A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT03524092
Last Updated: 2025-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1177 participants
INTERVENTIONAL
2018-10-19
2025-02-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Placebo SC
Administered SC
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.
Mirikizumab SC
Administered SC
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.
Placebo SC
Administered SC
Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV
Participants who received PBO SC or 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.
Mirikizumab IV
Administered IV
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.
Mirikizumab IV
Administered IV
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.
Mirikizumab SC
Administered SC
Interventions
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Mirikizumab SC
Administered SC
Mirikizumab IV
Administered IV
Placebo SC
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Dcr-Pi, Pc
Litchfield Park, Arizona, United States
Maricopa Integrated Health System
Phoenix, Arizona, United States
Physicians Research Group
Tempe, Arizona, United States
Valley Gastroenterology
Arcadia, California, United States
Care Access Research
Berkeley, California, United States
Om Research, LLC
Lancaster, California, United States
California Medical Research Associates
Northridge, California, United States
Clinical Applications Laboratories, Inc.
San Diego, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Nature Coast Clinical Research, LLC
Inverness, Florida, United States
SIH Research, LLC
Kissimmee, Florida, United States
Research Associates of South Florida, LLC
Miami, Florida, United States
Wellness Clinical Research
Miami Lakes, Florida, United States
Center for Interventional Endoscopy
Orlando, Florida, United States
Clintheory Healthcare
Orlando, Florida, United States
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, United States
Florida Medical Clinic LLC
Zephyrhills, Florida, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, United States
Grand Teton Research Group
Idaho Falls, Idaho, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States
Texas Digestive Disease Consultants
Baton Rouge, Louisiana, United States
Delta Research Partners LLC
Monroe, Louisiana, United States
Nola Research Works, LLC
New Orleans, Louisiana, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Henry Ford Health System
Novi, Michigan, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, United States
MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
Plymouth, Minnesota, United States
Care Access Research LLC
Jackson, Mississippi, United States
Digestive Health Specialists
Tupelo, Mississippi, United States
Northwell Health
Great Neck, New York, United States
Weill Cornell Medical College
New York, New York, United States
University of North Carolina Center for Inflammatory Bowel Disease
Chapel Hill, North Carolina, United States
Carolina Digestive Diseases and Endoscopy Center
Greenville, North Carolina, United States
Paramount Medical Research
Middleburg Heights, Ohio, United States
Care Access - Youngstown
Poland, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Digestive Disease Associates
Wyomissing, Pennsylvania, United States
Midwest Medical Care
Sioux Falls, South Dakota, United States
Gastro One
Germantown, Tennessee, United States
Galen Medical Group
Hixson, Tennessee, United States
Digestive Health Associates of Texas
Garland, Texas, United States
Houston Methodist Research Ins
Houston, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Texas Digestive Disease Consultants
Southlake, Texas, United States
Care Access Research LLC - Salt Lake City
Ogden, Utah, United States
Emeritas Research Group
Leesburg, Virginia, United States
The Gastroenterology Group, P.C.
Reston, Virginia, United States
Carilion Clinic
Roanoke, Virginia, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Centro de Investigaciones Metabólicas (CINME)
CABA, Buenos Aires, Argentina
Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
Ciudad Autonoma de Buenos Air, Buenos Aires, Argentina
CER Instituto Medico
Quilmes, Buenos Aires, Argentina
Fundación de Estudios Clínicos
Rosario, Santa Fe Province, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, Argentina
C.I.C.E. 9 de Julio
San Miguel de Tucumán, Tucumán Province, Argentina
Hospital Privado Centro Medico de Cordoba SA
Córdoba, , Argentina
Princess Alexandra Hospital
Harlow, Essex, Australia
Coastal Digestive Health
Maroochydore, Queensland, Australia
Mater University Hospital
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Box Hill Hospital Outpatients
Box Hill, Victoria, Australia
Melbourne Gastrointestinal Investigation Unit (MGIU)
Malvern, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Medizinische Universität Innsbruck
Innsbruck, , Austria
Universitätsklinikum Salzburg
Salzburg, , Austria
Medical University of Vienna
Vienna, , Austria
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, Belgium
Centre Hospitalier de Wallonie Picarde - Site Notre Dame
Tournai, Wallonne, Région, Belgium
AZ Klina
Brasschaat, , Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
West Edmonton Diabetes Center
Edmonton, Alberta, Canada
The Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
GI Research Institute
Vancouver, British Columbia, Canada
PerCuro Clinical Research
Victoria, British Columbia, Canada
Victoria Hospital
London, Ontario, Canada
University of Western Ontario
London, Ontario, Canada
Centre de santé et de services sociaux Champlain-Charles-Le Moyne
Greenfield Park, Quebec, Canada
Hopital Maisonneure-Rosemount
Montreal, Quebec, Canada
Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC
Montreal, Quebec, Canada
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Xiangya Hospital Central South University
Kaifu District, Changsha City, China
The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
Chongqing, Chongqing Municipality, China
The First Hospital Affiliated to AMU (Southwest Hospital)
Chongqing, Chongqing Municipality, China
The Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Jilin Central General Hospital
Jilin, Jilin, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Taian City Central Hospital
Taian, Shandong, China
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, China
Renji Hospital Affliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Kunming Medical College Affiliated First Hospital
Kunming, Yunnan, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
The Second Affiliated Hospital of Zhejiang University School of Med
Hangzhou, Zhejiang, China
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
Wenzhou, Zhejiang, China
Tongji Hospital of Tongji University
Wuhan, , China
Vojenská Nemocnice Brno
Brno, Brno-město, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Hl. M. Praha, Czechia
Hepato-Gastroenterologie HK
Hradec Králové, Hradec Králové, Czechia
MUDr. Gregar, s.r.o.
Olomouc, Olomoucký kraj, Czechia
A-Shine
Pilsen, Plzeň-město, Czechia
MEDIENDO
Prague, Praha 8, Czechia
Fakultni Nemocnice u sv. Anny v Brne
Brno, , Czechia
PreventaMed, s.r.o.
Olomouc, , Czechia
ISCARE Clinical Centre
Prague, , Czechia
Herlev and Gentofte Hospital
Herlev, , Denmark
Zealand University Hospital Køge
Køge, , Denmark
Hopital de Hautepierre - Service d'Hépatogastroentérolgie
Strasbourg, Bas Rhin, France
Hopital Saint-Louis
Paris, Cedex 10, France
CHU Lille - Hôpital Claude Huriez
Lille, Nord, France
Hôpital Beaujon
Clichy, Paris, France
Centre Hospitalier de Pau
Pau, Pyrénées-Atlantiques, France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
Pierre-Bénite, Rhone, France
CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro
Amiens, Somme, France
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours, , France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, , France
CHRU de Montpellier-Hopital St Eloi
Montpellier, , France
Hopital L'Archet 2
Nice, , France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, , France
Robert Debre Hospital
Reims, , France
CHU de Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, , France
CHRU Nancy Brabois - Hôpital d'Enfants
Vandœuvre-lès-Nancy, , France
Medizinische Hochschule Hanover
Hanover, Lower Saxony, Germany
Gemeinschaftspraxis Dr. Peter Uebel
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Studiengesellschaft BSF Unternehmergesellschaft
Halle, Saxony-Anhalt, Germany
Universitätsklinikum Halle
Halle, Saxony-Anhalt, Germany
Charité Campus Virchow-Klinikum
Berlin, , Germany
Krankenhaus Waldfriede
Berlin, , Germany
Städtisches Klinikum Brandenburg
Brandenburg, , Germany
HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
Hamburg, , Germany
Internistische Praxisgemeinschaft
Weyhe, , Germany
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred, EU, Hungary
Jávorszky Ödön Kórház
Vác, Pest County, Hungary
Óbudai Egészségügyi Centrum
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Endomedix Diagnosztikai Központ - Miskolc
Miskolc, , Hungary
Karolina Korhaz-Rendelointezet
Mosonmagyaróvár, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
Szeged, , Hungary
CLINFAN Szolgáltató Kft
Szekszárd, , Hungary
Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
Hyderabad, Andhra Pradesh, India
Apollo Research and Innovations, Apollo Hospitals International Ltd
Gandhinagar, Gujarat, India
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, India
Nirmal Hospital Pvt Ltd.
Surat, Gujarat, India
Bangalore Medical College and Research Institute
Bangalore, Karnataka, India
M S Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India
Midas Multispeciality Hospital Pvt.Ltd.
Nagpur, Maharashtra, India
Poona Medical Foundation. Ruby Hall Clinic
Pune, Maharashtra, India
Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital
Wardha, Maharashtra, India
Escorts Heart Institute and Research Centre Ltd
New Delhi, National Capital Territory of Delhi, India
Dayanand Medical College and Hospital
Ludhiana, Punjab, India
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India
Gandhi Hospital
Hyderabad, Telangana, India
King George Medical University
Lucknow, Uttar Pradesh, India
Beaumont Hospital, Dublin
Dublin, , Ireland
Shaare Zedek Medical Center
Bait Vagan, Jerusalem, Israel
Soroka Medical Center - Pediatric Outpatient Clinic
Beersheba, , Israel
Galilee Medical Center Department of Internal Medicine A
Nahariya, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
King Fahad Medical City
Ẕerifin, , Israel
Presidio di Rho
Rho, Milano, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia
San Donato Milanese, Milano, Italy
Ospedale Sandro Pertini
Rome, Roma, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Torre, Roma, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, , Italy
Azienda ospedaliero-universitaria Mater Domini
Catanzaro, , Italy
Azienda Ospedaliero Universitaria San Martino
Genova, , Italy
Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Milan, , Italy
Azienda Ospedaliera Universitaria Policlinico de Modena
Modena, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Policlinico Gemelli - Università Cattolica del Sacro Cuore
Roma, , Italy
Ospedale Mauriziano Umberto I
Torino, , Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia
Udine, , Italy
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, Japan
Fujita Health University
Toyoake, Aichi-ken, Japan
National Hospital Organization Hirosaki National Hospital
Hirosaki, Aomori, Japan
Toho University Sakura Medical Center
Sakura, Chiba, Japan
Kitakyushu Municipal Medical Center
Kitakyusyu-shi, Fukoka, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, Japan
Hidaka Coloproctology Clinic
Kurume-shi, Fukuoka, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
National Hospital Organization Takasaki General Medical Centar
Takasaki, Gunma, Japan
NHO Mito Medical Center
Ibaraki-machi, HigaShiibaraki-Gun, Japan
Asahikawa City Hospital
Asahikawa, Hokkaido, Japan
Tokushukai Sapporo Tokushukai Hospital
Sapporo, Hokkaido, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, Hokkaido, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, Japan
Aoyama Clinic GI Endoscopy & IBD Center
Kobe, Hyōgo, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, Japan
Ofuna Central Hospital
Kamakura, Kanagawa, Japan
Kawasaki Municipal Hospital
Kawasaki, Kanagawa, Japan
Sankikai Yokohama Shin midori General Hospital
Yokohama, Kanagawa, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Takagi Clinic - Sendai
Sendai, Miyagi, Japan
Nagaoka Chuo General Hospital
Nagaoka-shi, Niigata, Japan
Ishida Clinic of IBD and Gastroenterology
Ōita, Oita Prefecture, Japan
Sai Gastroenterologist Proctology
Fujiidera, Osaka, Japan
Infusion Clinic
Osaka, Osaka, Japan
NHO Osaka National Hospital
Osaka, Osaka, Japan
Saga-Ken Medical Center Koseikan
Saga, Saga-ken, Japan
Kumagaya General Hospital
Kumagaya-shi, Saitama, Japan
Matsuda Hospital
Hamamatsu, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Medical and Dental University Hospital
Bunkyō, Tokyo, Japan
Showa University Koto Toyosu Hospital
Koto-ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital
Minato-Ku, Tokyo, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
JHCO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, Japan
Mitsui Memorial Hospital
Chiyoda-ku, Tokyo-To, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku, Tokyo-To, Japan
Fukuoka University Hospital
Fukuoka, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Sameshima Hospital
Kagoshima, , Japan
National Hospital Organization Kyoto Medical Center
Kyoto, , Japan
Okayama University Hospital
Okayama, , Japan
Tokitokai Tokito Clinic
Saitama, , Japan
Toyama Prefectural Central Hospital
Toyama, , Japan
Pauls Stradins Clinical Univeristy Hospital
Riga, Rīga, Latvia
Digestive Diseases Center "Gastro"
Riga, , Latvia
Riga Eastern Clinical University Hospital
Riga, , Latvia
Respublikine Panevezio ligonine
Panevezys, Panevėžys, Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, , Lithuania
Republic Hospital of Klaipeda
Klaipėda, , Lithuania
Klaipeda Seamen's Hospital
Klaipėda, , Lithuania
Vilnius University Hospital Santariskiu Clinics
Vilnius, , Lithuania
Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Ampang
Ampang, Selangor, Malaysia
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Zapopan, Jalisco, Mexico
Centro de Investigación Clínica Acelerada
Mexico City, Mexico City, Mexico
Centro Para el Desarrollo de la Medicina y de Asistencia Medica S.C
Culiacán, Sinaloa, Mexico
Scientia Investigacion Clinica S.C.
Chihuahua City, , Mexico
Sociedad de Metabolismo y Corazon
Veracruz, , Mexico
St Elisabeth Ziekenhuis
Tilburg, North Brabant, Netherlands
Amsterdam UMC, locatie AMC
Amsterdam, North Holland, Netherlands
Bernhoven Ziekenhuis
Uden, , Netherlands
UMC Utrecht, Dept. of Internal Medicine, MDL
Utrecht, , Netherlands
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Topolowa Medicenter
Krakow, Lesser Poland Voivodeship, Poland
Medicenter Nowy Targ
Nowy Targ, Lesser Poland Voivodeship, Poland
NZOZ Formed
Wadowice, Lesser Poland Voivodeship, Poland
LexMedica
Wroclaw, Lower Silesian Voivodeship, Poland
ZOZ Gastromed
Lublin, Lublin Voivodeship, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, Lublin Voivodeship, Poland
NZOZ Vivamed
Warsaw, Masovian Voivodeship, Poland
Promedica Dental Clinic
Będzin, Silesian Voivodeship, Poland
SONOMED Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, Poland
All-Medicus
Katowice, , Poland
Wojewodzki Specjalistyczny Szpital w Olsztynie
Olsztyn, , Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, , Poland
Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii
Torun, , Poland
Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Centrum Zdrowia MDM
Warsaw, , Poland
Centrum Medyczne NeuroProtect
Warsaw, , Poland
PlanetMed Sp.z o.o.
Wroclaw, , Poland
ETG Zamość
Zamość, , Poland
KO-Med Centrum Medyczne
Straszów, Świętokrzyskie Voivodeship, Poland
CCBR Clinical Research
Bucharest, București, Romania
MedLife Grivita
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Institutul Clinic Fundeni
Bucharest, , Romania
Hifu Terramed Conformal SRL
Bucharest, , Romania
Spital Pelican Oradea
Oradea, , Romania
Scientific Centre of Reconstructive and Restorative Surgery
Irkutsk, Irkutsk Oblast, Russia
Karelia Republican Hospital V.A. Baranova
Petrozavodsk, Kareliya, Respublika, Russia
Nizhny Novgorod Regional Hospital N.A. Semashko
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Novosibirski Gastrocenter
Novosibirsk, Novosibirsk Oblast, Russia
Rostov State Medical University
Rostov-on-Don, Rostov Oblast, Russia
Scientific research center ECO-security
Saint Petersburg, Sankt-Peterburg, Russia
Multidisciplinary Medical Clinic "Anthurium"
Barnaul, , Russia
Medical and Sanitary Division of Severstal
Cherepovets, , Russia
Alliance Biomedical URAL Group
Izhevsk, , Russia
Clinical Trials Center of Medical Institute
Kaliningrad, , Russia
State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan
Kazan', , Russia
SIH Kemerovo Regional Clinical Hosptial
Kemerovo, , Russia
Medical rehabilitation center
Moscow, , Russia
LLC "Medicine Center SibNovoMed"
Novosibirsk, , Russia
Clinical Diagnostic Center Ultramed
Omsk, , Russia
City Mariinskaya Hospital
Saint Petersburg, , Russia
Pokrovskaya Municipal Hospital
Saint Petersburg, , Russia
Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways
Saint Petersburg, , Russia
Saint Petersburg State Medical University n.a. Pavlov I.P.
Saint Petersburg, , Russia
SBIH City Clinical Hospital #31
Saint Petersburg, , Russia
Medical Institute REAVIZ
Samara, , Russia
Stavropol State Medical University
Stavropol, , Russia
Yaroslavl Municipal HI Clinical Hospital #8
Yaroslavl, , Russia
LLC MA New Hospital
Yekaterinburg, , Russia
Clinical Hospital Center Zvezdara
Belgrade, Beograd, Serbia
University Medical Center "Bezanijska kosa"
Belgrade, NAP, Serbia
Regional Hospital Dr Radivoj Simonovic Sombor
Sombor, Vojvodina, Serbia
Sremska Mitrovica Health Centre
Sremska Mitrovica, Vojvodina, Serbia
General Hospital "Djordje Joanovic"
Zrenjanin, Vojvodina, Serbia
Clinical Center Kragujevac Gastroenterohepatology Clinic
Kragujevac, , Serbia
KM Management
Nitra, Nitra Region, Slovakia
Gastro
Prešov, Presov, Slovakia
Endomed, s.r.o.
Vranov N. Toplou, Presov, Slovakia
Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica
Banská Bystrica, , Slovakia
Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Severance Hospital, Yonsei University Health System
Wŏnju, Gangwon-do, South Korea
Kyung Hee University Hospital
Seoul, Korea, South Korea
Dong-A University Hospital
Busan, Pusan-Kwangyǒkshi, South Korea
Kangbuk Samsung Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daejeon, Taejǒn-Kwangyǒkshi, South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Yeungnam Univeristy Medical Center
Daegu, , South Korea
Hospital Universitario Virgen Del Rocio
Seville, Andalusia, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Baleares Islands, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital De Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo
Sagunto, Valencia, Spain
Complexo Hospitalario Universitario A Coruña, CHUAC
A Coruña, , Spain
Instituto de Ciencias Médicas
Alicante, , Spain
Hospital Universitari de Girona
Girona, , Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, , Spain
Hospital De Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Gastroenterologische Praxis Balsiger, Seibold & Partner
Bern, Canton of Bern, Switzerland
Inselspital Bern
Bern, , Switzerland
Kantonsspital St.Gallen
Sankt Gallen, , Switzerland
UniversitätsSpital Zürich
Zurich, , Switzerland
China Medical University Hospital
Taichung, , Taiwan
Health management center
Taipei, , Taiwan
Antalya Egitim ve Arastırma Hastanesi
Kocaeli, Antalya, Turkey (Türkiye)
Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
Kadıköy, Istanbul, Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital
İzmit, Kocaeli, Turkey (Türkiye)
Mersin University Medical Faculty
Yenişehir, Mersin, Turkey (Türkiye)
Ege Universitesi Hastanesi
Izmir, , Turkey (Türkiye)
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
City Clinical Hospital No. 2
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Kherson City Clinical Hospital
Kherson, Kherson Oblast, Ukraine
Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
Kiev, Kyiv Oblast, Ukraine
Lviv Railway Clinical Hospital
Lviv, Lviv Oblast, Ukraine
Lviv Regional Endocrinology Dispensary
Lviv, Lviv Oblast, Ukraine
Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
Lviv, Lviv Oblast, Ukraine
Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
Poltava, Poltava Oblast, Ukraine
Diaservis - Medical and Diagnostic Center
Zaporizhia, Zaporizhzhia Oblast, Ukraine
Kharkiv City Student Hospital
Kharkiv, , Ukraine
GI L.T. Malaya TI Namsu
Kharkiv, , Ukraine
Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
Kropyvnytskyi, , Ukraine
Kyiv Municipal Clinical Hospital #1
Kyiv, , Ukraine
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
Kyiv, , Ukraine
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
Kyiv, , Ukraine
Communal Enterprise "Odesa Regional Clinical Hospital"
Odesa, , Ukraine
A. Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, , Ukraine
Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
Vinnytsia, , Ukraine
MCIC MC LLC Health Clinic
Vinnytsia, , Ukraine
M.I. Pyrogov Regional Clinical Hospital
Vinnytsia, , Ukraine
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Vinnytsia, , Ukraine
Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
Zaporizhzhia, , Ukraine
Queens Hospital
Romford, Essex, United Kingdom
Fairfield General Hospital
Bury, Great Britain, United Kingdom
St Thomas' Hospital
Great Maze Pond, London, United Kingdom
Whipps Cross University Hospital
London, Surrey, United Kingdom
Morriston Hospital
Swansea, Swansea [Abertawe Gb-ata], United Kingdom
St James's University Hospital
Leeds, Vinnytsia, United Kingdom
Countries
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References
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Clemow 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.
Panaccione 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.
Lee 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 Mar 12. doi: 10.14309/ajg.0000000000003407. Online ahead of print.
Sands 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.
Danese 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.
Long 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.
Sands 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.
Chua L, Friedrich S, Zhang XC. Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. Clin Pharmacokinet. 2023 Oct;62(10):1479-1491. doi: 10.1007/s40262-023-01281-z. Epub 2023 Aug 23.
D'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.
Magro 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)
Other Identifiers
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I6T-MC-AMBG
Identifier Type: OTHER
Identifier Source: secondary_id
2017-003238-96
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16823
Identifier Type: -
Identifier Source: org_study_id
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