A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

Crohn's Disease Clinical Trial

— VIVID-2  

Official title:

A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04232553
• Other study ID #: 16628
• Secondary ID: I6T-MC-AMAX2019-
• Status: Recruiting
• Phase: Phase 3
• Start date: June 22, 2020
• Est. completion date: December 20, 2026

Study information

• Verified date: May 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

The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 778
• Est. completion date: December 20, 2026
• Est. primary completion date: January 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)

• If female, participant must meet the contraception requirements

Exclusion Criteria:

• Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.

• Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study.

Note: Participants with a history of active TB with documentation of treatment by the Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study.

• Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.

• Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Mirikizumab
Administered IV
• Mirikizumab
Administered SC

Locations

Country	Name	City	State
Argentina	DOM Centro de Reumatología	Ciudad Autónoma de Buenos Aires
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Coastal Digestive Health	Maroochydore	Queensland
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Australia	St Vincent's Hospital	Sydney	New South Wales
Austria	Medizinische Universitaet Innsbruck	Innsbruck	Tirol
Austria	Uniklinikum Salzburg	Salzburg
Austria	Medizinische Universität Wien	Vienna	Wien
Belgium	Imelda General Hospital	Bonheiden	Antwerpen
Belgium	Université Libre de Bruxelles - Hôpital Erasme	Brussels	Bruxelles-Capitale, Région De
Belgium	UZ Gent	Gent	Oost-Vlaanderen
Belgium	UZ Leuven	Leuven	Vlaams-Brabant
Brazil	Hospital Felicio Rocho	Belo Horizonte	Minas Gerais
Brazil	Faculdade de Medicina da UNESP	Botucatu	São Paulo
Brazil	Chronos Pesquisa Clínica	Brasília	Distrito Federal
Brazil	L2IP - Instituto de Pesquisas Clínicas - FC072920211954380192	Brasília	Distrito Federal
Brazil	Centro de Pesquisa Sao Lucas	Campinas	São Paulo
Brazil	Instituto de Pesquisas em Saúde (IPS)	Caxias do sul	Rio Grande Do Sul
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul
Brazil	Núcleo de Pesquisa Clínica do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição	Salvador	Bahia
Brazil	Praxis Pesquisa Medica	Santo Andre	São Paulo
Brazil	Pesquisare Saude	Santo André	São Paulo
Brazil	Centro Multidisciplinar de Estudos Clinicos	Sao Bernardo do Campo	São Paulo
Brazil	Hospital Sírio Libanês	Sao Paulo	São Paulo
Brazil	Clínica Hepatogastro JK	São Paulo
Brazil	CPQuali Pesquisa Clínica	São Paulo
Brazil	Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T	São Paulo
Canada	Gastroenterology and internal medicine research institute	Edmonton	Alberta
Canada	Private Practice- Dr Chadwick Williams	Kentville	Nova Scotia
Canada	Victoria Hospital	London	Ontario
Canada	Private Practice - Dr. Stephane M. Gauthier	North Bay	Ontario
Canada	GIRI GI Research Institute - Vancouver	Vancouver	British Columbia
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	West China Hospital of Sichuan University	Cheng Du	Sichuan
China	Chongqing General Hospital	Chongqing	Chongqing
China	The First People's Hospital of Foshan	Foshan	Guangdong
China	The First Affiliated Hospital Of Fujian Medical University	Fuzhou
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
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	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital of Chinese Medicine	Nanjing	Jiangsu
China	Shanghai Jiaotong University School of Medicine Ruijin Hospital	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university	Wenzhou	Zhejiang
China	Tongji Hospital Tongji Medical,Science & Technology	Wuhan	Hubei
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Zhongshan Hospital Affiliated to Xiamen University	Xiamen	Fujian
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
Croatia	Klinicki bolnicki centar Osijek	Osijek
Croatia	Klinicki bolnicki centar Zagreb	Zagreb	Grad Zagreb
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	Oblastni nemocnice Nachod	Nachod
Czechia	MUDr. Gregar, s.r.o.	Olomouc	Olomoucký Kraj
Czechia	PreventaMed	Olomouc
Czechia	MUDr. Radka Koskova, s.r.o.	Ostrava	Ostrava Mesto
Czechia	Fakultni Thomayerova nemocnice	Prague	Praha 4
Czechia	ISCARE klinické centrum	Prague	Praha 9
Czechia	Synexus Czech	Prague	Praha 2
Czechia	AXON Clinical	Praha	Praha 5
Czechia	Fakultni nemocnice Motol	Praha	Praha 5
Czechia	Institut Klinicke a Experimentalni Mediciny	Praha	Praha 4
Czechia	Masarykova Nemocnice V Usti Nad Labem	Usti nad Labem	Ústí Nad Labem
Czechia	Nemocnice Tomase Bati ve Zline	Zlín	Zlínský Kraj
Denmark	Aalborg Universitetshospital, Syd	Aalborg	Nordjylland
France	Chu Saint Eloi	Montpellier	Languedoc-Roussillon
France	Centre Hospitalier Universitaire de Poitiers	Poitiers	Vienne
France	Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois	Vandœuvre-lès-Nancy	Meurthe-et-Moselle
Germany	Knappschaftskrankenhaus Bottrop	Bottrop	Nordrhein-Westfalen
Germany	Synexus Clinical Research GmbH	Frankfurt am Main	Hessen
Germany	Studiengesellschaft BSF Unternehmergesellschaft	Halle (Saale)	Sachsen-Anhalt
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Universitätsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	Synexus Leipzig Clinical Research Centre	Leipzig	Sachsen
Germany	Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum	Nordhausen	Thüringen
Germany	RED-Institut GmbH	Oldenburg	Schleswig-Holstein
Germany	Siloah St. Trudpert Klinikum	Pforzheim	Baden-Württemberg
Germany	Gemeinschaftspraxis Jakobeit	Wipperfürth	Nordrhein-Westfalen
Germany	Universitaetsklinikum Wuerzburg	Wuerzburg	Bayern
Hungary	DRC Gyógyszervizsgáló Központ	Balatonfüred	Veszprém
Hungary	Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház	Békéscsaba
Hungary	Clinexpert Tatabánya Ltd.	Budapest
Hungary	Pannónia Magánorvosi Centrum	Budapest
Hungary	SYNEXUS Magyarország Kft. Eü.	Budapest
Hungary	Bugát Pál Kórház	Gyöngyös	Heves
Hungary	Synexus Magyarország Kft	Gyula	Békés
Hungary	CLINFAN Szolgáltató Kft	Szekszárd	Tolna
Hungary	Szent Borbala Korhaz	Tatabánya	Komárom-Esztergom
Hungary	Jávorszky Ödön Kórház	Vác	Pest
India	Postgraduate Institute of Medical Education & Research	Chandigarh
India	Apollo Speciality Hospital - Teynampet	Chennai	Tamil Nadu
India	SR Kalla Memorial Gastro & General Hospital	Jaipur	Rajasthan
India	Dayanand Medical College and Hospital	Ludhiana	Punjab
India	All India Institute of Medical Sciences	New Delhi	Delhi
India	Sir Ganga Ram Hospital	New Delhi	Delhi
India	Grant Medical Foundation - Ruby Hall Clinic	Pune	Maharashtra
India	Gujarat Hospital - Gastro & Vascular Centre	Surat	Gujarat
Israel	Soroka Medical Center	Be'er Sheva	HaDarom
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Israel	Galilee Medical Center	Nahariya	HaTsafon
Israel	Sheba Medical Center	Ramat Gan	HaMerkaz
Israel	Kaplan Medical Center	Rehovot	HaMerkaz
Israel	Yitzhak Shamir Medical Center	Zerifin	HaMerkaz
Italy	IRCCS Policlinico San Donato	Milan	Milano
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	Ospedale Di Circolo	Rho	Milano
Japan	Tokyo Medical And Dental University Medical Hospital	Bunkyo	Tokyo
Japan	Fukuoka University Chikushi Hospital	Chikushino	Fukuoka
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital	Chuo-ku, Sapporo-shi	Hokkaido
Japan	Fukuoka University Hospital	Fukuoka
Japan	Matsuaikai Matsuda Hospital	Hamamatsu	Shizuoka
Japan	National Hospital Organization Hirosaki National Hospital	Hirosaki	Aomori
Japan	Kagoshima University Hospital	Kagoshima
Japan	Sameshima Hospital	Kagoshima
Japan	Ofuna Central Hospital	Kamakura	Kanagawa
Japan	Ibaraki Prefectural Central Hospital	Kasama	Ibaraki
Japan	Tsujinaka Hospital Kashiwanoha	Kashiwa	Chiba
Japan	Kiryu Kosei General Hospital	Kiryu	Gunma
Japan	Kitakyushu Municipal Medical Center	Kitakyusyu-shi	Fukoka
Japan	Kumamoto University	Kumamoto
Japan	University Hospital,Kyoto Prefectural University of Medicine	Kyoto
Japan	Kyorin University Hospital	Mitaka	Tokyo
Japan	Hyogo College of Medicine	Nishinomiya	Hyogo
Japan	Okayama Saiseikai Outpatient Center Hospital	Okayama
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Tokushukai Sapporo Higashi Tokushukai Hospital	Sapporo	Hokkaido
Japan	Tokushukai Sapporo Tokushukai Hospital	Sapporo-shi	Hokkaido
Japan	Takagi Clinic - Sendai	Sendai	Miyagi
Japan	Center Hospital of the National Center for Global Health and Medicine	Shinjyuku-ku	Tokyo
Japan	Tokyo Yamate Medical Center	Tokyo
Japan	Toyama Prefectural Central Hospital	Toyama
Japan	Mie University Hospital	Tsu	Mie
Korea, Republic of	Korea University Ansan Hospital	Ansan-si	Gyeonggi-do
Korea, Republic of	Dong-A University Hospital	Busan	Pusan-Kwangyokshi
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu	Taegu-Kwangyokshi
Korea, Republic of	The Catholic University of Korea, Daejeon St. Mary's Hospital	Daejeon	Taejon-Kwangyokshi
Korea, Republic of	Kyungpook National University Chilgok Hospital	Deagu	Taegu-Kwan
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Kyonggi-do
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	Kyungpook National University Hospital	Jung-gu	Taegu-Kwangyokshi
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Chung-Ang University Hospital	Seoul	Korea
Korea, Republic of	Kangbuk Samsung Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Kyung Hee University Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Ajou University Hospital	Suwon-si	Kyonggi-do
Korea, Republic of	Yonsei University-Wonju Severance Christian Hospital	Wonju	Kang-won-do
Latvia	Pauls Stradins Clinical Univeristy Hospital	Riga	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas	Kaunas
Mexico	Scientia Investigacion Clinica S.C.	Chihuahua
Mexico	Christus Muguerza Hospital Sur	Monterrey	Nuevo León
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Mexico	Centro de Alta Especialidad en Reumatologia e Investigación del Potosi,S.C	San Luis Potosi	San Luis Potosí
Netherlands	Amsterdam UMC, locatie AMC	Amsterdam	Noord-Holland
Netherlands	ETZ Elisabeth	Tilburg	Noord-Brabant
Poland	Nova Reuma Spolka Partnerska	Bialystok	Podlaskie
Poland	Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne SYNEXUS	Czestochowa	Silesian
Poland	NZOZ TwojeZdrowie	Elblag	Warminsko-mazurskie
Poland	Synexus Polska Gdansku	Gdansk	Pomorskie
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdyni	Gdynia	Pomorskie
Poland	Synexus Polska - Katowicach	Katowice	Slaskie
Poland	Topolowa Medicenter	Krakow	Malopolskie
Poland	ZOZ Gastromed	Lublin	Lubelskie
Poland	Synexus Polska Sp. z o.o. Oddzial w Poznaniu	Poznan	Wielkopolskie
Poland	Centrum Medyczne MEDYK	Rzeszow	Podkarpackie
Poland	Private Practice - Dr. Korczowski Bartosz	Rzeszow	Podkarpackie
Poland	Endoskopia Sp. z.o.o.	Sopot	Pomorskie
Poland	Kiepury Clinic	Sosnowiec	Slaskie
Poland	Dc-Med	Swidnica	Dolnoslaskie
Poland	SONOMED Centrum Medyczne	Szczecin	Zachodniopomorskie
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin	Zachodniopomorskie
Poland	NZOZ Formed	Wadowice	Malopolskie
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warsaw	Mazowieckie
Poland	Centrum Zdrowia MDM	Warszawa	Mazowieckie
Poland	Melita Medical	Wroclaw	Dolnoslaskie
Poland	Reumatop	Wroclaw	Dolnoslaskie
Poland	Synexus - Wroclaw	Wroclaw	Dolnoslaskie
Poland	ETG Zamosc	Zamosc	Lubelskie
Romania	Delta Health Care	Bucharest	Bucure?ti
Romania	Spitalul de Oncologie Monza	Bucharest	Bucure?ti
Romania	S.C. Centrul Medical Medicum SRL	Bucuresti	Bucure?ti
Romania	Spitalul Clinic Colentina	Bucuresti	Bucure?ti
Romania	Gastromed S.R.L.	Constan?a
Romania	S.C Centrul de Gastroenterologie Dr. Goldis S.R.L	Timisoara	Timi?
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	Kemerovo Regional Clinical Hospital	Kemerovo	Kemerovskaya Oblast'
Russian Federation	Olla-Med	Moscow	Moskva
Russian Federation	Nizhny Novgorod Regional Hospital N.A. Semashko	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	Clinic of Omsk State Medical University	Omsk	Omskaya 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	Balt Med Clinic	Saint Petersburg	Sankt-Peterburg
Russian Federation	Reavita Med SPb	Saint Petersburg	Sankt-Peterburg
Russian Federation	Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31	Saint Petersburg	Sankt-Peterburg
Russian Federation	Saint-Petersburg City Hospital of Saint Elizabeth	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	Private Healthcare Institution "Clinical Hospital "RZhD-Medicina" City Samara"	Samara	Samarskaya Oblast'
Serbia	Clinical Center Bezanijska Kosa	Belgrade	Beograd
Serbia	Clinical Hospital Center Zvezdara	Belgrade	Beograd
Serbia	General Hospital "Djordje Joanovic"	Zrenjanin	Vojvodina
Slovakia	Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica	Banska Bystrica	Banskobystrický Kraj
Slovakia	Cliniq s.r.o.	Bratislava	Bratislavs
Slovakia	Gastromedic	Nové Zámky	Nitriansky Kraj
Slovakia	Gastro LM	Presov	Prešovský Kraj
Slovakia	Endomed, s.r.o.	Vranov N. Toplou	Prešovský Kraj
Switzerland	Gastroenterologische Praxis Balsiger, Seibold & Partner	Bern	Berne
Switzerland	Inselspital Bern	Berne
Switzerland	Cantonal Hospital St.Gallen	st.Gallen	Sankt Gallen
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara
Turkey	Gazi University Health Research and Application Center Gazi Hospital Pediatric Hematology BD	Ankara
Turkey	Hacettepe Universitesi	Ankara
Turkey	Antalya Egitim ve Arastirma Hastanesi	Antalya
Turkey	Uludag Universitesi	Bursa
Turkey	Trakya University	Edirne
Turkey	Eskisehir Osmangazi University	Eskisehir	Eskisehir
Turkey	Mustafa Kemal Universitesi	Hatay
Turkey	Acbadem Kozyatagi Hospital	Istanbul
Turkey	Medicana Kadiköy Hastanesi	Istanbul
Turkey	Istanbul Universitesi Cerrahpasa	Istanbul- Fatih	Istanbul
Turkey	Dokuz Eylul Universitesi Hastanesi	Izmir	Balçova
Turkey	Kocaeli University Medical Faculty Hospital	Izmit	Kocaeli
Turkey	Mersin University	Mersin
Ukraine	Chernivtsi Regional Clinical Hospital	Chernivtsi
Ukraine	Medical Center Family Medicine Clinic	Dnipro	Dnipropetrovska Oblast
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	Kiev Regional Clinical Hospital No. 1	Kyiv
Ukraine	Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Railway	Kyiv
Ukraine	Kyiv Regional Clinical Hospital	Kyiv
Ukraine	Medbud Clinic	Kyiv	Kyivska Oblast
Ukraine	Medical Center of Limited Liability Company "Medical Center "Consilium Medical"	Kyiv
Ukraine	Medical Center Ok!Clinic+	Kyiv
Ukraine	Lviv Railway Clinical Hospital	Lviv	Lvivska Oblast
Ukraine	Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council	Odesa	Odeska 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	VNMU	Vinnytsya	Vinnytska Oblast
Ukraine	Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council	Zaporizhia	Zaporizka Oblast
Ukraine	Diacenter	Zaporizhzhia	Zaporizka Oblast
United Kingdom	Addenbrooke's Hospital	Cambridge	Cambridgeshire
United Kingdom	Synexus Wales Clinical Research Centre	Cardiff
United Kingdom	Barts Health NHS Trust - Whipps Cross University Hospital	London	England
United States	Digestive Healthcare of Georgia	Atlanta	Georgia
United States	First Surgical Hospital	Bellaire	Texas
United States	Washington Gastroenterology - Bellevue	Bellevue	Washington
United States	Connecticut Clinical Research Institute	Bristol	Connecticut
United States	Clinical & Translational Research Center (CTRC)	Chapel Hill	North Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	The Digestive Health Center of Michigan (DHCMI)	Chesterfield	Michigan
United States	Capital Digestive Care - Chevy Chase	Chevy Chase	Maryland
United States	Clinical Research of West Florida, Inc. (Clearwater)	Clearwater	Florida
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Ohio Gastroenterology	Columbus	Ohio
United States	Gastroenterology Center Of The Midsouth	Cordova	Tennessee
United States	Digestive Health Specialists	Dothan	Alabama
United States	Qualmedica Research, LLC	Evansville	Indiana
United States	Revive Research Institute, Inc.	Farmington Hills	Michigan
United States	Care Access - Gilroy	Gilroy	California
United States	Woodholme Gastroenterology Associates - Glen Burnie	Glen Burnie	Maryland
United States	Carolina Digestive Diseases and Endoscopy Center	Greenville	North Carolina
United States	Ohio State University	Hilliard	Ohio
United States	Baylor College of Medicine Medical Center	Houston	Texas
United States	Christine Thai, MD	Huntington Beach	California
United States	Grand Teton Research Group	Idaho Falls	Idaho
United States	Indiana University Health University Hospital	Indianapolis	Indiana
United States	Care Access - Kinston	Kinston	North Carolina
United States	IHS Health Research	Kissimmee	Florida
United States	Care Access - Las Vegas	Las Vegas	Nevada
United States	Research Solutions of Arizona	Litchfield Park	Arizona
United States	West Texas Digestive Disease	Lubbock	Texas
United States	Gastrointestinal Specialists of Georgia	Marietta	Georgia
United States	Ezy Medical Research	Miami	Florida
United States	Delta Research Partners	Monroe	Louisiana
United States	California Medical Research Associates	Northridge	California
United States	Care Access - Ogden	Ogden	Utah
United States	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Gastroenterology Associates of Orangeburg	Orangeburg	South Carolina
United States	Care Access - Orlando	Orlando	Florida
United States	Gastroenterology Associates of Pensacola, PA	Pensacola	Florida
United States	Arizona Arthritis & Rheumatology Associates	Phoenix	Arizona
United States	MNGI Digestive Health - Plymouth Endoscopy Center & Clinic	Plymouth	Minnesota
United States	University Gastroenterology	Providence	Rhode Island
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Washington University Medical School	Saint Louis	Missouri
United States	Care Access - Salt Lake City	Salt Lake City	Utah
United States	Southern Star Research Institute	San Antonio	Texas
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Precision Clinical Research	Sunrise	Florida
United States	Washington Gastroenterology - Tacoma	Tacoma	Washington
United States	Alliance Clinical Research of Tampa	Tampa	Florida
United States	USF Health	Tampa	Florida
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	Digestive Health Specialists of Tyler	Tyler	Texas
United States	North Shore Gastroenterology & Endoscopy Centers	Westlake	Ohio
United States	Tidewater Physicians Multispecialty Group Clinical Research	Williamsburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Endoscopic Response	Endoscopic response based on Simple Endoscopic Score for Crohn's Disease (SES-CD) total score	Week 52
Primary	Percentage of Participants Achieving Clinical Remission	Clinical remission based on Crohn's Disease Activity Index (CDAI)	Week 52
Secondary	Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission based on SES-CD total score	Week 52
Secondary	Percentage of Participants Achieving Clinical Response	Clinical response by patient-reported outcomes (PRO) based on stool frequency (SF) and abdominal pain (AP)	Week 52
Secondary	Change from Baseline in C-Reactive Protein	Change from baseline in c-reactive protein	Baseline, Week 12
Secondary	Change from Baseline in Fecal Calprotectin	Change from baseline in fecal calprotectin	Baseline, Week 12
Secondary	Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ)	Change from baseline on the IBDQ	Baseline to Week 52

External Links

•   A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease