AzTrials
AzTrials

Ulcerative ColitisPhase 3NCT03519945

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

A Phase 3 study testing Mirikizumab in people with Ulcerative Colitis, run by Eli Lilly and Company at 352 sites in 36 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Mirikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,058 participants
Where
352 sitesin 36 countries
Study dates
18 Jul 2018to Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) who have had at least one study drug administration and have not had early termination of study drug.
  • Female participants must agree to contraception requirements.

Who cannot join

  • Participants must not have developed a new condition, including cancer in the originator study.
  • Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
  • Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
  • Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.

Trial locations and contacts

352 sites in 36 countries.

352 sites in 36 countries

United States48 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • InSite Digestive Health Care

    Arcadia, California, 91006

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30327

  • GI Alliance Research Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Care Access - Berkeley

    Berkeley, California, 94705

  • Clinical & Translational Research Center (CTRC)

    Chapel Hill, North Carolina, 27599-7080

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Digestive Health Specialists

    Dothan, Alabama, 36305

  • NorthShore University HealthSystem - Evanston Hospital

    Evanston, Illinois, 60201

  • GI Alliance

    Garland, Texas, 75044

  • Carolina Digestive Diseases and Endoscopy Center

    Greenville, North Carolina, 27834

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Grand Teton Research Group

    Idaho Falls, Idaho, 83404

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202

  • Encore Borland-Groover Clinical Research

    Jacksonville, Florida, 32256

  • Om Research LLC

    Lancaster, California, 93534

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340

  • Wellness Clinical Research

    Miami Lakes, Florida, 33016

  • Delta Research Partners

    Monroe, Louisiana, 71201

  • Nola Research Works, LLC

    New Orleans, Louisiana, 70125

  • Columbia University Medical Center

    New York, New York, 10032

  • California Medical Research Associates

    Northridge, California, 91324

  • Henry Ford Medical Center - Columbus Center

    Novi, Michigan, 48377

  • Care Access-Ogden

    Ogden, Utah, 84403

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104-5008

  • Central Sooner Research - Oklahoma - Northwest 47th Street

    Oklahoma City, Oklahoma, 73118

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Clintheory Healthcare

    Orlando, Florida, 32819

  • Gastroenterology Associates of Pensacola, PA

    Pensacola, Florida, 32503

  • Valleywise Health Medical Center

    Phoenix, Arizona, 85008

  • MNGI Digestive Health - Plymouth Endoscopy Center & Clinic

    Plymouth, Minnesota, 55446

  • Care Access - Youngstown

    Poland, Ohio, 44514

  • Care Access - Pottsville

    Pottsville, Pennsylvania, 17901

  • Inland Empire Clinical Trials, LLC

    Rialto, California, 92377

  • Carilion Clinic

    Roanoke, Virginia, 24014

  • Care Access Research LLC - Salt Lake City

    Salt Lake City, Utah, 84124

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229

  • Southern Star Research Institute

    San Antonio, Texas, 78229

  • Clinical Applications Laboratories, Inc.

    San Diego, California, 92103

  • Midwest Medical Care

    Sioux Falls, South Dakota, 57108

  • GI Alliance

    Southlake, Texas, 76092

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092

  • Washington Gastroenterology - Tacoma

    Tacoma, Washington, 98405

  • Cotton O'Neil Digestive Health Center

    Topeka, Kansas, 66606

  • West Michigan Clinical Research Center

    Wyoming, Michigan, 49519

  • Digestive Disease Associates

    Wyomissing, Pennsylvania, 19610

  • Florida Medical Clinic LLC

    Zephyrhills, Florida, 33542-7505

Other trials in United States

Japan44 sites

  • Asahikawa City Hospital

    Asahikawa, 070-8610

  • Tokyo Medical and Dental University Hospital

    Bunkyō, 113-8519

  • Juntendo University Hospital

    Bunkyō City, 113-8431

  • Mitsui Memorial Hospital

    Chiyoda-ku, 101-8643

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

    Chuo-ku, Sapporo-shi, 060-0033

  • Sai Gastroenterologist Proctology

    Fujiidera, 583-0027

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Matsuaikai Matsuda Hospital

    Hamamatsu, 432-8061

  • Mito Medical Center

    Higashiibaraki, 311-3117

  • National Hospital Organization Hirosaki National Hospital

    Hirosaki, 036-8545

  • Sameshima Hospital

    Kagoshima, 892-0846

  • Ofuna Central Hospital

    Kamakura, 247-0056

  • Kawasaki Municipal Hospital

    Kawasaki, 210-0013

  • Kitakyushu Municipal Medical Center

    Kitakyusyu-shi, 802-0077

  • Aoyama Clinic GI Endoscopy & IBD Center

    Kobe, 650 0015

  • Showa University Koto Toyosu Hospital

    Kōtoku, 135 8577

  • Kumagaya General Hospital

    Kumagaya-shi, 360-8567

  • Hidaka Coloproctology Clinic

    Kurume-shi, 839 0809

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-8555

  • Gunma University Hospital

    Maebashi, 371-8511

  • Kitasato University Kitasato Institute Hospital

    Minatoku, 108 8642

  • Kyorin University Hospital

    Mitaka, 181-8611

  • Nagaoka Chuo General Hospital

    Nagaoka, 940-8653

  • Hyogo College of Medicine

    Nishinomiya, 663-8501

  • Ishida Clinic of IBD and Gastroenterology

    Ōita, 870 0823

  • Okayama University Hospital

    Okayama, 700-8558

  • Infusion Clinic

    Osaka, 530-0011

  • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research

    Osaka, 540-0006

  • Saga-Ken Medical Center Koseikan

    Saga, 840-8571

  • Tokitokai Tokito Clinic Coloproctology Center

    Saitama, 336-0963

  • Toho University Sakura Medical Center

    Sakura, 285-0841

  • Tokushukai Sapporo Tokushukai Hospital

    Sapporo, 004 0041

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033

  • Takagi Clinic - Sendai

    Sendai, 981-3213

  • Jichi Medical University Hospital

    Shimotsuke, 329-0498

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjyuku-ku, 162-8655

  • Kagawa Prefectural Central Hospital

    Takamatsu, 760-8557

  • National Hospital Organization Takasaki General Medical Centar

    Takasaki, 370-0829

  • Tokyo Yamate Medical Center

    Tokyo, 169-0073

  • Toyama Prefectural Central Hospital

    Toyama, 930-8550

  • Mie University Hospital

    Tsu, 514-8507

  • Matsushima Hospital

    Yokohama, 220-0041

  • Yokohama City University Medical Center

    Yokohama, 232-0024

  • Showa University Northern Yokohama Hospital

    Yokohama, 234-0032

Other trials in Japan

China33 sites

  • Xiangya Hospital Central South University

    Changsha, 410008

  • Changzhou No.2 People's Hospital

    Changzhou

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, 350005

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510655

  • Hainan General Hospital

    Haikou, 570311

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, 310003

  • Sir Run Run Shaw Hospital

    Hangzhou, 310016

  • The Second Affiliated hospital of Zhejiang University school of medicine

    Hangzhou, 310052

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Anhui Provincial Hospital

    Hefei, 230071

  • Center-Jilin Center Hospital

    Jilin City, 132011

  • Shandong Provincial Hospital

    Jinan, 250001

  • Qilu Hospital of Shandong University

    Jinan, 250012

  • First Affiliated Hospital of Kunming Medical University

    Kunming, 650032

  • The First People's Hospital of Yunnan Province

    Kunming, 650034

  • Liaocheng People's Hospital

    Liaocheng, 252000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210000

  • Zhongda Hospital Southeast University

    Nanjing, 210009

  • Nanjing Medical University - Nanjing Jiangning Hospital

    Nanjing, 211100

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266003

  • Renji Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, 200001

  • Shanghai Jiaotong University School of Medicine Ruijin Hospital

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

  • The Second Afilliated Hospital of Hebei Medical University

    Shijiazhuang, 050000

  • Taian City Central Hospital

    Taian, 271000

  • The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

    Wenzhou, 315100

  • Wuhan Union Hospital

    Wuhan, 430022

  • Tongji Hospital Tongji Medical,Science & Technology

    Wuhan, 430030

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450014

  • ZhuZhou Central Hospital

    Zhuzhou, 412007

Other trials in China

Poland24 sites

  • Promedica Dental Clinic

    Będzin, 42-500

  • Centrum Medyczne "Medis" Manermed

    Bydgoszcz, 85-229

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, 85-796

  • Szpital Miejski im. Jana Pawła II w Elblagu

    Elblag, 02-300

  • All-Medicus

    Katowice, 40-659

  • Gabinet Endoskopii Przewodu Pokarmowego

    Krakow, 31-009

  • Topolowa Medicenter

    Krakow, 31-506

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20-090

  • ZOZ Gastromed

    Lublin, 20-582

  • Medicenter Nowy Targ

    Nowy Targ, 34-400

  • Wojewódzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, 11-041

  • Centrum Medyczne LUX MED - Rzeszow

    Rzeszów, 35-068

  • Endoskopia Sp. z.o.o.

    Sopot, 81-756

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • SONOMED Centrum Medyczne

    Szczecin, 71-685

  • Gastromed

    Torun, 87-100

  • NZOZ Formed

    Wadowice, 34-100

  • Centrum Zdrowia MDM

    Warsaw, 00-189

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, 02-507

  • Vivamed Sp. z o.o.

    Warsaw, 03-580

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501

  • Planetmed

    Wroclaw, 52-210

  • LexMedica

    Wroclaw, 53-114

  • ETG Zamość

    Zamość, 22-400

Other trials in Poland

Ukraine20 sites

  • Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"

    Ivano-Frankivsk, 76008

  • City Clinical Hospital No. 2

    Kharkiv, 61037

  • L.T. Mala National Institute of Therapy of NAMS of Ukraine

    Kharkiv, 61039

  • Kherson City Clinical Hospital

    Kherson, 73000

  • Medical Center of Limited Liability Company "Medical Center "Consilium Medical"

    Kiev, 4050

  • Private Enterprise Private Manufacturing Company Acinus

    Kropyvnytskyi, 25006

  • Municipal Nonprofit Enterprise of Kyiv Region Council "Kyiv Regional Clinical Hospital"

    Kyiv, 04106

  • Medical Center Ok!Clinic+

    Kyiv, 2091

  • Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Center for Rehabilitation Medicine"

    Kyiv, 4078

  • Lviv Railway Clinical Hospital

    Lviv, 79000

  • Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T

    Lviv, 79000

  • Lviv Regional Clinical Hospital - Lviv National Medical University named Danylo Galician

    Lviv, 79010

  • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council

    Odesa, 65025

  • Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho

    Poltava, 36000

  • Transcarpathian Regional Hospital im.Andriya Novak

    Uzhhorod, 88000

  • City Clinical Hospital #1, Vinnitsya National Medical University

    Vinnytsia, 21000

  • Medical Clinical Investigational Center of Medical Center Health Clinic

    Vinnytsia, 21009

  • VNMU

    Vinnytsia, 21018

  • NOVA Hospital

    Zaporizhzhya, 69059

  • Diacenter

    Zaporizhzhya, 69076

Other trials in Ukraine

Russia19 sites

  • Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"

    Barnaul, 656038

  • Scientific Centre of Reconstructive and Restorative Surgery

    Irkutsk, 664079

  • Alliance Biomedical URAL Group

    Izhevsk, 426061

  • Kazan State Medical University

    Kazan', 420064

  • SIH Kemerovo Regional Clinical Hosptial

    Kemerovo, 620109

  • Nizhny Novgorod Regional Hospital N.A. Semashko

    Nizhny Novgorod, 603126

  • Medical Center SibNovoMed

    Novosibirsk, 630008

  • Research Institute of Physiology and Fundamental Medicine

    Novosibirsk, 630117

  • Ultramed

    Omsk, 644024

  • Karelia Republican Hospital V.A. Baranova

    Petrozavodsk, 620109

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • North-Western State Medical University named after I.I.Mechnikov

    Saint Petersburg, 191015

  • City Mariinskaya Hospital

    Saint Petersburg, 191104

  • Scientific research center ECO-security

    Saint Petersburg, 196143

  • First Pavlov State Medical University of Saint Petersburg

    Saint Petersburg, 197022

  • Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31

    Saint Petersburg, 197110

  • Stavropol State Medical University

    Stavropol, 355017

  • SHI of Yaroslavl Region Clinical Hospital #8

    Yaroslavl, 150030

  • LLC MA New Hospital

    Yekaterinburg, 620109

Other trials in Russia

France13 sites

  • CHU d'Amiens-Picardie - Hôpital Sud

    Amiens, 80054

  • CHRU Troussau

    Chambray-lès-Tours, 37170

  • Hopital Claude Huriez - CHU de Lille

    Lille, 59037

  • Chu Saint Eloi

    Montpellier, 34295

  • Centres Médico Chirurgicaux - Clinique Ambroise Paré

    Neuilly-sur-Seine, 92200

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

    Nice, 06202

  • Hôpital Saint-Louis

    Paris, 75010

  • Centre Hospitalier de Pau

    Pau, 64000

  • CHU Bordeaux Haut-Leveque

    Pessac, 33600

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

  • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord

    Saint-Priest-en-Jarez, 42270

  • Nouvel Hôpital Civil (NHC)

    Strasbourg, 67091

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

India12 sites

  • Apollo Hospitals Ahmedabad

    Ahmedabad, 382428

  • M S Ramaiah Medical College and Hospitals

    Bangalore, 560054

  • Owaisi Hospital and Research Center

    Hyderabad, 500058

  • SR Kalla Memorial Gastro & General Hospital

    Jaipur, 302006

  • Dayanand Medical College and Hospital

    Ludhiana, 141001

  • Midas Multispeciality Hospital Pvt.Ltd.

    Nagpur, 440010

  • Fortis Hospital

    Noida, 201301

  • Grant Medical Foundation - Ruby Hall Clinic

    Pune, 411001

  • Shree Giriraj Multispeciality Hospital

    Rajkot, 360005

  • Gandhi Hospital

    Secunderabad, 500003

  • Nirmal Hospital

    Surat, 395002

  • Acharya Vinoba Bhave Rural Hospital

    Wardha, 442004

Other trials in India

Canada9 sites

  • CISSS de la Monteregie-Centre

    Greenfield Park, J4V 2H1

  • Victoria Hospital

    London, N6A 4G5

  • University Hospital - London Health Sciences Centre

    London, N6A 5A5

  • CIUSSS de l'Est-de-l'Île-de-Montréal

    Montreal, H1T 2M4

  • Montreal General Hospital

    Montreal, H3G 1A4

  • Fraser Clinical Trials Inc

    New Westminster, V3L 3W4

  • Vancouver General Hospital

    Vancouver, V5Z 1M9

  • GIRI GI Research Institute - Vancouver

    Vancouver, V5Z 2K5

  • PerCuro Clinical Research

    Victoria, V8V 3M9

Other trials in Canada

Czechia9 sites

  • Vojenská Nemocnice Brno

    Brno, 636 00

  • Fakultni Nemocnice u sv. Anny v Brne

    Brno, 656 91

  • Hepato-Gastroenterologie HK

    Hradec Králové, 500 12

  • MUDr. Gregar, s.r.o.

    Olomouc, 779 00

  • PreventaMed

    Olomouc, 779 00

  • A-Shine

    Pilsen, 312 00

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

  • MEDIENDO

    Prague, 186 00

  • ISCARE klinicke centrum

    Prague

Other trials in Czechia

Italy9 sites

  • Azienda Ospedaliera Mater Domini

    Catanzaro, 88100

  • Ospedale San Martino

    Genova, 16132

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56124

  • Ospedale Di Circolo

    Rho, 20017

  • Fondazione Policlinico Tor Vergata

    Roma, 00133

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Ospedale Sandro Pertini

    Rome, 00157

  • Humanitas

    Rozzano, 20089

  • Ospedale Mauriziano

    Torino, 10128

Other trials in Italy

South Korea9 sites

  • Dong-A University Hospital

    Busan, 49201

  • The Catholic University of Korea, Daejeon St. Mary's Hospital

    Daejeon, 34943

  • Yeungnam Univeristy Medical Center

    Gyeongsan-si, 42415

  • Inje University Haeundae Paik Hospital

    Haeundae-gu, 48108

  • Kyung Hee University Hospital

    Seoul, 02447

  • Asan Medical Center

    Seoul, 05505

  • Kangbuk Samsung Hospital

    Seoul, 3181

  • Samsung Medical Center

    Seoul, 6351

  • Yonsei University-Wonju Severance Christian Hospital

    Wŏnju, 26426

Other trials in South Korea

Spain9 sites

  • Instituto de Ciencias Médicas

    Alicante, 3004

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, 28942

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, 17007

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de GC, 35019

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital de Sagunto y C.E.

    Sagunto, 46520

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

Other trials in Spain

Germany8 sites

  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin

    Berlin, 12203

  • Krankenhaus Waldfriede

    Berlin, 14163

  • Städtisches Klinikum Brandenburg

    Brandenburg, 14770

  • Studiengesellschaft BSF Unternehmergesellschaft

    Halle, 06108

  • Universitätsklinikum Halle

    Halle, 6120

  • HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen

    Hamburg, 20251

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Haus der Gesundheit

    Ludwigshafen, 67067

Other trials in Germany

Hungary8 sites

  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

    Békéscsaba, 5600

  • Semmelweis University

    Budapest, 1088

  • Eszak-budai Szent Janos Centrumkorhaz

    Budapest, 1125

  • Petz Aladar Egyetemi Oktato Korhaz

    Győr, 9024

  • Endomedix Diagnosztikai Központ - Miskolc

    Miskolc, 3526

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, 6725

  • CLINFAN Szolgáltató Kft

    Szekszárd, 7100

  • Jávorszky Ödön Kórház

    Vác, 2600

Other trials in Hungary

Australia7 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Box Hill Hospital

    Box Hill, 3128

  • Mater Misericordiae Limited

    Brisbane, 4101

  • Princess Alexandra Hospital

    Brisbane, 4102

  • Coastal Digestive Health

    Maroochydore, 4558

  • St Vincent's Hospital

    Melbourne, 3065

  • The Royal Melbourne Hospital

    Parkville, 3050

Other trials in Australia

Israel6 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • Shaare Zedek Medical Center

    Jerusalem, 9778419

  • Galilee Medical Center

    Nahariya, 2210001

  • Kaplan Medical Center

    Rehovot, 7610001

  • Sourasky Medical Center

    Tel Aviv, 6423906

  • Yitzhak Shamir Medical Center

    Tsrifin, 70300

Other trials in Israel

Serbia6 sites

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000

  • University Medical Center "Bezanijska kosa"

    Belgrade, 11080

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Regional Hospital Dr Radivoj Simonovic Sombor

    Sombor, 25000

  • Sremska Mitrovica Health Centre

    Sremska Mitrovica, 22000

  • General Hospital "Djordje Joanovic"

    Zrenjanin, 23000

Other trials in Serbia

Argentina5 sites

  • Mautalen Salud e Investigación

    Buenos Aires, C1128AAF

  • CER medical Institute

    Quilmes, 1879

  • Fundacion Estudios Clinicos

    Rosario, S2000DEG

  • Centro de Investigaciones Médicas Tucuman

    SAN M. de Tucuman, T4000AXL

  • C.I.C.E. 9 de Julio

    San Miguel de Tucumán, 4000

Other trials in Argentina

Lithuania5 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas

    Kaunas, 50161

  • Viesoji Istaiga Klaipedos Miesto Poliklinika

    Klaipėda, 93200

  • Republic Hospital of Klaipeda

    Klaipėda, LT-91251

  • Respublikine Panevezio ligonine

    Panevezys, LT-35144

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT-08661

Other trials in Lithuania

Romania5 sites

  • SC Memorial Healthcare International SRL

    Bucharest, 013823

  • Monza - Ares

    Bucharest, 021967

  • Spitalul Clinic Colentina

    Bucharest, 20125

  • CCBR Clinical Research

    Bucharest, 30463

  • Spitalul Pelican

    Oradea, 410469

Other trials in Romania

Slovakia5 sites

  • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica

    Banská Bystrica, 97517

  • Cliniq s.r.o.

    Bratislava, 81109

  • KM Management

    Nitra, 949 01

  • Gastro

    Prešov, 080 01

  • Endomed, s.r.o.

    Vranov N. Toplou, 093 01

Other trials in Slovakia

Netherlands4 sites

  • Amsterdam UMC, locatie VUmc

    Amsterdam, 1081 HZ

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg, 5022 GC

  • Ziekenhuis Bernhoven

    Uden, 5406 PT

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Switzerland4 sites

  • Inselspital Bern

    Bern, 3010

  • Gastroenterologische Praxis Balsiger, Seibold & Partner

    Bern, 3012

  • Cantonal Hospital St.Gallen

    Sankt Gallen, 9007

  • UniversitätsSpital Zürich

    Zurich, 8091

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Turkey (Türkiye)4 sites

  • Antalya Egitim ve Arastırma Hastanesi

    Antalya, 7100

  • Ege University Medicine of Faculty

    Bornova, 35100

  • Kocaeli Üniversitesi

    Kocaeli, 41380

  • Mersin University

    Mersin, 33110

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United Kingdom4 sites

  • Fairfield General Hospital

    Bury, BL9 7TD

  • Barts Health NHS Trust

    London, E1 1RD

  • Guy's & St Thomas' NHS Foundation Trust

    London, NW1 2PG

  • The John Radcliffe Hospital

    Oxford, OX3 9DU

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Austria3 sites

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020

  • Uniklinikum Salzburg

    Salzburg, 5020

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090

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Belgium3 sites

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier de Wallonie Picarde - Site Notre Dame

    Tournai, 7500

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Denmark3 sites

  • Herlev and Gentofte Hospital

    Copenhagen, 2730

  • Sjællands Universitetshospital Køge

    Køge, 4600

  • Sygehusenheden Nyborg

    Nyborg, 5800

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Latvia3 sites

  • Digestive Diseases Center "Gastro"

    Riga, 1079

  • Pauls Stradins Clinical Univeristy Hospital

    Riga, LV-1002

  • RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia

    Riga, LV1079

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Malaysia3 sites

  • Hospital Serdang

    Kuala Selangor, 43300

  • Hospital Universiti Sains Malaysia

    Kubang Kerian, 16150

  • University Malaya Medical Centre

    Lembah Pantai, 59100

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Mexico3 sites

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31207

  • Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

    Culiacán, 80230

  • Sociedad de Metabolismo y Corazon

    Veracruz, 91900

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Taiwan2 sites

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

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Georgia1 site

  • LLC ARENSIA Exploratory Medicine

    Tbilisi, 0112

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Ireland1 site

  • Beaumont Hospital, Dublin

    Dublin, D9

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Moldova1 site

  • Republican Clinical Hospital

    Chisinau, MD2025

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About this study

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

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

Being tested
Mirikizumab
Keywords
Inflammatory Bowel Disease
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirikizumabDrug

    Also called LY3074828

    Administered SC.

Study groups in NCT03519945
Study groupRoleWhat they receive
MirikizumabExperimentalMirikizumab administered subcutaneously (SC).
Receives: Drug: Mirikizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants in Clinical Remission

    Clinical remission based on the modified Mayo Score (MMS).

    Measured: Week 52

Secondary outcomes (7)

  1. Percentage of Participants in Endoscopic Remission

    Endoscopic remission based on the MMS Endoscopic Subscore (ES).

    Measured: Week 52

  2. Percentage of Participants in Corticosteroid-free Remission

    Participants in corticosteroid-free remission.

    Measured: Week 52

  3. Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52

    Endoscopic remission based on the MMS ES and histologic remission based on histologic disease activity index.

    Measured: Week 52

  4. Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score

    Health Related Quality of Life based on IBDQ score.

    Measured: Baseline to Week 52

  5. UC Symptoms: Numeric Rating Score

    UC symptoms based on numeric rating score.

    Measured: Week 160

  6. Percentage of Participants Who are Hospitalized Due to UC

    Participants who are hospitalized due to UC.

    Measured: Baseline to Week 160

  7. Percentage of Participants Who Undergo UC Surgeries Including Colectomy

    Participants who undergo UC surgeries including colectomy.

    Measured: Baseline to Week 160

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2018
  2. Study start18 Jul 2018
  3. Primary completion4 Mar 2026
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,058 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03519945
Sponsor's protocol ID
16596
Other IDs
I6T-MC-AMAP, 2017 004092 31, 2023-507657-15-00, 2023, 2017
Status last verified
Apr 2026
First submitted
7 May 2018
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Publications

  • Lee SD, Ehrlich AC, Pellanda P, Kaiser C, Todd K, Moses R, Walsh A. Long-Term Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis: An Integrated 2-Year Safety Analysis. Am J Gastroenterol. 2025 Dec 1;120(12):2857-2866. doi: 10.14309/ajg.0000000000003407. Epub 2025 Mar 12.

    PubMed 40071779

  • Sands BE, D'Haens G, Clemow DB, Irving PM, Johns JT, Gibble TH, Abreu MT, Lee SD, Hisamatsu T, Kobayashi T, Dubinsky MC, Vermeire S, Siegel CA, Peyrin-Biroulet L, Moses RE, Milata J, Panaccione R, Dignass A. Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study. Inflamm Bowel Dis. 2025 Jul 7;31(7):1876-1890. doi: 10.1093/ibd/izae253.

    PubMed 39448057

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirikizumab in people with Ulcerative Colitis, run by Eli Lilly and Company at 352 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 352 sites in United States, Japan, China, Poland, Ukraine and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants in Clinical Remission (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03519945, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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