NCT03519945

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,058

participants targeted

Target at P75+ for phase_3

Timeline
19mo left

Started Jul 2018

Longer than P75 for phase_3

Geographic Reach
35 countries

349 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jul 2018Dec 2027

First Submitted

Initial submission to the registry

May 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2026

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

7.6 years

First QC Date

May 7, 2018

Last Update Submit

April 17, 2026

Conditions

Keywords

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants in Clinical Remission

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

    Week 52

Secondary Outcomes (7)

  • Percentage of Participants in Endoscopic Remission

    Week 52

  • Percentage of Participants in Corticosteroid-free Remission

    Week 52

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

    Week 52

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

    Baseline to Week 52

  • UC Symptoms: Numeric Rating Score

    Week 160

  • +2 more secondary outcomes

Study Arms (1)

Mirikizumab

EXPERIMENTAL

Mirikizumab administered subcutaneously (SC).

Drug: Mirikizumab

Interventions

Administered SC.

Also known as: LY3074828
Mirikizumab

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (352)

Digestive Health Specialists

Dothan, Alabama, 36305, United States

Location

Research Solutions of Arizona

Litchfield Park, Arizona, 85340, United States

Location

Valleywise Health Medical Center

Phoenix, Arizona, 85008, United States

Location

InSite Digestive Health Care

Arcadia, California, 91006, United States

Location

Care Access - Berkeley

Berkeley, California, 94705, United States

Location

Om Research LLC

Lancaster, California, 93534, United States

Location

California Medical Research Associates

Northridge, California, 91324, United States

Location

Inland Empire Clinical Trials, LLC

Rialto, California, 92377, United States

Location

Clinical Applications Laboratories, Inc.

San Diego, California, 92103, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Encore Borland-Groover Clinical Research

Jacksonville, Florida, 32256, United States

Location

Wellness Clinical Research

Miami Lakes, Florida, 33016, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Clintheory Healthcare

Orlando, Florida, 32819, United States

Location

Gastroenterology Associates of Pensacola, PA

Pensacola, Florida, 32503, United States

Location

Florida Medical Clinic LLC

Zephyrhills, Florida, 33542-7505, United States

Location

Digestive Healthcare of Georgia

Atlanta, Georgia, 30327, United States

Location

Grand Teton Research Group

Idaho Falls, Idaho, 83404, United States

Location

NorthShore University HealthSystem - Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Cotton O'Neil Digestive Health Center

Topeka, Kansas, 66606, United States

Location

GI Alliance Research Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

Delta Research Partners

Monroe, Louisiana, 71201, United States

Location

Nola Research Works, LLC

New Orleans, Louisiana, 70125, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Henry Ford Medical Center - Columbus Center

Novi, Michigan, 48377, United States

Location

West Michigan Clinical Research Center

Wyoming, Michigan, 49519, United States

Location

MNGI Digestive Health - Plymouth Endoscopy Center & Clinic

Plymouth, Minnesota, 55446, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Clinical & Translational Research Center (CTRC)

Chapel Hill, North Carolina, 27599-7080, United States

Location

Carolina Digestive Diseases and Endoscopy Center

Greenville, North Carolina, 27834, United States

Location

Care Access - Youngstown

Poland, Ohio, 44514, United States

Location

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104-5008, United States

Location

Central Sooner Research - Oklahoma - Northwest 47th Street

Oklahoma City, Oklahoma, 73118, United States

Location

Care Access - Pottsville

Pottsville, Pennsylvania, 17901, United States

Location

Digestive Disease Associates

Wyomissing, Pennsylvania, 19610, United States

Location

Midwest Medical Care

Sioux Falls, South Dakota, 57108, United States

Location

GI Alliance

Garland, Texas, 75044, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77084, United States

Location

Gastroenterology Research of San Antonio

San Antonio, Texas, 78229, United States

Location

Southern Star Research Institute

San Antonio, Texas, 78229, United States

Location

GI Alliance

Southlake, Texas, 76092, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092, United States

Location

Care Access-Ogden

Ogden, Utah, 84403, United States

Location

Care Access Research LLC - Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

Washington Gastroenterology - Tacoma

Tacoma, Washington, 98405, United States

Location

Mautalen Salud e Investigación

Buenos Aires, C1128AAF, Argentina

Location

CER medical Institute

Quilmes, 1879, Argentina

Location

Fundacion Estudios Clinicos

Rosario, S2000DEG, Argentina

Location

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, T4000AXL, Argentina

Location

C.I.C.E. 9 de Julio

San Miguel de Tucumán, 4000, Argentina

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Box Hill Hospital

Box Hill, 3128, Australia

Location

Mater Misericordiae Limited

Brisbane, 4101, Australia

Location

Princess Alexandra Hospital

Brisbane, 4102, Australia

Location

Coastal Digestive Health

Maroochydore, 4558, Australia

Location

St Vincent's Hospital

Melbourne, 3065, Australia

Location

The Royal Melbourne Hospital

Parkville, 3050, Australia

Location

Medizinische Universitaet Innsbruck

Innsbruck, 6020, Austria

Location

Uniklinikum Salzburg

Salzburg, 5020, Austria

Location

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier de Wallonie Picarde - Site Notre Dame

Tournai, 7500, Belgium

Location

CISSS de la Monteregie-Centre

Greenfield Park, J4V 2H1, Canada

Location

Victoria Hospital

London, N6A 4G5, Canada

Location

University Hospital - London Health Sciences Centre

London, N6A 5A5, Canada

Location

CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, H1T 2M4, Canada

Location

Montreal General Hospital

Montreal, H3G 1A4, Canada

Location

Fraser Clinical Trials Inc

New Westminster, V3L 3W4, Canada

Location

Vancouver General Hospital

Vancouver, V5Z 1M9, Canada

Location

GIRI GI Research Institute - Vancouver

Vancouver, V5Z 2K5, Canada

Location

PerCuro Clinical Research

Victoria, V8V 3M9, Canada

Location

Xiangya Hospital Central South University

Changsha, 410008, China

Location

Changzhou No.2 People's Hospital

Changzhou, China

Location

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, 350005, China

Location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510655, China

Location

Hainan General Hospital

Haikou, 570311, China

Location

The First Affiliated Hospital, Zhejiang University

Hangzhou, 310003, China

Location

Sir Run Run Shaw Hospital

Hangzhou, 310016, China

Location

The Second Affiliated hospital of Zhejiang University school of medicine

Hangzhou, 310052, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, 230022, China

Location

Anhui Provincial Hospital

Hefei, 230071, China

Location

Center-Jilin Center Hospital

Jilin, 132011, China

Location

Shandong Provincial Hospital

Jinan, 250001, China

Location

Qilu Hospital of Shandong University

Jinan, 250012, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, 650032, China

Location

The First People's Hospital of Yunnan Province

Kunming, 650034, China

Location

Liaocheng People's Hospital

Liaocheng, 252000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, 330006, China

Location

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

Nanjing, 210000, China

Location

Zhongda Hospital Southeast University

Nanjing, 210009, China

Location

Nanjing Medical University - Nanjing Jiangning Hospital

Nanjing, 211100, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, 266003, China

Location

Renji Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, 200001, China

Location

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Shanghai, China

Location

Shengjing Hospital of China Medical University

Shenyang, 110004, China

Location

The Second Afilliated Hospital of Hebei Medical University

Shijiazhuang, 050000, China

Location

Taian City Central Hospital

Taian, 271000, China

Location

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

Wenzhou, 315100, China

Location

Wuhan Union Hospital

Wuhan, 430022, China

Location

Tongji Hospital Tongji Medical,Science & Technology

Wuhan, 430030, China

Location

Renmin Hospital of Wuhan University

Wuhan, 430060, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, 450014, China

Location

ZhuZhou Central Hospital

Zhuzhou, 412007, China

Location

Vojenská Nemocnice Brno

Brno, 636 00, Czechia

Location

Fakultni Nemocnice u sv. Anny v Brne

Brno, 656 91, Czechia

Location

Hepato-Gastroenterologie HK

Hradec Králové, 500 12, Czechia

Location

MUDr. Gregar, s.r.o.

Olomouc, 779 00, Czechia

Location

PreventaMed

Olomouc, 779 00, Czechia

Location

A-Shine

Pilsen, 312 00, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 10034, Czechia

Location

MEDIENDO

Prague, 186 00, Czechia

Location

ISCARE klinicke centrum

Prague, Czechia

Location

Herlev and Gentofte Hospital

Copenhagen, 2730, Denmark

Location

Sjællands Universitetshospital Køge

Køge, 4600, Denmark

Location

Sygehusenheden Nyborg

Nyborg, 5800, Denmark

Location

CHU d'Amiens-Picardie - Hôpital Sud

Amiens, 80054, France

Location

CHRU Troussau

Chambray-lès-Tours, 37170, France

Location

Hopital Claude Huriez - CHU de Lille

Lille, 59037, France

Location

Chu Saint Eloi

Montpellier, 34295, France

Location

Centres Médico Chirurgicaux - Clinique Ambroise Paré

Neuilly-sur-Seine, 92200, France

Location

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

Nice, 06202, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

Centre Hospitalier de Pau

Pau, 64000, France

Location

CHU Bordeaux Haut-Leveque

Pessac, 33600, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord

Saint-Priest-en-Jarez, 42270, France

Location

Nouvel Hôpital Civil (NHC)

Strasbourg, 67091, France

Location

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

LLC ARENSIA Exploratory Medicine

Tbilisi, 0112, Georgia

Location

Charite Universitätsmedizin Berlin Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Krankenhaus Waldfriede

Berlin, 14163, Germany

Location

Städtisches Klinikum Brandenburg

Brandenburg, 14770, Germany

Location

Studiengesellschaft BSF Unternehmergesellschaft

Halle, 06108, Germany

Location

Universitätsklinikum Halle

Halle, 6120, Germany

Location

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

Hamburg, 20251, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Haus der Gesundheit

Ludwigshafen, 67067, Germany

Location

Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

Békéscsaba, 5600, Hungary

Location

Semmelweis University

Budapest, 1088, Hungary

Location

Eszak-budai Szent Janos Centrumkorhaz

Budapest, 1125, Hungary

Location

Petz Aladar Egyetemi Oktato Korhaz

Győr, 9024, Hungary

Location

Endomedix Diagnosztikai Központ - Miskolc

Miskolc, 3526, Hungary

Location

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

Szeged, 6725, Hungary

Location

CLINFAN Szolgáltató Kft

Szekszárd, 7100, Hungary

Location

Jávorszky Ödön Kórház

Vác, 2600, Hungary

Location

Apollo Hospitals Ahmedabad

Ahmedabad, 382428, India

Location

M S Ramaiah Medical College and Hospitals

Bangalore, 560054, India

Location

Owaisi Hospital and Research Center

Hyderabad, 500058, India

Location

SR Kalla Memorial Gastro & General Hospital

Jaipur, 302006, India

Location

Dayanand Medical College and Hospital

Ludhiana, 141001, India

Location

Midas Multispeciality Hospital Pvt.Ltd.

Nagpur, 440010, India

Location

Fortis Hospital

Noida, 201301, India

Location

Grant Medical Foundation - Ruby Hall Clinic

Pune, 411001, India

Location

Shree Giriraj Multispeciality Hospital

Rajkot, 360005, India

Location

Gandhi Hospital

Secunderabad, 500003, India

Location

Nirmal Hospital

Surat, 395002, India

Location

Acharya Vinoba Bhave Rural Hospital

Wardha, 442004, India

Location

Beaumont Hospital, Dublin

Dublin, D9, Ireland

Location

Soroka Medical Center

Beersheba, 8410101, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9778419, Israel

Location

Galilee Medical Center

Nahariya, 2210001, Israel

Location

Kaplan Medical Center

Rehovot, 7610001, Israel

Location

Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Yitzhak Shamir Medical Center

Ẕerifin, 70300, Israel

Location

Azienda Ospedaliera Mater Domini

Catanzaro, 88100, Italy

Location

Ospedale San Martino

Genova, 16132, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, 56124, Italy

Location

Ospedale Di Circolo

Rho, 20017, Italy

Location

Fondazione Policlinico Tor Vergata

Roma, 00133, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Ospedale Sandro Pertini

Rome, 00157, Italy

Location

Humanitas

Rozzano, 20089, Italy

Location

Ospedale Mauriziano

Torino, 10128, Italy

Location

Asahikawa City Hospital

Asahikawa, 070-8610, Japan

Location

Tokyo Medical and Dental University Hospital

Bunkyō, 113-8519, Japan

Location

Juntendo University Hospital

Bunkyō City, 113-8431, Japan

Location

Mitsui Memorial Hospital

Chiyoda-ku, 101-8643, Japan

Location

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

Chuo-ku, Sapporo-shi, 060-0033, Japan

Location

Sai Gastroenterologist Proctology

Fujiidera, 583-0027, Japan

Location

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

Matsuaikai Matsuda Hospital

Hamamatsu, 432-8061, Japan

Location

Mito Medical Center

Higashiibaraki, 311-3117, Japan

Location

National Hospital Organization Hirosaki National Hospital

Hirosaki, 036-8545, Japan

Location

Sameshima Hospital

Kagoshima, 892-0846, Japan

Location

Ofuna Central Hospital

Kamakura, 247-0056, Japan

Location

Kawasaki Municipal Hospital

Kawasaki, 210-0013, Japan

Location

Kitakyushu Municipal Medical Center

Kitakyusyu-shi, 802-0077, Japan

Location

Aoyama Clinic GI Endoscopy & IBD Center

Kobe, 650 0015, Japan

Location

Showa University Koto Toyosu Hospital

Kōtoku, 135 8577, Japan

Location

Kumagaya General Hospital

Kumagaya-shi, 360-8567, Japan

Location

Hidaka Coloproctology Clinic

Kurume-shi, 839 0809, Japan

Location

National Hospital Organization Kyoto Medical Center

Kyoto, 612-8555, Japan

Location

Gunma University Hospital

Maebashi, 371-8511, Japan

Location

Kitasato University Kitasato Institute Hospital

Minatoku, 108 8642, Japan

Location

Kyorin University Hospital

Mitaka, 181-8611, Japan

Location

Nagaoka Chuo General Hospital

Nagaoka, 940-8653, Japan

Location

Hyogo College of Medicine

Nishinomiya, 663-8501, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Infusion Clinic

Osaka, 530-0011, Japan

Location

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

Osaka, 540-0006, Japan

Location

Ishida Clinic of IBD and Gastroenterology

Ōita, 870 0823, Japan

Location

Saga-Ken Medical Center Koseikan

Saga, 840-8571, Japan

Location

Tokitokai Tokito Clinic Coloproctology Center

Saitama, 336-0963, Japan

Location

Toho University Sakura Medical Center

Sakura, 285-0841, Japan

Location

Tokushukai Sapporo Tokushukai Hospital

Sapporo, 004 0041, Japan

Location

Sapporo Higashi Tokushukai Hospital

Sapporo, 065-0033, Japan

Location

Takagi Clinic - Sendai

Sendai, 981-3213, Japan

Location

Jichi Medical University Hospital

Shimotsuke, 329-0498, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Shinjyuku-ku, 162-8655, Japan

Location

Kagawa Prefectural Central Hospital

Takamatsu, 760-8557, Japan

Location

National Hospital Organization Takasaki General Medical Centar

Takasaki, 370-0829, Japan

Location

Tokyo Yamate Medical Center

Tokyo, 169-0073, Japan

Location

Toyama Prefectural Central Hospital

Toyama, 930-8550, Japan

Location

Mie University Hospital

Tsu, 514-8507, Japan

Location

Matsushima Hospital

Yokohama, 220-0041, Japan

Location

Yokohama City University Medical Center

Yokohama, 232-0024, Japan

Location

Showa University Northern Yokohama Hospital

Yokohama, 234-0032, Japan

Location

Digestive Diseases Center "Gastro"

Riga, 1079, Latvia

Location

Pauls Stradins Clinical Univeristy Hospital

Riga, LV-1002, Latvia

Location

RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia

Riga, LV1079, Latvia

Location

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, 50161, Lithuania

Location

Viesoji Istaiga Klaipedos Miesto Poliklinika

Klaipėda, 93200, Lithuania

Location

Republic Hospital of Klaipeda

Klaipėda, LT-91251, Lithuania

Location

Respublikine Panevezio ligonine

Panevezys, LT-35144, Lithuania

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, LT-08661, Lithuania

Location

Hospital Serdang

Kuala Selangor, 43300, Malaysia

Location

Hospital Universiti Sains Malaysia

Kubang Kerian, 16150, Malaysia

Location

University Malaya Medical Centre

Lembah Pantai, 59100, Malaysia

Location

Scientia Investigacion Clinica S.C.

Chihuahua City, 31207, Mexico

Location

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

Culiacán, 80230, Mexico

Location

Sociedad de Metabolismo y Corazon

Veracruz, 91900, Mexico

Location

Republican Clinical Hospital

Chisinau, MD2025, Moldova

Location

Amsterdam UMC, locatie VUmc

Amsterdam, 1081 HZ, Netherlands

Location

Elisabeth-TweeSteden Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

Ziekenhuis Bernhoven

Uden, 5406 PT, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Promedica Dental Clinic

Będzin, 42-500, Poland

Location

Centrum Medyczne "Medis" Manermed

Bydgoszcz, 85-229, Poland

Location

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, 85-796, Poland

Location

Szpital Miejski im. Jana Pawła II w Elblagu

Elblag, 02-300, Poland

Location

All-Medicus

Katowice, 40-659, Poland

Location

Gabinet Endoskopii Przewodu Pokarmowego

Krakow, 31-009, Poland

Location

Topolowa Medicenter

Krakow, 31-506, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

Lublin, 20-090, Poland

Location

ZOZ Gastromed

Lublin, 20-582, Poland

Location

Medicenter Nowy Targ

Nowy Targ, 34-400, Poland

Location

Wojewódzki Szpital Specjalistyczny w Olsztynie

Olsztyn, 11-041, Poland

Location

Centrum Medyczne LUX MED - Rzeszow

Rzeszów, 35-068, Poland

Location

Endoskopia Sp. z.o.o.

Sopot, 81-756, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

Location

SONOMED Centrum Medyczne

Szczecin, 71-685, Poland

Location

Gastromed

Torun, 87-100, Poland

Location

NZOZ Formed

Wadowice, 34-100, Poland

Location

Centrum Zdrowia MDM

Warsaw, 00-189, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, 02-507, Poland

Location

Vivamed Sp. z o.o.

Warsaw, 03-580, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 04-501, Poland

Location

Planetmed

Wroclaw, 52-210, Poland

Location

LexMedica

Wroclaw, 53-114, Poland

Location

ETG Zamość

Zamość, 22-400, Poland

Location

SC Memorial Healthcare International SRL

Bucharest, 013823, Romania

Location

Monza - Ares

Bucharest, 021967, Romania

Location

Spitalul Clinic Colentina

Bucharest, 20125, Romania

Location

CCBR Clinical Research

Bucharest, 30463, Romania

Location

Spitalul Pelican

Oradea, 410469, Romania

Location

Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"

Barnaul, 656038, Russia

Location

Scientific Centre of Reconstructive and Restorative Surgery

Irkutsk, 664079, Russia

Location

Alliance Biomedical URAL Group

Izhevsk, 426061, Russia

Location

Kazan State Medical University

Kazan', 420064, Russia

Location

SIH Kemerovo Regional Clinical Hosptial

Kemerovo, 620109, Russia

Location

Nizhny Novgorod Regional Hospital N.A. Semashko

Nizhny Novgorod, 603126, Russia

Location

Medical Center SibNovoMed

Novosibirsk, 630008, Russia

Location

Research Institute of Physiology and Fundamental Medicine

Novosibirsk, 630117, Russia

Location

Ultramed

Omsk, 644024, Russia

Location

Karelia Republican Hospital V.A. Baranova

Petrozavodsk, 620109, Russia

Location

Rostov State Medical University

Rostov-on-Don, 344022, Russia

Location

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

Saint Petersburg, 191015, Russia

Location

City Mariinskaya Hospital

Saint Petersburg, 191104, Russia

Location

Scientific research center ECO-security

Saint Petersburg, 196143, Russia

Location

First Pavlov State Medical University of Saint Petersburg

Saint Petersburg, 197022, Russia

Location

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

Saint Petersburg, 197110, Russia

Location

Stavropol State Medical University

Stavropol, 355017, Russia

Location

SHI of Yaroslavl Region Clinical Hospital #8

Yaroslavl, 150030, Russia

Location

LLC MA New Hospital

Yekaterinburg, 620109, Russia

Location

Clinical Hospital Center Zvezdara

Belgrade, 11000, Serbia

Location

University Medical Center "Bezanijska kosa"

Belgrade, 11080, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Regional Hospital Dr Radivoj Simonovic Sombor

Sombor, 25000, Serbia

Location

Sremska Mitrovica Health Centre

Sremska Mitrovica, 22000, Serbia

Location

General Hospital "Djordje Joanovic"

Zrenjanin, 23000, Serbia

Location

Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica

Banská Bystrica, 97517, Slovakia

Location

Cliniq s.r.o.

Bratislava, 81109, Slovakia

Location

KM Management

Nitra, 949 01, Slovakia

Location

Gastro

Prešov, 080 01, Slovakia

Location

Endomed, s.r.o.

Vranov N. Toplou, 093 01, Slovakia

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

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

Daejeon, 34943, South Korea

Location

Yeungnam Univeristy Medical Center

Gyeongsan-si, 42415, South Korea

Location

Inje University Haeundae Paik Hospital

Haeundae-gu, 48108, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 3181, South Korea

Location

Samsung Medical Center

Seoul, 6351, South Korea

Location

Yonsei University-Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

Instituto de Ciencias Médicas

Alicante, 3004, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, 28942, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario Juan Ramon Jimenez

Huelva, 21005, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de GC, 35019, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital de Sagunto y C.E.

Sagunto, 46520, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Gastroenterologische Praxis Balsiger, Seibold & Partner

Bern, 3012, Switzerland

Location

Cantonal Hospital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Antalya Egitim ve Arastırma Hastanesi

Antalya, 7100, Turkey (Türkiye)

Location

Ege University Medicine of Faculty

Bornova, 35100, Turkey (Türkiye)

Location

Kocaeli Üniversitesi

Kocaeli, 41380, Turkey (Türkiye)

Location

Mersin University

Mersin, 33110, Turkey (Türkiye)

Location

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

Ivano-Frankivsk, 76008, Ukraine

Location

City Clinical Hospital No. 2

Kharkiv, 61037, Ukraine

Location

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

Kharkiv, 61039, Ukraine

Location

Kherson City Clinical Hospital

Kherson, 73000, Ukraine

Location

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

Kiev, 4050, Ukraine

Location

Private Enterprise Private Manufacturing Company Acinus

Kropyvnytskyi, 25006, Ukraine

Location

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

Kyiv, 04106, Ukraine

Location

Medical Center Ok!Clinic+

Kyiv, 2091, Ukraine

Location

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

Kyiv, 4078, Ukraine

Location

Lviv Railway Clinical Hospital

Lviv, 79000, Ukraine

Location

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

Lviv, 79000, Ukraine

Location

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

Lviv, 79010, Ukraine

Location

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

Odesa, 65025, Ukraine

Location

Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho

Poltava, 36000, Ukraine

Location

Transcarpathian Regional Hospital im.Andriya Novak

Uzhhorod, 88000, Ukraine

Location

City Clinical Hospital #1, Vinnitsya National Medical University

Vinnytsia, 21000, Ukraine

Location

Medical Clinical Investigational Center of Medical Center Health Clinic

Vinnytsia, 21009, Ukraine

Location

VNMU

Vinnytsia, 21018, Ukraine

Location

NOVA Hospital

Zaporizhzhia, 69059, Ukraine

Location

Diacenter

Zaporizhzhia, 69076, Ukraine

Location

Fairfield General Hospital

Bury, BL9 7TD, United Kingdom

Location

Barts Health NHS Trust

London, E1 1RD, United Kingdom

Location

Guy's & St Thomas' NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

The John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel Diseases

Interventions

mirikizumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2018

First Posted

May 9, 2018

Study Start

July 18, 2018

Primary Completion

March 4, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Locations