A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

Crohn's Disease Clinical Trial

— VIVID-1  

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926130
• Other study ID #: 16590
• Secondary ID: I6T-MC-AMAM2018-
• Status: Completed
• Phase: Phase 3
• Start date: July 23, 2019
• Est. completion date: October 2, 2023

Study information

• Verified date: December 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1158
• Est. completion date: October 2, 2023
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of CD for at least 3 months prior to baseline

• Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD

• Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD

• If female, subject must meet the contraception recommendations

Exclusion Criteria:

• Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome

• Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery

• Have a stoma, ileoanal pouch or ostomy

• Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline

• Have ever received any monoclonal antibodies binding IL-23

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Locations

Country	Name	City	State
Argentina	Centro de Investigaciones Metabólicas (CINME)	Buenos Aires
Argentina	CEMIC- Servicio de Reumatología	Caba	Buenos Aires
Argentina	DOM- Centro de Reumatologia	Caba	Buenos Aires
Argentina	Mautalen Salud e Investigación	Caba	Buenos Aires
Argentina	CIPREC	Ciudad Autonoma de Buenos Aire	Ciudad Autónoma De Buenos Aire
Argentina	Instituto Medico Elsa Perez SRL (IMEP)	Ciudadela	Buenos Aires
Argentina	Centro de Investigaciones Médicas Tucuman	SAN M. DE Tucuman	Tucumán
Australia	Emeritus Research	Camberwell	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St. Vincents Hospital Sydney	Darlinghurst	New South Wales
Australia	Northern Hospital	Epping	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Coastal Digestive Health	Maroochydore	Queensland
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Coral Sea Clinical Research Institute	North Mackay	Queensland
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Austria	Medizinische Universität Innsbruck	Innsbruck
Austria	Universitätsklinikum Salzburg	Salzburg
Austria	AKH	Wien
Austria	Krankenhaus der Barmherzigen Schwestern Wien	Wien
Belgium	Imelda General Hospital	Bonheiden	Antwerpen
Belgium	UZ Brussel	Brussel
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles	Brussel
Belgium	AZ Groeninge	Kortrijk
Belgium	Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg	Leuven
Brazil	Hospital Felício Rocho	Belo Horizonte	MG
Brazil	Faculdade de Medicina de Botucatu	Botucatu	SP
Brazil	Chronos Pesquisa Clínica	Brasília	Distrito Federal
Brazil	L2IP - Instituto de Pesquisas Clinicas Ltda.	Brasília	Distrito Federal
Brazil	HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas	Campinas	Sao Paulo
Brazil	Instituto de Pesquisa em Saúde - Fundação Universidade de Caxias do Sul	Caxias do Sul	Rio Grande Do Sul
Brazil	Associacao Paranaense de Cultura - PUCPR	Curitiba	Parana
Brazil	HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará	Fortaleza	Ceara
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda	Goiania	GO
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Ernesto Dornelles	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul
Brazil	Irmandade da Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Gloria Dor	Rio de Janeiro
Brazil	Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao	Salvador	Bahia
Brazil	Faculdade de Medicina do ABC	Santo Andre	SP
Brazil	Pesquisare	Santo Andre	Sao Paulo
Brazil	Praxis Pesquisa Medica	Santo Andre	São Paulo
Brazil	CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda	São Bernardo do Campo	São Paulo
Brazil	Hepatogastro	Sao Paulo
Brazil	Hospital Sírio Libanês	Sao Paulo
Brazil	Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual	Sao Paulo	SP
Brazil	Clinica Onco Star	São Paulo
Brazil	CPQuali Pesquisa Clínica	São Paulo
Brazil	Eurolatino Pesquisas Medicas Ltda.	Uberlandia	Minas Gerais
Canada	Milestone Clinical	Dartmouth	Nova Scotia
Canada	Gastroenterology and internal medicine research institute	Edmonton	Alberta
Canada	K&M Medical	Kentville	Nova Scotia
Canada	London Health Sciences Centre	London	Ontario
Canada	Victoria Hospital	London	Ontario
Canada	CIUSS-de-L'Est-de-l'île-de-Montréal-Hôpital	Montreal	Quebec
Canada	Fraser Clinical Trials Inc	New Westminster	British Columbia
Canada	The Medical Arts Health Research Group	North Vancouver	British Columbia
Canada	Viable Clinical Research	Sudbury	Ontario
Canada	GI Research Institute	Vancouver	British Columbia
China	Peking University First Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
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 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 First People's Hospital of Foshan	Foshan	Guangdong
China	The First Affiliated Hospital of Fujian Medical University	Fujian	Fuzhou
China	First affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
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 Medicine	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
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	Shanghai 6th people's hospital	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai	Pudong District
China	Shanghai Jiaotong University School of Medicine Ruijin Hospital	Shanghai	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university	Wenzhou	Zhejiang
China	Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech	Wu Han	Hubei
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Zhongshan Hospital Xiamen University	Xiamen
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
Croatia	Clinical Medical Centre Osijek	Osijek
Croatia	CHC Zagreb	Zagreb
Czechia	Fakultni Nemocnice U svate Anny	Brno
Czechia	Vojenská Nemocnice Brno	Brno	Brno-mesto
Czechia	Hepato-Gastroenterologie HK	Hradec Kralove	Hradec Králové
Czechia	Oblastni nemocnice Nachod-Endoskopicke centrum	Nachod
Czechia	MUDr. Gregar, s.r.o.	Olomouc	Olomoucký Kraj
Czechia	PreventaMed, s.r.o.	Olomouc
Czechia	MUDr. Radka Koskova, s.r.o., Gastroenterologicka ambulance	Ostrava - Muglinov
Czechia	A-Shine, s.r.o.	Plzen
Czechia	Synexus Czech	Prague	Praha 2
Czechia	Thomayerova nemocnice	Prague	Praha 4
Czechia	Institut Klinicke a Experimentalni Mediciny	Praha 4	Prague
Czechia	AXON Clinical	Praha 5
Czechia	Mediendo, s.r.o.	Praha 8
Czechia	ISCARE Clinical Centre	Praha 9
Czechia	Krajska zdravotni, a.s.-Masarykova nemocnice Usti nad Labem	Usti nad Labem	Czech Republic
Czechia	Nemocnice Tomase Bati ve Zline	Zlín	Zlínský Kraj
Denmark	Aalborg Hospital	Aalborg
Denmark	Aarhus Universitetshospital, Skejby	Aarhus	Midtjylland
France	CHU Amiens Picardie Site Sud - Service d'Hepato-gastro-entérologie	Amiens
France	Hôpital Beaujon	Clichy	Paris
France	Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre	Le Kremlin-Bicêtre	Paris
France	Centre Hospitalier du Mans	Le Mans
France	CHRU de Montpellier-Hopital St Eloi	Montpellier Cedex 5
France	GH Necker - Enfants Malades	Paris
France	Hôpital Saint Antoine	Paris	Cedex 12
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	CHU Charles Nicolle in Rouen	Rouen cedex
France	CHU St Etienne Hopital Nord	Saint Etienne Cedex 2
France	Hopital de Hautepierre - Service d'Hépatogastroentérolgie	Strasbourg Cedex	Bas Rhin
France	CHRU de Nancy	Vand?uvre-lès-Nancy
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	Synexus Clinical Research GmbH	Berlin
Germany	Knappschaftskrankenhaus Bottrop	Bottrop	Nordrhein Westfalen
Germany	Florence-Nightingale-Krankenhaus	Düsseldorf
Germany	Universitaetsklinikum Essen	Essen	North Rhine-Westphalia
Germany	Synexus Clinical Research GmbH	Frankfurt am Main	Hessen
Germany	Practice Dr.med. Denger and Dr.med. Pfitzner	Friedrichsthal	Saarland
Germany	Studiengesellschaft BSF Unternehmergesellschaft	Halle (Saale),	Sachsen Anhalt
Germany	HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen	Hamburg
Germany	Medizinische Hochschule Hanover	Hannover	Niedersachsen
Germany	Universitätsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	Krankenhaus Eichhof	Lauterbach	Hessen
Germany	Synexus Clinical Research GmbH-Leipzig Research Centre	Leipzig	Saxony-Anhalt
Germany	St. Marienkrankenhaus-Medizinische Klinik I	Ludwigshafen	Rhineland-Palatinate
Germany	Gastroenterologische Gemeinschaftspraxis Mainz	Mainz
Germany	Johanna Etienne Krankenhaus-Klinik für Allgemeine Innere Medizin	Neuss	North Rhine-Westphalia
Germany	RED-Institut GmbH	Oldenburg	Schleswig-Holstein
Germany	Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin	Pforzheim	Baden-Württemberg
Germany	Tumorzentrum Nordthüringen	Uslar
Germany	Gemeinschaftspraxis Jakobeit	Wipperfurth	North Rhine-Westphalia
Germany	Universitätsklinikum Würzburg A. ö. R.	Würzburg	Bayern
Hungary	DRC Gyogyszervizsgalo Kozpont Kft.	Balatonfüred	EU
Hungary	Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház	Békéscsaba
Hungary	Clinexpert SMO	Budapest
Hungary	Pannonia Maganorvosi Centrum	Budapest
Hungary	Synexus Magyarorszag Kft.	Budapest
Hungary	Bugát Pál Kórház	Gyöngyös
Hungary	Synexus Gyula	Gyula	Bekes
Hungary	Endomedix Diagnosztikai Központ - Miskolc	Miskolc
Hungary	SZTE AOK Belgyogyaszati Klinika	Szeged	Csongrad
Hungary	CLINFAN Szolgáltató Kft	Szekszard
Hungary	Clinexpert Tatabánya Ltd.	Tatabánya	Komárom-Esztergom
India	Postgraduate Institute of Medical Education & Research	Chandigarh
India	Apollo Speciality Hospital - Teynampet	Chennai	Tamil Nadu
India	Asian Institute of Gastroenterology	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	Aakash Healthcare Super Speciality Hospital	New Delhi
India	All India Institute of Medical Sciences	New Delhi	Delhi
India	Sir Ganga Ram Hospital	New Delhi	Delhi
India	Ruby Hall Clinic and Grant Medical Foundation	Pune	Maharashtra
India	Gujarat Hospital - Gastro and Vascular Centre	Surat	Gujarat
India	Gandhi Hospital	Telangana
India	Yashoda Super Speciality Hospital	Telangana
India	International Gastro Institute	Vadodara	Gujarat
Israel	Soroka Medical Center	Beer Sheva
Israel	Bnai Zion Medical Center	Haifa
Israel	Edith Wolfson Medical Center	Holon
Israel	Hadassah Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Galilee Medical Center Department of Internal Medicine A	Nahariya
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rehovot
Israel	Assaf Harofeh Medical Center	Zerifin
Italy	Azienda Ospedaliera Policlinico Consorziale	Bari
Italy	Università degli Studi c/o Spedali Civili	Brescia
Italy	Azienda Ospedaliera Giuseppe Brotzu	Cagliari
Italy	Azienda Ospedaliera Saverio De Bellis	Castellana Grotte	Bari
Italy	Azienda ospedaliero-universitaria Mater Domini	Germaneto	Catanzaro
Italy	Istituto Mangiagalli	Milano	MI
Italy	Ospedale Luigi Sacco	Milano
Italy	Azienda Ospedaliera Universitaria Policlinico de Modena	Modena
Italy	Università di Cagliari - Presidio Policlinico Monserrato	Monserrato	Cagliari
Italy	Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli	Napoli
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Arcispedale Santa Maria Nuova	Reggio Emilia
Italy	Presidio di Rho	Rho	Milano
Italy	Polic.Umberto I -Univ. La Sapienza	Roma
Italy	Policlinico Gemelli - Università Cattolica del Sacro Cuore	Roma	Lazio
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Italy	Ospedale Clinicizzato San Donato	San Donato Milanese	Milan
Italy	Azienda Ospedaliera Santa Maria Della Misericordia	Udine
Japan	Asahikawa Medical College Hospital	Asahikawa	Hokkaido
Japan	Tokyo Medical and Dental University 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, Jonan-Ku	Fukuoka
Japan	National Hospital Organization Fukuyama Medical Center	Fukuyama	Hiroshima
Japan	Matsuda Hospital	Hamamatsu-shi	Shizuoka-Ken
Japan	National Hospital Organization Hirosaki General Medical Center	Hirosaki	Aomori
Japan	Isesakishimin Hospital	Isesaki	Gunma
Japan	Kagoshima University Hospital	Kagoshima
Japan	Sameshima Hospital	Kagoshima
Japan	Ofuna Central Hospital	Kamakura	Kanagawa
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	Ibaraki Prefectural Central Hospital	Kasama	Ibaraki
Japan	Tsujinaka Hospital	Kashiwa	Chiba
Japan	Kiryu Kosei Hospital	Kiryu	Gunma
Japan	Hoshi General Hospital	Koriyama	Fukushima
Japan	Showa University Koto Toyosu Hospital	Koto-ku	Tokyo
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kyoto Furitsu Medical University Hospital	Kyoto
Japan	Maebashi Red Cross Hospital	Maebashi	Gunma
Japan	Nagasaki Harbor Medical Center	Nagasaki City	Nagasaki
Japan	Kojunkai Daido Clinic	Nagoya	Aichi
Japan	Hyogo College of Medicine	Nishinomiya	Hyogo
Japan	Okayama Saiseikai General Hospital Outpatient Center	Okayama
Japan	Okayama University Hospital	Okayama
Japan	Infusion Clinic	Osaka-shi	Osaka-Fu
Japan	Saga-Ken Medical Center Koseikan	Saga-shi	Saga
Japan	Kitasato University Hospital	Sagamihara	Kanagawa
Japan	Tokitokai Tokito Clinic	Saitama
Japan	Sapporo Higashi Tokushukai Hospital	Sapporo	Hokkaido
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Tokushukai Sapporo Tokushukai Hospital	Sapporo-shi	Hokkaido
Japan	IMS Meirikai Sendai General Hospital	Sendai	Miyagi
Japan	Takagi Clinic - Sendai	Sendai	Miyagi
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	JHCO Tokyo Yamate Medical Center	Shinjuku-ku	Tokyo
Japan	National Center for Global Health and Medicine	Shinjuku-ku	Tokyo
Japan	Kagawa Prefectural Central Hospital	Takamatsu	Kagawa
Japan	Toyama Prefectural Central Hospital	Toyama
Japan	Fujita Health University	Toyoake	Aichi
Japan	Mie University Hospital	Tsu	Mie
Japan	Yamagata University Hospital	Yamagata
Japan	Matsushima Cinic	Yokohama	Kanagawa
Japan	Tottori University Hospital	Yonago	Tottori
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Kyung Pook National University Hospital	Daegu	Korea
Korea, Republic of	Kyungpook National University Medical Center Chilgok Hospital	Daegu
Korea, Republic of	The Catholic University of Korea, Daejeon St. Mary's Hospital	Daejeon	Taejon-Kwangyokshi
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Gangwon-do
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Gyeonggido
Korea, Republic of	Korea University Ansan Hospital	Gyeonggi-do
Korea, Republic of	Yeungnam Univeristy Medical Center	Gyeongsan-si	Kyongsangbuk-do
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Chungang University Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul	Korea
Korea, Republic of	Kyunghee University Hospital at Gangdong	Seoul	Korea
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul, Korea
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul	Korea
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-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	Health Pharma Professional Research S.A. de C.V:	Ciudad de México	Distrito Federal
Mexico	Instituto de Investigaciones Clínicas para la Salud	Durango
Mexico	PanAmerican Clinical Research S.A.de C.V. Guadalajara	Guadalajara	JA
Mexico	Grupo Medico Camino Sc	México City	Distrito Federal
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo Leon
Mexico	Centro de Alta Especialidad Reumatologia Inv del Potosi SC	San Luis Potosi
Mexico	PanAmerican Clinical Research Mexico S.A. de C.V.	Santiago de Queretaro	Queretaro
Mexico	Sociedad de Metabolismo y Corazon	Veracruz
Netherlands	ETZ Elisabeth Tilburg	Tilburg	North Brabant
Netherlands	Bernhoven Uden	Uden
Poland	Nova Reuma Spolka Partnerska	Bialystok	Podlaskie
Poland	Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy	Bydgoszcz
Poland	Centrum Medyczne SYNEXUS	Czestochowa	Slaskie
Poland	NZOZ "Twoje Zdrowie EL" Sp. z o.o.	Elblag
Poland	Synexus Polska Gdansku	Gdansk	Pomorskie
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdyni	Gdynia	Pomorskie
Poland	MED-ROZ	Karwiany	Dolnoslaskie
Poland	Synexus Polska - Katowicach	Katowice	Slaskie
Poland	Indywidualna Specjalistyczna Praktyka Lekarska	Knurow
Poland	Topolowa Medicenter	Krakow	Malopolskie
Poland	Synexus Polska Oddzial w Lodzi	Lodz
Poland	ZOZ Gastromed	Lublin	Lubelskie
Poland	Medicenter Nowy Targ	Nowy Targ	Malopolskie
Poland	Synexus Polska Sp. z o.o. Oddzial w Poznaniu	Poznan	Wielkopolskie
Poland	Centrum Medyczne Medyk	Rzeszow	Subcarpathian
Poland	Private Practice - Dr. Korczowski Bartosz	Rzeszow	Podkarpackie
Poland	Endoskopia Sp. z.o.o.	Sopot	Pomorskie
Poland	Kiepury Clinic	Sosnowiec	Silesian
Poland	Dc-Med. Sp. z o.o.	Swidnica	Lower Silesian
Poland	Sonomed Sp. z o.o.	Szczecin	West Pomeranian
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin
Poland	NZOZ Formed	Wadowice	Malopolskie
Poland	NZOZ Vivamed	Warsaw	Mazowieckie
Poland	Instytut Pomnik-Centrum Zdrowia Dziecka	Warszawa	Woj Mazowieckie
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warszawa
Poland	M. Sklodowskiej-Curie 12	Wroclaw	Lower Silesian
Poland	Melita Medical	Wroclaw	Dolnoslaskie
Poland	ETG Zamosc	Zamosc
Puerto Rico	Caguas Gastroenterology and Hepatology Center, LLC	Caguas
Puerto Rico	Pan American Center for Oncology Trials	Rio Piedras
Puerto Rico	Latin Clinical Trial Center	San Juan
Puerto Rico	Wellness clinical Research Vega Baja	Vega Baja
Romania	Spitalul Universitar de Urgen?a Bucure?ti	Bucure?ti
Romania	CCBR Clinical Research	Bucuresti
Romania	Institutul Clinic Fundeni	Bucuresti
Romania	S.C. Centrul Medical Medicum SRL	Bucuresti
Romania	SC Med Life SA	Bucuresti
Romania	Spitalul Clinic CF 2 Bucuresti	Bucuresti
Romania	Spitalul Clinic Colentina	Bucuresti
Romania	Spitalul Euroclinic	Bucureti	Bucure?ti
Romania	Sc Tvm Med Serv	Cluj-Napoca	Cluj
Romania	Affidea Medical Research Center	Constanta
Romania	Gastromed S.R.L.	Constanta
Romania	Spitalul Pelican	Oradea	Bihor
Romania	Spitalul Clinic Judetean Targu Mures	Targu Mures
Romania	S.C. Materna Care S.R.L.	Timisoara
Russian Federation	Multidisciplinary Medical Clinic "Anthurium"	Barnaul
Russian Federation	LLC Evimed	Chelyabinsk
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	Clinical Trials Center of Medical Institute	Kaliningrad
Russian Federation	Kazan State Medical University	Kazan
Russian Federation	SIH Kemerovo Regional Clinical Hosptial	Kemerovo
Russian Federation	LLC ?Medsanchast No 14?	Moscow
Russian Federation	Olla-Med	Moscow	Moskva
Russian Federation	State Scientific Centre of Coloproctology	Moscow
Russian Federation	Nizhny Novgorod Regional Hospital N.A. Semashko	Nizhny Novgorod	Nizhegorodskaya Oblast'
Russian Federation	LLC "Medicine Center SibNovoMed"	Novosibirsk
Russian Federation	Novosibirski Gastrocenter	Novosibirsk	Novosibirskaya Oblast'
Russian Federation	The University Clinic of OSMU	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	LLC Medical Center Reavita Med SPb	Saint Petersburg	Sankt-Peterburg
Russian Federation	Saint-Petersburg City Hospital of Saint Elizabeth	Saint Petersburg
Russian Federation	Scientific research center ECO-security	Saint Petersburg	Sankt-Peterburg
Russian Federation	LLC Gastroenterology Centre Expert	Saint-Petersburg
Russian Federation	Pokrovskaya Municipal Hospital	Saint-Petersburg
Russian Federation	SBIH City Clinical Hospital #31	Saint-Petersburg
Russian Federation	SPb SBIH "City Polyclinic # 106"	Saint-Petersburg
Russian Federation	NonState Healthcare Institution Central Clinical Hospital	Samara
Russian Federation	Academician I.P. Pavlov First St-Petersburg State Medical University	St-Petersburg
Serbia	Clinical Center " Dr Dragisa Misovic Dedinje"	Belgrade
Serbia	Clinical Hospital Center Zvezdara	Belgrade	Beograd
Serbia	University Medical Center "Bezanijska kosa"	Belgrade	NAP
Serbia	Clinical Center Kragujevac Gastroenterohepatology Clinic	Kragujevac
Serbia	Clinical Center Nis	Nis	Nišavski Okrug
Serbia	Sremska Mitrovica Health Centre	Sremska Mitrovica	Vojvodina
Serbia	Zemun Medical Centre	Zemun	Beograd
Serbia	General Hospital "Djordje Joanovic"	Zrenjanin	Vojvodina
Slovakia	FNsP FDRoosevelta Banska Bystrica	Banska Bystrica
Slovakia	CLINIQ, s.r.o	Bratislava
Slovakia	Gastromedic	Nove Zamky
Slovakia	Gastro	Prešov	Prešovský Kraj
Slovakia	Gastro LM s.r.o.	Presov
Slovakia	Endomed, s.r.o.	Vranov N. Toplou	Prešovský Kraj
Spain	Instituto de Ciencias Médicas	Alicante
Spain	Centro Medico Teknon - DIGESTIVO	Barcelona
Spain	Hospital Reina Sofia	Cordoba
Spain	Hospital Universitari de Girona Dr. Josep Trueta	Girona	Barcelona
Spain	Complexo Hospitalario Universitario A Coruña, CHUAC	La Coruña
Spain	Hospital De Gran Canaria Dr. Negrin	Las Palmas de Gran Canaria
Spain	Hospital La Princesa	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Complejo Hospitalario de Navarra NAVARRABIOMED UNIDAD EC	Pamplona	Navarra
Spain	Hospital Universitario Nuestra Señora de la Candelaria	Santa Cruz de Tenerife
Spain	Clínica Gaias - Santiago	Santiago de Compostela	A Coruña [La Coruña]
Switzerland	Gastroenterologische Praxis Balsiger, Seibold & Partner	Bern
Switzerland	Inselspital Bern	Bern
Switzerland	Cantonal Hospital St.Gallen	St. Gallen	Sankt Gallen
Turkey	Ankara City Hospital	Ankara
Turkey	Gazi University Faculty of Medicine	Ankara
Turkey	Hacettepe University Faculty of Medicine	Ankara
Turkey	Uludag Universitesi	Bursa
Turkey	Trakya University	Edirne
Turkey	Eskisehir Osmangazi University Gastroenterology	Eskisehir
Turkey	Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi	Gaziantep
Turkey	Mustafa Kemal Universitesi Tayfur Ata Sokmen Tip Fakultesi	Hatay
Turkey	Fulya Acibadem	Istanbul
Turkey	Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi	Istanbul
Turkey	Marmara University Pendik Research and Training Hospital	Istanbul
Turkey	Medicana Kadiköy Hastanesi	Istanbul
Turkey	Dokuz Eylül Üniversitesi	Izmir
Turkey	Kocaeli University Medical Faculty Hospital	Izmit
Turkey	Acibadem Universitesi - Acibadem Kozyatagi Hastanesi	Kadikoy	Istanbul
Turkey	Erciyes University Hospital	Kayseri
Turkey	Antalya Egitim ve Arastirma Hastanesi	Kocaeli	Antalya
Turkey	Konya Necmettin Erbakan Gastroenterology	Konya
Turkey	Inonu Universitesi Turgut Ozal Tip Merkezi	Malatya
Turkey	Mersin University Medical Faculty	Yenisehir	Mersin
Ukraine	RCI Chernivtsi Regional Clinical Hospital	Chernivtsi
Ukraine	Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine	Dnipro
Ukraine	Ivano-Frankivsk State Medical University	Ivano-Frankivsk
Ukraine	City Clinical Hospital No. 2	Kharkiv	Kharkivska Oblast
Ukraine	Kharkiv Regional Council Regional Clinical Hospital	Kharkiv
Ukraine	Medical Center of Limited Liability Company "Medical Center "Consilium Medical"	Kiev	Kyiv
Ukraine	Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"	Kyiv
Ukraine	Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"	Kyiv
Ukraine	International Institute of Clinical Trials LLC	Kyiv
Ukraine	Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Railway	Kyiv
Ukraine	LLC Medbud-Clinic Medical Center	Kyiv
Ukraine	Medical Centre of Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV	Kyiv
Ukraine	Lviv Railway Clinical Hospital	Lviv	Lvivska Oblast
Ukraine	Lviv Regional Endocrinology Dispensary	Lviv	Lvivska Oblast
Ukraine	Communal Enterprise "Odesa Regional Clinical Hospital"	Odesa
Ukraine	A. Novak Transcarpathian Regional Clinical Hospital	Uzhgorod
Ukraine	Medical Center "Health Clinic" LLC	Vinnitsa
Ukraine	CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM	Vinnytsia
Ukraine	Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU	Vinnytsia
Ukraine	Vinnytsya Regional Clinical Hospital	Vinnytsya
Ukraine	Diacenter LLC	Zaporizhzhia
Ukraine	Zaporozhye City Clinical Hospital #6	Zaporizhzhia
United Kingdom	Synexus Midlands Clinical Research Center	Birmingham	Wstmid
United Kingdom	Addenbrookes Hospital	Cambridge	Cambridgeshire
United Kingdom	Synexus Wales Clinical Research Centre	Cardiff	South Glamorgan
United Kingdom	Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust	Doncaster
United Kingdom	Paediatric Clinical Research Facility Royal Hospital for Children and Young People	Edinburgh
United Kingdom	Chelsea and Westminster Hospital	Fulham	London
United Kingdom	Synexus North East Clinical Research Centre	Hexham
United Kingdom	Whipps Cross University Hospital	London	England
United Kingdom	Synexus Manchester Clinical Research Centre	Manchester	Greater Manchester
United States	Lovelace Scientific Resources - Albuquerque	Albuquerque	New Mexico
United States	Radiant Research	Anderson	South Carolina
United States	inSite Digestive Health Care	Arcadia	California
United States	Digestive Healthcare of Georgia	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Amel Med LLC	Austin	Texas
United States	IMR of South Florida	Aventura	Florida
United States	Washington Gastroenterology, PLLC	Bellevue	Washington
United States	University of Alabama-The Kirklin Clinic	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Care Access Research - Wyoming	Casper	Wyoming
United States	Unc Hospitals	Chapel Hill	North Carolina
United States	Javara	Charlotte	North Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	MGG Group, Inc.., Co., Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Eagle Clinical Research	Chicago	Illinois
United States	Gastroenterology Consultants of Clearwater	Clearwater	Florida
United States	West Central Gastroenterology d/b/a Gastro Florida	Clearwater	Florida
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Ohio State University Hospital	Columbus	Ohio
United States	Baylor Scott & White Center for Inflammatory Bowel Diseases	Dallas	Texas
United States	Advanced Gastroenterology Associates	Decatur	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Digestive Health Specialists	Dothan	Alabama
United States	Ohio Gastroenterology Group Inc.	Dublin	Ohio
United States	B G Clinical Research, Inc.	Encinitas	California
United States	Qualmedica Research, LLC	Evansville	Indiana
United States	Pediatrics Specialists of Virginia	Fairfax	Virginia
United States	Revive Research Institute	Farmington Hills	Michigan
United States	Gastrointestinal Associates	Flowood	Mississippi
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	Gastro One	Germantown	Tennessee
United States	Care Access - Gilroy	Gilroy	California
United States	Woodholme Gastroenterology Associates - Glen Burnie	Glen Burnie	Maryland
United States	Infusion Associates	Grand Rapids	Michigan
United States	Medication Management	Greensboro	North Carolina
United States	Lakeview Clinical Research	Guntersville	Alabama
United States	Doral Medical Research	Hialeah	Florida
United States	Inpatient Research Clinic	Hialeah	Florida
United States	Peters Medical Research	High Point	North Carolina
United States	CroNola LLC	Houma	Louisiana
United States	Baylor College of Medicine	Houston	Texas
United States	Biopharma Informatic, LLC	Houston	Texas
United States	University of Texas Health Services Center - Houston	Houston	Texas
United States	Marshall Medical Center	Huntington	West Virginia
United States	Newport Huntington Med Grp	Huntington Beach	California
United States	Grand Teton Research Group	Idaho Falls	Idaho
United States	Indiana University Health	Indianapolis	Indiana
United States	Southern Therapy and Advanced Research (STAR) LLC	Jackson	Mississippi
United States	University of Mississippi School of Medicine	Jackson	Mississippi
United States	C2 Research Center, LLC	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Katy Gastro Health & Nutrition	Katy	Texas
United States	Care Access Research-Kinston	Kinston	North Carolina
United States	Central Florida Gastro Research	Kissimmee	Florida
United States	I.H.S. Health, LLC	Kissimmee	Florida
United States	GIA Clinical Trials, LLC	Knoxville	Tennessee
United States	NYU Langone Long Island Clinical Research Associates	Lake Success	New York
United States	Florida Research Institute	Lakewood Ranch	Florida
United States	Om Research, LLC	Lancaster	California
United States	Advanced Biomedical Research of America - South Eastern Avenue	Las Vegas	Nevada
United States	Care Access - Las Vegas	Las Vegas	Nevada
United States	Wellness Clinical Research	Lehigh Acres	Florida
United States	BVL Research	Liberty	Missouri
United States	Research Solutions of Arizona	Litchfield Park	Arizona
United States	GastroIntestinal Biosciences Clinical Trials	Los Angeles	California
United States	Robley Rex VA Medical Center	Louisville	Kentucky
United States	Caprock Gastro Research, LLC	Lubbock	Texas
United States	Care Access Research-Lumberton	Lumberton	North Carolina
United States	Connecticut Gastroenterology	Manchester	Connecticut
United States	Gastrointestinal Specialists of Georgia	Marietta	Georgia
United States	Biopharma Informatic, LLC	McAllen	Texas
United States	Central Arizona Medical Associates, PC	Mesa	Arizona
United States	Columbus Clinical Services, LLC	Miami	Florida
United States	Coral Research Clinic Corp	Miami	Florida
United States	Ezy Medical Research	Miami	Florida
United States	Infinite Clinical Research	Miami	Florida
United States	Nickalus Children's Hospital Research Institute	Miami	Florida
United States	Research Associates of South Florida, LLC	Miami	Florida
United States	SaludMax Medical Corp	Miami	Florida
United States	Goji Group - Research Trials Group	Miami Lakes	Florida
United States	Wellness Clinical Research	Miami Lakes	Florida
United States	Delta Research Partners LLC	Monroe	Louisiana
United States	Strand GI	Myrtle Beach	South Carolina
United States	Nola Research Works, LLC	New Orleans	Louisiana
United States	Children's Specialty Group, PPLC	Norfolk	Virginia
United States	California Medical Research Associates	Northridge	California
United States	Care Access Research LLC - Salt Lake City	Ogden	Utah
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	University of California Irvine	Orange	California
United States	Gastroenterology Associates of Orangeburg	Orangeburg	South Carolina
United States	Care Access Research - Orlando	Orlando	Florida
United States	Center for Interventional Endoscopy	Orlando	Florida
United States	Clintheory Healthcare	Orlando	Florida
United States	Digestive and Liver Center of Florida	Orlando	Florida
United States	Endoscopic Research Inc	Orlando	Florida
United States	Orlando Health, Inc	Orlando	Florida
United States	Digestive System Healthcare	Pasadena	Texas
United States	inSite Digestive Health Care	Pasadena	California
United States	Gastroenterology Associates of Pensacola, PA	Pensacola	Florida
United States	The Center for Gastrointestinal Health	Petersburg	Virginia
United States	Arizona Arthritis & Rheumatology Research, PLLC	Phoenix	Arizona
United States	Synexus Clinical Research US, Inc.	Pinellas Park	Florida
United States	MNGI Digestive Health, P.A.	Plymouth	Minnesota
United States	Care Access Research LLC	Pottsville	Pennsylvania
United States	University Gastroenterology	Providence	Rhode Island
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Velocity Clinical Research/Gut Whisperer	Riverton	Utah
United States	Carilion Clinic	Roanoke	Virginia
United States	Capital Digestive Care	Rockville	Maryland
United States	Care Access Research LLC - Salt Lake City	Salt Lake City	Utah
United States	Kalo Clinical Research	Salt Lake City	Utah
United States	Southern Star Research Institute, LLC	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	VIP Trials	San Antonio	Texas
United States	Care Access Research - San Jose	San Jose	California
United States	Wolverine Clinical Trials, LLC	Santa Ana	California
United States	Reliance Research	Scottsdale	Arizona
United States	Care Access Research - Scranton	Scranton	Pennsylvania
United States	Louisiana Clinical Research, LLC	Shreveport	Louisiana
United States	USPA Advance Concept Medical Research Group LLC.	South Miami	Florida
United States	Advanced Clinical Research-Spokane Gastroenterology	Spokane	Washington
United States	Virginia Gastroenterology Institute	Suffolk	Virginia
United States	Precision Clinical Research	Sunrise	Florida
United States	Washington Gastroenterology, PLLC	Tacoma	Washington
United States	Advanced Research	Tamarac	Florida
United States	Alliance Clinical Research, LLC	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	Synexus Site Network	Tempe	Arizona
United States	Care Access Research - Terre Haute	Terre Haute	Indiana
United States	Fomat Medical Research, Inc.	Thousand Oaks	California
United States	Digestive Health Specialists	Tupelo	Mississippi
United States	Care Access Research - Tuscaloosa	Tuscaloosa	Alabama
United States	Tyler Research Institute, LLC	Tyler	Texas
United States	Northshore Gastroenterology Research, LLC	Westlake	Ohio
United States	TPMG Clinical Research Williamsburg	Williamsburg	Virginia
United States	Gastroenterology Associates of the Piedmont	Winston-Salem	North Carolina
United States	Care Access Research - Yonkers	Yonkers	New York

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,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52	Clinical response by Patient Reported Outcome (PRO) based on stool frequency (SF) and abdominal pain (AP); Endoscopic response based on Simple Endoscopic Score for Crohn's Disease (SES-CD) total score	Baseline to Week 52
Primary	Percentage of Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52	Clinical response by PRO based on SF and AP; Clinical remission based on CDAI	Baseline to Week 52
Secondary	Percentage of Participants Achieving Endoscopic Response	Endoscopic response based on Simple Endoscopic Score for Crohn's Disease (SES-CD) total score	Week 52
Secondary	Percentage of Participants Achieving Clinical Remission	Clinical remission based on Crohn's Disease Activity Index (CDAI)	Week 52
Secondary	Percentage of Participants Achieving Endoscopic Response	Endoscopic Response based on SES-CD total score	Week 12
Secondary	Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission based on SES-CD total score	Week 12
Secondary	Percentage of Participants Achieving Clinical Remission	Clinical remission based on CDAI	Week 12
Secondary	Change from Baseline in Urgency Numeric Rating Score (NRS)	Change from Baseline in Urgency NRS	Baseline, Week 12
Secondary	Change from Baseline in Urgency NRS	Change from Baseline in Urgency NRS	Baseline, Week 52
Secondary	Percentage of Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52	Clinical Response and Clinical Remission based on PRO	Baseline to Week 52
Secondary	Percentage of Participants Achieving Clinical Response at Week 12 and Endoscopic Remission at Week 52	Clinical Response by PRO and Endoscopic Remission by SES-CD	Baseline to Week 52
Secondary	Percentage of Participants Achieving Clinical Response at Week 12 and Corticosteroid-free AND either in Clinical Remission or Endoscopic Remission at Week 52	Clinical Response by PRO, Clinical remission by CDAI, Endoscopic Remission by SES-CD	Baseline to Week 52
Secondary	Change from Baseline in C-Reactive Protein	Change from baseline in C-Reactive Protein	Baseline, Week 52
Secondary	Change from Baseline in Fecal Calprotectin	Change from baseline in fecal calprotectin	Baseline, Week 52
Secondary	Percentage of Participants with Extraintestinal Manifestations (EIMs) of Crohn's Disease	Percentage of participants with EIMs of Crohn's Disease	Week 52
Secondary	Percentage of Participants with Fistulae Response	Percentage of participants with fistulae response	Week 52
Secondary	Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Mirikizumab	PK: AUC of mirikizumab	Baseline through Week 52
Secondary	Change from Baseline in Health Related Quality of Life	Health related quality of life based on Inflammatory Bowel Disease Questionnaire (IBDQ) score	Baseline, Week 52

External Links

•   A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease