AzTrials
AzTrials

Ulcerative ColitisPhase 3NCT03518086

An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

A Phase 3 study testing Mirikizumab in people with Ulcerative Colitis, run by Eli Lilly and Company at 502 sites in 35 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC. 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?
Yes, some participants may receive a placebo
How many people
1,281 participants
Where
502 sitesin 35 countries
Study dates
18 Jun 2018to 15 May 2024
Phase
Phase 3

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

  • Diagnosis of UC for at least 3 months prior to baseline.
  • Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
  • Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
  • If female, must meet the contraception requirements.

Who cannot join

  • Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).
  • Participants with a previous colectomy.
  • Participants with current evidence of toxic megacolon.
  • Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).

Trial locations and contacts

502 sites in 35 countries.

502 sites in 35 countries

United States98 sites

  • Valley Gastroenterology

    Arcadia, California, 91006

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • University of Colorado

    Aurora, Colorado, 80045

  • Texas Digestive Disease Consultants

    Baton Rouge, Louisiana, 70809

  • Care Access Research

    Berkeley, California, 94705

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Gastroenterology Consultants of Clearwater

    Clearwater, Florida, 33756

  • West Central Gastroenterology d/b/a Gastro Florida

    Clearwater, Florida, 33761

  • Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida, 33765

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Delta Waves Sleep Disorders and Research Center

    Colorado Springs, Colorado, 80918

  • Gastrointestinal Diseases Research

    Columbus, Georgia, 31904

  • Pioneer Clinical Research

    Coral Springs, Florida, 33067

  • Citrus Valley Health Partners

    Covina, California, 91722

  • META Medical Research Institute, LLC

    Dayton, Ohio, 45432

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555

  • Valley View Internal Medicine

    Garden Grove, California, 92843

  • Digestive Health Associates of Texas

    Garland, Texas, 75044

  • Gastro One

    Germantown, Tennessee, 38138

  • Northwell Health

    Great Neck, New York, 11021

  • Carolina Digestive Diseases and Endoscopy Center

    Greenville, North Carolina, 27834

  • Direct Helpers Medical Center

    Hialeah, Florida, 33012

  • Galen Medical Group

    Hixson, Tennessee, 37343

  • The Center for Gastrointestinal Disorders

    Hollywood, Florida, 33021

  • Houston Methodist Research Ins

    Houston, Texas, 77030

  • Biopharma Informatic, Inc.

    Houston, Texas, 77043

  • Grand Teton Research Group

    Idaho Falls, Idaho, 83404

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Nature Coast Clinical Research, LLC

    Inverness, Florida, 34452

  • Care Access Research LLC

    Jackson, Mississippi, 39206

  • SIH Research, LLC

    Kissimmee, Florida, 34741

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana, 70601

  • NYU Langone Long Island Clinical Research Associates

    Lake Success, New York, 11042

  • Om Research, LLC

    Lancaster, California, 93534

  • Emeritas Research Group

    Leesburg, Virginia, 20176

  • Ocean State Clinical Research Partners

    Lincoln, Rhode Island, 02865

  • Dcr-Pi, Pc

    Litchfield Park, Arizona, 85340

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Invocare Clinical Research Center

    Mauldin, South Carolina, 29662

  • Columbus Clinical Services, LLC

    Miami, Florida, 33125

  • Research Associates of South Florida, LLC

    Miami, Florida, 33134

  • IMIC, Inc.

    Miami, Florida, 33176

  • Inpatient Research Clinic, LLC

    Miami Lakes, Florida, 33014

  • Life Medical Center & Research, Inc

    Miami Lakes, Florida, 33014

  • Wellness Clinical Research

    Miami Lakes, Florida, 33016

  • Paramount Medical Research

    Middleburg Heights, Ohio, 44130

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Allegiance Research Specialists, LLC

    Milwaukee, Wisconsin, 53226

  • Trinity Health Center Medical Arts

    Minot, North Dakota, 58701

  • Delta Research Partners LLC

    Monroe, Louisiana, 71201

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Pharma Research International, Inc.

    Naples, Florida, 34110

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Tulane Univ School of Med

    New Orleans, Louisiana, 70112 2715

  • Nola Research Works, LLC

    New Orleans, Louisiana, 70125

  • Weill Cornell Medical College

    New York, New York, 10021

  • Central Sooner Research

    Norman, Oklahoma, 73071

  • California Medical Research Associates

    Northridge, California, 91324

  • Henry Ford Health System

    Novi, Michigan, 48377

  • Care Access Research LLC - Salt Lake City

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Center for Interventional Endoscopy

    Orlando, Florida, 32803

  • Clintheory Healthcare

    Orlando, Florida, 32818

  • Gastroenterology Associates

    Pasadena, California, 91105

  • Capital Health Medical Center Hopewell

    Pennington, New Jersey, 08534

  • Gastroenterology Associates of Pensacola, PA

    Pensacola, Florida, 32503

  • Maricopa Integrated Health System

    Phoenix, Arizona, 85008

  • MNGI Digestive Health - Plymouth Endoscopy Center & Clinic

    Plymouth, Minnesota, 55446

  • Care Access Research - Youngstown

    Poland, Ohio, 44514

  • The Gastroenterology Group, P.C.

    Reston, Virginia, 20191

  • Carilion Clinic

    Roanoke, Virginia, 24016

  • 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, LLC

    San Antonio, Texas, 78229

  • Bandera Family Health Care

    San Antonio, Texas, 78249

  • Clinical Applications Laboratories, Inc.

    San Diego, California, 92103

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158

  • University of Washington Medical Center

    Seattle, Washington, 98195-6424

  • Midwest Medical Care

    Sioux Falls, South Dakota, 57108

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092

  • Washington University Medical School

    St Louis, Missouri, 63110

  • Florida Digestive Specialist

    St. Petersburg, Florida, 33709

  • Atlanta Gastroenterology Specialists, PC

    Suwanee, Georgia, 30024

  • Physicians Research Group

    Tempe, Arizona, 85284

  • Cotton-O'Neil Clinical Research Center, Digestive Health

    Topeka, Kansas, 66606

  • Digestive Health Specialists

    Tupelo, Mississippi, 38801

  • GI and Liver Research, LLC

    Webster, Texas, 77598

  • Invocare Clinical Research Center

    West Columbia, South Carolina, 29169

  • Great Lakes Medical Research, LLC

    Westlake, Ohio, 44145

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157-1045

  • Gastroenterology Associates of Western Michigan, P.L.C.

    Wyoming, Michigan, 49519

  • Digestive Disease Associates

    Wyomissing, Pennsylvania, 19610

  • Huron Gastroenterology Associates

    Ypsilanti, Michigan, 48197

  • Yuma Gastro LLC

    Yuma, Arizona, 85364

  • Florida Medical Clinic LLC

    Zephyrhills, Florida, 33542-7505

Other trials in United States

Japan52 sites

  • Asahikawa City Hospital

    Asahikawa, Hokkaido, 070-8610

  • Tokyo Medical And Dental University Medical Hospital

    Bunkyō, Tokyo, 113-8519

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka, 818 8502

  • Mitsui Memorial Hospital

    Chiyoda-ku, Tokyo-To, 101-8643

  • Sai Gastroenterology, proctology

    Fujiidera, Osaka, 583-0027

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Matsuda Hospital

    Hamamatsu, Shizuoka, 4328061

  • National Hospital Organization Hirosaki National Hospital

    Hirosaki, Aomori, 036-8545

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • NHO Mito Medical Center

    Ibaraki-machi, HigaShiibaraki-Gun, 311 3193

  • Sameshima Hospital

    Kagoshima, 892-0846

  • Ofuna Central Hospital

    Kamakura, Kanagawa, 247-0056

  • Kawasaki Municipal Hospital

    Kawasaki, Kanagawa, 210-0013

  • Kitakyushu Municipal Medical Center

    Kitakyusyu-shi, Fukoka, 802-0077

  • Aoyama Clinic GI Endoscopy & IBD Center

    Kobe, Hyōgo, 650 0015

  • Showa University Koto Toyosu Hospital

    Koto-ku, Tokyo, 135 8577

  • Kumagaya General Hospital

    Kumagaya-shi, Saitama, 360-8567

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-0012

  • Yukinoseibokai St. Mary's Hospital

    Kurume-shi, Fukuoka, 830 8543

  • Hidaka Coloproctology Clinic

    Kurume-shi, Fukuoka, 839 0809

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-8555

  • Gunma University Hosptial

    Maebashi, Gunma, 371-8511

  • Kitasato University Kitasato Institute Hospital

    Minato-Ku, Tokyo, 108 8642

  • Kyorin University Hospital

    Mitaka, Tokyo, 181-8611

  • Aichi Medical University Hospital

    Nagakute-shi, Aichi-ken, 480-1195

  • Nagaoka Chuo General Hospital

    Nagaoka-shi, Niigata, 940-8653

  • Ishida Clinic of IBD and Gastroenterology

    Ōita, Oita Prefecture, 870 0823

  • Okayama University Hospital

    Okayama, 700-8558

  • NHO Osaka National Hospital

    Osaka, Osaka, 540 0006

  • Infusion Clinic

    Osaka, 530-0011

  • Saga-Ken Medical Center Koseikan

    Saga, Saga-ken, 840-8571

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375

  • Tokitokai Tokito Clinic

    Saitama, 336 0963

  • Toho University Sakura Medical Center

    Sakura, Chiba, 285-8741

  • Tokushukai Sapporo Tokushukai Hospital

    Sapporo, Hokkaido, 004 0041

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

    Sapporo, Hokkaido, 060 0033

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido, 065-0033

  • Takagi Clinic - Sendai

    Sendai, Miyagi, 981 3213

  • Jichi Medical University Hospital

    Shimotsuke-shi, Tochigi, 329-0498

  • JHCO Tokyo Yamate Medical Center

    Shinjuku-ku, Tokyo, 169-0073

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

    Shinjuku-ku, Tokyo-To, 162 8655

  • Osaka University Hospital

    Suita, Osaka, 565-0871

  • Takamatsu Red Cross Hospital

    Takamatsu, Kagawa-ken, 760-0017

  • Kagawa Prefectural Central Hospital

    Takamatsu, Kagawa-ken, 760-8557

  • National Hospital Organization Takasaki General Medical Centar

    Takasaki, Gunma, 370-0829

  • Toyama Prefectural Central Hospital

    Toyama, 930-8550

  • Fujita Health University

    Toyoake, Aichi-ken, 470-1192

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • Sankikai Yokohama Shin midori General Hospital

    Yokohama, Kanagawa, 226 0025

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • Showa University Northern Yokohama Hospital

    Yokohama, Kanagawa, 234-0032

Other trials in Japan

China44 sites

  • Beijing Friendship Hospital

    Beijing, Beijing Municipality, 100050

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu, 213003

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

  • The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA

    Chongqing, Chongqing Municipality, 400037

  • The First Hospital Affiliated to AMU (Southwest Hospital)

    Chongqing, Chongqing Municipality, 400038

  • The Second Hospital of Dalian Medical University

    Dalian, Lianing, 116000

  • The First Affiliated Hospital Of Fujian Medical University

    Fujian, Fuzhou, 350005

  • Fujian Province Hospital

    Fuzhou, Fujian, 350001

  • The Sixth Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510655

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • The Second Affiliated Hospital of Zhejiang University School of Med

    Hangzhou, Zhejiang, 310000

  • First Affiliated Hosp of College of Med, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310016

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

  • The First Affiliated Hospital of Anhui Medical University

    HefeiCity, Anhui, 230022

  • Jilin Central General Hospital

    Jilin City, Jilin, 132011

  • Shandong Provincial Hospital

    Jinan, Shandong, 250001

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250014

  • Xiangya Hospital Central South University

    Kaifu District, Changsha City, 410008

  • Kunming Medical College Affiliated First Hospital

    Kunming, Yunnan, 650032

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan, 650034

  • Liaocheng People's hospital

    Liaocheng, Shandong, 252000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, Jiangsu, 210008

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, Jiangsu, 210029

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210029

  • Nanjing Medical University - Nanjing Jiangning Hospital

    Nanjing, Jiangsu, 211106

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337055

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • Shanghai Jiaotong University School of Medicine Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

  • Renji Hospital Affliated to Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200127

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110022

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong, 518053

  • Taian City Central Hospital

    Taian, Shandong, 271000

  • No.1 Hospital Affiliated to Xinjiang Medical University

    Ürümqi, Urumchi, 830054

  • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university

    Wenzhou, Zhejiang, 325027

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Tongji Hospital of Tongji University

    Wuhan, 430030

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450014

  • ZhuZhou Central Hospital

    Zhuzhou, Hunan, 412007

Other trials in China

Russia30 sites

  • Multidisciplinary Medical Clinic "Anthurium"

    Barnaul, 656043

  • Medical and Sanitary Division of Severstal

    Cherepovets, 162600

  • Scientific Centre of Reconstructive and Restorative Surgery

    Irkutsk, Irkutsk Oblast, 664079

  • Alliance Biomedical URAL Group

    Izhevsk, 426061

  • Clinical Trials Center of Medical Institute

    Kaliningrad, 236035

  • State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan"

    Kazan', 420064

  • SIH Kemerovo Regional Clinical Hosptial

    Kemerovo, 650066

  • SBHI Regional Clinical Hospital #2 MoH of Krasnodar region

    Krasnodar, 350000

  • Medical rehabilitation center

    Moscow, 125367

  • Nizhny Novgorod Regional Hospital N.A. Semashko

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603126

  • Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603140

  • Novosibirsk GastroCenter

    Novosibirsk, Novosibirsk Oblast, 630007

  • LLC "Medicine Center SibNovoMed"

    Novosibirsk, 630005

  • Clinical Diagnostic Center Ultramed

    Omsk, 644024

  • Karelia Republican Hospital V.A. Baranova

    Petrozavodsk, Kareliya, Respublika, 185019

  • Rostov State Medical University

    Rostov-on-Don, Rostov Oblast, 344091

  • Scientific research center ECO-security

    Saint Petersburg, Sankt-Peterburg, 196143

  • City Mariinskaya Hospital

    Saint Petersburg, 191104

  • Pokrovskaya Municipal Hospital

    Saint Petersburg, 195067

  • Saint-Petersburg City Hospital of Saint Elizabeth

    Saint Petersburg, 195257

  • Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways"

    Saint Petersburg, 195271

  • Saint Petersburg State Medical University n.a. Pavlov I.P.

    Saint Petersburg, 197022

  • LLC Gastroenterology Centre Expert

    Saint Petersburg, 197110

  • SBIH City Clinical Hospital #31

    Saint Petersburg, 197110

  • OOO "OrKli"

    Saint Petersburg, 199147

  • Medical Institute REAVIZ

    Samara, 443001

  • Stavropol State Medical Academy

    Stavropol, 355018

  • SBI of Healthcare of Leningrad region "Clinical Interregional Hospital of Tosno

    Tosno, 187000

  • Yaroslavl Municipal HI Clinical Hospital #8

    Yaroslavl, 150030

  • LLC MA New Hospital

    Yekaterinburg, 620109

Other trials in Russia

Poland24 sites

  • Promedica Dental Clinic

    Będzin, 42-500

  • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • All-Medicus

    Katowice, 40-660

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Knurów, 44-190

  • Topolowa Medicenter

    Krakow, Lesser Poland Voivodeship, 31-506

  • ZOZ Gastromed

    Lublin, Lublin Voivodeship, 20-582

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, Lublin Voivodeship, 20-954

  • Medicenter Nowy Targ

    Nowy Targ, Lesser Poland Voivodeship, 34-400

  • Wojewodzki Specjalistyczny Szpital w Olsztynie

    Olsztyn, 10-561

  • Endoskopia sp z o. o

    Sopot, Pomeranian Voivodeship, 81-756

  • KO-Med Centrum Medyczne

    Staszów, Świętokrzyskie Voivodeship, 28-200

  • SONOMED Centrum Medyczne

    Szczecin, West Pomeranian Voivodeship, 71-685

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii

    Torun, 87-100

  • Nzoz Formed

    Wadowice, Lesser Poland Voivodeship, 34-100

  • NZOZ Vivamed

    Warsaw, Masovian Voivodeship, 03-580

  • Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

  • Centrum Zdrowia MDM

    Warsaw, 00635

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-697

  • Centralny Szpital Kliniczny MSWiA

    Warsaw, 02-507

  • LexMedica

    Wroclaw, Lower Silesian Voivodeship, 53-114

  • PlanetMed Sp.z o.o.

    Wroclaw, 52-210

  • ETG Zamosc

    Zamość, 22-400

Other trials in Poland

Ukraine24 sites

  • Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine

    Dnipro, 49038

  • Ivano-Frankivsk Regional Clinical Hospital

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008

  • City Clinical Hospital #2

    Kharkiv, Kharkiv Oblast, 61037

  • Kharkiv City Student Hospital

    Kharkiv, 61002

  • GI L.T. Malaya TI Namsu

    Kharkiv, 61039

  • Kherson City Clinical Hospital

    Kherson, Kherson Oblast, 73000

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

    Kiev, Kyiv Oblast, 04050

  • Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus

    Kropyvnytskyi, 25006

  • Kyiv Municipal Clinical Hospital #1

    Kyiv, 02091

  • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"

    Kyiv, 04078

  • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"

    Kyiv, 04107

  • Lviv Railway Clinical Hospital

    Lviv, Lviv Oblast, 79000

  • Lviv Regional Endocrinology Dispensary

    Lviv, Lviv Oblast, 79000

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

    Lviv, Lviv Oblast, 79000

  • Communal Enterprise "Odesa Regional Clinical Hospital"

    Odesa, 65000

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

    Poltava, Poltava Oblast, 36000

  • A. Novak Transcarpathian Regional Clinical Hospital

    Uzhhorod, 88000

  • Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU

    Vinnytsia, 21005

  • MCIC MC LLC Health Clinic

    Vinnytsia, 21009

  • M.I. Pyrogov Regional Clinical Hospital

    Vinnytsia, 21018

  • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

    Vinnytsia, 21029

  • Private Small Enterprise, Medical Center Pulse

    Vinnytsia, 21029

  • Diaservis - Medical and Diagnostic Center

    Zaporizhzhya, Zaporizhzhia Oblast, 69076

  • Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2

    Zaporizhzhya, 69104

Other trials in Ukraine

India22 sites

  • Bangalore Medical College and Research Institute

    Bangalore, Karnataka, 560 002

  • M S Ramaiah Medical College Hospital

    Bangalore, Karnataka, 560054

  • Apollo Research and Innovations, Apollo Hospitals International Ltd

    Gandhinagar, Gujarat, 382428

  • Institute of Digestive and Liver Diseases

    Guwahati, Assam, 781 006

  • Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre

    Hyderabad, Andhra Pradesh, 500058

  • Asian Institute of Gastroenterology

    Hyderabad, Telangana, 500032

  • SR Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302001

  • SSKM Post Graduate Hospital

    Kolkata, West Bengal, 700020

  • Nil Ratan Sircar Medical College

    Kolkata, West Bengal, 700073

  • King George Medical University

    Lucknow, Uttar Pradesh, 226003

  • Dayanand Medical College and Hospital

    Ludhiana, Punjab, 141001

  • Lokmanya Hospital

    Mumbai, Maharashtra, 400022

  • Midas Multispecilaity Hopsital Pvt Ltd

    Nagpur, Maharashtra, 440010

  • Escorts Heart Institute and Research Centre Ltd

    New Delhi, National Capital Territory of Delhi, 110 025

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

  • Fortis Hospital

    Noida, Uttar Pradesh, 201301

  • Poona Medical Foundation. Ruby Hall Clinic

    Pune, Maharashtra, 411 001

  • K E M Hospital and Research Centre

    Pune, Maharashtra, 411011

  • Shree Giriraj Multispeciality Hospital

    Rajkot, Gujarat, 360005

  • Nirmal Hospital

    Surat, Gujarat, 395002

  • Gandhi Hospital

    Telangana, 500003

  • Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital

    Wardha, Maharashtra, 442004

Other trials in India

France16 sites

  • CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro

    Amiens, Somme, 80480

  • CHU Tours - Hôpital Trousseau

    Chambray-lès-Tours, 37170

  • Hopital Beaujon

    Clichy, Paris, 92110

  • CHU Lille - Hôpital Claude Huriez

    Lille, Nord, 59037

  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord

    Marseille, 13915

  • Hopital Saint Eloi

    Montpellier, 34295

  • Hopital L'Archet 2

    Nice, 06200

  • Hopital Saint-Louis

    Paris, Cedex 10, 75475

  • Centre Hospitalier de Pau

    Pau, Pyrénées-Atlantiques, 64046

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33604

  • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -

    Pierre-Bénite, Rhone, 69495

  • CHU de Poitiers- Service d'Hépato-gastro-entérologie,

    Poitiers, 86021

  • Robert Debre Hospital

    Reims, 51092

  • CHU de Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • Hopital de Hautepierre - Service d'Hépatogastroentérolgie

    Strasbourg, Bas Rhin, 67098

  • CHRU Nancy Brabois - Hôpital d'Enfants

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Italy16 sites

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia, 25123

  • Azienda ospedaliero-universitaria Mater Domini

    Catanzaro, 88100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • Azienda Ospedaliero Universitaria San Martino

    Genova, 16132

  • Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation

    Milan, 20122

  • Azienda Ospedaliera Universitaria Policlinico de Modena

    Modena, 41124

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56124

  • Presidio di Rho

    Rho, Milano, 20017

  • Policlinico Gemelli - Università Cattolica del Sacro Cuore

    Roma, 00168

  • Ospedale Sandro Pertini

    Rome, Roma, 00157

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona Medicina Interna

    Salerno, 84131

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese (MI), San Donato Milanese (MI), 20097

  • Ospedale Mauriziano Umberto I

    Torino, 10128

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Torre, Roma, 00133

  • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia

    Udine, 33100

Other trials in Italy

Spain14 sites

  • Complexo Hospitalario Universitario A Coruña, CHUAC

    A Coruña, 15006

  • Instituto de Ciencias Médicas

    Alicante, 03004

  • Hospital Universitario Reina Sofia Comite Etico

    Córdoba, 14004

  • Hospital De Fuenlabrada

    Fuenlabrada, Madrid, 28942

  • Hospital Universitari de Girona

    Girona, 17007

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005

  • Hospital De Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, 35010

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 3306

  • Hospital Universitari Son Espases

    Palma de Mallorca, Baleares Islands, 07120

  • Complejo Hospitalario De Navarra

    Pamplona, Navarre, 31008

  • Hospital de Sagunto y C.E.

    Sagunto, Valencia, 46520

  • Hospital Universitario Marques De Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen Del Rocio

    Seville, Andalusia, 41013

Other trials in Spain

Germany11 sites

  • Charité Campus Virchow-Klinikum

    Berlin, 12203

  • Krankenhaus Waldfriede

    Berlin, 14163

  • Staedisches Klinikum Brandenburg

    Brandenburg, 14770

  • Studiengesellschaft BSF Unternehmergesellschaft

    Halle, Saxony-Anhalt, 06108

  • Universitätsklinikum Halle

    Halle, Saxony-Anhalt, 06120

  • HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen

    Hamburg, 20251

  • Medizinische Hochschule Hanover

    Hanover, Lower Saxony, 30625

  • Haus der Gesundheit

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67067

  • Gastro Campus Research GbR

    Münster, North Rhine-Westphalia, 48159

  • Praxiszentrum Alte Maelzerei

    Regensburg, 93053

  • Internistische Praxisgemeinschaft

    Weyhe, 28844

Other trials in Germany

South Korea11 sites

  • Dong-A University Hospital

    Busan, Pusan-Kwangyǒkshi, 49201

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Kyungpook National University Medical Center Chilgok Hospital

    Daegu, 41404

  • Yeungnam Univeristy Medical Center

    Daegu, 42415

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

    Daejeon, Taejǒn-Kwangyǒkshi, 34943

  • Kyung Hee University Hospital

    Seoul, Korea, 02447

  • Asan Medical Center

    Seoul, Korea, 05505

  • Kangbuk Samsung Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 03181

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 06351

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

    Suwon, Gyeonggi-do, 16247

  • Severance Hospital, Yonsei University Health System

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Australia10 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Box Hill Hospital Outpatients

    Box Hill, Victoria, 3128

  • Princess Alexandra Hospital

    Harlow, Essex, CM20 1QX

  • Melbourne Gastrointestinal Investigation Unit (MGIU)

    Malvern, Victoria, 3144

  • Coastal Digestive Health

    Maroochydore, Queensland, 4558

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Northern Hospital

    Melbourne, Victoria, 3076

  • John Hunter Hospital

    Newcastle, New South Wales, 2305

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Mater University Hospital

    South Brisbane, Queensland, 4101

Other trials in Australia

Czechia10 sites

  • Vojenska nemocnice Brno

    Brno, Brno-město, 636 00

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 65691

  • Hepato-gastroenterologie HK

    Hradec Králové, Hradec Králové, 50012

  • MUDr. Gregar, s.r.o.

    Olomouc, Olomouc Region, 779 00

  • PreventaMed, s.r.o.

    Olomouc, 779

  • A-Shine

    Pilsen, Plzeň-město, 301 00

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Hl. M. Praha, 100 34

  • Klinika ResTrial

    Prague, Modrany, 14300

  • Mediendo

    Prague, Praha 8, 18600

  • ISCARE Clinical Centre

    Prague, 19000

Other trials in Czechia

Canada9 sites

  • Gastroenterology and internal medicine research institute

    Edmonton, Alberta, T5R 1W2

  • Centre de santé et de services sociaux Champlain-Charles-Le Moyne

    Greenfield Park, Quebec, J4V 2H1

  • Victoria Hospital

    London, Ontario, N6A 4G5

  • University of Western Ontario

    London, Ontario, N6A 5G1

  • Hopital Maisonneure-Rosemount

    Montreal, Quebec, H1T 2M4

  • Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC

    Montreal, Quebec, H3G 1A4

  • The Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia, V5Z 1M9

  • GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • PerCuro Clinical Research

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

Hungary9 sites

  • DRC Gyogyszervizsgalo Kozpont Kft.

    Balatonfüred, EU, 8230

  • Óbudai Egészségügyi Centrum

    Budapest, 1036

  • Semmelweis Egyetem

    Budapest, 1088

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Endomedix Diagnosztikai Központ - Miskolc

    Miskolc, 3526

  • Karolina Korhaz-Rendelointezet

    Mosonmagyaróvár, 9200

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika

    Szeged, 6720

  • Clinfan Szolgaltato Kft.

    Szekszárd, 7100

  • Jávorszky Ödön Kórház

    Vác, Pest County, 2600

Other trials in Hungary

Serbia9 sites

  • University Medical Center "Bezanijska kosa"

    Belgrade, NAP, 11080

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000

  • Clinical Center Kragujevac Gastroenterohepatology Clinic

    Kragujevac, 34000

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Regional Hospital Dr Radivoj Simonovic Sombor

    Sombor, Vojvodina, 25000

  • Sremska Mitrovica Health Centre

    Sremska Mitrovica, Vojvodina, 22000

  • General Hospital Uzice

    Užice, 31000

  • Zemun Medical Centre

    Zemun, Beograd, 11080

  • General Hospital "Djordje Joanovic"

    Zrenjanin, Vojvodina, 23000

Other trials in Serbia

United Kingdom9 sites

  • Fairfield General Hospital

    Bury, Great Britain, BL9 7TD

  • Ninewells Hospital

    Dundee, Scotland, DD1 9SY

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • St Thomas' Hospital

    Great Maze Pond, London, SE1 9RT

  • St James's University Hospital

    Leeds, Vinnytsia, LS9 7TF

  • Whipps Cross University Hospital

    London, Surrey, E11 1NR

  • Queens Hospital

    Romford, Essex, RM7 0AG

  • Morriston Hospital

    Swansea, Swansea [Abertawe Gb-ata], SA6 6SG

  • Royal Hampshire County Hospital

    Winchester, Hants, SO22 5DG

Other trials in United Kingdom

Argentina8 sites

  • Centro de Investigaciones Metabólicas (CINME)

    CABA, Buenos Aires, C1027AAP

  • Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

    Ciudad Autonoma de Buenos Air, Buenos Aires, C1128AAF

  • Hospital Privado Centro Medico de Cordoba SA

    Córdoba, X5016KEH

  • CER Instituto Medico

    Quilmes, Buenos Aires, B1878DVC

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, Buenos Aires, B1878GEG

  • Fundación de Estudios Clínicos

    Rosario, Santa Fe Province, S2000DEJ

  • Centro de Investigaciones Médicas Tucuman

    SAN M. de Tucuman, Tucumán Province, T4000AXL

  • C.I.C.E. 9 de Julio

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Israel8 sites

  • Shaare Zedek Medical Center

    Bait Vagan, Jerusalem, 91031

  • Soroka Medical Center - Pediatric Outpatient Clinic

    Beersheba, 8410101

  • Meir Medical Center

    Kfar Saba, Central District, 4428164

  • Galilee Medical Center Department of Internal Medicine A

    Nahariya, 2210001

  • Chaim Sheba Medical Center

    Ramat Gan, 5262100

  • Kaplan Medical Center

    Rehovot, 7610001

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • King Fahad Medical City

    Ẕerifin, 70300

Other trials in Israel

Mexico7 sites

  • Scientia Investigacion Clinica S.C.

    Chihuahua City, 31203

  • Centro Para el Desarrollo de la Medicina y de Asistencia Med S.C

    Culiacán, Sinaloa, 80230

  • Clinicos Asociados BOCM, S.C.

    Mexico City, Mexico City, 03300

  • Centro de Investigación Clínica Acelerada

    Mexico City, Mexico City, 07020

  • Clinical Research Institute S C

    Tlalnepantla, Edo de Mex, 54055

  • Sociedad de Metabolismo y Corazon

    Veracruz, 91900

  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

    Zapopan, Jalisco, 45030

Other trials in Mexico

Romania7 sites

  • CCBR Clinical Research

    Bucharest, Bucharest, 030463

  • MedLife Grivita

    Bucharest, 010719

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Hifu Terramed Conformal SRL

    Bucharest, 031864

  • Centrul Medical Unirea SRL

    Bucharest, 040055

  • Spital Pelican Oradea

    Oradea, 410469

Other trials in Romania

Slovakia7 sites

  • Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica

    Banská Bystrica, 975 17

  • Alian, s.r.o.

    Bardejov, Slovak Republic, 08501

  • Univerzitna nemocnica Bratislava-Nemocnica Stare Mesteo

    Bratislava, 813 69

  • Univerzitna nemocnica Bratislava

    Bratislava, 82007

  • KM Management

    Nitra, Nitra Region, 94901

  • Gastro

    Prešov, Presov, 08001

  • Endomed, s.r.o.

    Vranov N. Toplou, Presov, 09301

Other trials in Slovakia

Turkey (Türkiye)7 sites

  • Gazi University Faculty of Medicine

    Beşevler, Ankara, 65600

  • Ege Universitesi Hastanesi

    Izmir, 35100

  • Kocaeli University Medical Faculty Hospital

    İzmit, Kocaeli, 41380

  • Acibadem Universitesi - Acibadem Kozyatagi Hastanesi

    Kadıköy, Istanbul, 34734

  • Antalya Egitim ve Arastırma Hastanesi

    Kocaeli, Antayla, 7100

  • Hacettepe University Faculty of Medicine

    Sihhiye, Ankara, 6100

  • Mersin University Medical Faculty

    Yenişehir, Mersin, 33110

Other trials in Turkey (Türkiye)

Belgium5 sites

  • AZ Klina

    Brasschaat, 2930

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen, 9000

  • AZ Groeninge

    Kortrijk, 8500

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier de Wallonie Picarde - Site Notre Dame

    Tournai, Wallonne, Région, 7500

Other trials in Belgium

Lithuania5 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas

    Kaunas, 50009

  • Republic Hospital of Klaipeda

    Klaipėda, 92231

  • Klaipeda Seamen's Hospital

    Klaipėda, 92288

  • Respublikine Panevezio Ligonine

    Panevezys, Panevėžys, LT-35144

  • Vilnius University Hospital Santariskiu Clinics

    Vilnius, LT-08661

Other trials in Lithuania

Malaysia5 sites

  • Hospital Sultanah Bahiyah

    Alor Star, Kedah, 05460

  • Hospital Ampang

    Ampang, Selangor, 68000

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10450

  • Universiti Sains Malaysia

    Kubang Kerian, Kelantan, 16150

  • University Malaya Medical Centre

    Lembah Pantai, Kuala Lumpur, 59100

Other trials in Malaysia

Austria4 sites

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

  • Universitätsklinikum Salzburg

    Salzburg, 5020

  • Krankenhaus der Barmherzigen Schwestern Wien

    Vienna, State of Vienna, 1060

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Netherlands4 sites

  • Amsterdam UMC, locatie AMC

    Amsterdam, North Holland, 1105 AZ

  • St Elisabeth Ziekenhuis

    Tilburg, North Brabant, 5022 GC

  • Bernhoven Ziekenhuis

    Uden, 5406 PT

  • UMC Utrecht, Dept. of Internal Medicine, MDL

    Utrecht, 3584 CX

Other trials in Netherlands

Switzerland4 sites

  • Inselspital Bern

    Bern, 3010

  • Gastroenterologische Praxis Balsiger, Seibold & Partner

    Bern, 3012

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

Croatia3 sites

  • University Hospital Center Osijek

    Osijek, 31000

  • CHC Zagreb

    Zagreb, 10000

  • Polyclinic Bonifarm

    Zagreb, 10000

Other trials in Croatia

Denmark3 sites

  • Sydvestjysk Sygehus Esbjerg

    Esbjerg, 6700

  • Herlev and Gentofte Hospital

    Herlev, 2730

  • Zealand University Hospital Køge

    Køge, 4600

Other trials in Denmark

Latvia3 sites

  • Pauls Stradins Clinical Univeristy Hospital

    Riga, Riga, LV-1002

  • Digestive Diseases Center "Gastro"

    Riga, 1079

  • Riga Eastern Clinical University Hospital

    Riga, LV-1038

Other trials in Latvia

Taiwan3 sites

  • Changhua Christian Hospital

    Changhua, 500

  • China Medical University Hospital

    Taichung, 40447

  • Health management center

    Taipei, 10002

Other trials in Taiwan

Ireland1 site

  • Beaumont Hospital, Dublin

    Dublin, D9

Other trials in Ireland

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Being tested
Mirikizumab, Placebo
Keywords
Interleukin-23 (IL-23) antibody, IL-23p19
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • MirikizumabDrug

    Also called LY3074828

    Administered IV

  • PlaceboDrug

    Administered IV

Study groups in NCT03518086
Study groupRoleWhat they receive
Placebo Intravenous (IV) Every 4 Weeks (Q4W)Placebo comparatorPlacebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Receives: Drug: Placebo
300 Milligram (mg) Mirikizumab IV Q4WExperimental300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Receives: Drug: Mirikizumab
Placebo IV Q4W Maximum Extended Enrollment (ME2)Placebo comparatorPlacebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Receives: Drug: Placebo
300 mg Mirikizumab IV Q4W ME2Experimental300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Receives: Drug: Mirikizumab

What is being measured

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

  1. Percentage of Participants With Clinical Remission at Week 12

    Clinical remission at week 12 is defined as achieving a modified Mayo score (MMS) subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability), excluding consideration of Physician's Global Assessment (PGA).

    Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).

    The confidence interval of 99.88% was chosen to match the significance level.

    Measured: Week 12

Secondary outcomes (10)

  1. Percentage of Participants With Clinical Response at Week 12

    Clinical response at week 12 is defined as a decrease in the 9-point modified Mayo score (MMS) [rectal bleeding, stool frequency and the endoscopic findings] inclusive of >= 2 points and >=30% from baseline with either a decrease of rectal bleeding subscore of >=1 or rectal bleeding subscore of 0 or 1.The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration).The MMS ranges from 0 to 9 points,with higher scores representing more severe disease. The confidence interval of 99.88% was chosen to match the significance level.

    Measured: Week 12

  2. Percentage of Participants With Endoscopic Remission at Week 12

    Endoscopic remission at week 12 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 12. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration);

    The Mayo endoscopic score ranges from 0 to 3 points, with higher scores representing more severe disease.

    The confidence interval of 99.88% was chosen to match the significance level.

    Measured: Week 12

  3. Percentage of Participants With Symptomatic Remission at Week 12

    Symptomatic remission at week 12 is defined as a Mayo subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline.

    Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal).

    Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed).

    The confidence interval of 99.88% was chosen to match the significance level.

    Measured: Week 12

  4. Percentage of Participants With Symptomatic Response at Week 12

    Symptomatic response at week 12 is defined as ≥30% decrease from baseline in the sum of stool frequency and rectal bleeding subscores.

    Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal).

    Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed). The sum of stool frequency and rectal bleeding subscores ranges from 0 to 6.

    Measured: Week 12

  5. Percentage of Participants With Histologic Remission at Week 12

    Histologic remission was assessed using the Geboes histologic scoring system developed for assessment of histologic disease activity in ulcerative colitis. Remission was defined as Geboes histological subscore of 0 for grades: 2b (lamina propria neutrophils), and 3 (neutrophils in epithelium), and 4 (crypt destruction), and 5 (erosion or ulceration).

    Measured: Week 12

  6. Percentage of Participants With Endoscopic Response at Week 12

    Endoscopic response at week 12 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.

    The Mayo endoscopic subscore ranges from 0 to 3 points, with higher scores representing more severe disease.

    Measured: Week 12

  7. Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)

    The Urgency NRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency).Higher scores indicate more severe urgency. Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes: treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other).

    Measured: Baseline, Week 12

  8. Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score

    The IBDQ is a 32-item participant-completed questionnaire that measures 4 aspects of subjects' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function (Guyatt et al. 1989). 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." Scores range from 32 to 224; a higher score indicates a better quality of life. Least square (LS) Mean was calculated using analysis of covariance (ANCOVA) model for post-baseline measures: The ANCOVA model includes: treatment, baseline value, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other).

    Measured: Baseline, Week 12

  9. Change From Baseline to Week 12 in Fecal Calprotectin

    Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes: treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other).

    Measured: Baseline, Week 12

  10. Pharmacokinetics (PK): Clearance of Mirikizumab

    Clearance of mirikizumab was evaluated. Clearance is estimated based on concentration data collected in the time frame of 0-12 weeks.

    Measured: Predose on week 0, week 4, week 8 and post dose on week 0, 4 and 12

Timeline

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

  1. First posted8 May 2018
  2. Study start18 Jun 2018
  3. Primary completion21 Jan 2021
  4. Study completion15 May 2024

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03518086
Sponsor's protocol ID
16591
Other IDs
I6T-MC-AMAN, 2017-003229-14, 2017
Status last verified
May 2025
First submitted
4 May 2018
Last updated
31 May 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Ran Z, Chen Y, Miao Y, Wang Y, Gao X, Zhong J, Ding X, Wang C, Zhang X, Ding Y, Hu N, Tang D, Yu J, Qian C, Shen J. Mirikizumab as Induction and Maintenance Therapy in Chinese Patients with Ulcerative Colitis: A Subpopulation Analysis of the Randomized, Global Phase 3 LUCENT-1 and LUCENT-2 Trials. BioDrugs. 2026 Jul;40(4):733-745. doi: 10.1007/s40259-026-00776-y. Epub 2026 May 12.

    PubMed 42120652

  • Hart A, Navabi S, D'Haens G, Matsuoka K, Martin-Arranz MD, Atreya R, Samaan KH, Dhesi E, Redondo I, Zhu B, Paulissen J, Zaremba-Pechmann L, Baygani S, Limdi J, Laharie D, Danese S. Effect of Mirikizumab on Clinical and Endoscopic Outcomes Based on Prior Advanced Therapy Failure in Patients With Moderately to Severely Active Ulcerative Colitis. United European Gastroenterol J. 2026 May;14(4):e70214. doi: 10.1002/ueg2.70214.

    PubMed 42104877

  • Clemow DB, Dubinsky MC, Baygani SK, Sands BE, Keohane A, Danese S, Schreiber S, Walsh AJ, Hibi T, Gibble TH, Moses RE, Travis SPL. Bowel urgency in ulcerative colitis: effect of baseline urgency and change in urgency in response to mirikizumab. J Patient Rep Outcomes. 2025 Jul 1;9(1):75. doi: 10.1186/s41687-025-00906-0.

    PubMed 40591171

  • Panaccione R, Chan-Diehl F, Baygani S, Fisher DA, Moses RE, Siegmund B, Walsh A, Kobayashi T, Dulai PS, Travis S. Fecal Calprotectin and C-Reactive Protein Association With Histologic and Endoscopic Endpoints in Mirikizumab-Treated Patients With Ulcerative Colitis. Crohns Colitis 360. 2025 Jun 14;7(2):otaf043. doi: 10.1093/crocol/otaf043. eCollection 2025 Apr.

    PubMed 40589947

  • 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

  • Danese S, Dignass A, Matsuoka K, Ferrante M, Long M, Redondo I, Moses R, Maier S, Hunter Gibble T, Morris N, Milch C, Abreu MT. Early and Sustained Symptom Control with Mirikizumab in Patients with Ulcerative Colitis in the Phase 3 LUCENT Programme. J Crohns Colitis. 2024 Nov 4;18(11):1845-1856. doi: 10.1093/ecco-jcc/jjae088.

    PubMed 38869019

  • Friedrich S, Chua L, Adams DH, Crandall W, Zhang XC. Mirikizumab Exposure-Response Relationships in Patients with Moderately-to-Severely Active Ulcerative Colitis in Randomized Phase II and III Studies. Clin Pharmacol Ther. 2024 Aug;116(2):435-447. doi: 10.1002/cpt.3305. Epub 2024 May 26.

    PubMed 38797892

  • Long MD, Schreiber S, Hibi T, Gibble TH, Fisher DA, Park G, Moses RE, Higgins PDR, Lindsay JO, Lee SD, Escobar R, Jairath V. Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies. Crohns Colitis 360. 2024 Jan 6;6(1):otae001. doi: 10.1093/crocol/otae001. eCollection 2024 Jan.

    PubMed 38313767

  • Sands BE, Feagan BG, Hunter Gibble T, Traxler KA, Morris N, Eastman WJ, Schreiber S, Jairath V, Long MD, Armuzzi A. Mirikizumab Improves Quality of Life in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Induction and LUCENT-2 Maintenance Studies. Crohns Colitis 360. 2023 Nov 7;5(4):otad070. doi: 10.1093/crocol/otad070. eCollection 2023 Oct.

    PubMed 38034882

  • Chua L, Friedrich S, Zhang XC. Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. Clin Pharmacokinet. 2023 Oct;62(10):1479-1491. doi: 10.1007/s40262-023-01281-z. Epub 2023 Aug 23.

    PubMed 37610533

  • D'Haens G, Dubinsky M, Kobayashi T, Irving PM, Howaldt S, Pokrotnieks J, Krueger K, Laskowski J, Li X, Lissoos T, Milata J, Morris N, Arora V, Milch C, Sandborn W, Sands BE; LUCENT Study Group. Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2023 Jun 29;388(26):2444-2455. doi: 10.1056/NEJMoa2207940.

    PubMed 37379135

  • Magro F, Pai RK, Kobayashi T, Jairath V, Rieder F, Redondo I, Lissoos T, Morris N, Shan M, Park M, Peyrin-Biroulet L. Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. J Crohns Colitis. 2023 Oct 20;17(9):1457-1470. doi: 10.1093/ecco-jcc/jjad050.

    PubMed 37057827

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