Sioux Falls, South Dakota, 57108
Texas Digestive Disease Consultants
Southlake, Texas, 76092
Physicians Research Group
Tempe, Arizona, 85284
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, 66606
Digestive Health Specialists
Tupelo, Mississippi, 38801
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, 49519
Digestive Disease Associates
Wyomissing, Pennsylvania, 19610
Huron Gastroenterology Associates
Ypsilanti, Michigan, 48197
Florida Medical Clinic LLC
Zephyrhills, Florida, 33542-7505
Japan48 sites
Asahikawa City Hospital
Asahikawa, Hokkaido, 070-8610
Tokyo Medical and Dental University Hospital
Bunkyō, Tokyo, 113-8519
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, 818-8502
Mitsui Memorial Hospital
Chiyoda-ku, Tokyo-To, 101-8643
Sai Gastroenterologist Proctology
Fujiidera, Osaka, 583-0027
Fukuoka University Hospital
Fukuoka, 814-0180
Matsuda Hospital
Hamamatsu, Shizuoka, 4328061
National Hospital Organization Hirosaki National Hospital
Hirosaki, Aomori, 036-8545
Hiroshima University Hospital
Hiroshima, 734-8551
NHO Mito Medical Center
Ibaraki-machi, HigaShiibaraki-Gun, 311 3193
Sameshima Hospital
Kagoshima, 892-0846
Ofuna Central Hospital
Kamakura, Kanagawa, 247-0056
Kawasaki Municipal Hospital
Kawasaki, Kanagawa, 210-0013
Kitakyushu Municipal Medical Center
Kitakyusyu-shi, Fukoka, 802-0077
Aoyama Clinic GI Endoscopy & IBD Center
Kobe, Hyōgo, 650 0015
Showa University Koto Toyosu Hospital
Koto-ku, Tokyo, 135 8577
Kumagaya General Hospital
Kumagaya-shi, Saitama, 360-8567
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-0012
Hidaka Coloproctology Clinic
Kurume-shi, Fukuoka, 839 0809
National Hospital Organization Kyoto Medical Center
Kyoto, 612-8555
Gunma University Hospital
Maebashi, Gunma, 371-8511
Kitasato University Kitasato Institute Hospital
Minato-Ku, Tokyo, 108 8642
Kyorin University Hospital
Mitaka, Tokyo, 181-8611
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, 480-1195
Nagaoka Chuo General Hospital
Nagaoka-shi, Niigata, 940-8653
Ishida Clinic of IBD and Gastroenterology
Ōita, Oita Prefecture, 870 0823
Okayama University Hospital
Okayama, 700-8558
Infusion Clinic
Osaka, Osaka, 530 0011
NHO Osaka National Hospital
Osaka, Osaka, 540 0006
Saga-Ken Medical Center Koseikan
Saga, Saga-ken, 840-8571
Tokitokai Tokito Clinic
Saitama, 336-0963
Toho University Sakura Medical Center
Sakura, Chiba, 285-8741
Tokushukai Sapporo Tokushukai Hospital
Sapporo, Hokkaido, 004 0041
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, Hokkaido, 060 0033
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, 065-0033
Takagi Clinic - Sendai
Sendai, Miyagi, 981 3213
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, 329-0498
JHCO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, 169-0073
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku, Tokyo-To, 162 8655
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557
National Hospital Organization Takasaki General Medical Centar
Takasaki, Gunma, 370-0829
Toyama Prefectural Central Hospital
Toyama, 930-0975
Fujita Health University
Toyoake, Aichi-ken, 470-1192
Mie University Hospital
Tsu, Mie-ken, 514-8507
Sankikai Yokohama Shin midori General Hospital
Yokohama, Kanagawa, 226 0025
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, 234-0032
China28 sites
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
Chongqing, Chongqing Municipality, 400037
The First Hospital Affiliated to AMU (Southwest Hospital)
Chongqing, Chongqing Municipality, 400038
The Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510655
The Second Affiliated Hospital of Zhejiang University School of Med
Hangzhou, Zhejiang, 310000
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou, Zhejiang, 310003
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Anhui Provincial Hospital
Hefei, Anhui, 230000
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Jilin Central General Hospital
Jilin City, Jilin, 132011
Qilu Hospital of Shandong University
Jinan, Shandong, 250014
Shandong Provincial Hospital
Jinan, Shandong, 250021
Xiangya Hospital Central South University
Kaifu District, Changsha City, 410008
Kunming Medical College Affiliated First Hospital
Kunming, Yunnan, 650032
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650034
Liaocheng People's Hospital
Liaocheng, Shandong, 252000
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210029
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211106
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Renji Hospital Affliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
Taian City Central Hospital
Taian, Shandong, 271000
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
Wenzhou, Zhejiang, 325027
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Tongji Hospital of Tongji University
Wuhan, 430030
Russia25 sites
Multidisciplinary Medical Clinic "Anthurium"
Barnaul, 656043
Medical and Sanitary Division of Severstal
Cherepovets, 162600
Scientific Centre of Reconstructive and Restorative Surgery
Irkutsk, Irkutsk Oblast, 664079
Alliance Biomedical URAL Group
Izhevsk, 426061
Clinical Trials Center of Medical Institute
Kaliningrad, 236035
State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan
Kazan', 420064
SIH Kemerovo Regional Clinical Hosptial
Kemerovo, 650066
Medical rehabilitation center
Moscow, 125367
Nizhny Novgorod Regional Hospital N.A. Semashko
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126
Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
Nizhny Novgorod, Nizhny Novgorod Oblast, 603140
Novosibirski Gastrocenter
Novosibirsk, Novosibirsk Oblast, 630007
LLC "Medicine Center SibNovoMed"
Novosibirsk, 630005
Clinical Diagnostic Center Ultramed
Omsk, 644024
Karelia Republican Hospital V.A. Baranova
Petrozavodsk, Kareliya, Respublika, 185019
Rostov State Medical University
Rostov-on-Don, Rostov Oblast, 344091
Scientific research center ECO-security
Saint Petersburg, Sankt-Peterburg, 196143
City Mariinskaya Hospital
Saint Petersburg, 191104
Pokrovskaya Municipal Hospital
Saint Petersburg, 195067
Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways
Saint Petersburg, 195271
Saint Petersburg State Medical University n.a. Pavlov I.P.
Saint Petersburg, 197022
SBIH City Clinical Hospital #31
Saint Petersburg, 197110
Medical Institute REAVIZ
Samara, 443001
Stavropol State Medical University
Stavropol, 355018
Yaroslavl Municipal HI Clinical Hospital #8
Yaroslavl, 150030
LLC MA New Hospital
Yekaterinburg, 620109
Ukraine22 sites
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008
City Clinical Hospital No. 2
Kharkiv, Kharkiv Oblast, 61037
Kharkiv City Student Hospital
Kharkiv, 61002
GI L.T. Malaya TI Namsu
Kharkiv, 61039
Kherson City Clinical Hospital
Kherson, Kherson Oblast, 73000
Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
Kiev, Kyiv Oblast, 4050
Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
Kropyvnytskyi, 25006
Kyiv Municipal Clinical Hospital #1
Kyiv, 02091
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
Kyiv, 04078
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
Kyiv, 04107
Lviv Railway Clinical Hospital
Lviv, Lviv Oblast, 79000
Lviv Regional Endocrinology Dispensary
Lviv, Lviv Oblast, 79000
Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
Lviv, Lviv Oblast, 79000
Communal Enterprise "Odesa Regional Clinical Hospital"
Odesa, 65000
Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
Poltava, Poltava Oblast, 36000
A. Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, 88000
Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
Vinnytsia, 21005
MCIC MC LLC Health Clinic
Vinnytsia, 21009
M.I. Pyrogov Regional Clinical Hospital
Vinnytsia, 21018
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Vinnytsia, 21029
Diaservis - Medical and Diagnostic Center
Zaporizhia, Zaporizhzhia Oblast, 69076
Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
Zaporizhzhya, 69104
Poland20 sites
Promedica Dental Clinic
Będzin, Silesian Voivodeship, 42-500
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168
All-Medicus
Katowice, 40-660
Topolowa Medicenter
Krakow, Lesser Poland Voivodeship, 31-506
ZOZ Gastromed
Lublin, Lublin Voivodeship, 20-582
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, Lublin Voivodeship, 20-954
Medicenter Nowy Targ
Nowy Targ, Lesser Poland Voivodeship, 34-400
Wojewodzki Specjalistyczny Szpital w Olsztynie
Olsztyn, 10-561
KO-Med Centrum Medyczne
Straszów, Świętokrzyskie Voivodeship, 28-200
SONOMED Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-685
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434
Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii
Torun, 87-100
NZOZ Formed
Wadowice, Lesser Poland Voivodeship, 34-100
NZOZ Vivamed
Warsaw, Masovian Voivodeship, 03-580
Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728
Centrum Zdrowia MDM
Warsaw, 00635
Centrum Medyczne NeuroProtect
Warsaw, 01-697
LexMedica
Wroclaw, Lower Silesian Voivodeship, 53-114
PlanetMed Sp.z o.o.
Wroclaw, 52-210
ETG Zamość
Zamość, 22-400
France15 sites
CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro
Amiens, Somme, 80480
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours, 37170
Hôpital Beaujon
Clichy, Paris, 92110
CHU Lille - Hôpital Claude Huriez
Lille, Nord, 59037
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, 13915
CHRU de Montpellier-Hopital St Eloi
Montpellier, 34295
Hopital L'Archet 2
Nice, 06200
Hopital Saint-Louis
Paris, Cedex 10, 75475
Centre Hospitalier de Pau
Pau, Pyrénées-Atlantiques, 64046
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
Pierre-Bénite, Rhone, 69495
Robert Debre Hospital
Reims, 51092
CHU de Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, 42270
Hopital de Hautepierre - Service d'Hépatogastroentérolgie
Strasbourg, Bas Rhin, 67098
CHRU Nancy Brabois - Hôpital d'Enfants
Vandœuvre-lès-Nancy, 54500
India14 sites
Bangalore Medical College and Research Institute
Bangalore, Karnataka, 560 002
M S Ramaiah Medical College and Hospitals
Bangalore, Karnataka, 560054
Apollo Research and Innovations, Apollo Hospitals International Ltd
Gandhinagar, Gujarat, 382428
Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
Hyderabad, Andhra Pradesh, 500058
Gandhi Hospital
Hyderabad, Telangana, 500003
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001
King George Medical University
Lucknow, Uttar Pradesh, 226003
Dayanand Medical College and Hospital
Ludhiana, Punjab, 141001
Midas Multispeciality Hospital Pvt.Ltd.
Nagpur, Maharashtra, 440010
Escorts Heart Institute and Research Centre Ltd
New Delhi, National Capital Territory of Delhi, 110 025
Poona Medical Foundation. Ruby Hall Clinic
Pune, Maharashtra, 411 001
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, 360005
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, 395002
Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital
Wardha, Maharashtra, 442004
Italy14 sites
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, 25123
Azienda ospedaliero-universitaria Mater Domini
Catanzaro, 88100
Azienda Ospedaliero Universitaria San Martino
Genova, 16132
Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Milan, 20122
Azienda Ospedaliera Universitaria Policlinico de Modena
Modena, 41124
Azienda Ospedaliera Universitaria Pisana
Pisa, 56124
Presidio di Rho
Rho, Milano, 20017
Policlinico Gemelli - Università Cattolica del Sacro Cuore
Roma, 00168
Ospedale Sandro Pertini
Rome, Roma, 00157
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia
San Donato Milanese, Milano, 20097
Ospedale Mauriziano Umberto I
Torino, 10128
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Torre, Roma, 00133
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia
Udine, 33100
Spain12 sites
Complexo Hospitalario Universitario A Coruña, CHUAC
A Coruña, 15006
Instituto de Ciencias Médicas
Alicante, 3004
Hospital De Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital Universitari de Girona
Girona, 17007
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005
Hospital De Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, 35010
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Central de Asturias
Oviedo, 3306
Hospital Universitari Son Espases
Palma de Mallorca, Baleares Islands, 07120
Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo
Sagunto, Valencia, 46520
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Virgen Del Rocio
Seville, Andalusia, 41013
Canada9 sites
West Edmonton Diabetes Center
Edmonton, Alberta, T5R 1W2
Centre de santé et de services sociaux Champlain-Charles-Le Moyne
Greenfield Park, Quebec, J4V 2H1
Victoria Hospital
London, Ontario, N6A 4G5
University of Western Ontario
London, Ontario, N6A 5G1
Hopital Maisonneure-Rosemount
Montreal, Quebec, H1T 2M4
Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC
Montreal, Quebec, H3G 1A4
The Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9
GI Research Institute
Vancouver, British Columbia, V6Z 2K5
PerCuro Clinical Research
Victoria, British Columbia, V8V 3M9
Czechia9 sites
Vojenská Nemocnice Brno
Brno, Brno-město, 636 00
Fakultni Nemocnice u sv. Anny v Brne
Brno, 65691
Hepato-Gastroenterologie HK
Hradec Králové, Hradec Králové, 500 12
MUDr. Gregar, s.r.o.
Olomouc, Olomouc Region, 779 00
PreventaMed, s.r.o.
Olomouc, 779
A-Shine
Pilsen, Plzeň-město, 301 00
Fakultni nemocnice Kralovske Vinohrady
Prague, Hl. M. Praha, 100 34
MEDIENDO
Prague, Praha 8, 186 00
ISCARE Clinical Centre
Prague, 19000
Germany9 sites
Charité Campus Virchow-Klinikum
Berlin, 12203
Krankenhaus Waldfriede
Berlin, 14163
Städtisches Klinikum Brandenburg
Brandenburg, 14770
Studiengesellschaft BSF Unternehmergesellschaft
Halle, Saxony-Anhalt, 06108
Universitätsklinikum Halle
Halle, Saxony-Anhalt, 06120
HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
Hamburg, 20251
Medizinische Hochschule Hanover
Hanover, Lower Saxony, 30625
Gemeinschaftspraxis Dr. Peter Uebel
Ludwigshafen am Rhein, Rhineland-Palatinate, 67067
Internistische Praxisgemeinschaft
Weyhe, 28844
Hungary9 sites
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred, EU, 8230
Óbudai Egészségügyi Centrum
Budapest, 1036
Semmelweis Egyetem
Budapest, 1088
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Endomedix Diagnosztikai Központ - Miskolc
Miskolc, 3526
Karolina Korhaz-Rendelointezet
Mosonmagyaróvár, 9200
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
Szeged, 6720
CLINFAN Szolgáltató Kft
Szekszárd, 7100
Jávorszky Ödön Kórház
Vác, Pest County, 2600
South Korea9 sites
Dong-A University Hospital
Busan, Pusan-Kwangyǒkshi, 49201
Inje University Haeundae Paik Hospital
Busan, 48108
Yeungnam Univeristy Medical Center
Daegu, 42415
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daejeon, Taejǒn-Kwangyǒkshi, 34943
Kyung Hee University Hospital
Seoul, Korea, 02447
Kangbuk Samsung Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03181
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Severance Hospital, Yonsei University Health System
Wŏnju, Gangwon-do, 26426
Australia8 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Box Hill Hospital Outpatients
Box Hill, Victoria, 3128
Princess Alexandra Hospital
Harlow, Essex, CM20 1QX
Melbourne Gastrointestinal Investigation Unit (MGIU)
Malvern, Victoria, 3144
Coastal Digestive Health
Maroochydore, Queensland, 4558
The Alfred Hospital
Melbourne, Victoria, 3004
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Mater University Hospital
South Brisbane, Queensland, 4101
Argentina7 sites
Centro de Investigaciones Metabólicas (CINME)
CABA, Buenos Aires, C1027AAP
Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
Ciudad Autonoma de Buenos Air, Buenos Aires, C1128AAF
Hospital Privado Centro Medico de Cordoba SA
Córdoba, X5016KEH
CER Instituto Medico
Quilmes, Buenos Aires, B1878DVC
Fundación de Estudios Clínicos
Rosario, Santa Fe Province, S2000DEJ
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, T4000AXL
C.I.C.E. 9 de Julio
San Miguel de Tucumán, Tucumán Province, 4000
Israel6 sites
Shaare Zedek Medical Center
Bait Vagan, Jerusalem, 91031
Soroka Medical Center - Pediatric Outpatient Clinic
Beersheba, 8410101
Galilee Medical Center Department of Internal Medicine A
Nahariya, 2210001
Kaplan Medical Center
Rehovot, 7610001
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
King Fahad Medical City
Ẕerifin, 70300
Romania6 sites
CCBR Clinical Research
Bucharest, Bucharest, 030463
MedLife Grivita
Bucharest, 010719
Spitalul Clinic Colentina
Bucharest, 020125
Institutul Clinic Fundeni
Bucharest, 022328
Hifu Terramed Conformal SRL
Bucharest, 031864
Spital Pelican Oradea
Oradea, 410469
Serbia6 sites
Clinical Hospital Center Zvezdara
Belgrade, Beograd, 11000
University Medical Center "Bezanijska kosa"
Belgrade, NAP, 11080
Clinical Center Kragujevac Gastroenterohepatology Clinic
Kragujevac, 34000
Regional Hospital Dr Radivoj Simonovic Sombor
Sombor, Vojvodina, 25000
Sremska Mitrovica Health Centre
Sremska Mitrovica, Vojvodina, 22000
General Hospital "Djordje Joanovic"
Zrenjanin, Vojvodina, 23000
United Kingdom6 sites
Fairfield General Hospital
Bury, Great Britain, BL9 7TD
St Thomas' Hospital
Great Maze Pond, London, SE1 9RT
St James's University Hospital
Leeds, Vinnytsia, LS9 7TF
Whipps Cross University Hospital
London, Surrey, E11 1NR
Queens Hospital
Romford, Essex, RM7 0AG
Morriston Hospital
Swansea, Swansea [Abertawe Gb-ata], SA6 6SG
Lithuania5 sites
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, 50009
Republic Hospital of Klaipeda
Klaipėda, 92231
Klaipeda Seamen's Hospital
Klaipėda, 92288
Respublikine Panevezio ligonine
Panevezys, Panevėžys, LT-35144
Vilnius University Hospital Santariskiu Clinics
Vilnius, LT-08661
Mexico5 sites
Scientia Investigacion Clinica S.C.
Chihuahua City, 31203
Centro Para el Desarrollo de la Medicina y de Asistencia Medica S.C
Culiacán, Sinaloa, 80230
Centro de Investigación Clínica Acelerada
Mexico City, Mexico City, 07020
Sociedad de Metabolismo y Corazon
Veracruz, 91900
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Zapopan, Jalisco, 45030
Slovakia5 sites
Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica
Banská Bystrica, 975 17
Univerzitna nemocnica Bratislava
Bratislava, 82007
KM Management
Nitra, Nitra Region, 949 01
Gastro
Prešov, Presov, 080 01
Endomed, s.r.o.
Vranov N. Toplou, Presov, 093 01
Turkey (Türkiye)5 sites
Ege Universitesi Hastanesi
Izmir, Turkey, 35100
Kocaeli University Medical Faculty Hospital
İzmit, Kocaeli, 41380
Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
Kadıköy, Istanbul, 34734
Antalya Egitim ve Arastırma Hastanesi
Kocaeli, Antalya, 7100
Mersin University Medical Faculty
Yenişehir, Mersin, 33110
Belgium4 sites
AZ Klina
Brasschaat, 2930
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, 9000
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000
Centre Hospitalier de Wallonie Picarde - Site Notre Dame
Tournai, Wallonne, Région, 7500
Netherlands4 sites
Amsterdam UMC, locatie AMC
Amsterdam, North Holland, 1105 AZ
St Elisabeth Ziekenhuis
Tilburg, North Brabant, 5022 GC
Bernhoven Ziekenhuis
Uden, 5406 PT
UMC Utrecht, Dept. of Internal Medicine, MDL
Utrecht, 3584 CX
Switzerland4 sites
Gastroenterologische Praxis Balsiger, Seibold & Partner
Bern, Canton of Bern, 3012
Inselspital Bern
Bern, 3010
Kantonsspital St.Gallen
Sankt Gallen, 9007
UniversitätsSpital Zürich
Zurich, 8091
Austria3 sites
Medizinische Universität Innsbruck
Innsbruck, 6020
Universitätsklinikum Salzburg
Salzburg, 5020
Medical University of Vienna
Vienna, 1090
Latvia3 sites
Pauls Stradins Clinical Univeristy Hospital
Riga, Riga, LV-1002
Digestive Diseases Center "Gastro"
Riga, 1079
Riga Eastern Clinical University Hospital
Riga, LV-1038
Malaysia3 sites
Hospital Ampang
Ampang, Selangor, 68000
Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100
Denmark2 sites
Herlev and Gentofte Hospital
Herlev, 2730
Zealand University Hospital Køge
Køge, 4600
Taiwan2 sites
China Medical University Hospital
Taichung, 40447
Health management center
Taipei, 10002
About this study
Official title: 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).
- Conditions
- Ulcerative Colitis
- Being tested
- Mirikizumab SC, Mirikizumab IV, Placebo SC
- Keywords
- Interleukin-23 (IL-23), IL-23p19, Inflammatory Bowel Disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirikizumab SCDrug
Also called LY3074828
Administered SC
Mirikizumab IVDrug
Also called LY3074828
Administered IV
Placebo SCDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Period: Miri Induction Responder (IR) - Placebo (PBO) Subcutaneous (SC) | Placebo comparator | 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. Receives: Drug: Placebo SC |
| Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC | Experimental | 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. Receives: Drug: Mirikizumab SC |
| Maintenance Period: PBO IR - PBO SC | Experimental | 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. Receives: Drug: Placebo SC |
| Maintenance Period: Miri IR - PBO SC - ME2 Cohort | Experimental | 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. Receives: Drug: Placebo SC |
| Maintenance Period: Miri IR - 200 mg Miri SC - ME2 Cohort | Experimental | 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. Receives: Drug: Mirikizumab SC |
| Maintenance Period: PBO IR - PBO SC - ME2 Cohort | Experimental | 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. Receives: Drug: Mirikizumab IV; Drug: Placebo SC |
| Loss of Response (LOR) Rescue Period: LOR Cohort-300 mg Miri IV | Experimental | 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. Receives: Drug: Mirikizumab IV |
| LOR Rescue Period: LOR Cohort-300 mg Miri IV - ME2 Cohort | Experimental | 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. Receives: Drug: Mirikizumab IV |
| Extended Induction: Induction Nonresponders - 300mg Miri IV | Experimental | 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. Receives: Drug: Mirikizumab IV |
| Extended Induction: Induction Nonresponders - 300mg Miri IV - ME2 Cohort | Experimental | 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. Receives: Drug: Mirikizumab IV |
| Open Label Maintenance: Delayed Responders - 200 mg Miri SC | Experimental | 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). Receives: Drug: Mirikizumab SC |
| Open Label Maintenance: Delayed Responders - 200 mg Miri SC - ME2 Cohort | Experimental | 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). Receives: Drug: Mirikizumab SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders)
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.
Measured: Week 40
Secondary outcomes (10)
Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders)
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).
Measured: Week 40
Percentage of Participants With Histologic Remission at Week 40 (Mirikizumab Induction Responders)
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).
Measured: Week 40
Percentage of Participants in Symptomatic Remission at Week 40 (Mirikizumab Induction Responders)
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).
Measured: Week 40
Percentage of Participants in Endoscopic Response at Week 40 (Mirikizumab Induction Responders)
Endoscopic response at week 40 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.
Measured: Week 40
Percentage of Participants in Clinical Response at Week 40 (Mirikizumab Induction Responders)
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).
Measured: Week 40
Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Mirikizumab Induction Responders)
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).
Measured: Induction Baseline, Week 40
Change From Baseline to Week 40 in Fecal Calprotectin (Mirikizumab Induction Responders)
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.
Measured: Induction Baseline, Week 40
Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) (Mirikizumab Induction Responders)
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).
Measured: Induction Baseline, Week 40
Percentage of Participants Hospitalized for Ulcerative Colitis (UC) (Mirikizumab Induction Responders)
Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with >=24 hours stay were recorded.
Measured: Week 40
Pharmacokinetics (PK): Clearance of Mirikizumab
Clearance of mirikizumab was evaluated.
Measured: Predose: Weeks 0, 4, 12, 24 and 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start19 Oct 2018
- Primary completion3 Nov 2021
- Study completion17 Feb 2025
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 (13)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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524092
- Sponsor's protocol ID
- 16823
- Other IDs
- I6T-MC-AMBG, 2017-003238-96, 2017
- Acronym
- LUCENT 2
- Status last verified
- May 2026
- First submitted
- 10 May 2018
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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
Ran Z, Chen Y, Miao Y, Wang Y, Gao X, Zhong J, Ding X, Wang C, Zhang X, Ding Y, Hu N, Tang D, Yu J, Qian C, Shen J. Mirikizumab as Induction and Maintenance Therapy in Chinese Patients with Ulcerative Colitis: A Subpopulation Analysis of the Randomized, Global Phase 3 LUCENT-1 and LUCENT-2 Trials. BioDrugs. 2026 Jul;40(4):733-745. doi: 10.1007/s40259-026-00776-y. Epub 2026 May 12.
PubMed 42120652Hart A, Navabi S, D'Haens G, Matsuoka K, Martin-Arranz MD, Atreya R, Samaan KH, Dhesi E, Redondo I, Zhu B, Paulissen J, Zaremba-Pechmann L, Baygani S, Limdi J, Laharie D, Danese S. Effect of Mirikizumab on Clinical and Endoscopic Outcomes Based on Prior Advanced Therapy Failure in Patients With Moderately to Severely Active Ulcerative Colitis. United European Gastroenterol J. 2026 May;14(4):e70214. doi: 10.1002/ueg2.70214.
PubMed 42104877Clemow DB, Dubinsky MC, Baygani SK, Sands BE, Keohane A, Danese S, Schreiber S, Walsh AJ, Hibi T, Gibble TH, Moses RE, Travis SPL. Bowel urgency in ulcerative colitis: effect of baseline urgency and change in urgency in response to mirikizumab. J Patient Rep Outcomes. 2025 Jul 1;9(1):75. doi: 10.1186/s41687-025-00906-0.
PubMed 40591171Panaccione R, Chan-Diehl F, Baygani S, Fisher DA, Moses RE, Siegmund B, Walsh A, Kobayashi T, Dulai PS, Travis S. Fecal Calprotectin and C-Reactive Protein Association With Histologic and Endoscopic Endpoints in Mirikizumab-Treated Patients With Ulcerative Colitis. Crohns Colitis 360. 2025 Jun 14;7(2):otaf043. doi: 10.1093/crocol/otaf043. eCollection 2025 Apr.
PubMed 40589947Lee SD, Ehrlich AC, Pellanda P, Kaiser C, Todd K, Moses R, Walsh A. Long-Term Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis: An Integrated 2-Year Safety Analysis. Am J Gastroenterol. 2025 Dec 1;120(12):2857-2866. doi: 10.14309/ajg.0000000000003407. Epub 2025 Mar 12.
PubMed 40071779Sands BE, D'Haens G, Clemow DB, Irving PM, Johns JT, Gibble TH, Abreu MT, Lee SD, Hisamatsu T, Kobayashi T, Dubinsky MC, Vermeire S, Siegel CA, Peyrin-Biroulet L, Moses RE, Milata J, Panaccione R, Dignass A. Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study. Inflamm Bowel Dis. 2025 Jul 7;31(7):1876-1890. doi: 10.1093/ibd/izae253.
PubMed 39448057Danese S, Dignass A, Matsuoka K, Ferrante M, Long M, Redondo I, Moses R, Maier S, Hunter Gibble T, Morris N, Milch C, Abreu MT. Early and Sustained Symptom Control with Mirikizumab in Patients with Ulcerative Colitis in the Phase 3 LUCENT Programme. J Crohns Colitis. 2024 Nov 4;18(11):1845-1856. doi: 10.1093/ecco-jcc/jjae088.
PubMed 38869019Friedrich 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 38797892Long MD, Schreiber S, Hibi T, Gibble TH, Fisher DA, Park G, Moses RE, Higgins PDR, Lindsay JO, Lee SD, Escobar R, Jairath V. Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies. Crohns Colitis 360. 2024 Jan 6;6(1):otae001. doi: 10.1093/crocol/otae001. eCollection 2024 Jan.
PubMed 38313767Sands BE, Feagan BG, Hunter Gibble T, Traxler KA, Morris N, Eastman WJ, Schreiber S, Jairath V, Long MD, Armuzzi A. Mirikizumab Improves Quality of Life in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Induction and LUCENT-2 Maintenance Studies. Crohns Colitis 360. 2023 Nov 7;5(4):otad070. doi: 10.1093/crocol/otad070. eCollection 2023 Oct.
PubMed 38034882Chua 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 37610533D'Haens G, Dubinsky M, Kobayashi T, Irving PM, Howaldt S, Pokrotnieks J, Krueger K, Laskowski J, Li X, Lissoos T, Milata J, Morris N, Arora V, Milch C, Sandborn W, Sands BE; LUCENT Study Group. Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2023 Jun 29;388(26):2444-2455. doi: 10.1056/NEJMoa2207940.
PubMed 37379135Magro F, Pai RK, Kobayashi T, Jairath V, Rieder F, Redondo I, Lissoos T, Morris N, Shan M, Park M, Peyrin-Biroulet L. Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. J Crohns Colitis. 2023 Oct 20;17(9):1457-1470. doi: 10.1093/ecco-jcc/jjad050.
PubMed 37057827