A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-2)

November 27, 2025 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

996

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1111
        • DOM Centro de Reumatología
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Maroochydore, Queensland, Australia, 4558
        • Coastal Digestive Health
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Austria
      • Salzburg, Austria, 5020
        • Uniklinikum Salzburg
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medizinische Universitaet Innsbruck
    • Vienna
      • Vienna, Vienna, Austria, 1090
        • Universitaetsklinikum Allgemeines Krankenhaus Wien
  • Belgium
    • Antwerpen
      • Bonheiden, Antwerpen, Belgium, 2930
        • Imelda General Hospital
    • Bruxelles-Capitale, Région de
      • Brussels, Bruxelles-Capitale, Région de, Belgium, 1070
        • Université Libre de Bruxelles - Hôpital Erasme
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven
  • Brazil
      • São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica
      • São Paulo, Brazil, 04038-034
        • Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T
      • São Paulo, Brazil, 04543-011
        • Clínica Hepatogastro JK
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41500-300
        • CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • L2IP - Instituto de Pesquisas Clínicas
      • Brasília, Federal District, Brazil, 72145-450
        • Chronos Pesquisa Clínica
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-934
        • Hospital Felicio Rocho
    • Rio Grande do Sul
      • Caxias do Sul, Rio Grande do Sul, Brazil, 95070-560
        • Fundação Universidade de Caxias do Sul (FUCS)
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
        • Núcleo de Pesquisa Clínica do Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560-030
        • Hospital Moinhos de Vento
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-686
        • Faculdade de Medicina da UNESP
      • Campinas, São Paulo, Brazil, 13034-685
        • Centro de Pesquisa Sao Lucas
      • Santo André, São Paulo, Brazil, 09080-110
        • Pesquisare Saude
      • Santo André, São Paulo, Brazil, 09790790
        • Praxis Pesquisa Médica
      • São Bernardo do Campo, São Paulo, Brazil, 09715-090
        • Centro Multidisciplinar de Estudos Clinicos
      • São Paulo, São Paulo, Brazil, 01308-060
        • Hospital Sírio Libanês
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5R 1W2
        • Gastroenterology and internal medicine research institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2K5
        • GIRI GI Research Institute - Vancouver
    • Nova Scotia
      • Kentville, Nova Scotia, Canada, B4N 0A3
        • Private Practice - Dr. Bruce Musgrave
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Victoria Hospital
      • North Bay, Ontario, Canada, P1B 2H3
        • Private Practice - Dr. Stephane M. Gauthier
  • China
      • Fuzhou, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
    • Anhui
      • Hefei, Anhui, China, 230071
        • Anhui Provincial Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400014
        • Chongqing General Hospital
    • Fujian
      • Xiamen, Fujian, China, 350001
        • Zhongshan Hospital Affiliated to Xiamen University
    • Guangdong
      • Foshan, Guangdong, China, 528041
        • The First People's Hospital of Foshan
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital of Sun Yat-sen University
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Tongji Medical,Science & Technology
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University
      • Changsha, Hunan, China, 410013
        • The Third Xiangya Hospital of Central South University
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • The First People's Hospital of Changzhou
      • Changzhou, Jiangsu, China, 213004
        • Changzhou No.2 People's Hospital
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital of Chinese Medicine
      • Suzhou, Jiangsu, China, 215004
        • The Second Affiliated Hospital of Soochow University
      • Wuxi, Jiangsu, China, 214023
        • Wuxi People's Hospital
      • Zhenjiang, Jiangsu, China, 212000
        • Affiliated Hospital of Jiangsu University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital of China Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital
      • Hangzhou, Zhejiang, China, 310052
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Wenzhou, Zhejiang, China, 325000
        • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
  • Croatia
      • Osijek, Croatia, 31000
        • Klinički bolnički centar Osijek
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Klinički bolnički centar Zagreb
  • Czechia
      • Olomouc, Czechia, 779 00
        • PreventaMed
    • Brno-město
      • Brno, Brno-město, Czechia, 636 00
        • Vojenska nemocnice Brno
      • Brno, Brno-město, Czechia, 656 91
        • Fakultni nemocnice u sv. Anny v Brne
    • Hradec Králové
      • Hradec Králové, Hradec Králové, Czechia, 500 12
        • Hepato-Gastroenterologie HK
    • Náchod
      • Náchod, Náchod, Czechia, 547 69
        • Oblastni nemocnice Nachod
    • Olomoucký kraj
      • Olomouc, Olomoucký kraj, Czechia, 779 00
        • MUDr. Gregar, s.r.o.
    • Ostrava Město
      • Ostrava, Ostrava Město, Czechia, 712 00
        • MUDr. Radka Koskova, s.r.o.
    • Praha 2
      • Prague, Praha 2, Czechia, 120 00
        • Synexus Czech
    • Praha 4
      • Prague, Praha 4, Czechia, 14059
        • Fakultni Thomayerova nemocnice
      • Prague, Praha 4, Czechia, 140 21
        • Institut Klinicke a Experimentalni Mediciny
    • Praha 5
      • Prague, Praha 5, Czechia, 150 00
        • AXON Clinical
      • Prague, Praha 5, Czechia, 150 06
        • Fakultni nemocnice Motol
    • Praha 9
      • Prague, Praha 9, Czechia, 19000
        • ISCARE klinické centrum
    • Zlín
      • Zlín, Zlín, Czechia, 762 75
        • Nemocnice Tomase Bati ve Zline
    • Ústí Nad Labem
      • Ústí nad Labem, Ústí Nad Labem, Czechia, 40113
        • Masarykova Nemocnice V Usti Nad Labem
  • Denmark
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Gastroenterologische Praxis Balsiger, Seibold & Partner
  • France
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34295
        • Chu Saint Eloi
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Centre Hospitalier Universitaire De Poitiers
  • Germany
    • Baden-Wurttemberg
      • Pforzheim, Baden-Wurttemberg, Germany, 75179
        • Siloah St. Trudpert Klinikum
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Universitaetsklinikum Wuerzburg
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60313
        • Synexus Clinical Research GmbH
      • Lauterbach, Hesse, Germany, 36341
        • Siteworks GmbH - Lauterbach
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Medizinische Hochschule Hannover
    • North Rhine-Westphalia
      • Bottrop, North Rhine-Westphalia, Germany, 52074
        • Knappschaftskrankenhaus Bottrop
      • Wipperfürth, North Rhine-Westphalia, Germany, 51688
        • Gemeinschaftspraxis Jakobeit
    • Saxony
      • Leipzig, Saxony, Germany, 4103
        • Synexus Leipzig Clinical Research Centre
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06108
        • Studiengesellschaft BSF Unternehmergesellschaft
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Allgemeine Innere Medizin I
      • Oldenburg in Holstein, Schleswig-Holstein, Germany, 23758
        • RED-Institut GmbH
    • Thuringia
      • Nordhausen, Thuringia, Germany, 99734
        • Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
  • Hungary
      • Budapest, Hungary, 1033
        • Clinexpert Kft.
      • Budapest, Hungary
        • Pannónia Magánorvosi Centrum
      • Budapest, Hungary, 1036
        • SYNEXUS Magyarország Kft. Eü.
      • Békéscsaba, Hungary, 5600
        • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
    • Bekes County
      • Gyula, Bekes County, Hungary, 5700
        • Synexus Magyarorszag Kft
    • Heves County
      • Gyöngyös, Heves County, Hungary
        • Bugat Pal Korhaz
    • Komárom-Esztergom
      • Tatabánya, Komárom-Esztergom, Hungary, 2800
        • Szent Borbala Korhaz
    • Pest County
      • Vác, Pest County, Hungary, 2600
        • Jávorszky Ödön Kórház
    • Tolna County
      • Szekszárd, Tolna County, Hungary, 7100
        • CLINFAN Szolgáltató Kft
    • Veszprém megye
      • Balatonfüred, Veszprém megye, Hungary, 8230
        • DRC Gyógyszervizsgáló Központ
  • India
      • Chandigarh, India, 160012
        • Postgraduate Institute of Medical Education & Research
    • Gujarat
      • Surat, Gujarat, India, 395009
        • Gujarat Hospital - Gastro & Vascular Centre
    • Maharashtra
      • Pune, Maharashtra, India, 411001
        • Grant Medical Foundation - Ruby Hall Clinic
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • All India Institute of Medical Sciences
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College and Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
        • SR Kalla Memorial Gastro & General Hospital
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600035
        • Apollo Speciality Hospital - Teynampet
  • Israel
    • Central District
      • Ramat Gan, Central District, Israel, 5262100
        • Sheba Medical Center
      • Rehovot, Central District, Israel, 7610001
        • Kaplan Medical Center
      • Ẕerifin, Central District, Israel, 70300
        • Yitzhak Shamir Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9778419
        • Shaare Zedek Medical Center
    • Northern District
      • Nahariya, Northern District, Israel, 2210001
        • Galilee Medical Center
    • Southern District
      • Beersheba, Southern District, Israel, 8410101
        • Soroka Medical Center
  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
    • Milano
      • Milan, Milano, Italy, 20097
        • IRCCS Policlinico San Donato
      • Rho, Milano, Italy, 20017
        • Ospedale Di Circolo
  • Japan
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Kagoshima, Japan, 892-0846
        • Sameshima Hospital
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital,Kyoto Prefectural University of Medicine
      • Okayama, Japan, 700-0013
        • Okayama Saiseikai Outpatient Center Hospital
      • Tokyo, Japan, 169-0073
        • Tokyo Yamate Medical Center
      • Toyama, Japan, 930-0975
        • Toyama Prefectural Central Hospital
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8545
        • National Hospital Organization Hirosaki General Medical Center
    • Chiba
      • Kashiwa, Chiba, Japan, 277-0871
        • Tsujinaka Hospital - Kashiwanoha
    • Fukoka
      • Kitakyusyu-shi, Fukoka, Japan, 802-0077
        • Kitakyushu Municipal Medical Center
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-0067
        • Fukuoka University Chikushi Hospital
    • Gunma
      • Kiryū, Gunma, Japan, 376-0024
        • Kiryu Kosei General Hospital
    • Hokkaido
      • Chuo-ku, Sapporo-shi, Hokkaido, Japan, 060-0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
      • Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital
      • Sapporo, Hokkaido, Japan, 065-0033
        • Sapporo Higashi Tokushukai Hospital
      • Sapporo, Hokkaido, Japan, 004 0041
        • Tokushukai Sapporo Tokushukai Hospital
    • Hyōgo
      • Nishinomiya, Hyōgo, Japan, 663-8501
        • Hyogo College of Medicine
    • Ibaraki
      • Kasama, Ibaraki, Japan, 890-8520
        • Ibaraki Prefectural Central Hospital
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-0056
        • Ofuna Central Hospital
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Mie University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 981-3213
        • Takagi Clinic - Sendai
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 432-8061
        • Matsuda Hospital
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8519
        • Institute of Science Tokyo Hospital
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin University Hospital
      • Shinjyuku-ku, Tokyo, Japan, 162-8655
        • Center Hospital of the National Center for Global Health and Medicine
  • Latvia
    • Rīga
      • Riga, Rīga, Latvia, LV-1002
        • Pauls Stradins Clinical Univeristy Hospital
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Hospital of Lithuanian University of Health Sciences Kaunas
  • Mexico
      • Chihuahua City, Mexico, 31207
        • Scientia Investigacion Clinica S.C.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
      • Monterrey, Nuevo León, Mexico, 64000
        • Christus Muguerza Hospital Sur
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexico, 78213
        • Centro de Alta Especialidad en Reumatologia e Investigación del Potosi,S.C
  • Netherlands
    • North Brabant
      • Tilburg, North Brabant, Netherlands, 5022 GC
        • Elisabeth-TweeSteden Ziekenhuis
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081 HZ
        • Amsterdam UMC, locatie VUmc
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-702
        • Synexus Polska Sp. z o.o. Oddzial w Poznaniu
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-229
        • Centrum Medyczne "Medis" Manermed
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-506
        • Topolowa Medicenter
      • Wadowice, Lesser Poland Voivodeship, Poland, 34-100
        • NZOZ Formed
    • Lower Silesian Voivodeship
      • Swidnica, Lower Silesian Voivodeship, Poland, 58-100
        • DC-MED
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-449
        • Melita Medical
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
        • Reumatop
      • Wroclaw, Lower Silesian Voivodeship, Poland, 58-100
        • Synexus - Wroclaw
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-582
        • ZOZ Gastromed
      • Zamość, Lublin Voivodeship, Poland, 22-400
        • ETG Zamość
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-189
        • Centrum Zdrowia MDM
      • Warsaw, Masovian Voivodeship, Poland, 04-501
        • WIP Warsaw IBD Point Profesor Kierkus
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Poland, 35-326
        • Centrum Medyczne Medyk
      • Rzeszów, Podkarpackie Voivodeship, Poland, 35-302
        • Private Practice - Dr. Korczowski Bartosz
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-707
        • Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-382
        • Synexus Polska Gdansku
      • Gdynia, Pomeranian Voivodeship, Poland, 81-537
        • Synexus Polska Sp. z o.o. Oddzial w Gdyni
      • Sopot, Pomeranian Voivodeship, Poland, 81-756
        • Endoskopia Sp. z.o.o.
    • Silesian Voivodeship
      • Częstochowa, Silesian Voivodeship, Poland, 42-202
        • Synexus Polska Sp. z o.o. Oddzial w Czestochowie
      • Katowice, Silesian Voivodeship, Poland, 40-588
        • Synexus Polska - Katowicach
      • Sosnowiec, Silesian Voivodeship, Poland, 40-588
        • Kiepury Clinic
    • Warmian-Masurian Voivodeship
      • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
        • NZOZ TwojeZdrowie
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-685
        • SONOMED Centrum Medyczne
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Romania
      • Constanța, Romania, 900178
        • Gastromed S.R.L.
    • București
      • Bucharest, București, Romania, 013812
        • Spitalul de Oncologie Monza
      • Bucharest, București, Romania, 014142
        • Delta Health Care
      • Bucharest, București, Romania, 12015
        • S.C. Centrul Medical Medicum SRL
      • Bucharest, București, Romania, 20125
        • Spitalul Clinic Colentina
    • Timiș County
      • Timișoara, Timiș County, Romania, 300002
        • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
  • Russia
    • Altayskiy Kray
      • Barnaul, Altayskiy Kray, Russia, 656038
        • Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"
    • Irkutsk Oblast
      • Irkutsk, Irkutsk Oblast, Russia, 664079
        • Scientific Centre of Reconstructive and Restorative Surgery
    • Kareliya, Respublika
      • Petrozavodsk, Kareliya, Respublika, Russia, 620109
        • Karelia Republican Hospital V.A. Baranova
    • Kemerovo Oblast
      • Kemerovo, Kemerovo Oblast, Russia, 620109
        • SIH Kemerovo Regional Clinical Hosptial
    • Moscow
      • Moscow, Moscow, Russia, 105554
        • Olla-Med
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603126
        • Nizhny Novgorod Regional Hospital N.A. Semashko
    • Novosibirsk Oblast
      • Novosibirsk, Novosibirsk Oblast, Russia, 630005
        • LLC "Medicine Center SibNovoMed"
      • Novosibirsk, Novosibirsk Oblast, Russia, 630117
        • Research Institute of Physiology and Fundamental Medicine
    • Omsk Oblast
      • Omsk, Omsk Oblast, Russia, 644050
        • Clinic of Omsk State Medical University
    • Rostov Oblast
      • Rostov-on-Don, Rostov Oblast, Russia, 344091
        • Rostov State Medical University
    • Samara Oblast
      • Samara, Samara Oblast, Russia, 443029
        • NonState Healthcare Institution Central Clinical Hospital
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 196143
        • Scientific research center ECO-security
      • Saint Petersburg, Sankt-Peterburg, Russia, 197022
        • First Pavlov State Medical University of Saint Petersburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 194354
        • LLC Medical Center Reavita Med SPb
      • Saint Petersburg, Sankt-Peterburg, Russia, 194356
        • Balt Med Clinic
      • Saint Petersburg, Sankt-Peterburg, Russia, 195257
        • Saint-Petersburg City Hospital of Saint Elizabeth
      • Saint Petersburg, Sankt-Peterburg, Russia, 197110
        • Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31
    • Sverdlovsk Oblast
      • Yekaterinburg, Sverdlovsk Oblast, Russia, 620109
        • LLC MA New Hospital
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Clinical Hospital Center Zvezdara
      • Belgrade, Beograd, Serbia, 11080
        • University Medical Center "Bezanijska kosa"
    • Vojvodina
      • Zrenjanin, Vojvodina, Serbia, 23000
        • General Hospital "Djordje Joanovic"
  • Slovakia
    • Banská Bystrica Region
      • Banská Bystrica, Banská Bystrica Region, Slovakia, 97517
        • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 81109
        • Cliniq s.r.o.
    • Nitra Region
      • Nové Zámky, Nitra Region, Slovakia, 940 81
        • Gastromedic
    • Presov
      • Prešov, Presov, Slovakia, 080 01
        • Gastro LM
      • Vranov N. Toplou, Presov, Slovakia, 093 01
        • Endomed, s.r.o.
  • South Korea
    • Kang-won-do
      • Wŏnju, Kang-won-do, South Korea, 26426
        • Yonsei University-Wonju Severance Christian Hospital
    • Kyǒnggi-do
      • Ansan-si, Kyǒnggi-do, South Korea, 15355
        • Korea University Ansan Hospital
      • Guri-si, Kyǒnggi-do, South Korea, 11923
        • Hanyang University Guri Hospital
      • Suwon, Kyǒnggi-do, South Korea, 16499
        • Ajou University Hospital
    • Kyǒngsangbuk-do
      • Gyeongsan-si, Kyǒngsangbuk-do, South Korea, 42415
        • Yeungnam Univeristy Medical Center
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, South Korea, 49201
        • Dong-A University Hospital
      • Haeundae-gu, Pusan-Kwangyǒkshi, South Korea, 48108
        • Inje University Haeundae Paik Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Dongjak-gu, Seoul-teukbyeolsi [Seoul], South Korea, 6973
        • Chungang University Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
        • Asan Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 6591
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 02447
        • Kyung Hee University Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 3181
        • Kangbuk Samsung Hospital
    • Taegu-Kwangyǒkshi
      • Daegu, Taegu-Kwangyǒkshi, South Korea, 42601
        • Keimyung University Dongsan Hospital
      • Deagu, Taegu-Kwangyǒkshi, South Korea, 41404
        • Kyungpook National University Chilgok Hospital
      • Junggu, Taegu-Kwangyǒkshi, South Korea, 41944
        • Kyungpook National University Hospital
    • Taejǒn-Kwangyǒkshi
      • Daejeon, Taejǒn-Kwangyǒkshi, South Korea, 34943
        • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital Bern
    • Canton of Bern
      • Bern, Canton of Bern, Switzerland, 3012
        • Gastroenterologische Praxis Balsiger, Seibold & Partner
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Cantonal Hospital St.Gallen
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Ankara City Hospital
      • Ankara, Turkey (Türkiye), 6230
        • Hacettepe Universite Hastaneleri
      • Ankara, Turkey (Türkiye), 6560
        • Gazi University Health Research and Application Center Gazi Hospital
      • Antalya, Turkey (Türkiye), 7100
        • Antalya Egitim ve Arastırma Hastanesi
      • Bursa, Turkey (Türkiye), 16059
        • Uludag Universitesi
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University
      • Hatay, Turkey (Türkiye), 31001
        • Mustafa Kemal Universitesi
      • Istanbul, Turkey (Türkiye), 34724
        • Medicana Kadiköy Hastanesi
      • Istanbul, Turkey (Türkiye), 34734
        • Acbadem Kozyatagi Hospital
      • Mersin, Turkey (Türkiye), 33343
        • Mersin University
    • Eskişehir
      • Eskişehir, Eskişehir, Turkey (Türkiye), 26480
        • Eskisehir Osmangazi University
    • Istanbul
      • Istanbul- Fatih, Istanbul, Turkey (Türkiye), 34098
        • Istanbul Universitesi Cerrahpasa
    • Kocaeli
      • İzmit, Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli University Medical Faculty Hospital
    • İzmir
      • Balçova, İzmir, Turkey (Türkiye), 35340
        • Dokuz Eylul Universitesi
  • Ukraine
      • Chernivtsi, Ukraine, 58000
        • Chernivtsi Regional Clinical Hospital
      • Kyiv, Ukraine, 02091
        • Medical Center Ok!Clinic+
      • Kyiv, Ukraine, 03049
        • Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Ra -T
      • Kyiv, Ukraine, 04050
        • Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
      • Kyiv, Ukraine, 04078
        • Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Center for Rehabilitation Medicine"
      • Kyiv, Ukraine, 04106
        • Municipal Nonprofit Enterprise of Kyiv Region Council "Kyiv Regional Clinical Hospital"
    • Dnipropetrovsk Oblast
      • Dnipro, Dnipropetrovsk Oblast, Ukraine, 49038
        • Medical Center Family Medicine Clinic
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76008
        • Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"
    • Kharkivs’ka Oblast’
      • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61037
        • City Clinical Hospital No. 2
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 03037
        • Medbud Clinic
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79000
        • University Hospital branch of Danylo Halytsky Lviv National Medical University (UH DHLNMU)
    • Odesa Oblast
      • Odesa, Odesa Oblast, Ukraine, 65025
        • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21000
        • City Clinical Hospital #1, Vinnitsya National Medical University
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21009
        • Medical Clinical Investigational Center of Medical Center Health Clinic
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21018
        • Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia Regio -T
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21018
        • VNMU
    • Zakarpattia Oblast
      • Uzhhorod, Zakarpattia Oblast, Ukraine, 88018
        • Transcarpathian Regional Hospital im.Andriya Novak
    • Zaporizhzhia Oblast
      • Zaporizhia, Zaporizhzhia Oblast, Ukraine, 69035
        • Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council
      • Zaporizhzhia, Zaporizhzhia Oblast, Ukraine, 69076
        • Diacenter
  • United Kingdom
      • Cardiff, United Kingdom, CF15 9SS
        • Synexus Wales Clinical Research Centre
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital
    • England
      • London, England, United Kingdom, E11 1NR
        • Whipps Cross University Hospital
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Research Solutions of Arizona
      • Phoenix, Arizona, United States, 85037
        • Arizona Arthritis & Rheumatology Research, PLLC
    • California
      • Gilroy, California, United States, 95020
        • Care Access - Gilroy
      • Huntington Beach, California, United States, 92648
        • Newport Huntington Medical Group
      • Northridge, California, United States, 91324
        • California Medical Research Associates
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Connecticut Clinical Research Institute
    • Florida
      • Clearwater, Florida, United States, 33756
        • Gastroenterology Consultants of Clearwater
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc. (Clearwater)
      • Kissimmee, Florida, United States, 34741
        • IHS Health Research
      • Miami, Florida, United States, 33175
        • Ezy Medical Research
      • Orlando, Florida, United States, 32825
        • Care Access - Orlando
      • Pensacola, Florida, United States, 32503
        • Gastroenterology Associates of Pensacola, PA
      • Sunrise, Florida, United States, 33351
        • Precision Clinical Research
      • Tampa, Florida, United States, 33615
        • Alliance Clinical Research of Tampa
      • Tampa, Florida, United States, 33612
        • USF Health
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Digestive Healthcare of Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Grand Teton Research Group
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Qualmedica Research, LLC
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health University Hospital
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Capital Digestive Care - Chevy Chase
      • Glen Burnie, Maryland, United States, 21061
        • Woodholme Gastroenterology Associates - Glen Burnie
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • The Digestive Health Center of Michigan (DHCMI)
      • Farmington Hills, Michigan, United States, 48334
        • Revive Research Institute, Inc.
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University Medical School
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Care Access - Las Vegas
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7080
        • Clinical & Translational Research Center (CTRC)
      • Greenville, North Carolina, United States, 27834
        • Carolina Digestive Diseases and Endoscopy Center
      • Kinston, North Carolina, United States, 28501
        • Care Access - Kinston
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43202
        • Ohio Gastroenterology
      • Hilliard, Ohio, United States, 43026
        • Ohio State University
      • Westlake, Ohio, United States, 44145
        • North Shore Gastroenterology & Endoscopy Centers
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104-5008
        • The University of Oklahoma Health Sciences Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Gastroenterology Associates of Orangeburg
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Gastroenterology Center Of The Midsouth
    • Texas
      • Bellaire, Texas, United States, 77401
        • First Surgical Hospital
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine Medical Center
      • Lubbock, Texas, United States, 79424
        • West Texas Digestive Disease
      • San Antonio, Texas, United States, 78229
        • Southern Star Research Institute
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute
    • Utah
      • Ogden, Utah, United States, 84403
        • Care Access - Ogden
      • Salt Lake City, Utah, United States, 84124
        • Care Access - Salt Lake City
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Richmond, Virginia, United States, 23226
        • Clinical Research Partners, LLC
      • Williamsburg, Virginia, United States, 23188
        • Tidewater Physicians Multispecialty Group Clinical Research
    • Washington
      • Bellevue, Washington, United States, 98004
        • Washington Gastroenterology - Bellevue
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Tacoma, Washington, United States, 98405
        • Washington Gastroenterology - Tacoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMAM Mirikizumab (Miri): Miri 300 mg SC
Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) for 52 weeks.
Drug: Mirikizumab
Administered Q4W
Other Names:
  • LY3074828
Experimental: AMAM Miri: Miri 900 mg IV Then 300 mg SC
Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg intravenously (IV) Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
Drug: Mirikizumab
Administered Q4W
Other Names:
  • LY3074828
Experimental: AMAM Placebo (PBO)/Miri: Miri 300 mg SC
Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.
Drug: Mirikizumab
Administered Q4W
Other Names:
  • LY3074828
Experimental: AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC
Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
Drug: Mirikizumab
Administered Q4W
Other Names:
  • LY3074828
Experimental: AMAM Ustekinumab (Uste): Miri 300 mg SC
Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.
Drug: Mirikizumab
Administered Q4W
Other Names:
  • LY3074828
Experimental: AMAM Uste: Miri 900 mg IV Then 300 mg SC
Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
Drug: Mirikizumab
Administered Q4W
Other Names:
  • LY3074828
Experimental: AMAM PBO: Miri 300 mg SC
Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks.
Drug: Mirikizumab
Administered Q4W
Other Names:
  • LY3074828
Experimental: AMAM PBO: Miri 900 mg IV Then 300 mg SC
Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks.
Drug: Mirikizumab
Administered Q4W
Other Names:
  • LY3074828
Experimental: All AMAG Participants: Miri 300 mg SC
Participants from Study AMAG who continued into Study AMAX received mirikizumab 300 mg SC Q4W for 52 weeks.
Drug: Mirikizumab
Administered Q4W
Other Names:
  • LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Endoscopic Response at Week 52 (Participants Originating From AMAM Study)
Time Frame: Week 52
Endoscopic Response defined as ≥50% reduction from AMAM study baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.
Week 52
Percentage of Participants Achieving Clinical Remission at Week 52 (Participants Originating From AMAM Study)
Time Frame: Week 52
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) total score < (less than) 150. The CDAI measures the severity of active disease using 8 disease variables: stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations, presence or absence of fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight. Each variable is assigned a specific weight/multiplier, and the weighted values are summed to produce a CDAI total score. CDAI total scores can range from 0 to 600, with higher scores indicating more severe disease.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Alternate Endoscopic Remission at Week 52 (Participants Originating From AMAM Study)
Time Frame: Week 52
Alternate endoscopic remission is defined as SES-CD Total Score ≤4 with at least a 2-point reduction from the AMAM study baseline and no subscore >1. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore >1 is defined as no individual assessment score >1 across all 20 individual assessments.
Week 52
Percentage of Participants Achieving Clinical Response by Patient Reported Outcome (PRO) at Week 52 - (Participants Originating From AMAM Study)
Time Frame: Week 52
Clinical response by Patient Reported Outcome (PRO) was defined as a ≥30% decrease from baseline in stool frequency (SF) and/or abdominal pain (AP) score, with neither symptom worsening from baseline. SF was measured as the number of liquid or very soft stools per day. AP was scored daily on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
Week 52
Fecal Calprotectin at Week 12 (Participants Originating From AMAM Study)
Time Frame: Week 12
Fecal calprotectin is an indicator of inflammation in the intestines with higher levels indicative of higher levels of inflammation.
Week 12
C-Reactive Protein (CRP) at Week 12 (Participants Originating From AMAM Study)
Time Frame: Week 12
C-Reactive Protein is a biomarker of systemic inflammation measured in the blood, with elevated levels indicating increased inflammatory activity in the body.
Week 12
Change From Baseline in Health Related Quality of Life at Week 52 : Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Participants Originating From AMAM Study)
Time Frame: Baseline, Week 52
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item participant completed questionnaire that measures 4 aspects of patients' lives: symptoms directly related to the primary bowel disturbance (10 items), systemic symptoms (5 items), emotional function (12 items), and social function(5 items). Responses are graded on a 7-point Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." IBDQ total score is calculated as the sum of all questions. Total scores range from 32 to 224; a higher score indicates a better quality of life.
Baseline, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2020

Primary Completion (Actual)

November 28, 2024

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16628
  • I6T-MC-AMAX (Other Identifier: Eli Lilly and Company)
  • 2019-002687-27 (EudraCT Number)
  • 2022-502841-91-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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