An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

Ulcerative Colitis Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03518086
• Other study ID #: 16591
• Secondary ID: I6T-MC-AMAN2017-
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 18, 2018
• Est. completion date: May 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 safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1281
• Est. completion date: May 2024
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of UC for at least 3 months prior to baseline.

• Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).

• Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.

• If female, must meet the contraception requirements.

Exclusion Criteria:

• Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).

• Participants with a previous colectomy.

• Participants with current evidence of toxic megacolon.

• Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Mirikizumab
Administered IV
• Placebo
Administered IV

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	Instituto de Investigaciones Clinicas Quilmes	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 Tucuman	Tucuman
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	Northern Hospital	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	John Hunter Hospital	Newcastle	New South Wales
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Australia	Mater University Hospital	South Brisbane	Queensland
Austria	Medizinische Universität Innsbruck	Innsbruck
Austria	Universitätsklinikum Salzburg	Salzburg
Austria	Krankenhaus der Barmherzigen Schwestern Wien	Vienna	Wien
Austria	Medical University of Vienna	Vienna
Belgium	AZ Klina	Brasschaat
Belgium	Universitair Ziekenhuis Gent	Gent	Oost-Vlaanderen
Belgium	AZ Groeninge	Kortrijk
Belgium	Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg	Leuven
Belgium	Centre Hospitalier de Wallonie Picarde - Site Notre Dame	Tournai	Wallonne, Région
Canada	Gastroenterology and internal medicine research institute	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	The First Hospital of Jilin University	Changchun	Jilin
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	The First Affiliated Hospital Of Fujian Medical University	Fujian	Fuzhou
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	HefeiCity	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	Henan
China	ZhuZhou Central Hospital	Zhuzhou	Hunan
Croatia	University Hospital Center Osijek	Osijek
Croatia	CHC Zagreb	Zagreb
Croatia	Polyclinic Bonifarm	Zagreb
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Vojenska 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	Plzen	Plzen-mesto
Czechia	Mediendo	Prague	Praha 8
Czechia	Klinika ResTrial	Praha	Modrany
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10	Hl. M. Praha
Czechia	ISCARE Clinical Centre	Praha 9
Denmark	Sydvestjysk Sygehus Esbjerg	Esbjerg
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	Hopital Beaujon	Clichy	Paris
France	CHU Lille - Hôpital Claude Huriez	Lille cedex	Nord
France	Assistance Publique Hôpitaux de Marseille - Hôpital Nord	Marseille Cedex 20
France	Hopital Saint Eloi	Montpellier
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	CHU de Poitiers- Service d'Hépato-gastro-entérologie,	Poitiers Cedex
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	Staedisches 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	Haus der Gesundheit	Ludwigshafen	Rheinland-Pfalz
Germany	Gastro Campus Research GbR	Muenster	Nordrhein Westfalen
Germany	Praxiszentrum Alte Maelzerei	Regensburg
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 Szolgaltato Kft.	Szekszard
Hungary	Jávorszky Ödön Kórház	Vac	Pest
India	Bangalore Medical College and Research Institute	Bangalore	Karnataka
India	M S Ramaiah Medical College Hospital	Bangalore	Karnataka
India	Apollo Research and Innovations, Apollo Hospitals International Ltd	Gandhinagar	Gujarat
India	Institute of Digestive and Liver Diseases	Guwahati	Assam
India	Asian Institute of Gastroenterology	Hyderabad	Telangana
India	Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre	Hyderabad	Andhra Pradesh
India	SR Kalla Memorial Gastro & General Hospital	Jaipur	Rajasthan
India	Nil Ratan Sircar Medical College	Kolkata	West Bengal
India	SSKM Post Graduate Hospital	Kolkata	West Bengal
India	King George Medical University	Lucknow	Uttar Pradesh
India	Dayanand Medical College and Hospital	Ludhiana	Punjab
India	Lokmanya Hospital	Mumbai	Maharashtra
India	Midas Multispecilaity Hopsital Pvt Ltd	Nagpur	Maharashtra
India	Escorts Heart Institute and Research Centre Ltd	New Delhi	Delhi
India	Sir Ganga Ram Hospital	New Delhi	Delhi
India	Fortis Hospital	Noida	Uttar Pradesh
India	K E M Hospital and Research Centre	Pune	Maharashtra
India	Poona Medical Foundation. Ruby Hall Clinic	Pune	Maharashtra
India	Shree Giriraj Multispeciality Hospital	Rajkot	Gujarat
India	Nirmal Hospital	Surat	Gujarat
India	Gandhi Hospital	Telangana
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	Meir Medical Center	Kfar Saba	HaMerkaz
Israel	Galilee Medical Center Department of Internal Medicine A	Nahariya
Israel	Chaim Sheba Medical Center	Ramat Gan
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 Ospedaliera Universitaria Careggi	Firenze
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	Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona Medicina Interna	Salerno
Italy	I.R.C.C.S Policlinico San Donato	San Donato Milanese (MI)
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 Medical 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 Gastroenterology, 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-shi	Hiroshima-ken
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	Yukinoseibokai St. Mary's Hospital	Kurume-shi	Fukuoka-Ken
Japan	National Hospital Organization Kyoto Medical Center	Kyoto
Japan	Gunma University Hosptial	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
Japan	NHO Osaka National Hospital	Osaka-shi	Osaka
Japan	Saga-Ken Medical Center Koseikan	Saga-Shi	Saga-Ken
Japan	Kitasato University Hospital	Sagamihara	Kanagawa
Japan	Tokitokai Tokito Clinic	Saitama
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital	Sapporo-shi	Hokkaido
Japan	Sapporo Higashi Tokushukai 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	Osaka University Hospital	Suita	Osaka
Japan	Kagawa Prefectural Central Hospital	Takamatsu	Kagawa
Japan	Takamatsu Red Cross 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	Kyungpook National University Medical Center Chilgok Hospital	Daegu
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	Korea
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	The Catholic University of Korea, St. Vincent's Hospital	Suwon-si	Gyeonggi-do
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 Sultanah Bahiyah	Alor Star	Kedah
Malaysia	Hospital Ampang	Ampang	Selangor
Malaysia	Hospital Pulau Pinang	Georgetown	Penang
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 Med S.C	Culiacan	Sinaloa
Mexico	Clinicos Asociados BOCM, S.C.	Mexico	DF
Mexico	Centro de Investigación Clínica Acelerada	Mexico City	Distrito Federal
Mexico	Clinical Research Institute S C	Tlalnepantla	Edo De Mex
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
Poland	Centrum Medyczne Pratia Bydgoszcz	Bydgoszcz	Kujawsko-pomorskie
Poland	Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy	Bydgoszcz	Kujawsko-pomorskie
Poland	All-Medicus	Katowice
Poland	Indywidualna Specjalistyczna Praktyka Lekarska	Knurow
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	Endoskopia sp z o. o	Sopot	Pomorskie
Poland	KO-Med Centrum Medyczne	Staszow	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	Centralny Szpital Kliniczny MSWiA	Warszawa
Poland	Centrum Medyczne NeuroProtect	Warszawa
Poland	Centrum Zdrowia MDM	Warszawa
Poland	NZOZ Vivamed	Warszawa	Mazowieckie
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	Centrul Medical Unirea SRL	Bucuresti
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	SBHI Regional Clinical Hospital #2 MoH of Krasnodar region	Krasnodar
Russian Federation	Medical rehabilitation center	Moscow
Russian Federation	Nizhny Novgorod Regional Hospital N.A. Semashko	Nizhniy Novgorod	Nizhegorodskaya Oblast'
Russian Federation	Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod	Nizhniy Novgorod	Nizhegorodskaya Oblast'
Russian Federation	LLC "Medicine Center SibNovoMed"	Novosibirsk
Russian Federation	Novosibirsk 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	LLC Gastroenterology Centre Expert	Saint-Petersburg
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	OOO "OrKli"	St. Petersburg
Russian Federation	Saint-Petersburg City Hospital of Saint Elizabeth	St. Petersburg
Russian Federation	Scientific research center ECO-security	St. Petersburg	Sankt-Peterburg
Russian Federation	Stavropol State Medical Academy	Stavropol
Russian Federation	SBI of Healthcare of Leningrad region "Clinical Interregional Hospital of Tosno	Tosno
Russian Federation	Yaroslavl Municipal HI Clinical Hospital #8	Yaroslavl
Serbia	Clinical Hospital Center Zvezdara	Belgrade
Serbia	University Medical Center "Bezanijska kosa"	Belgrade	NAP
Serbia	Clinical Center Kragujevac	Kragujevac
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 Uzice	Uzice
Serbia	Zemun Medical Centre	Zemun	Beograd
Serbia	General Hospital "Djordje Joanovic"	Zrenjanin	Vojvodina
Slovakia	Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica	Banska Bystrica
Slovakia	Alian, s.r.o.	Bardejov	Slovak Republic
Slovakia	Univerzitna nemocnica Bratislava	Bratislava
Slovakia	Univerzitna nemocnica Bratislava-Nemocnica Stare Mesteo	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 Universitario Reina Sofia Comite Etico	Cordoba
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	Asturias
Spain	Hospital Universitari Son Espases	Palma de Mallorca	Baleares Islands
Spain	Complejo Hospitalario De Navarra	Pamplona	Navarra
Spain	Hospital de Sagunto y C.E.	Sagunto	Valencia
Spain	Hospital Universitario Marques De Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Virgen Del Rocio	Sevilla	Andalucía
Switzerland	Gastroenterologische Praxis Balsiger, Seibold & Partner	Bern
Switzerland	Inselspital Bern	Bern
Switzerland	Kantonsspital St.Gallen	St.Gallen
Switzerland	Universitätsspital Zürich	Zürich
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	China Medical University Hospital	Taichung
Taiwan	Health management center	Taipei
Turkey	Gazi University Faculty of Medicine	Besevler	Ankara
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	Antayla
Turkey	Hacettepe University Faculty of Medicine	Sihhiye	Ankara
Turkey	Mersin University Medical Faculty	Yenisehir	Mersin
Ukraine	Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine	Dnipro
Ukraine	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivsk	Ivano-Frankivsk Region
Ukraine	City Clinical Hospital #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 Centre 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 Regional Endocrinology Dispensary	Liviv	Lvivska Oblast
Ukraine	Lviv Railway Clinical Hospital	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	Private Small Enterprise, Medical Center Pulse	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	Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2	Zaporizhzhia
Ukraine	Diaservis - Medical and Diagnostic Center	Zaporizhzhia	Zaporizka Oblast
United Kingdom	Fairfield General Hospital	Bury	Great Britain
United Kingdom	Ninewells Hospital	Dundee	Scotland
United Kingdom	Queen Elizabeth University Hospital	Glasgow
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 Kingdom	Royal Hampshire County Hospital	Winchester	Hants
United States	Valley Gastroenterology	Arcadia	California
United States	Digestive Healthcare of Georgia	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Texas Digestive Disease Consultants	Baton Rouge	Louisiana
United States	Care Access Research	Berkeley	California
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Clinical Research of West Florida, Inc. (Clearwater)	Clearwater	Florida
United States	Gastroenterology Consultants of Clearwater	Clearwater	Florida
United States	West Central Gastroenterology d/b/a Gastro Florida	Clearwater	Florida
United States	Iowa Digestive Disease Center	Clive	Iowa
United States	Delta Waves Sleep Disorders and Research Center	Colorado Springs	Colorado
United States	Gastrointestinal Diseases Research	Columbus	Georgia
United States	Pioneer Clinical Research	Coral Springs	Florida
United States	Citrus Valley Health Partners	Covina	California
United States	META Medical Research Institute, LLC	Dayton	Ohio
United States	Digestive Health Specialists of the Southeast	Dothan	Alabama
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	Valley View Internal Medicine	Garden Grove	California
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 Medical Center	Hialeah	Florida
United States	Galen Medical Group	Hixson	Tennessee
United States	The Center for Gastrointestinal Disorders	Hollywood	Florida
United States	Biopharma Informatic, Inc.	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	Clinical Trials of SWLA, LLC	Lake Charles	Louisiana
United States	NYU Langone Long Island Clinical Research Associates	Lake Success	New York
United States	Om Research, LLC	Lancaster	California
United States	Emeritas Research Group	Leesburg	Virginia
United States	Ocean State Clinical Research Partners	Lincoln	Rhode Island
United States	Dcr-Pi, Pc	Litchfield Park	Arizona
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	Invocare Clinical Research Center	Mauldin	South Carolina
United States	Columbus Clinical Services, LLC	Miami	Florida
United States	IMIC, Inc.	Miami	Florida
United States	Research Associates of South Florida, LLC	Miami	Florida
United States	Inpatient Research Clinic, LLC	Miami Lakes	Florida
United States	Life Medical Center & Research, Inc	Miami Lakes	Florida
United States	Wellness Clinical Research	Miami Lakes	Florida
United States	Paramount Medical Research	Middleburg Heights	Ohio
United States	Allegiance Research Specialists, LLC	Milwaukee	Wisconsin
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Trinity Health Center Medical Arts	Minot	North Dakota
United States	Delta Research Partners LLC	Monroe	Louisiana
United States	Catalina Research Institute, LLC	Montclair	California
United States	Pharma Research International, Inc.	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Nola Research Works, LLC	New Orleans	Louisiana
United States	Tulane Univ School of Med	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	Pasadena	California
United States	Capital Health Medical Center Hopewell	Pennington	New Jersey
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 Research - Youngstown	Poland	Ohio
United States	The Gastroenterology Group, P.C.	Reston	Virginia
United States	Carilion Clinic	Roanoke	Virginia
United States	Washington University Medical School	Saint Louis	Missouri
United States	Florida Digestive Specialist	Saint Petersburg	Florida
United States	Care Access Research LLC - Salt Lake City	Salt Lake City	Utah
United States	Bandera Family Health Care	San Antonio	Texas
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	University of Washington Medical Center	Seattle	Washington
United States	Midwest Medical Care	Sioux Falls	South Dakota
United States	Texas Digestive Disease Consultants	Southlake	Texas
United States	Atlanta Gastroenterology Specialists, PC	Suwanee	Georgia
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	GI and Liver Research, LLC	Webster	Texas
United States	Invocare Clinical Research Center	West Columbia	South Carolina
United States	Great Lakes Medical Research, LLC	Westlake	Ohio
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina
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	Yuma Gastro LLC	Yuma	Arizona
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,  Croatia,  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 With Clinical Remission at Week 12	Clinical remission at week 12 is defined as achieving a modified Mayo score (MMS) subscore for rectal bleeding=0, stool frequency=0 or 1 with = 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability), excluding consideration of Physician's Global Assessment (PGA).; 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).; The confidence interval of 99.875% was chosen to match the significance level.	Week 12
Secondary	Percentage of Participants With Clinical Response at Week 12	Clinical response at week 12 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).The MMS ranges from 0 to 9 points,with higher scores representing more severe disease. The confidence interval of 99.875% was chosen to match the significance level.	Week 12
Secondary	Percentage of Participants With Endoscopic Remission at Week 12	Endoscopic remission at week 12 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 12. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); The Mayo endoscopic score ranges from 0 to 3 points, with higher scores representing more severe disease.; The confidence interval of 99.875% was chosen to match the significance level.	Week 12
Secondary	Percentage of Participants With Symptomatic Remission at Week 12	Symptomatic remission at week 12 is defined as a Mayo subscore 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).; The confidence interval of 99.875% was chosen to match the significance level.	Week 12
Secondary	Percentage of Participants With Symptomatic Response at Week 12	Symptomatic response at week 12 is defined as =30% decrease from baseline in the sum of stool frequency and rectal bleeding 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). The sum of stool frequency and rectal bleeding subscores ranges from 0 to 6.	Week 12
Secondary	Percentage of Participants With Histologic Remission at Week 12	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 12
Secondary	Percentage of Participants With Endoscopic Response at Week 12	Endoscopic response at week 12 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.; The Mayo endoscopic subscore ranges from 0 to 3 points, with higher scores representing more severe disease.	Week 12
Secondary	Change From Baseline to Week 12 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), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other).	Baseline, Week 12
Secondary	Change From Baseline to Week 12 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 (Guyatt et al. 1989). 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), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other).	Baseline, Week 12
Secondary	Change From Baseline to Week 12 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 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), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other).	Baseline, Week 12
Secondary	Pharmacokinetics (PK): Clearance of Mirikizumab	Clearance of mirikizumab was evaluated. Clearance is estimated based on concentration data collected in the time frame of 0-12 weeks.	Predose on week 0, week 4, week 8 and post dose on week 0, 4 and 12

External Links

•   An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)