A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03519945
Collaborator
(none)
960
356
1
83.4
2.7
0
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
960 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Jul 18, 2018
Anticipated Primary Completion Date
:
Jun 6, 2025
Anticipated Study Completion Date
:
Jul 1, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mirikizumab Mirikizumab administered subcutaneously (SC). |
Drug: Mirikizumab
Administered SC.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants in Clinical Remission [Week 52]
Clinical remission based on the modified Mayo Score (MMS).
Secondary Outcome Measures
- Percentage of Participants in Endoscopic Remission [Week 52]
Endoscopic remission based on the MMS Endoscopic Subscore (ES).
- Percentage of Participants in Corticosteroid-free Remission [Week 52]
Participants in corticosteroid-free remission.
- Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52 [Week 52]
Endoscopic remission based on the MMS ES and histologic remission based on histologic disease activity index.
- Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score [Baseline to Week 52]
Health Related Quality of Life based on IBDQ score.
- UC Symptoms: Numeric Rating Score [Week 160]
UC symptoms based on numeric rating score.
- Percentage of Participants Who are Hospitalized Due to UC [Baseline to Week 160]
Participants who are hospitalized due to UC.
- Percentage of Participants Who Undergo UC Surgeries Including Colectomy [Baseline to Week 160]
Participants who undergo UC surgeries including colectomy.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
-
Inclusion Criteria
-
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.
-
Exclusion Criteria
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Digestive Health Specialists | Dothan | Alabama | United States | 36305 |
| 2 | Research Solutions of Arizona | Litchfield Park | Arizona | United States | 85340 |
| 3 | Valleywise Health | Phoenix | Arizona | United States | 85008 |
| 4 | inSite Digestive Health Care | Arcadia | California | United States | 91006 |
| 5 | Care Access Research | Berkeley | California | United States | 94705 |
| 6 | Om Research, LLC | Lancaster | California | United States | 93534 |
| 7 | California Medical Research Associates | Northridge | California | United States | 91324 |
| 8 | Inland Empire Liver Foundation | Rialto | California | United States | 92377 |
| 9 | Clinical Applications Laboratories, Inc. | San Diego | California | United States | 92103 |
| 10 | Direct Helpers Research Center | Hialeah | Florida | United States | 33012 |
| 11 | Encore Borland-Groover Clinical Research | Jacksonville | Florida | United States | 32256 6004 |
| 12 | Wellness Clinical Research | Miami Lakes | Florida | United States | 33016 |
| 13 | Research Associates of South Florida, LLC | Miami | Florida | United States | 33156 |
| 14 | AdventHealth Orlando | Orlando | Florida | United States | 32803 |
| 15 | Clintheory Healthcare | Orlando | Florida | United States | 32818 |
| 16 | Gastroenterology Associates of Pensacola, PA | Pensacola | Florida | United States | 32503 |
| 17 | Florida Medical Clinic LLC | Zephyrhills | Florida | United States | 33542-7505 |
| 18 | Digestive Healthcare of Georgia | Atlanta | Georgia | United States | 30309 |
| 19 | Grand Teton Research Group | Idaho Falls | Idaho | United States | 83404 |
| 20 | NorthShore University HealthSystem | Evanston | Illinois | United States | 60201 |
| 21 | Indiana University School of Medicine | Indianapolis | Indiana | United States | 46202 |
| 22 | Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | United States | 66606 |
| 23 | GI Alliance Research Baton Rouge | Baton Rouge | Louisiana | United States | 70809 |
| 24 | Delta Research Partners LLC | Monroe | Louisiana | United States | 71201 |
| 25 | Nola Research Works, LLC | New Orleans | Louisiana | United States | 70125 |
| 26 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 27 | Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | United States | 48047 |
| 28 | Henry Ford Health System | Novi | Michigan | United States | 48377 |
| 29 | Gastroenterology Associates of Western Michigan, P.L.C. | Wyoming | Michigan | United States | 49519 |
| 30 | MNGI Digestive Health - Plymouth Endoscopy Center & Clinic | Plymouth | Minnesota | United States | 55446 |
| 31 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 32 | University of North Carolina Center for Inflammatory Bowel Disease | Chapel Hill | North Carolina | United States | 27599 |
| 33 | Carolina Digestive Diseases and Endoscopy Center | Greenville | North Carolina | United States | 27834 |
| 34 | Care Access - Youngstown | Poland | Ohio | United States | 44514 |
| 35 | Central Sooner Research | Norman | Oklahoma | United States | 73071 |
| 36 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 37 | Care Access Research LLC | Pottsville | Pennsylvania | United States | 17901 |
| 38 | Digestive Disease Associates | Wyomissing | Pennsylvania | United States | 19610 |
| 39 | Midwest Medical Care | Sioux Falls | South Dakota | United States | 57108 |
| 40 | Texas Digestive Disease Consultants | Dallas | Texas | United States | 75231 |
| 41 | Digestive Health Associates of Texas | Garland | Texas | United States | 75044 |
| 42 | Biopharma Informatic, LLC | Houston | Texas | United States | 77084 |
| 43 | Gastroenterology Research of San Antonio | San Antonio | Texas | United States | 78229 |
| 44 | Southern Star Research Institute, LLC | San Antonio | Texas | United States | 78229 |
| 45 | Texas Digestive Disease Consultants | Southlake | Texas | United States | 76092 |
| 46 | Care Access Research LLC - Salt Lake City | Ogden | Utah | United States | 84403 |
| 47 | Care Access Research LLC - Salt Lake City | Salt Lake City | Utah | United States | 84124 |
| 48 | The Gastroenterology Group, P.C. | Reston | Virginia | United States | 20191 |
| 49 | Carilion Clinic | Roanoke | Virginia | United States | 24014 |
| 50 | Washington Gastroenterology, PLLC | Tacoma | Washington | United States | 98405 |
| 51 | Mautalen Salud e Investigación | Caba | Buenos Aires | Argentina | C1128AAF |
| 52 | CER Instituto Medico | Quilmes | Buenos Aires | Argentina | B1878DVC |
| 53 | Fundación de Estudios Clínicos | Rosario | Santa Fe | Argentina | S2000DEJ |
| 54 | C.I.C.E. 9 de Julio | San Miguel de Tucumán | Tucumán (t4000dgi) | Argentina | 4000 |
| 55 | Centro de Investigaciones Médicas Tucuman | SAN M. DE Tucuman | Tucumán | Argentina | T4000AXL |
| 56 | Princess Alexandra Hospital | Brisbane | Queensland | Australia | 4102 |
| 57 | Coastal Digestive Health | Maroochydore | Queensland | Australia | 4558 |
| 58 | Mater University Hospital | South Brisbane | Queensland | Australia | 4101 |
| 59 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
| 60 | Box Hill Hospital Outpatients | Box Hill | Victoria | Australia | 3128 |
| 61 | St Vincent's Hospital | Fitzroy | Victoria | Australia | 3065 |
| 62 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
| 63 | The Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
| 64 | AKH - Gastroenterologie und Hepatologie - Interne Medizin III | Wien | Vienna | Austria | 1090 |
| 65 | Medizinische Universität Innsbruck | Innsbruck | Austria | 6020 | |
| 66 | Universitätsklinikum Salzburg | Salzburg | Austria | 5020 | |
| 67 | Centre Hospitalier de Wallonie Picarde - Site Notre Dame | Tournai | Wallonne, Région | Belgium | 7500 |
| 68 | Universitair Ziekenhuis Gent | Gent | Belgium | 9000 | |
| 69 | Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | Belgium | 3000 | |
| 70 | West Edmonton Diabetes Center | Edmonton | Alberta | Canada | T5R 1W2 |
| 71 | The Gordon and Leslie Diamond Health Care Centre | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 72 | GI Research Institute | Vancouver | British Columbia | Canada | V6Z 2K5 |
| 73 | PerCuro Clinical Research | Victoria | British Columbia | Canada | V8V 3M9 |
| 74 | London Health Sciences Centre | London | Ontario | Canada | N6A 5A5 |
| 75 | Victoria Hospital | London | Ontario | Canada | N6A 5W9 |
| 76 | CIUSS-de-L'Est-de-l'île-de-Montréal-Hôpital | Montreal | Quebec | Canada | H1T 2M4 |
| 77 | McGill University | Montreal | Quebec | Canada | H3G 1A4 |
| 78 | The First Affiliated Hospital of Anhui Medical University | HefeiCity | Anhui | China | 230022 |
| 79 | Anhui Provincial Hospital | Hefei | Anhui | China | 230001 |
| 80 | The First Hospital Affiliated to AMU (Southwest Hospital) | Chongqing | Chongqing | China | 400038 |
| 81 | The Sixth Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | China | 510655 |
| 82 | Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech | Wu Han | Hubei | China | 430030 |
| 83 | Wuhan Union Hospital | Wuhan | Hubei | China | 430022 |
| 84 | Renmin Hospital of Wuhan University | Wuhan | Hubei | China | 430060 |
| 85 | Xiangya Hospital Central South University | Changsha | Hunan | China | 410008 |
| 86 | Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | China | 210000 |
| 87 | Zhongda Hospital Southeast University | Nanjing | Jiangsu | China | 210009 |
| 88 | Nanjing Medical University - Nanjing Jiangning Hospital | Nanjing | Jiangsu | China | 211100 |
| 89 | Jiangxi Pingxiang People's Hospital | Pingxiang | Jiangxi | China | 337055 |
| 90 | Jilin Central General Hospital | Jilin | Jilin | China | 132011 |
| 91 | Jiangsu Province Hospital | Nanjing | Nanjing | China | 210029 |
| 92 | People's Hospital of Liaocheng City | Liaocheng | Shandong | China | 252000 |
| 93 | The Affiliated Hospital of Qingdao University | Qingdao | Shandong | China | 266003 |
| 94 | Taian City Central Hospital | Taian | Shandong | China | 271000 |
| 95 | Shanghai Jiaotong University School of Medicine Ruijin Hospital | Shanghai | Shanghai | China | 200025 |
| 96 | Renji Hospital Affliated to Shanghai Jiaotong University | Shanghai | Shanghai | China | 201204 |
| 97 | West China Hospital of Sichuan University | Cheng Du | Sichuan | China | 610041 |
| 98 | The First People's Hospital of Yunnan Province | Kunming | Yunnan | China | 650034 |
| 99 | First Affiliated Hosp of College of Med, Zhejiang University | Hangzhou | Zhejiang | China | 310003 |
| 100 | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China | 310009 |
| 101 | Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | China | 310016 |
| 102 | The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university | Wenzhou | Zhejiang | China | 310015 |
| 103 | Liaocheng People's Hospital | Liaocheng | China | 252000 | |
| 104 | Vojenská Nemocnice Brno | Brno | Brno-město | Czechia | 636 00 |
| 105 | Hepato-Gastroenterologie HK | Hradec Kralove | Hradec Králové | Czechia | 500 12 |
| 106 | A-Shine | Plzen | Město | Czechia | 301 00 |
| 107 | MEDIENDO | Prague | Praha 8 | Czechia | 186 00 |
| 108 | Fakultni Nemocnice U svate Anny | Brno | Czechia | 65691 | |
| 109 | MUDr. Gregar, s.r.o. | Olomouc | Czechia | 779 00 | |
| 110 | PreventaMed, s.r.o. | Olomouc | Czechia | 779 00 | |
| 111 | Fakultni nemocnice Kralovske Vinohrady | Praha 10 | Czechia | 10034 | |
| 112 | ISCARE Clinical Centre | Praha 9 | Czechia | 19000 | |
| 113 | Sygehusenheden Nyborg | Nyborg | Syddanmark | Denmark | 5800 |
| 114 | Herlev and Gentofte Hospital | Herlev | Denmark | 2730 | |
| 115 | Zealand University Hospital Køge | Køge | Denmark | 4600 | |
| 116 | Hôpital Beaujon | Clichy | Paris | France | 92110 |
| 117 | CHU Amiens Picardie Site Sud - Service d'Hepato-gastro-entérologie | Amiens | France | 80054 | |
| 118 | Hôpital Trousseau, CHRU de Tours | Chambray-lès-Tours | France | 37170 | |
| 119 | Hôpital C. HURIEZ | Lille | France | 59037 | |
| 120 | CHRU de Montpellier-Hopital St Eloi | Montpellier | France | 34295 | |
| 121 | CHU de Nice Hopital de L'Archet | Nice cedex 3 | France | 06202 | |
| 122 | Hopital Saint-Louis | Paris | France | 75475 | |
| 123 | CH Francois Mitterand | PAU | France | 64000 | |
| 124 | Centre hospitalier universitaire de Haut Leveque | Pessac Cedex | France | 33604 | |
| 125 | Centre Hospitalier Lyon Sud | Pierre Benite Cedex | France | 69495 | |
| 126 | CHU St Etienne Hopital Nord | Saint Etienne Cedex 2 | France | 42055 | |
| 127 | Nouvel Hopital Civil | Strasbourg Cedex | France | 67091 | |
| 128 | CHRU Nancy Brabois - Hôpital d'Enfants | Vandoeuvre les Nancy | France | 54500 | |
| 129 | LLC ARENSIA Exploratory Medicine | Tbilisi | Georgia | 0112 | |
| 130 | Medizinische Hochschule Hanover | Hannover | Niedersachsen | Germany | 30625 |
| 131 | Universitätsklinikum Halle | Halle (Saale) | Sachsen-Anhalt | Germany | 06120 |
| 132 | Charité Campus Virchow-Klinikum | Berlin | Germany | 12200 | |
| 133 | Krankenhaus Waldfriede | Berlin | Germany | 14163 | |
| 134 | Städtisches Klinikum Brandenburg | Brandenburg | Germany | 14770 | |
| 135 | Studiengesellschaft BSF Unternehmergesellschaft | Halle (Saale), | Germany | 06108 | |
| 136 | HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen | Hamburg | Germany | 20251 | |
| 137 | Haus der Gesundheit | Ludwigshafen | Germany | 67067 | |
| 138 | SZTE AOK Belgyogyaszati Klinika | Szeged | Csongrad | Hungary | 6725 |
| 139 | DRC Gyogyszervizsgalo Kozpont Kft. | Balatonfüred | EU | Hungary | 8230 |
| 140 | Petz Aladar Egyetemi Oktato Korhaz | Győr | Gyor-Moson-Sopron | Hungary | 9024 |
| 141 | Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet | Debrecen | Hajdu-Bihar | Hungary | 4032 |
| 142 | Jávorszky Ödön Kórház | Vác | Pest | Hungary | 2600 |
| 143 | Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz IV. Belgyogyaszat | Bekescsaba | Hungary | 5600 | |
| 144 | SE Belgyogyaszati és Hematologiai Klinika | Budapest | Hungary | 1088 | |
| 145 | Szent János Kórház | Budapest | Hungary | 1125 | |
| 146 | Endomedix Diagnosztikai Központ - Miskolc | Miskolc | Hungary | 3525 | |
| 147 | CLINFAN Szolgáltató Kft | Szekszard | Hungary | 7100 | |
| 148 | Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre | Hyderabad | Andhra Pradesh | India | 500058 |
| 149 | Apollo Research and Innovations, Apollo Hospitals International Ltd | Gandhinagar | Gujarat | India | 382428 |
| 150 | Shree Giriraj Multispeciality Hospital | Rajkot | Gujarat | India | 360005 |
| 151 | Nirmal Hospital Pvt Ltd. | Surat | Gujarat | India | 395002 |
| 152 | M S Ramaiah Medical College and Hospitals | Bangalore | Karnataka | India | 560054 |
| 153 | Midas Multispeciality Hospital Pvt.Ltd. | Nagpur | Maharashtra | India | 440010 |
| 154 | Poona Medical Foundation. Ruby Hall Clinic | Pune | Maharashtra | India | 411 001 |
| 155 | Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital | Wardha | Maharashtra | India | 442004 |
| 156 | Dayanand Medical College and Hospital | Ludhiana | Punjab | India | 141001 |
| 157 | SR Kalla Memorial Gastro & General Hospital | Jaipur | Rajasthan | India | 302001 |
| 158 | King George Medical University | Lucknow | Uttar Pradesh | India | 226003 |
| 159 | Fortis Hospital | Noida | Uttar Pradesh | India | 201301 |
| 160 | Gandhi Hospital | Telangana | India | 500003 | |
| 161 | Beaumont Hospital, Dublin | Dublin | Ireland | D9 | |
| 162 | Soroka Medical Center | Beer Sheva | Israel | 8410101 | |
| 163 | Shaare Zedek Medical Center | Jerusalem | Israel | 91031 | |
| 164 | Galilee Medical Center Department of Internal Medicine A | Nahariya | Israel | 22100 | |
| 165 | Kaplan Medical Center | Rehovot | Israel | 7610001 | |
| 166 | Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | 6423906 | |
| 167 | Assaf Harofeh Medical Center | Zerifin | Israel | 70300 | |
| 168 | Policlinico Gemelli - Università Cattolica del Sacro Cuore | Roma | Lazio | Italy | 00168 |
| 169 | Presidio di Rho | Rho | Milano | Italy | 20017 |
| 170 | Istituto Clinico Humanitas | Rozzano | Milano | Italy | 20089 |
| 171 | Ospedale Sandro Pertini | Roma | RM | Italy | 00157 |
| 172 | Policlinico Mater Domini | Catanzaro | Italy | 88100 | |
| 173 | IRCCS Ospedale Policlinico San Martino | Genova | Italy | 16132 | |
| 174 | Azienda Ospedlaliero-Univeristaria Pisana - Ospedale di Cisanello - Gastroenterologia | Pisa | Italy | 56124 | |
| 175 | Policlinico di Tor Vergata | Roma | Italy | 00133 | |
| 176 | Ospedale Mauriziano Umberto I | Torino | Italy | 10128 | |
| 177 | National Hospital Organization Hirosaki General Medical Center | Hirosaki | Aomori | Japan | 036-8545 |
| 178 | Toho University Sakura Medical Center | Sakura | Chiba | Japan | 285-8741 |
| 179 | Kitakyushu Municipal Medical Center | Kitakyusyu-shi | Fukoka | Japan | 802-0077 |
| 180 | Hidaka Coloproctology Clinic | Kurume-shi | Fukuoka-Ken | Japan | 839 0809 |
| 181 | Fukuoka University Hospital | Fukuoka, Jonan-Ku | Fukuoka | Japan | 814-0180 |
| 182 | Gunma University Hospital | Maebashi | Gunma | Japan | 371-8511 |
| 183 | National Hospital Organization Takasaki General Medical Centar | Takasaki | Gunma | Japan | 370-0829 |
| 184 | NHO Mito Medical Center | Ibaraki-machi | HigaShiibaraki-Gun | Japan | 311 3193 |
| 185 | Asahikawa City Hospital | Asahikawa | Hokkaido | Japan | 070-8610 |
| 186 | Tokushukai Sapporo Tokushukai Hospital | Sapporo-shi | Hokkaido | Japan | 004 0041 |
| 187 | Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital | Sapporo-shi | Hokkaido | Japan | 060 0033 |
| 188 | Sapporo Higashi Tokushukai Hospital | Sapporo | Hokkaido | Japan | 065-0033 |
| 189 | Aoyama Clinic GI Endoscopy & IBD Center | Kobe-shi | Hyogo-Ken | Japan | 650 0015 |
| 190 | Hyogo College of Medicine | Nishinomiya | Hyogo | Japan | 663-8501 |
| 191 | Kagawa Prefectural Central Hospital | Takamatsu | Kagawa | Japan | 760-8557 |
| 192 | Ofuna Central Hospital | Kamakura | Kanagawa | Japan | 247-0056 |
| 193 | Kawasaki Municipal Hospital | Kawasaki | Kanagawa | Japan | 210-0013 |
| 194 | Matsushima Cinic | Yokohama | Kanagawa | Japan | 220-0045 |
| 195 | Yokohama City University Medical Center | Yokohama | Kanagawa | Japan | 232-0024 |
| 196 | Showa University Northern Yokohama Hospital | Yokohama | Kanagawa | Japan | 234-0032 |
| 197 | Mie University Hospital | Tsu | Mie | Japan | 514-8507 |
| 198 | Takagi Clinic - Sendai | Sendai-shi | Miyagi-Ken | Japan | 981 3213 |
| 199 | Nagaoka Chuo General Hospital | Nagaoka-shi | Niigata | Japan | 940-8653 |
| 200 | Ishida Clinic of IBD and Gastroenterology | Oita-shi | Oita-Ken | Japan | 870 0823 |
| 201 | Sai Gastroenterologist Proctology | Fujiidera | Osaka | Japan | 583-0027 |
| 202 | Infusion Clinic | Osaka-shi | Osaka | Japan | 530 0011 |
| 203 | NHO Osaka National Hospital | Osaka-shi | Osaka | Japan | 540 0006 |
| 204 | Saga-Ken Medical Center Koseikan | Saga-shi | Saga | Japan | 840 8571 |
| 205 | Kumagaya General Hospital | Kumagaya-shi | Saitama-Ken | Japan | 360-8567 |
| 206 | Matsuda Hospital | Hamamatsu-shi | Shizuoka-Ken | Japan | 4328061 |
| 207 | Jichi Medical University Hospital | Shimotsuke | Tochigi | Japan | 329-0498 |
| 208 | Center Hospital of the National Center for Global Health and Medicine | Shinjuku-ku | Tokyo-To | Japan | 162 8655 |
| 209 | Juntendo University Hospital | Bunkyo-ku | Tokyo | Japan | 113-8431 |
| 210 | Tokyo Medical and Dental University Hospital | Bunkyō | Tokyo | Japan | 113-8519 |
| 211 | Mitsui Memorial Hospital | Chiyoda-ku | Tokyo | Japan | 101-8643 |
| 212 | Showa University Koto Toyosu Hospital | Koto-ku | Tokyo | Japan | 135 8577 |
| 213 | Kitasato University Kitasato Institute Hospital | Minato-Ku | Tokyo | Japan | 108 8642 |
| 214 | Kyorin University Hospital | Mitaka | Tokyo | Japan | 181-8611 |
| 215 | JHCO Tokyo Yamate Medical Center | Shinjuku-ku | Tokyo | Japan | 169-0073 |
| 216 | Sameshima Hospital | Kagoshima | Japan | 892-0846 | |
| 217 | National Hospital Organization Kyoto Medical Center | Kyoto | Japan | 612-8555 | |
| 218 | Okayama University Hospital | Okayama | Japan | 700-8558 | |
| 219 | Tokitokai Tokito Clinic | Saitama | Japan | 336-0963 | |
| 220 | Toyama Prefectural Central Hospital | Toyama | Japan | 930-8550 | |
| 221 | Kyung Hee University Hospital | Seoul | Korea | Korea, Republic of | 02447 |
| 222 | Yeungnam Univeristy Medical Center | Gyeongsan-si | Kyǒngsangbuk-do | Korea, Republic of | 42415 |
| 223 | Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 05505 |
| 224 | Samsung Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 06351 |
| 225 | The Catholic University of Korea, Daejeon St. Mary's Hospital | Daejeon | Taejǒn-Kwangyǒkshi | Korea, Republic of | 34943 |
| 226 | Inje University Haeundae Paik Hospital | Busan | Korea, Republic of | 48108 | |
| 227 | Dong-A University Hospital | Busan | Korea, Republic of | 49201 | |
| 228 | Yonsei University Wonju Severance Christian Hospital | Gangwon-do | Korea, Republic of | 26426 | |
| 229 | Kangbuk Samsung Hospital | Seoul | Korea, Republic of | 03181 | |
| 230 | Pauls Stradins Clinical Univeristy Hospital | Riga | Rīga | Latvia | LV-1002 |
| 231 | Digestive Diseases Center "Gastro" | Riga | Latvia | 1079 | |
| 232 | Riga Eastern Clinical University Hospital | Riga | Latvia | LV-1038 | |
| 233 | Respublikine Panevezio ligonine | Panevezys | Panevėžio Apskritis | Lithuania | LT-35144 |
| 234 | Hospital of Lithuanian University of Health Sciences Kaunas | Kaunas | Lithuania | 50009 | |
| 235 | Republic Hospital of Klaipeda | Klaipeda | Lithuania | 92231 | |
| 236 | Klaipeda Seamen's Hospital | Klaipeda | Lithuania | 92288 | |
| 237 | Vilniaus Universiteto Ligonines Santariskiu Klinikos | Vilnius | Lithuania | LT-08661 | |
| 238 | Hospital Sultanah Bahiyah | Alor Star | Kedah | Malaysia | 05460 |
| 239 | Hospital Raja Perempuan Zainab II | Kota Bahru | Kelantan | Malaysia | 15586 |
| 240 | Pusat Perubatan University Kebangsaan Malaysia | Cheras, Kuala Lumpur | Malaysia | 56000 | |
| 241 | Hospital Universiti Sains Malaysia | Kelantan | Malaysia | 16150 | |
| 242 | University Malaya Medical Centre | Kuala Lumpur | Malaysia | 59100 | |
| 243 | University Malaya Medical Centre | Kuala Lumpur | Malaysia | 59100 | |
| 244 | Hospital Serdang | Selangor | Malaysia | 43000 | |
| 245 | Centro Para el Desarrollo de la Medicina y de Asistencia Medica S.C | Culiacan | Sinaloa | Mexico | 80230 |
| 246 | Scientia Investigacion Clinica S.C. | Chihuahua | Mexico | 31203 | |
| 247 | Sociedad de Metabolismo y Corazon | Veracruz | Mexico | 91900 | |
| 248 | Republican Clinical Hospital | Chisinau | Moldova, Republic of | MD2025 | |
| 249 | ETZ Elisabeth Tilburg | Tilburg | North Brabant | Netherlands | 5042AD |
| 250 | Amsterdam UMC, locatie AMC | Amsterdam | Netherlands | 1105 AZ | |
| 251 | Bernhoven Uden | Uden | Netherlands | 5406 PT | |
| 252 | Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | 3584 | |
| 253 | Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy | Bydgoszcz | Kujawsko-pomorskie | Poland | 85-168 |
| 254 | Centrum Medyczne Pratia Bydgoszcz | Bydgoszcz | Kujawsko-pomorskie | Poland | 85-796 |
| 255 | ZOZ Gastromed | Lublin | Lubelskie | Poland | 20-582 |
| 256 | NZOZ Vivamed | Warsaw | Mazowieckie | Poland | 03-580 |
| 257 | Gabinet Endoskopii Przewodu Pokarmowego | Krakow | Małopolskie | Poland | 31-009 |
| 258 | Topolowa Medicenter | Krakow | Małopolskie | Poland | 31-506 |
| 259 | Medicenter Nowy Targ | Nowy Targ | Małopolskie | Poland | 34-400 |
| 260 | NZOZ Formed | Wadowice | Małopolskie | Poland | 34-100 |
| 261 | Endoskopia Sp. z.o.o. | Sopot | Pomorskie | Poland | 81-756 |
| 262 | SONOMED Centrum Medyczne | Szczecin | Zachodniopomorskie | Poland | 71-685 |
| 263 | Szpital Miejski Sw. Jana Pawla II | Elblag | Poland | 82-300 | |
| 264 | Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie | Lublin | Poland | 20-954 | |
| 265 | Wojewodzki Specjalistyczny Szpital w Olsztynie | Olsztyn | Poland | 10-561 | |
| 266 | Centrum Medyczne Lux Med Poradnia Gastroenterologii | Rzeszow | Poland | 35-068 | |
| 267 | Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | Poland | 71-434 | |
| 268 | Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii | Torun | Poland | 87-100 | |
| 269 | WIP Warsaw IBD Point Profesor Kierkus | Warszawa | Poland | 00-728 | |
| 270 | Centrum Zdrowia MDM | Warszawa | Poland | 00635 | |
| 271 | Centralny Szpital Kliniczny MSWiA | Warszawa | Poland | 02-507 | |
| 272 | PlanetMed Sp.z o.o. | Wroclaw | Poland | 52-210 | |
| 273 | LexMedica | Wroclaw | Poland | 53-114 | |
| 274 | ETG Zamość | Zamosc | Poland | 22-400 | |
| 275 | Promedica Dental Clinic | Bedzin | Śląskie | Poland | 42-500 |
| 276 | All-Medicus | Katowice | Śląskie | Poland | 40-659 |
| 277 | SC Pelican SRL | Oradea | Bihor | Romania | 410469 |
| 278 | SC Med Life SA | Bucuresti | Romania | 010719 | |
| 279 | S.C. Centrul Medical Medicum SRL | Bucuresti | Romania | 012015 | |
| 280 | Spitalul Clinic Colentina | Bucuresti | Romania | 21155 | |
| 281 | CCBR Clinical Research | Bucuresti | Romania | 30463 | |
| 282 | Scientific Centre of Reconstructive and Restorative Surgery | Irkutsk | Irkutskaya Oblast' | Russian Federation | 664079 |
| 283 | Karelia Republican Hospital V.A. Baranova | Petrozavodsk | Kareliya, Respublika | Russian Federation | 185019 |
| 284 | Nizhny Novgorod Regional Hospital N.A. Semashko | Nizhny Novgorod | Nizhegorodskaya Oblast' | Russian Federation | 603126 |
| 285 | Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod | Nizhny Novgorod | Nizhegorodskaya Oblast' | Russian Federation | 603140 |
| 286 | Novosibirski Gastrocenter | Novosibirsk | Novosibirskaya Oblast' | Russian Federation | 630007 |
| 287 | Rostov State Medical University | Rostov-on-Don | Rostovskaya Oblast' | Russian Federation | 344091 |
| 288 | Scientific research center ECO-security | Saint Petersburg | Sankt-Peterburg | Russian Federation | 196143 |
| 289 | Stavropol State Medical University | Stavropol | Stavropol'skiy Kray | Russian Federation | 355017 |
| 290 | Multidisciplinary Medical Clinic "Anthurium" | Barnaul | Russian Federation | 656043 | |
| 291 | LLC MA New Hospital | Ekaterinburg | Russian Federation | 620109 | |
| 292 | Alliance Biomedical URAL Group | Izhevsk | Russian Federation | 426061 | |
| 293 | Kazan State Medical University | Kazan | Russian Federation | 420012 | |
| 294 | SIH Kemerovo Regional Clinical Hosptial | Kemerovo | Russian Federation | 650066 | |
| 295 | LLC "Medicine Center SibNovoMed" | Novosibirsk | Russian Federation | 630005 | |
| 296 | Ultramed | Omsk | Russian Federation | 644024 | |
| 297 | SPb SBIH "City Mariinskaya Hospital" | Saint-Petersburg | Russian Federation | 194104 | |
| 298 | SBIH City Clinical Hospital #31 | Saint-Petersburg | Russian Federation | 197110 | |
| 299 | Academician I.P. Pavlov First St-Petersburg State Medical University | St-Petersburg | Russian Federation | 197022 | |
| 300 | GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health | St. Petersburg | Russian Federation | 195067 | |
| 301 | Railway clinical hospital | St. Petersburg | Russian Federation | 195271 | |
| 302 | SHI of Yaroslavl Region Clinical Hospital #8 | Yaroslavl | Russian Federation | 150030 | |
| 303 | Clinical Hospital Center Zvezdara | Belgrade | Beograd | Serbia | 11000 |
| 304 | University Medical Center "Bezanijska kosa" | Belgrade | NAP | Serbia | 11080 |
| 305 | Regional Hospital Dr Radivoj Simonovic Sombor | Sombor | Vojvodina | Serbia | 25000 |
| 306 | Sremska Mitrovica Health Centre | Sremska Mitrovica | Vojvodina | Serbia | 22000 |
| 307 | General Hospital "Djordje Joanovic" | Zrenjanin | Vojvodina | Serbia | 23000 |
| 308 | Clinical Center Kragujevac Gastroenterohepatology Clinic | Kragujevac | Serbia | 34000 | |
| 309 | KM Management | Nitra | Nitriansky Kraj | Slovakia | 949 01 |
| 310 | Endomed, s.r.o. | Vranov N. Toplou | Prešovský Kraj | Slovakia | 093 01 |
| 311 | Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica | Banska Bystrica | Slovakia | 975 17 | |
| 312 | CLINIQ, s.r.o | Bratislava | Slovakia | 811 09 | |
| 313 | GASTRO I., s.r.o. | Presova | Slovakia | 08001 | |
| 314 | Hospital Universitario Central de Asturias | Oviedo | Asturias | Spain | 33011 |
| 315 | Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | Spain | 39008 |
| 316 | Hospital De Fuenlabrada | Fuenlabrada | Madrid | Spain | 28942 |
| 317 | Hospital de Sagunto y C.E. | Sagunto | València | Spain | 46520 |
| 318 | Instituto de Ciencias Médicas | Alicante | Spain | 03004 | |
| 319 | Hospital Universitari de Girona Dr. Josep Trueta | Girona | Spain | 17007 | |
| 320 | Hospital Universitario Juan Ramon Jimenez | Huelva | Spain | 21005 | |
| 321 | Hospital De Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria | Spain | 35010 | |
| 322 | Hospital Universitario La Paz | Madrid | Spain | 28046 | |
| 323 | Cantonal Hospital St.Gallen | St. Gallen | Sankt Gallen | Switzerland | 9007 |
| 324 | Inselspital Bern | Berne | Switzerland | 3010 | |
| 325 | Gastroenterologische Praxis Balsiger, Seibold & Partner | Bern | Switzerland | 3012 | |
| 326 | UniversitätsSpital Zürich | Zürich | Switzerland | 8091 | |
| 327 | China Medical University Hospital | Taichung | Taiwan | 40447 | |
| 328 | National Taiwan University Hospital | Taipei City | Taiwan | 10048 | |
| 329 | Antalya Egitim ve Arastırma Hastanesi | Kocaeli | Antalya | Turkey | 7100 |
| 330 | Ege University Medicine of Faculty | Izmir | Turkey | 35100 | |
| 331 | Kocaeli University Medical Faculty Hospital | Izmit | Turkey | 41380 | |
| 332 | Mersin University | Mersin | Turkey | 33343 | |
| 333 | City Clinical Hospital No. 2 | Kharkiv | Kharkivska Oblast | Ukraine | 61037 |
| 334 | Kherson City Clinical Hospital | Kherson | Khersonska Oblast | Ukraine | 73000 |
| 335 | Medical Center of Limited Liability Company "Medical Center "Consilium Medical" | Kiev | Kyiv | Ukraine | 4050 |
| 336 | Lviv Railway Clinical Hospital | Lviv | Lvivska Oblast | Ukraine | 79000 |
| 337 | Lviv Regional Endocrinology Dispensary | Lviv | Lvivska Oblast | Ukraine | 79000 |
| 338 | Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho | Poltava | Poltavska Oblast | Ukraine | 36000 |
| 339 | Diaservis - Medical and Diagnostic Center | Zaporizhia | Zaporizka Oblast | Ukraine | 69076 |
| 340 | Ivano-Frankivsk State Medical University | Ivano-Frankivsk | Ukraine | 76018 | |
| 341 | GI L.T. Malaya TI Namsu | Kharkiv | Ukraine | 61039 | |
| 342 | ACINUS Medical and Diagnostic Center | Kropyvnytskyi | Ukraine | 25006 | |
| 343 | International Institute of Clinical Trials LLC | Kyiv | Ukraine | 02091 | |
| 344 | Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary" | Kyiv | Ukraine | 04078 | |
| 345 | Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary" | Kyiv | Ukraine | 04107 | |
| 346 | Communal City Clinical Emergency Hospital, Danylo Galytskyy Lviv National Medical University | Lviv | Ukraine | 79059 | |
| 347 | Communal Enterprise "Odesa Regional Clinical Hospital" | Odesa | Ukraine | 65117 | |
| 348 | A. Novak Transcarpathian Regional Clinical Hospital | Uzhgorod | Ukraine | 88018 | |
| 349 | Medical Center "Health Clinic" LLC | Vinnitsa | Ukraine | 21009 | |
| 350 | Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU | Vinnytsia | Ukraine | 21005 | |
| 351 | Vinnytsia M.I. Pyrogov NMU Ch of internal medicine #1 | Vinnytsia | Ukraine | 21018 | |
| 352 | Diacenter LLC | Zaporizhzhia | Ukraine | 69076 | |
| 353 | Fairfield General Hospital | Bury | Great Britain | United Kingdom | BL9 7TD |
| 354 | Whipps Cross University Hospital | Leytonstone | London | United Kingdom | E11 1NR |
| 355 | The John Radcliffe Hospital | Oxford | Oxfordshire | United Kingdom | OX3 9DU |
| 356 | Guys/St. Thomas Hospital | London | Surrey | United Kingdom | SE1 9RT |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT03519945
Other Study ID Numbers:
- 16596
- I6T-MC-AMAP
- 2017 004092 31
First Posted:
May 9, 2018
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms: