A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

Ulcerative Colitis Clinical Trial

Official title:

A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03519945
• Other study ID #: 16596
• Secondary ID: I6T-MC-AMAP2017
• Status: Recruiting
• Phase: Phase 3
• Start date: July 18, 2018
• Est. completion date: December 20, 2027

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1063
• Est. completion date: December 20, 2027
• Est. primary completion date: July 7, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

• Inclusion Criteria
• Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) who have had at least one study drug administration and have not had early termination of study drug.
• Female participants must agree to contraception requirements.
• Exclusion Criteria
• Participants must not have developed a new condition, including cancer in the originator study.
• Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
• Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
• Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Mirikizumab
Administered SC.

Locations

Country	Name	City	State
Argentina	Mautalen Salud e Investigación	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	CER medical Institute	Quilmes	Ciudad Autónoma De Buenos Aires
Argentina	Fundacion Estudios Clinicos	Rosario	Santa Fe
Argentina	Centro Medico Privado de Reumatologia	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	Box Hill	Victoria
Australia	Mater Misericordiae Limited	Brisbane	Queensland
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	St Vincent's Hospital	Fitzroy	Victoria
Australia	Coastal Digestive Health	Maroochydore	Queensland
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Austria	Medizinische Universitaet Innsbruck	Innsbruck	Tirol
Austria	Uniklinikum Salzburg	Salzburg
Austria	Medizinische Universität Wien	Vienna	Wien
Belgium	UZ Gent	Gent	Oost-Vlaanderen
Belgium	UZ Leuven	Leuven	Vlaams-Brabant
Belgium	Centre Hospitalier de Wallonie Picarde - Site Notre Dame	Tournai	Wallonne, Région
Canada	West Edmonton Diabetes Center	Edmonton	Alberta
Canada	University Hospital - London Health Sciences Centre (IBD Clinical Trials)	London	Ontario
Canada	Victoria Hospital	London	Ontario
Canada	CIUSSS de l'Est-de-l'Île-de-Montréal	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec
Canada	GIRI GI Research Institute - Vancouver	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	PerCuro Clinical Research	Victoria	British Columbia
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Southwest Hospital of Third Military Medical University	Chongqing	Chongqing
China	The First Affiliated Hospital Of Fujian Medical University	Fujian	Fuzhou
China	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Hainan General Hospital	Haikou	Hainan
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	The Second Affiliated hospital of Zhejiang University school of medicine	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Center-Jilin Center Hospital	Jilin	Jilin
China	Shandong Provincial Hospital	Jinan	Shandong
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	Liaocheng People's Hospital	Liaocheng
China	People's Hospital of Liaocheng City	Liaocheng	Shandong
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Nanjing Medical University - Nanjing Jiangning Hospital	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 Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Jiaotong University School of Medicine Ruijin Hospital	Shanghai	Shanghai
China	The Second Afilliated Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Taian City Central Hospital	Taian	Shandong
China	The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Tongji Hospital Tongji Medical,Science & Technology	Wuhan	Hubei
China	Wuhan Union Hospital	Wuhan	Hubei
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	ZhuZhou Central Hospital	Zhuzhou	Hunan
Czechia	Fakultni Nemocnice u sv. Anny v Brne	Brno	Brno-mesto
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	Olomouc
Czechia	A-Shine	Pilsen	Plzen-mesto
Czechia	MEDIENDO	Praha 8
Czechia	ISCARE klinické centrum	Praha 9
Denmark	Herlev and Gentofte Hospital	Copenhagen	Hovedstaden
Denmark	Sjællands Universitetshospital Køge	Køge	Sjælland
Denmark	Sygehusenheden Nyborg	Nyborg	Syddanmark
France	CHU d'Amiens-Picardie - Hôpital Sud	Amiens	Somme
France	CHRU Troussau	Chambray Les Tours	Centre
France	Hopital Claude Huriez - CHU de Lille	Lille	Nord
France	Chu Saint Eloi	Montpellier	Languedoc-Roussillon
France	Centres Médico Chirurgicaux - Clinique Ambroise Paré	Neuilly-sur-Seine	Hauts-de-Seine
France	Centre Hospitalier Universitaire de Nice - Hôpital l'Archet	Nice	Alpes-Maritimes
France	Hôpital Saint-Louis	Paris
France	Centre Hospitalier de Pau	Pau	Pyrénées-Atlantiques
France	CHU Bordeaux Haut-Leveque	Pessac	Aquitaine
France	Centre Hospitalier Lyon Sud	Pierre-Bénite	Rhône
France	Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord	Saint Priest En Jarez	Loire
France	CHU Strasbourg-Hautepierre	Strasbourg	Alsace
France	Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois	Vandoeuvre lès Nancy	Lorraine
Georgia	LLC ARENSIA Exploratory Medicine	Tbilisi
Germany	Charite Universitätsmedizin Berlin Campus Benjamin Franklin	Berlin
Germany	Krankenhaus Waldfriede	Berlin
Germany	Städtisches Klinikum Brandenburg	Brandenburg
Germany	Universitätsklinikum Halle	Halle	Sachsen-Anhalt
Germany	Studiengesellschaft BSF Unternehmergesellschaft	Halle (Saale)	Sachsen-Anhalt
Germany	HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen	Hamburg
Germany	Haus der Gesundheit	Ludwigshafen	Rheinland-Pfalz
Hungary	Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház	Békéscsaba
Hungary	Semmelweis University	Budapest
Hungary	Petz Aladar Egyetemi Oktato Korhaz	Gyor	Gyor-Moson-Sopron
Hungary	Endomedix Diagnosztikai Központ - Miskolc	Miskolc
Hungary	Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ	Szeged	Csongrád
Hungary	CLINFAN Szolgáltató Kft	Szekszárd	Tolna
Hungary	Clinexpert Tatabánya Ltd.	Tatabánya	Komárom-Esztergom
Hungary	Jávorszky Ödön Kórház	Vác	Pest
India	Apollo Hospitals Ahmedabad	Ahmedabad	Gujarat
India	M S Ramaiah Medical College and Hospitals	Bangalore	Karnataka
India	Owaisi Hospital and Research Center	Hyderabad	Telangana
India	SR Kalla Memorial Gastro & General Hospital	Jaipur	Rajasthan
India	Dayanand Medical College and Hospital	Ludhiana	Punjab
India	Midas Multispeciality Hospital Pvt.Ltd.	Nagpur	Maharashtra
India	Fortis Hospital	Noida	Uttar Pradesh
India	Grant Medical Foundation - Ruby Hall Clinic	Pune	Maharashtra
India	Shree Giriraj Multispeciality Hospital	Rajkot	Gujarat
India	Gandhi Hospital	Secunderabad	Telangana
India	Nirmal Hospital	Surat	Gujarat
India	Acharya Vinoba Bhave Rural Hospital	Wardha	Maharashtra
Ireland	Beaumont Hospital, Dublin	Dublin
Israel	Soroka Medical Center	Be'er Sheva	HaDarom
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Israel	Galilee Medical Center	Nahariya	HaTsafon
Israel	Kaplan Medical Center	Rehovot	HaMerkaz
Israel	Sourasky Medical Center	Tel Aviv	Tell Abib
Israel	Yitzhak Shamir Medical Center	Zerifin	HaMerkaz
Italy	Azienda Ospedaliera Mater Domini	Catanzaro
Italy	Ospedale San Martino	Genova
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa	Toscana
Italy	Ospedale Di Circolo	Rho	Milano
Italy	Fondazione Policlinico Tor Vergata	Roma	Lazio
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma	Lazio
Italy	Ospedale Sandro Pertini	Rome	Roma
Italy	Humanitas	Rozzano	Lombardia
Italy	Ospedale Mauriziano	Torino
Japan	Asahikawa City Hospital	Asahikawa	Hokkaido
Japan	Tokyo Medical And Dental University Medical Hospital	Bunkyo	Tokyo
Japan	Mitsui Memorial Hospital	Chiyoda-ku	Tokyo
Japan	Sai Gastroenterologist Proctology	Fujiidera	Osaka
Japan	Fukuoka University Hospital	Fukuoka
Japan	Matsuaikai Matsuda Hospital	Hamamatsu	Shizuoka
Japan	Mito Medical Center	Higashiibaraki	Ibaraki
Japan	National Hospital Organization Hirosaki National Hospital	Hirosaki	Aomori
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	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	Nagaoka Chuo General Hospital	Nagaoka-shi	Niigata
Japan	Hyogo College of Medicine	Nishinomiya	Hyogo
Japan	Ishida Clinic of IBD and Gastroenterology	Oita-shi	Oita-Ken
Japan	Okayama University Hospital	Okayama
Japan	Infusion Clinic	Osaka
Japan	National Hospital Organization - Osaka National Hospital - Institute For Clinical Research	Osaka
Japan	Saga-Ken Medical Center Koseikan	Saga
Japan	Tokitokai Tokito Clinic	Saitama
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Tokushukai 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	Miyagi
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Center Hospital of the National Center for Global Health and Medicine	Shinjyuku-ku	Tokyo
Japan	Kagawa Prefectural Central Hospital	Takamatsu	Kagawa
Japan	National Hospital Organization Takasaki General Medical Centar	Takasaki	Gunma
Japan	Tokyo Yamate Medical Center	Tokyo
Japan	Toyama Prefectural Central Hospital	Toyama
Japan	Mie University Hospital	Tsu	Mie
Japan	Matsushima Hospital	Yokohama	Kanagawa
Japan	Showa University Northern Yokohama Hospital	Yokohama	Kanagawa
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa
Korea, Republic of	Dong-A University Hospital	Busan	Pusan-Kwangyokshi
Korea, Republic of	The Catholic University of Korea, Daejeon St. Mary's Hospital	Daejeon	Taejon-Kwangyokshi
Korea, Republic of	Yeungnam Univeristy Medical Center	Gyeongsan-si	Kyongsangbuk-do
Korea, Republic of	Inje University Haeundae Paik Hospital	Haeundae-gu	Pusan-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	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Yonsei University-Wonju Severance Christian Hospital	Wonju	Kang-won-do
Latvia	Digestive Diseases Center "Gastro"	Riga
Latvia	Pauls Stradins Clinical Univeristy Hospital	Riga	Riga
Latvia	RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas	Kaunas
Lithuania	Klaipeda University Hospital	Klaipeda	Klaipedos Miestas
Lithuania	Republic Hospital of Klaipeda	Klaipeda
Lithuania	Respublikine Panevezio ligonine	Panevezys	Panevežio Apskritis
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius
Malaysia	Hospital Sultanah Bahiyah	Alor Star	Kedah
Malaysia	Pusat Perubatan University Kebangsaan Malaysia	Cheras	Kuala Lumpur
Malaysia	Hospital Universiti Sains Malaysia	Kelantan
Malaysia	Hospital Raja Perempuan Zainab II	Kota Bahru	Kelantan
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	University Malaya Medical Centre	Lembah Pantai	Wilayah Persekutuan Kuala Lumpur
Malaysia	Hospital Serdang	Selangor
Mexico	Scientia Investigacion Clinica S.C.	Chihuahua
Mexico	Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.	Culiacán	Sinaloa
Mexico	Sociedad de Metabolsimo y Corazón S.C.	Veracruz
Moldova, Republic of	Republican Clinical Hospital	Chisinau
Netherlands	Amsterdam UMC, locatie AMC	Amsterdam	Noord-Holland
Netherlands	ETZ Elisabeth	Tilburg	Noord-Brabant
Netherlands	Ziekenhuis Bernhoven	Uden	Noord-Brabant
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Poland	Promedica Dental Clinic	Bedzin	Slaskie
Poland	Centrum Medyczne Pratia Bydgoszcz	Bydgoszcz	Kujawsko-pomorskie
Poland	Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej	Bydgoszcz	Kujawsko-pomorskie
Poland	Szpital Miejski im. Jana Pawla II w Elblagu	Elblag	Warminsko-mazurskie
Poland	All-Medicus	Katowice	Slaskie
Poland	Gabinet Endoskopii Przewodu Pokarmowego	Krakow	Malopolskie
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	Wojewódzki Szpital Specjalistyczny w Olsztynie	Olsztyn	Warminsko-mazurskie
Poland	Centrum Medyczne LUX MED - Rzeszow	Rzeszow	Podkarpackie
Poland	Endoskopia Sp. z.o.o.	Sopot	Pomorskie
Poland	SONOMED Centrum Medyczne	Szczecin	Zachodniopomorskie
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin	Zachodniopomorskie
Poland	Gastromed	Torun	Kujawsko-pomorskie
Poland	NZOZ Formed	Wadowice	Malopolskie
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warsaw	Malopolskie
Poland	NZOZ Vivamed	Warsaw	Mazowieckie
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warsaw	Mazowieckie
Poland	Centrum Zdrowia MDM	Warszawa	Mazowieckie
Poland	Ars-Medica	Wroclaw	Dolnoslaskie
Poland	LexMedica	Wroclaw	Dolnoslaskie
Poland	ETG Zamosc	Zamosc	Lubelskie
Romania	Spitalul de Oncologie Monza	Bucharest	Bucure?ti
Romania	CCBR Clinical Research	Bucuresti	Bucure?ti
Romania	S.C. Centrul Medical Medicum SRL	Bucuresti
Romania	Spitalul Clinic Colentina	Bucuresti	Bucure?ti
Romania	Spitalul Pelican	Oradea	Bihor
Russian Federation	Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"	Barnaul	Altayskiy Kray
Russian Federation	MO New Hospital	Ekaterinburg	Sverdlovskaya Oblast'
Russian Federation	Scientific Centre of Reconstructive and Restorative Surgery	Irkutsk	Irkutskaya Oblast'
Russian Federation	Alliance Biomedical URAL Group	Izhevsk	Udmurtskaya Respublika
Russian Federation	Kazan State Medical University	Kazan	Tatarstan, Respublika
Russian Federation	Kemerovo Regional Clinical Hospital	Kemerovo	Kemerovskaya Oblast'
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	Medical Center SibNovoMed	Novosibirsk	Novosibirskaya Oblast'
Russian Federation	Research Institute of Physiology and Fundamental Medicine	Novosibirsk	Novosibirskaya Oblast'
Russian Federation	Karelia Republican Hospital V.A. Baranova	Petrozavodsk	Kareliya, Respublika
Russian Federation	Rostov State Medical University	Rostov-on-Don	Rostovskaya Oblast'
Russian Federation	City Mariinskaya Hospital	Saint Petersburg	Leningradskaya Oblast'
Russian Federation	Clinical Hospital "RZhD-Medicine"	Saint Petersburg	Sankt-Peterburg
Russian Federation	North-Western State Medical University named after I.I.Mechnikov	Saint Petersburg
Russian Federation	Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31	Saint Petersburg	Sankt-Peterburg
Russian Federation	Scientific research center ECO-security	Saint Petersburg	Sankt-Peterburg
Russian Federation	First Pavlov State Medical University of Saint Petersburg	Saint-Petersburg	Sankt-Peterburg
Russian Federation	Stavropol State Medical University	Stavropol	Stavropol'skiy Kray
Russian Federation	SHI of Yaroslavl Region Clinical Hospital #8	Yaroslavl	Yaroslavskaya Oblast'
Serbia	Clinical Center Bezanijska Kosa	Belgrade	Beograd
Serbia	Clinical Hospital Center Zvezdara	Belgrade	Beograd
Serbia	Clinical Center Kragujevac	Kragujevac	Šumadijski Okrug
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 F.D.Roosevelta Banska Bystrica	Banská Bystrica	Banskobystrický Kraj
Slovakia	Univerzitná nemocnica Bratislava - Nemocnica Ružinov	Bratislava	Bratislavský Kraj
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 de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitari de Girona Doctor Josep Trueta	Girona	Girona [Gerona]
Spain	Hospital Universitario Juan Ramon Jimenez	Huelva
Spain	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas De GC	Las Palmas
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital de Sagunto y C.E.	Sagunto	València
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Switzerland	Gastroenterologische Praxis Balsiger, Seibold & Partner	Bern	Berne
Switzerland	Inselspital Bern	Berne
Switzerland	Cantonal Hospital St.Gallen	st.Gallen	Sankt Gallen
Switzerland	UniversitätsSpital Zürich	Zürich
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Turkey	Antalya Egitim ve Arastirma Hastanesi	Antalya
Turkey	Ege Universitesi Hastanesi	Bornova	Izmir
Turkey	Kocaeli Üniversitesi	Kocaeli
Turkey	Mersin University	Mersin
Ukraine	Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"	Ivano-Frankivsk	Ivano-Frankivska Oblast
Ukraine	City Clinical Hospital No. 2	Kharkiv	Kharkivska Oblast
Ukraine	L.T. Mala National Institute of Therapy of NAMS of Ukraine	Kharkiv	Kharkivska Oblast
Ukraine	Kherson City Clinical Hospital	Kherson	Khersonska Oblast
Ukraine	Medical Center of Limited Liability Company "Medical Center "Consilium Medical"	Kiev	Kyiv
Ukraine	Private Enterprise Private Manufacturing Company Acinus	Kropyvnytskyi	Kirovohradska Oblast
Ukraine	Kiev Regional Clinical Hospital No. 1	Kyiv
Ukraine	Kyiv Regional Clinical Hospital	Kyiv
Ukraine	Medical Center Ok!Clinic+	Kyiv
Ukraine	Lviv Railway Clinical Hospital	Lviv	Lvivska Oblast
Ukraine	Lviv Regional Clinical Hospital - Lviv National Medical University named Danylo Galician	Lviv	Lvivska Oblast
Ukraine	Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T	Lviv	Lvivska Oblast
Ukraine	Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council	Odesa	Odeska Oblast
Ukraine	Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho	Poltava	Poltavska Oblast
Ukraine	Transcarpathian Regional Hospital im.Andriya Novak	Uzhgorod	Zakarpatska Oblast
Ukraine	Medical Clinical Investigational Center of Medical Center Health Clinic	Vinnytsia	Vinnytska Oblast
Ukraine	City Clinical Hospital #1, Vinnitsya National Medical University	Vinnytsya	Vinnytska Oblast
Ukraine	VNMU	Vinnytsya	Vinnytska Oblast
Ukraine	Diaservis - Medical and Diagnostic Center	Zaporizhia	Zaporizka Oblast
Ukraine	Diacenter	Zaporizhzhia	Zaporizka Oblast
United Kingdom	Fairfield General Hospital	Bury	Great Britain
United Kingdom	Barts Health NHS Trust	London	Waltham Forest
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London	London, Ci
United Kingdom	The John Radcliffe Hospital	Oxford	Oxfordshire
United States	University of Michigan	Ann Arbor	Michigan
United States	InSite Digestive Health Care	Arcadia	California
United States	Digestive Healthcare of Georgia	Atlanta	Georgia
United States	GI Alliance Research Baton Rouge	Baton Rouge	Louisiana
United States	Care Access - Berkeley	Berkeley	California
United States	Clinical & Translational Research Center (CTRC)	Chapel Hill	North Carolina
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Digestive Health Specialists	Dothan	Alabama
United States	NorthShore University HealthSystem - Evanston Hospital	Evanston	Illinois
United States	Texas Digestive Disease Consultants	Fort Worth	Texas
United States	GI Alliance	Garland	Texas
United States	Direct Helpers Research Center	Hialeah	Florida
United States	Indiana University Health University Hospital	Indianapolis	Indiana
United States	Encore Borland-Groover Clinical Research	Jacksonville	Florida
United States	Om Research LLC	Lancaster	California
United States	Research Solutions of Arizona	Litchfield Park	Arizona
United States	Research Associates of South Florida	Miami	Florida
United States	Wellness Clinical Research	Miami Lakes	Florida
United States	Delta Research Partners	Monroe	Louisiana
United States	Nola Research Works, LLC	New Orleans	Louisiana
United States	California Medical Research Associates	Northridge	California
United States	Henry Ford Medical Center - Columbus Center	Novi	Michigan
United States	Care Access - Ogden	Ogden	Utah
United States	Central Sooner Research - Oklahoma - Northwest 47th Street	Oklahoma City	Oklahoma
United States	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	AdventHealth Orlando	Orlando	Florida
United States	Clintheory Healthcare	Orlando	Florida
United States	Gastroenterology Associates of Pensacola, PA	Pensacola	Florida
United States	Valleywise Health Medical Center	Phoenix	Arizona
United States	MNGI Digestive Health - Plymouth Endoscopy Center & Clinic	Plymouth	Minnesota
United States	Care Access - Youngstown	Poland	Ohio
United States	Care Access - Pottsville	Pottsville	Pennsylvania
United States	Inland Empire Clinical Trials, LLC	Rialto	California
United States	Carilion Clinic	Roanoke	Virginia
United States	Gastroenterology Research of San Antonio	San Antonio	Texas
United States	Southern Star Research Institute	San Antonio	Texas
United States	Clinical Applications Laboratories, Inc.	San Diego	California
United States	Midwest Medical Care	Sioux Falls	South Dakota
United States	GI Alliance	Southlake	Texas
United States	Washington Gastroenterology - Tacoma	Tacoma	Washington
United States	Cotton O'Neil Digestive Health Center	Topeka	Kansas
United States	West Michigan Clinical Research Center	Wyoming	Michigan
United States	Digestive Disease Associates	Wyomissing	Pennsylvania
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,  Georgia,  Germany,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Moldova, Republic of,  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	Clinical remission based on the modified Mayo Score (MMS).	Week 52
Secondary	Percentage of Participants in Endoscopic Remission	Endoscopic remission based on the MMS Endoscopic Subscore (ES).	Week 52
Secondary	Percentage of Participants in Corticosteroid-free Remission	Participants in corticosteroid-free remission.	Week 52
Secondary	Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52	Endoscopic remission based on the MMS ES and histologic remission based on histologic disease activity index.	Week 52
Secondary	Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score	Health Related Quality of Life based on IBDQ score.	Baseline to Week 52
Secondary	UC Symptoms: Numeric Rating Score	UC symptoms based on numeric rating score.	Week 160
Secondary	Percentage of Participants Who are Hospitalized Due to UC	Participants who are hospitalized due to UC.	Baseline to Week 160
Secondary	Percentage of Participants Who Undergo UC Surgeries Including Colectomy	Participants who undergo UC surgeries including colectomy.	Baseline to Week 160

External Links

•   A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)