A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— LUCENT 2  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03524092
• Other study ID #: 16823
• Secondary ID: I6T-MC-AMBG2017-
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 19, 2018
• Est. completion date: December 20, 2024

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1177
• Est. completion date: December 20, 2024
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Mirikizumab SC
Administered SC
• Mirikizumab IV
Administered IV
• Placebo SC
Administered SC

Locations

Country	Name	City	State
Argentina	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	Hospital Privado Centro Medico de Cordoba SA	Cordoba
Argentina	CER Instituto Medico	Quilmes	Buenos Aires
Argentina	Fundación de Estudios Clínicos	Rosario	Santa Fe
Argentina	Centro de Investigaciones Médicas Tucuman	SAN M. DE Tucuman	Tucumán
Argentina	C.I.C.E. 9 de Julio	San Miguel de Tucumán	Tucumán
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Box Hill Hospital Outpatients	Box Hill	Victoria
Australia	Princess Alexandra Hospital	Harlow	Essex
Australia	Melbourne Gastrointestinal Investigation Unit (MGIU)	Malvern	Victoria
Australia	Coastal Digestive Health	Maroochydore	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Australia	Mater University Hospital	South Brisbane	Queensland
Austria	Medizinische Universität Innsbruck	Innsbruck
Austria	Universitätsklinikum Salzburg	Salzburg
Austria	Medical University of Vienna	Vienna
Belgium	AZ Klina	Brasschaat
Belgium	Universitair Ziekenhuis Gent	Gent	Oost-Vlaanderen
Belgium	Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg	Leuven
Belgium	Centre Hospitalier de Wallonie Picarde - Site Notre Dame	Tournai	Wallonne, Région
Canada	West Edmonton Diabetes Center	Edmonton	Alberta
Canada	Centre de santé et de services sociaux Champlain-Charles-Le Moyne	Greenfield Park	Quebec
Canada	University of Western Ontario	London	Ontario
Canada	Victoria Hospital	London	Ontario
Canada	Hopital Maisonneure-Rosemount	Montreal	Quebec
Canada	Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC	Montreal	Quebec
Canada	GI Research Institute	Vancouver	British Columbia
Canada	The Gordon and Leslie Diamond Health Care Centre	Vancouver	British Columbia
Canada	PerCuro Clinical Research	Victoria	British Columbia
China	Beijing Friendship Hospital	Beijing	Beijing
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA	Chongqing	Chongqing
China	The First Hospital Affiliated to AMU (Southwest Hospital)	Chongqing	Chongqing
China	The Second Hospital of Dalian Medical University	Dalian	Lianing
China	Fujian Province Hospital	Fuzhou	Fujian
China	The Sixth Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Hainan General Hospital	Haikou	Hainan
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 of Zhejiang University School of Med	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei City	Anhui
China	The First Affiliated Hospital of Anhui Medical University	Hefei City	Anhui
China	Jilin Central General Hospital	Jilin	Jilin
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Xiangya Hospital Central South University	Kaifu District	Changsha City
China	Kunming Medical College Affiliated First Hospital	Kunming	Yunnan
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	Liaocheng People's Hospital	Liaocheng	Shandong
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Jiangsu Province Hospital of Chinese Medicine	Nanjing	Jiangsu
China	Nanjing Medical University - Nanjing Jiangning Hospital	Nanjing	Jiangsu
China	The Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Renji Hospital Affliated to Shanghai Jiaotong University	Shanghai	Shanghai
China	Shanghai Jiaotong University School of Medicine Ruijin Hospital	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang City	Liaoning
China	The University of Hong Kong-Shenzhen Hospital	Shenzhen	Guangdong
China	Taian City Central Hospital	Taian	Shandong
China	No.1 Hospital Affiliated to Xinjiang Medical University	Urumchi	Urumchi
China	The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university	Wenzhou	Zhejiang
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Tongji Hospital of Tongji University	Wuhan
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou Shi	Henan
China	ZhuZhou Central Hospital	ZhuZhou	Hunan
Czechia	Fakultni Nemocnice u sv. Anny v Brne	Brno
Czechia	Vojenská Nemocnice Brno	Brno	Brno-mesto
Czechia	Hepato-Gastroenterologie HK	Hradec Kralove	Hradec Králové
Czechia	MUDr. Gregar, s.r.o.	Olomouc	Olomoucký Kraj
Czechia	PreventaMed, s.r.o.	Olomouc
Czechia	A-Shine	Pilsen	Plzen-mesto
Czechia	MEDIENDO	Prague	Praha 8
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10	Hl. M. Praha
Czechia	ISCARE Clinical Centre	Praha 9
Denmark	Herlev and Gentofte Hospital	Herlev
Denmark	Zealand University Hospital Køge	Køge
France	CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro	Amiens Cedex	Somme
France	CHU Tours - Hôpital Trousseau	Chambray les Tours
France	Hôpital Beaujon	Clichy	Paris
France	CHU Lille - Hôpital Claude Huriez	Lille cedex	Nord
France	Assistance Publique Hôpitaux de Marseille - Hôpital Nord	Marseille Cedex 20
France	CHRU de Montpellier-Hopital St Eloi	Montpellier Cedex 5
France	Hopital L'Archet 2	Nice Cedex
France	Hopital Saint-Louis	Paris	Cedex 10
France	Centre Hospitalier de Pau	Pau	Pyrénées-Atlantiques
France	CHU Bordeaux - Hôpital Haut-Lévêque	Pessac Cedex
France	Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -	Pierre Benite cedex	Rhone
France	Robert Debre Hospital	Reims
France	CHU de Saint Etienne Hopital Nord	Saint Priest en Jarez
France	Hopital de Hautepierre - Service d'Hépatogastroentérolgie	Strasbourg Cedex	Bas Rhin
France	CHRU Nancy Brabois - Hôpital d'Enfants	Vandoeuvre les Nancy
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	Krankenhaus Waldfriede	Berlin
Germany	Städtisches Klinikum Brandenburg	Brandenburg
Germany	Studiengesellschaft BSF Unternehmergesellschaft	Halle (Saale)	Sachsen-Anhalt
Germany	Universitätsklinikum Halle	Halle (Saale)	Sachsen-Anhalt
Germany	HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen	Hamburg
Germany	Medizinische Hochschule Hanover	Hannover	Niedersachsen
Germany	Gemeinschaftspraxis Dr. Peter Uebel	Ludwigshafen am Rhein	Rheinland-Pfalz
Germany	Internistische Praxisgemeinschaft	Weyhe
Hungary	DRC Gyogyszervizsgalo Kozpont Kft.	Balatonfüred	EU
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	Mosonmagyarovar
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika	Szeged
Hungary	CLINFAN Szolgáltató Kft	Szekszard
Hungary	Jávorszky Ödön Kórház	Vác	Pest
India	Bangalore Medical College and Research Institute	Bangalore	Karnataka
India	M S Ramaiah Medical College and Hospitals	Bangalore	Karnataka
India	Apollo Research and Innovations, Apollo Hospitals International Ltd	Gandhinagar	Gujarat
India	Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre	Hyderabad	Andhra Pradesh
India	Gandhi Hospital	Hyderabad	Telangana
India	SR Kalla Memorial Gastro & General Hospital	Jaipur	Rajasthan
India	King George Medical University	Lucknow	Uttar Pradesh
India	Dayanand Medical College and Hospital	Ludhiana	Punjab
India	Midas Multispeciality Hospital Pvt.Ltd.	Nagpur	Maharashtra
India	Escorts Heart Institute and Research Centre Ltd	New Delhi	Delhi
India	Poona Medical Foundation. Ruby Hall Clinic	Pune	Maharashtra
India	Shree Giriraj Multispeciality Hospital	Rajkot	Gujarat
India	Nirmal Hospital Pvt Ltd.	Surat	Gujarat
India	Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital	Wardha	Maharashtra
Ireland	Beaumont Hospital, Dublin	Dublin
Israel	Shaare Zedek Medical Center	Bait Vagan	Jerusalem
Israel	Soroka Medical Center - Pediatric Outpatient Clinic	Beer-Sheva
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	Zerifin
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	Milano
Italy	Azienda Ospedaliera Universitaria Policlinico de Modena	Modena
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa
Italy	Presidio di Rho	Rho	Milano
Italy	Policlinico Gemelli - Università Cattolica del Sacro Cuore	Roma
Italy	Ospedale Sandro Pertini	Rome	Roma
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 Mauriziano Umberto I	Torino
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata	Torre	Roma
Italy	Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia	Udine
Japan	Asahikawa City Hospital	Asahikawa	Hokkaido
Japan	Tokyo Medical and Dental University Hospital	Bunkyo	Tokyo
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	Fukuoka University Chikushi Hospital	Chikushino	Fukuoka
Japan	Mitsui Memorial Hospital	Chiyoda-ku	Tokyo-To
Japan	Sai Gastroenterologist Proctology	Fujiidera	Osaka
Japan	Fukuoka University Hospital	Fukuoka
Japan	Matsuda Hospital	Hamamatsu-shi	Shizuoka-Ken
Japan	National Hospital Organization Hirosaki National Hospital	Hirosaki	Aomori
Japan	Hiroshima University Hospital	Hiroshima
Japan	NHO Mito Medical Center	Ibaraki-machi	HigaShiibaraki-Gun
Japan	Sameshima Hospital	Kagoshima
Japan	Ofuna Central Hospital	Kamakura	Kanagawa
Japan	Kawasaki Municipal Hospital	Kawasaki	Kanagawa
Japan	Kitakyushu Municipal Medical Center	Kitakyusyu-shi	Fukoka
Japan	Aoyama Clinic GI Endoscopy & IBD Center	Kobe-shi	Hyogo-Ken
Japan	Showa University Koto Toyosu Hospital	Koto-ku	Tokyo
Japan	Kumagaya General Hospital	Kumagaya-shi	Saitama-Ken
Japan	Kumamoto University Hospital	Kumamoto-shi	Kumamoto
Japan	Hidaka Coloproctology Clinic	Kurume-shi	Fukuoka-Ken
Japan	National Hospital Organization Kyoto Medical Center	Kyoto
Japan	Gunma University Hospital	Maebashi	Gunma
Japan	Kitasato University Kitasato Institute Hospital	Minato-Ku	Tokyo
Japan	Kyorin University Hospital	Mitaka	Tokyo
Japan	Aichi Medical University Hospital	Nagakute-shi	Aichi-ken
Japan	Nagaoka Chuo General Hospital	Nagaoka-shi	Niigata
Japan	Ishida Clinic of IBD and Gastroenterology	Oita-shi	Oita-Ken
Japan	Okayama University Hospital	Okayama
Japan	Infusion Clinic	Osaka-shi	Osaka
Japan	NHO Osaka National Hospital	Osaka-shi	Osaka
Japan	Saga-Ken Medical Center Koseikan	Saga-Shi	Saga-Ken
Japan	Tokitokai Tokito Clinic	Saitama
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Sapporo Higashi Tokushukai Hospital	Sapporo	Hokkaido
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital	Sapporo-shi	Hokkaido
Japan	Tokushukai Sapporo Tokushukai Hospital	Sapporo-shi	Hokkaido
Japan	Takagi Clinic - Sendai	Sendai-shi	Miyagi-Ken
Japan	Jichi Medical University Hospital	Shimotsuke-shi	Tochigi-Ken
Japan	Center Hospital of the National Center for Global Health and Medicine	Shinjuku-ku	Tokyo-To
Japan	JHCO Tokyo Yamate Medical Center	Shinjuku-ku	Tokyo
Japan	Kagawa Prefectural Central Hospital	Takamatsu	Kagawa
Japan	National Hospital Organization Takasaki General Medical Centar	Takasaki	Gunma
Japan	Toyama Prefectural Central Hospital	Toyama
Japan	Fujita Health University	Toyoake	Aichi
Japan	Mie University Hospital	Tsu	Mie
Japan	Showa University Northern Yokohama Hospital	Yokohama	Kanagawa
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa
Japan	Sankikai Yokohama Shin midori General Hospital	Yokohama-shi	Kanagawa-Ken
Korea, Republic of	Dong-A University Hospital	Busan	Pusan-Kwangyokshi
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Yeungnam Univeristy Medical Center	Daegu
Korea, Republic of	The Catholic University of Korea, Daejeon St. Mary's Hospital	Daejeon	Taejon-Kwangyokshi
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Kangbuk Samsung Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Kyung Hee University Hospital	Seoul	Korea
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Wonju-si	Gangwon-do
Latvia	Digestive Diseases Center "Gastro"	Riga
Latvia	Pauls Stradins Clinical Univeristy Hospital	Riga	Riga
Latvia	Riga Eastern Clinical University Hospital	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas	Kaunas
Lithuania	Klaipeda Seamen's Hospital	Klaipeda
Lithuania	Republic Hospital of Klaipeda	Klaipeda
Lithuania	Respublikine Panevezio ligonine	Panevezys	Panevežio Apskritis
Lithuania	Vilnius University Hospital Santariskiu Clinics	Vilnius
Malaysia	Hospital Ampang	Ampang	Selangor
Malaysia	Universiti Sains Malaysia	Kubang Kerian	Kelantan
Malaysia	University Malaya Medical Centre	Lembah Pantai	Kuala Lumpur
Mexico	Scientia Investigacion Clinica S.C.	Chihuahua
Mexico	Centro Para el Desarrollo de la Medicina y de Asistencia Medica S.C	Culiacan	Sinaloa
Mexico	Centro de Investigación Clínica Acelerada	Mexico City	Distrito Federal
Mexico	Sociedad de Metabolismo y Corazon	Veracruz
Mexico	Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.	Zapopan	Jalisco
Netherlands	Amsterdam UMC, locatie AMC	Amsterdam	Noord-Holland
Netherlands	St Elisabeth Ziekenhuis	Tilburg	Noord Brabant
Netherlands	Bernhoven Ziekenhuis	Uden
Netherlands	UMC Utrecht, Dept. of Internal Medicine, MDL	Utrecht
Poland	Promedica Dental Clinic	Bedzin	Slaskie
Poland	Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy	Bydgoszcz	Kujawsko-pomorskie
Poland	All-Medicus	Katowice
Poland	Topolowa Medicenter	Krakow	Malopolskie
Poland	Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie	Lublin	Lubelskie
Poland	ZOZ Gastromed	Lublin	Lubelskie
Poland	Medicenter Nowy Targ	Nowy Targ	Malopolskie
Poland	Wojewodzki Specjalistyczny Szpital w Olsztynie	Olsztyn
Poland	KO-Med Centrum Medyczne	Straszów	Swietokrzyskie
Poland	SONOMED Centrum Medyczne	Szczecin	Zachodniopomorskie
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin
Poland	Gastromed Kopon Zmudzinski I Wspólnicy Spólka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii	Torun
Poland	NZOZ Formed	Wadowice	Malopolskie
Poland	NZOZ Vivamed	Warsaw	Mazowieckie
Poland	Centrum Medyczne NeuroProtect	Warszawa
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Warsaw IBD Point Profesor Kierkus	Warszawa
Poland	LexMedica	Wroclaw	Dolnoslaskie
Poland	PlanetMed Sp.z o.o.	Wroclaw
Poland	ETG Zamosc	Zamosc
Romania	CCBR Clinical Research	Bucharest	Bucure?ti
Romania	Hifu Terramed Conformal SRL	Bucuresti
Romania	Institutul Clinic Fundeni	Bucuresti
Romania	MedLife Grivita	Bucuresti
Romania	Spitalul Clinic Colentina	Bucuresti
Romania	Spital Pelican Oradea	Oradea
Russian Federation	Multidisciplinary Medical Clinic "Anthurium"	Barnaul
Russian Federation	Medical and Sanitary Division of Severstal	Cherepovets
Russian Federation	LLC MA New Hospital	Ekaterinburg
Russian Federation	Scientific Centre of Reconstructive and Restorative Surgery	Irkutsk	Irkutskaya Oblast'
Russian Federation	Alliance Biomedical URAL Group	Izhevsk
Russian Federation	Clinical Trials Center of Medical Institute	Kaliningrad
Russian Federation	State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan	Kazan
Russian Federation	SIH Kemerovo Regional Clinical Hosptial	Kemerovo
Russian Federation	Medical rehabilitation center	Moscow
Russian Federation	Nizhny Novgorod Regional Hospital N.A. Semashko	Nizhny Novgorod	Nizhegorodskaya Oblast'
Russian Federation	Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod	Nizhny Novgorod	Nizhegorodskaya Oblast'
Russian Federation	LLC "Medicine Center SibNovoMed"	Novosibirsk
Russian Federation	Novosibirski Gastrocenter	Novosibirsk	Novosibirskaya Oblast'
Russian Federation	Clinical Diagnostic Center Ultramed	Omsk
Russian Federation	Karelia Republican Hospital V.A. Baranova	Petrozavodsk	Kareliya, Respublika
Russian Federation	Rostov State Medical University	Rostov-on-Don	Rostovskaya Oblast'
Russian Federation	Saint Petersburg State Medical University n.a. Pavlov I.P.	Saint Petersburg
Russian Federation	Scientific research center ECO-security	Saint Petersburg	Sankt-Peterburg
Russian Federation	Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways	Saint-Petersburg
Russian Federation	Pokrovskaya Municipal Hospital	Saint-Petersburg
Russian Federation	SBIH City Clinical Hospital #31	Saint-Petersburg
Russian Federation	Medical Institute REAVIZ	Samara
Russian Federation	City Mariinskaya Hospital	St. Petersburg
Russian Federation	Stavropol State Medical University	Stavropol
Russian Federation	Yaroslavl Municipal HI Clinical Hospital #8	Yaroslavl
Serbia	Clinical Hospital Center Zvezdara	Belgrade	Beograd
Serbia	University Medical Center "Bezanijska kosa"	Belgrade	NAP
Serbia	Clinical Center Kragujevac Gastroenterohepatology Clinic	Kragujevac
Serbia	Regional Hospital Dr Radivoj Simonovic Sombor	Sombor	Vojvodina
Serbia	Sremska Mitrovica Health Centre	Sremska Mitrovica	Vojvodina
Serbia	General Hospital "Djordje Joanovic"	Zrenjanin	Vojvodina
Slovakia	Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica	Banska Bystrica
Slovakia	Univerzitna nemocnica Bratislava	Bratislava
Slovakia	KM Management	Nitra	Nitriansky Kraj
Slovakia	Gastro	Prešov	Prešovský Kraj
Slovakia	Endomed, s.r.o.	Vranov N. Toplou	Prešovský Kraj
Spain	Instituto de Ciencias Médicas	Alicante
Spain	Hospital De Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitari de Girona	Girona
Spain	Hospital Universitario Juan Ramon Jimenez	Huelva
Spain	Complexo Hospitalario Universitario A Coruña, CHUAC	La Coruña
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	Hospital Universitari Son Espases	Palma de Mallorca	Baleares Islands
Spain	Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo	Sagunto	Valencia
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Virgen Del Rocio	Sevilla	Andalucía
Switzerland	Gastroenterologische Praxis Balsiger, Seibold & Partner	Bern	Berne
Switzerland	Inselspital Bern	Berne
Switzerland	Kantonsspital St.Gallen	St.Gallen
Switzerland	UniversitätsSpital Zürich	Zürich
Taiwan	China Medical University Hospital	Taichung
Taiwan	Health management center	Taipei
Turkey	Ege Universitesi Hastanesi	Izmir
Turkey	Kocaeli University Medical Faculty Hospital	Izmit	Kocaeli
Turkey	Acibadem Universitesi - Acibadem Kozyatagi Hastanesi	Kadikoy	Istanbul
Turkey	Antalya Egitim ve Arastirma Hastanesi	Kocaeli	Antalya
Turkey	Mersin University Medical Faculty	Yenisehir	Mersin
Ukraine	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivsk	Ivano-Frankivsk Region
Ukraine	City Clinical Hospital No. 2	Kharkiv	Kharkivska Oblast
Ukraine	GI L.T. Malaya TI Namsu	Kharkiv
Ukraine	Kharkiv City Student Hospital	Kharkiv
Ukraine	Kherson City Clinical Hospital	Kherson	Khersonska Oblast
Ukraine	Medical Center of Limited Liability Company "Medical Center "Consilium Medical"	Kiev	Kyiv
Ukraine	Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus	Kropyvnytskyi
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	Kyiv Municipal Clinical Hospital #1	Kyiv
Ukraine	Lviv Railway Clinical Hospital	Lviv	Lvivska Oblast
Ukraine	Lviv Regional Endocrinology Dispensary	Lviv	Lvivska Oblast
Ukraine	Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T	Lviv	Lvivska Oblast
Ukraine	Communal Enterprise "Odesa Regional Clinical Hospital"	Odesa
Ukraine	Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho	Poltava	Poltavska Oblast
Ukraine	A. Novak Transcarpathian Regional Clinical Hospital	Uzhgorod
Ukraine	CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM	Vinnytsia
Ukraine	MCIC MC LLC Health Clinic	Vinnytsia
Ukraine	Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU	Vinnytsia
Ukraine	M.I. Pyrogov Regional Clinical Hospital	Vinnytsya
Ukraine	Diaservis - Medical and Diagnostic Center	Zaporizhia	Zaporizka Oblast
Ukraine	Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2	Zaporizhzhia
United Kingdom	Fairfield General Hospital	Bury	Great Britain
United Kingdom	St Thomas' Hospital	Great Maze Pond	London
United Kingdom	St James's University Hospital	Leeds	Vinnytsia
United Kingdom	Whipps Cross University Hospital	London	Surrey
United Kingdom	Queens Hospital	Romford	Essex
United Kingdom	Morriston Hospital	Swansea	Swansea [Abertawe Gb-ata]
United States	Valley Gastroenterology	Arcadia	California
United States	Digestive Healthcare of Georgia	Atlanta	Georgia
United States	Texas Digestive Disease Consultants	Baton Rouge	Louisiana
United States	Care Access Research	Berkeley	California
United States	University of North Carolina Center for Inflammatory Bowel Disease	Chapel Hill	North Carolina
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Digestive Health Specialists of the Southeast	Dothan	Alabama
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Digestive Health Associates of Texas	Garland	Texas
United States	Gastro One	Germantown	Tennessee
United States	Northwell Health	Great Neck	New York
United States	Carolina Digestive Diseases and Endoscopy Center	Greenville	North Carolina
United States	Direct Helpers Research Center	Hialeah	Florida
United States	Galen Medical Group	Hixson	Tennessee
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Houston Methodist Research Ins	Houston	Texas
United States	Grand Teton Research Group	Idaho Falls	Idaho
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Nature Coast Clinical Research, LLC	Inverness	Florida
United States	Care Access Research LLC	Jackson	Mississippi
United States	SIH Research, LLC	Kissimmee	Florida
United States	Om Research, LLC	Lancaster	California
United States	Emeritas Research Group	Leesburg	Virginia
United States	Dcr-Pi, Pc	Litchfield Park	Arizona
United States	Research Associates of South Florida, LLC	Miami	Florida
United States	Wellness Clinical Research	Miami Lakes	Florida
United States	Paramount Medical Research	Middleburg Heights	Ohio
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Delta Research Partners LLC	Monroe	Louisiana
United States	Nola Research Works, LLC	New Orleans	Louisiana
United States	Weill Cornell Medical College	New York	New York
United States	Central Sooner Research	Norman	Oklahoma
United States	California Medical Research Associates	Northridge	California
United States	Henry Ford Health System	Novi	Michigan
United States	Care Access Research LLC - Salt Lake City	Ogden	Utah
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
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	Maricopa Integrated Health System	Phoenix	Arizona
United States	MNGI Digestive Health - Plymouth Endoscopy Center & Clinic	Plymouth	Minnesota
United States	Care Access - Youngstown	Poland	Ohio
United States	The Gastroenterology Group, P.C.	Reston	Virginia
United States	Carilion Clinic	Roanoke	Virginia
United States	Gastroenterology Research of San Antonio	San Antonio	Texas
United States	Southern Star Research Institute, LLC	San Antonio	Texas
United States	Clinical Applications Laboratories, Inc.	San Diego	California
United States	UCSF Medical Center at Mission Bay	San Francisco	California
United States	Midwest Medical Care	Sioux Falls	South Dakota
United States	Texas Digestive Disease Consultants	Southlake	Texas
United States	Physicians Research Group	Tempe	Arizona
United States	Cotton-O'Neil Clinical Research Center, Digestive Health	Topeka	Kansas
United States	Digestive Health Specialists	Tupelo	Mississippi
United States	Gastroenterology Associates of Western Michigan, P.L.C.	Wyoming	Michigan
United States	Digestive Disease Associates	Wyomissing	Pennsylvania
United States	Huron Gastroenterology Associates	Ypsilanti	Michigan
United States	Florida Medical Clinic LLC	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  China,  Czechia,  Denmark,  France,  Germany,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants in Clinical Remission at 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).	Week 40
Secondary	Percentage of Participants in Endoscopic Remission at 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
Secondary	Percentage of Participants With Histologic Remission at 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
Secondary	Percentage of Participants in Symptomatic Remission at 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
Secondary	Percentage of Participants in Endoscopic Response at 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
Secondary	Percentage of Participants in Clinical Response at 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
Secondary	Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score	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
Secondary	Change From Baseline to Week 40 in Fecal Calprotectin	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
Secondary	Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)	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
Secondary	Percentage of Participants Hospitalized for Ulcerative Colitis (UC)	Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with >=24 hours stay were recorded.	Week 40
Secondary	Pharmacokinetics (PK): Clearance of Mirikizumab	Clearance of mirikizumab was evaluated.	Predose: Weeks 0, 4, 12, 24 and 40

External Links

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