LUCENT 2: A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03524092
Collaborator
(none)
1,044
400
3
58.3
2.6
0
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1044 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)
Actual Study Start Date
:
Oct 19, 2018
Actual Primary Completion Date
:
Nov 3, 2021
Anticipated Study Completion Date
:
Aug 27, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mirikizumab Dose #1 Mirikizumab Dose #1 administered subcutaneously (SC) |
Drug: Mirikizumab
Administered SC
Other Names:
|
| Experimental: Mirikizumab Dose #2 Mirikizumab Dose #2 administered intravenously (IV) |
Drug: Mirikizumab
Administered IV
Other Names:
|
| Placebo Comparator: Placebo Placebo administered SC |
Drug: Placebo
Administered SC
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants in Clinical Remission [Week 40]
Clinical remission based on modified Mayo Score (MMS).
Secondary Outcome Measures
- Percentage of Participants in Endoscopic Remission [Week 40]
Endoscopic remission based on MMS Endoscopic Subscore (ES).
- Percentage of Participants with Histologic Remission [Week 40]
Histologic remission based on histology.
- Percentage of Participants in Symptomatic Remission [Week 40]
Symptomatic remission based on MMS stool frequency (SF) and rectal bleeding (RB) subscores
- Percentage of Participants in Endoscopic Response [Week 40]
Endoscopic response based on the MMS ES.
- Percentage of Participants in Clinical Response [Week 40]
Clinical response based on the MMS.
- Change from Baseline to Week 40 in Health Related Quality of Life [Baseline, Week 40]
Health Related Quality of Life based on Inflammatory Bowel Disease Questionnaire (IBDQ) score.
- Change from Baseline to Week 40 in Fecal Calprotectin [Baseline, Week 40]
Change from baseline in fecal calprotectin.
- Change from Baseline to Week 40 in Ulcerative Colitis (UC) Symptoms: Numeric Rating Score (NRS) [Baseline, Week 40]
UC symptoms based on NRS scores.
- Percentage of Participants Hospitalized for UC [Week 40]
Percentage of participants hospitalized for UC.
- Pharmacokinetics (PK): Clearance of Mirikizumab [Weeks 0, 4, 12, 24, and 40]
Clearance of mirikizumab
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
-
Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
-
If female, must meet the contraception requirements.
Exclusion Criteria:
-
Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
-
Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
-
Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
-
Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
-
Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
-
Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Digestive Health Specialists | Dothan | Alabama | United States | 36305 |
| 2 | Dcr-Pi, Pc | Litchfield Park | Arizona | United States | 85340 |
| 3 | Maricopa Integrated Health System | Phoenix | Arizona | United States | 85008 |
| 4 | Physicians Research Group | Tempe | Arizona | United States | 85284 |
| 5 | Valley Gastroenterology | Arcadia | California | United States | 91006 |
| 6 | Care Access Research | Berkeley | California | United States | 94705 |
| 7 | Om Research, LLC | Lancaster | California | United States | 93534 |
| 8 | California Medical Research Associates | Northridge | California | United States | 91324 |
| 9 | Clinical Applications Laboratories, Inc. | San Diego | California | United States | 92103 |
| 10 | UCSF Medical Center at Mission Bay | San Francisco | California | United States | 94158 |
| 11 | Direct Helpers Research Center | Hialeah | Florida | United States | 33012 |
| 12 | Nature Coast Clinical Research, LLC | Inverness | Florida | United States | 34452 |
| 13 | SIH Research, LLC | Kissimmee | Florida | United States | 34741 |
| 14 | Wellness Clinical Research | Miami Lakes | Florida | United States | 33016 |
| 15 | Columbus Clinical Services, LLC | Miami | Florida | United States | 33125 |
| 16 | Research Associates of South Florida, LLC | Miami | Florida | United States | 33134 |
| 17 | Center for Interventional Endoscopy | Orlando | Florida | United States | 32803 |
| 18 | Clintheory Healthcare | Orlando | Florida | United States | 32818 |
| 19 | Gastroenterology Associates of Pensacola, PA | Pensacola | Florida | United States | 32503 |
| 20 | Florida Digestive Specialist | Saint Petersburg | Florida | United States | 33709 |
| 21 | Florida Medical Clinic LLC | Zephyrhills | Florida | United States | 33542-7505 |
| 22 | Digestive Healthcare of Georgia | Atlanta | Georgia | United States | 30309 |
| 23 | Grand Teton Research Group | Idaho Falls | Idaho | United States | 83404 |
| 24 | NorthShore University HealthSystem | Evanston | Illinois | United States | 60201 |
| 25 | Indiana University School of Medicine | Indianapolis | Indiana | United States | 46202 |
| 26 | Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | United States | 66606 |
| 27 | Texas Digestive Disease Consultants | Baton Rouge | Louisiana | United States | 70809 |
| 28 | Delta Research Partners LLC | Monroe | Louisiana | United States | 71201 |
| 29 | Nola Research Works, LLC | New Orleans | Louisiana | United States | 70125 |
| 30 | Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | United States | 48047 |
| 31 | Henry Ford Health System | Novi | Michigan | United States | 48377 |
| 32 | Gastroenterology Associates of Western Michigan, P.L.C. | Wyoming | Michigan | United States | 49519 |
| 33 | Huron Gastroenterology Associates | Ypsilanti | Michigan | United States | 48197 |
| 34 | MNGI Digestive Health - Plymouth Endoscopy Center & Clinic | Plymouth | Minnesota | United States | 55446 |
| 35 | Gen1 Research - Gastroenterology & Nutrition, PC | Forest Hills | New York | United States | 11375 |
| 36 | Northwell Health | Great Neck | New York | United States | 11021 |
| 37 | Weill Cornell Medical College | New York | New York | United States | 10021 |
| 38 | University of North Carolina Center for Inflammatory Bowel Disease | Chapel Hill | North Carolina | United States | 27599 |
| 39 | Carolina Digestive Diseases and Endoscopy Center | Greenville | North Carolina | United States | 27834 |
| 40 | Paramount Medical Research | Middleburg Heights | Ohio | United States | 44130 |
| 41 | Care Access - Youngstown | Poland | Ohio | United States | 44514 |
| 42 | Central Sooner Research | Norman | Oklahoma | United States | 73071 |
| 43 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 44 | Care Access Research LLC | Pottsville | Pennsylvania | United States | 17901 |
| 45 | Digestive Disease Associates | Wyomissing | Pennsylvania | United States | 19610 |
| 46 | Midwest Medical Care | Sioux Falls | South Dakota | United States | 57108 |
| 47 | Gastro One | Germantown | Tennessee | United States | 38138 |
| 48 | Galen Medical Group | Hixson | Tennessee | United States | 37343 |
| 49 | Digestive Health Associates of Texas | Garland | Texas | United States | 75044 |
| 50 | Houston Methodist Research Ins | Houston | Texas | United States | 77030 |
| 51 | Biopharma Informatic, LLC | Houston | Texas | United States | 77084 |
| 52 | Gastroenterology Research of San Antonio | San Antonio | Texas | United States | 78229 |
| 53 | Southern Star Research Institute, LLC | San Antonio | Texas | United States | 78229 |
| 54 | Texas Digestive Disease Consultants | Southlake | Texas | United States | 76092 |
| 55 | Care Access Research LLC - Salt Lake City | Ogden | Utah | United States | 84403 |
| 56 | Emeritas Research Group | Leesburg | Virginia | United States | 20176 |
| 57 | The Gastroenterology Group, P.C. | Reston | Virginia | United States | 20191 |
| 58 | Carilion Clinic | Roanoke | Virginia | United States | 24016 |
| 59 | Digestive Health Specialists | Tacoma | Washington | United States | 98405 |
| 60 | Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | United States | 53215 |
| 61 | Centro de Investigaciones Metabólicas (CINME) | Caba | Buenos Aires | Argentina | C1027AAP |
| 62 | Mautalen Salud e Investigacion-Centro de Osteopatías Médicas | Ciudad Autonoma De Buenos Air | Buenos Aires | Argentina | C1128AAF |
| 63 | CER Instituto Medico | Quilmes | Buenos Aires | Argentina | B1878DVC |
| 64 | Fundación de Estudios Clínicos | Rosario | Santa Fe | Argentina | S2000DEJ |
| 65 | Centro de Investigaciones Médicas Tucuman | SAN M. DE Tucuman | Tucumán | Argentina | T4000AXL |
| 66 | C.I.C.E. 9 de Julio | San Miguel de Tucumán | Tucumán | Argentina | 4000 |
| 67 | Hospital Privado Centro Medico de Cordoba SA | Cordoba | Argentina | X5016KEH | |
| 68 | Princess Alexandra Hospital | Brisbane | Queensland | Australia | 4102 |
| 69 | Coastal Digestive Health | Maroochydore | Queensland | Australia | 4558 |
| 70 | Mater University Hospital | South Brisbane | Queensland | Australia | 4101 |
| 71 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
| 72 | Box Hill Hospital Outpatients | Box Hill | Victoria | Australia | 3128 |
| 73 | Melbourne Gastrointestinal Investigation Unit (MGIU) | Malvern | Victoria | Australia | 3144 |
| 74 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
| 75 | The Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
| 76 | Medizinische Universität Innsbruck | Innsbruck | Austria | 6020 | |
| 77 | Universitätsklinikum Salzburg | Salzburg | Austria | 5020 | |
| 78 | Medical University of Vienna | Vienna | Austria | 1090 | |
| 79 | Universitair Ziekenhuis Gent | Gent | Oost-Vlaanderen | Belgium | 9000 |
| 80 | Centre Hospitalier de Wallonie Picarde - Site Notre Dame | Tournai | Wallonne, Région | Belgium | 7500 |
| 81 | AZ Klina | Brasschaat | Belgium | 2930 | |
| 82 | Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | Belgium | 3000 | |
| 83 | West Edmonton Diabetes Center | Edmonton | Alberta | Canada | T5R 1W2 |
| 84 | The Gordon and Leslie Diamond Health Care Centre | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 85 | GI Research Institute | Vancouver | British Columbia | Canada | V6Z 2K5 |
| 86 | PerCuro Clinical Research | Victoria | British Columbia | Canada | V8V 3M9 |
| 87 | Victoria Hospital | London | Ontario | Canada | N6A 4G5 |
| 88 | University of Western Ontario | London | Ontario | Canada | N6A 5G1 |
| 89 | Centre de santé et de services sociaux Champlain-Charles-Le Moyne | Greenfield Park | Quebec | Canada | J4V 2H1 |
| 90 | Hopital Maisonneure-Rosemount | Montreal | Quebec | Canada | H1T 2M4 |
| 91 | Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC | Montreal | Quebec | Canada | H3G 1A4 |
| 92 | Anhui Provincial Hospital | Hefei City | Anhui | China | 230000 |
| 93 | The First Affiliated Hospital of Anhui Medical University | HefeiCity | Anhui | China | 230022 |
| 94 | Beijing Friendship Hospital Affiliate of Capital University | Beijing | Beijing | China | 100050 |
| 95 | Xiangya Hospital Central South University | Kaifu District | Changsha City | China | 410008 |
| 96 | The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA | Chongqing | Chongqing | China | 400037 |
| 97 | The First Hospital Affiliated to AMU (Southwest Hospital) | Chongqing | Chongqing | China | 400038 |
| 98 | Fujian Province Hospital | Fuzhou | Fujian | China | 350001 |
| 99 | The Sixth Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | China | 510655 |
| 100 | The University of Hong Kong-Shenzhen Hospital | Shenzhen | Guangdong | China | 518053 |
| 101 | Hainan General Hospital | Haikou | Hainan | China | 570311 |
| 102 | Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | China | 430022 |
| 103 | Renmin Hospital of Wuhan University | Wuhan | Hubei | China | 430060 |
| 104 | Changzhou No.2 People's Hospital | Changzhou | Jiangsu | China | 213003 |
| 105 | The Affiliated Drum Tower Hospital of Nanjing University | Nanjing | Jiangsu | China | 210008 |
| 106 | Jiangsu Province Hospital of Chinese Medicine | Nanjing | Jiangsu | China | 210029 |
| 107 | Jiangsu Province Hospital | Nanjing | Jiangsu | China | 210029 |
| 108 | Zhongda Hospital Southeast University | Nanjing | Jiangsu | China | 210029 |
| 109 | Nanjing Medical University - Nanjing Jiangning Hospital | Nanjing | Jiangsu | China | 211106 |
| 110 | Jiangxi Pingxiang People's Hospital | Pingxiang | Jiangxi | China | 337055 |
| 111 | Jilin Central General Hospital | Jilin | Jilin | China | 132011 |
| 112 | The Second Hospital of Dalian Medical University | Dalian | Lianing | China | 116000 |
| 113 | Shengjing Hospital of China Medical University | Shenyang | Liaoning | China | 110004 |
| 114 | Qilu Hospital of Shandong University | Jinan | Shandong | China | 250014 |
| 115 | Liaocheng People's Hospital | Liaocheng | Shandong | China | 252000 |
| 116 | The Affiliated Hospital of Medical College Qingdao Univ | Qingdao | Shandong | China | 266000 |
| 117 | Taian City Central Hospital | Taian | Shandong | China | 271000 |
| 118 | Shanghai Jiaotong University School of Medicine Ruijin Hospital | Shanghai | Shanghai | China | 200025 |
| 119 | Renji Hospital Affliated to Shanghai Jiaotong University | Shanghai | Shanghai | China | 200127 |
| 120 | West China Hospital of Sichuan University | Chengdu | Sichuan | China | 610041 |
| 121 | No.1 Hospital Affiliated to Xinjiang Medical University | Urumchi | Urumchi | China | 830054 |
| 122 | Kunming Medical College Affiliated First Hospital | Kunming | Yunnan | China | 650032 |
| 123 | The First People's Hospital of Yunnan Province | Kunming | Yunnan | China | 650034 |
| 124 | The Second Affiliated Hospital of Zhejiang University School of Med | Hangzhou | Zhejiang | China | 310000 |
| 125 | First Affiliated Hosp of College of Med, Zhejiang University | Hangzhou | Zhejiang | China | 310003 |
| 126 | Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | China | 310016 |
| 127 | The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university | Wenzhou | Zhejiang | China | 325027 |
| 128 | Tongji Hospital of Tongji University | Wuhan | China | 430030 | |
| 129 | Vojenská Nemocnice Brno | Brno | Brno-město | Czechia | 636 00 |
| 130 | Fakultni nemocnice Kralovske Vinohrady | Praha 10 | Hl. M. Praha | Czechia | 100 34 |
| 131 | Hepato-Gastroenterologie HK | Hradec Kralove | Hradec Králové | Czechia | 500 12 |
| 132 | MUDr. Gregar, s.r.o. | Olomouc | Olomoucký Kraj | Czechia | 779 00 |
| 133 | A-Shine | Pilsen | Plzeň-město | Czechia | 312 00 |
| 134 | MEDIENDO | Prague | Praha 8 | Czechia | 186 00 |
| 135 | Fakultni Nemocnice u sv. Anny v Brne | Brno | Czechia | 65691 | |
| 136 | PreventaMed, s.r.o. | Olomouc | Czechia | 779 00 | |
| 137 | ISCARE Clinical Centre | Praha 9 | Czechia | 19000 | |
| 138 | Herlev and Gentofte Hospital | Herlev | Denmark | 2730 | |
| 139 | Zealand University Hospital Køge | Køge | Denmark | 4600 | |
| 140 | Hopital de Hautepierre - Service d'Hépatogastroentérolgie | Strasbourg Cedex | Bas Rhin | France | 67098 |
| 141 | Hopital Saint-Louis | Paris | Cedex 10 | France | 75475 |
| 142 | CHU Lille - Hôpital Claude Huriez | Lille cedex | Nord | France | 59037 |
| 143 | Hôpital Beaujon | Clichy | Paris | France | 92110 |
| 144 | Centre Hospitalier de Pau | Pau | Pyrénées-Atlantiques | France | 64000 |
| 145 | Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - | Pierre Benite cedex | Rhone | France | 69495 |
| 146 | CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro | Amiens Cedex | Somme | France | 80480 |
| 147 | CHU Tours - Hôpital Trousseau | Chambray les Tours | France | 37170 | |
| 148 | Assistance Publique Hôpitaux de Marseille - Hôpital Nord | Marseille Cedex 20 | France | 13915 | |
| 149 | CHRU de Montpellier-Hopital St Eloi | Montpellier Cedex 5 | France | 34295 | |
| 150 | Hopital L'Archet 2 | Nice Cedex | France | 06200 | |
| 151 | CHU Bordeaux - Hôpital Haut-Lévêque | Pessac Cedex | France | 33604 | |
| 152 | Robert Debre Hospital | Reims | France | 51092 | |
| 153 | CHU de Saint Etienne Hopital Nord | Saint Priest en Jarez | France | 42270 | |
| 154 | CHRU Nancy Brabois - Hôpital d'Enfants | Vandoeuvre les Nancy | France | 54500 | |
| 155 | Medizinische Hochschule Hanover | Hannover | Niedersachsen | Germany | 30625 |
| 156 | Gemeinschaftspraxis Dr. Peter Uebel | Ludwigshafen am Rhein | Rheinland-Pfalz | Germany | 67067 |
| 157 | Studiengesellschaft BSF Unternehmergesellschaft | Halle (Saale) | Sachsen-Anhalt | Germany | 06108 |
| 158 | Universitätsklinikum Halle | Halle (Saale) | Sachsen-Anhalt | Germany | 06120 |
| 159 | Charité Campus Virchow-Klinikum | Berlin | Germany | 12203 | |
| 160 | Krankenhaus Waldfriede | Berlin | Germany | 14163 | |
| 161 | Städtisches Klinikum Brandenburg | Brandenburg | Germany | 14770 | |
| 162 | HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen | Hamburg | Germany | 20251 | |
| 163 | Internistische Praxisgemeinschaft | Weyhe | Germany | 28844 | |
| 164 | DRC Gyogyszervizsgalo Kozpont Kft. | Balatonfüred | EU | Hungary | 8230 |
| 165 | Jávorszky Ödön Kórház | Vác | Pest | Hungary | 2600 |
| 166 | Óbudai Egészségügyi Centrum | Budapest | Hungary | 1036 | |
| 167 | Semmelweis Egyetem | Budapest | Hungary | 1088 | |
| 168 | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary | 4032 | |
| 169 | Endomedix Diagnosztikai Központ - Miskolc | Miskolc | Hungary | 3526 | |
| 170 | Karolina Korhaz-Rendelointezet | Mosonmagyarovar | Hungary | 9200 | |
| 171 | Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika | Szeged | Hungary | 6720 | |
| 172 | CLINFAN Szolgáltató Kft | Szekszard | Hungary | 7100 | |
| 173 | Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre | Hyderabad | Andhra Pradesh | India | 500058 |
| 174 | Escorts Heart Institute and Research Centre Ltd | New Delhi | Delhi | India | 110 025 |
| 175 | Apollo Research and Innovations, Apollo Hospitals International Ltd | Gandhinagar | Gujarat | India | 382428 |
| 176 | Shree Giriraj Multispeciality Hospital | Rajkot | Gujarat | India | 360005 |
| 177 | Nirmal Hospital Pvt Ltd. | Surat | Gujarat | India | 395002 |
| 178 | Bangalore Medical College and Research Institute | Bangalore | Karnataka | India | 560 002 |
| 179 | M S Ramaiah Medical College and Hospitals | Bangalore | Karnataka | India | 560054 |
| 180 | Midas Multispeciality Hospital Pvt.Ltd. | Nagpur | Maharashtra | India | 440010 |
| 181 | Poona Medical Foundation. Ruby Hall Clinic | Pune | Maharashtra | India | 411 001 |
| 182 | Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital | Wardha | Maharashtra | India | 442004 |
| 183 | Dayanand Medical College and Hospital | Ludhiana | Punjab | India | 141001 |
| 184 | SR Kalla Memorial Gastro & General Hospital | Jaipur | Rajasthan | India | 302001 |
| 185 | King George Medical University | Lucknow | Uttar Pradesh | India | 226003 |
| 186 | Fortis Hospital | Noida | Uttar Pradesh | India | 201301 |
| 187 | Gandhi Hospital | Telangana | India | 500003 | |
| 188 | Beaumont Hospital, Dublin | Dublin | Ireland | D9 | |
| 189 | Shaare Zedek Medical Center | Bait Vagan | Jerusalem | Israel | 91031 |
| 190 | Soroka Medical Center - Pediatric Outpatient Clinic | Beer-Sheva | Israel | 8410101 | |
| 191 | Galilee Medical Center Department of Internal Medicine A | Nahariya | Israel | 2210001 | |
| 192 | Kaplan Medical Center | Rehovot | Israel | 7610001 | |
| 193 | Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | 6423906 | |
| 194 | Assaf Harofeh Medical Center | Zerifin | Israel | 70300 | |
| 195 | Presidio di Rho | Rho | Milano | Italy | 20017 |
| 196 | Istituto Clinico Humanitas | Rozzano | Milano | Italy | 20089 |
| 197 | Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia | San Donato Milanese | Milano | Italy | 20097 |
| 198 | Ospedale Sandro Pertini | Rome | Roma | Italy | 00157 |
| 199 | Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Torre | Roma | Italy | 00133 |
| 200 | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Brescia | Italy | 25123 | |
| 201 | Azienda ospedaliero-universitaria Mater Domini | Catanzaro | Italy | 88100 | |
| 202 | Azienda Ospedaliero Universitaria San Martino | Genova | Italy | 16132 | |
| 203 | Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation | Milano | Italy | 20122 | |
| 204 | Azienda Ospedaliera Universitaria Policlinico de Modena | Modena | Italy | 41124 | |
| 205 | Azienda Ospedaliera Universitaria Pisana | Pisa | Italy | 56124 | |
| 206 | Policlinico Gemelli - Università Cattolica del Sacro Cuore | Roma | Italy | 00168 | |
| 207 | Ospedale Mauriziano Umberto I | Torino | Italy | 10128 | |
| 208 | Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia | Udine | Italy | 33100 | |
| 209 | Aichi Medical University Hospital | Nagakute-shi | Aichi-ken | Japan | 480-1195 |
| 210 | Fujita Health University Hospital | Toyoake-shi | Aichi-ken | Japan | 470-1192 |
| 211 | National Hospital Organization Hirosaki General Medical Center | Hirosaki | Aomori | Japan | 036-8545 |
| 212 | Toho University Sakura Medical Center | Sakura | Chiba | Japan | 285-0841 |
| 213 | Kitakyushu Municipal Medical Center | Kitakyusyu-shi | Fukoka | Japan | 802-0077 |
| 214 | Hidaka Coloproctology Clinic | Kurume-shi | Fukuoka-Ken | Japan | 839 0809 |
| 215 | Fukuoka University Chikushi Hospital | Chikushino | Fukuoka | Japan | |
| 216 | Gunma University Hospital | Maebashi | Gunma | Japan | 371-8511 |
| 217 | National Hospital Organization Takasaki General Medical Centar | Takasaki | Gunma | Japan | 370-0829 |
| 218 | NHO Mito Medical Center | Ibaraki-machi | HigaShiibaraki-Gun | Japan | 311 3193 |
| 219 | Asahikawa City Hospital | Asahikawa | Hokkaido | Japan | 070-8610 |
| 220 | Tokushukai Sapporo Tokushukai Hospital | Sapporo-shi | Hokkaido | Japan | 004 0041 |
| 221 | Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital | Sapporo-shi | Hokkaido | Japan | 060 0033 |
| 222 | Sapporo Higashi Tokushukai Hospital | Sapporo | Hokkaido | Japan | 065-0033 |
| 223 | Aoyama Clinic GI Endoscopy & IBD Center | Kobe-shi | Hyogo-Ken | Japan | 650 0015 |
| 224 | Kagawa Prefectural Central Hospital | Takamatsu | Kagawa | Japan | 760-8557 |
| 225 | Sankikai Yokohama Shin midori General Hospital | Yokohama-shi | Kanagawa-Ken | Japan | 226 0025 |
| 226 | Ofuna Central Hospital | Kamakura | Kanagawa | Japan | 247-0056 |
| 227 | Kawasaki Municipal Hospital | Kawasaki | Kanagawa | Japan | 210-0013 |
| 228 | Yokohama City University Medical Center | Yokohama | Kanagawa | Japan | 232-0024 |
| 229 | Showa University Northern Yokohama Hospital | Yokohama | Kanagawa | Japan | 234-0032 |
| 230 | Kumamoto University Hospital | Kumamoto-shi | Kumamoto | Japan | 860-0012 |
| 231 | Mie University Hospital | Tsu | Mie | Japan | 514-8507 |
| 232 | Takagi Clinic - Sendai | Sendai-shi | Miyagi-Ken | Japan | 981 3213 |
| 233 | Nagaoka Chuo General Hospital | Nagaoka-shi | Niigata | Japan | 940-8653 |
| 234 | Ishida Clinic of IBD and Gastroenterology | Oita-shi | Oita-Ken | Japan | 870 0823 |
| 235 | Sai Gastroenterologist Proctology | Fujiidera | Osaka | Japan | 583-0027 |
| 236 | Infusion Clinic | Osaka-shi | Osaka | Japan | 530 0011 |
| 237 | NHO Osaka National Hospital | Osaka-shi | Osaka | Japan | 540 0006 |
| 238 | Saga-Ken Medical Center Koseikan | Saga-Shi | Saga-Ken | Japan | 840-8571 |
| 239 | Kumagaya General Hospital | Kumagaya-shi | Saitama-Ken | Japan | 360-8567 |
| 240 | Matsuda Hospital | Hamamatsu-shi | Shizuoka-Ken | Japan | 4328061 |
| 241 | Jichi Medical University Hospital | Shimotsuke-shi | Tochigi-Ken | Japan | 329-0498 |
| 242 | Mitsui Memorial Hospital | Chiyoda-ku | Tokyo-To | Japan | 101-8643 |
| 243 | Center Hospital of the National Center for Global Health and Medicine | Shinjuku-ku | Tokyo-To | Japan | 162 8655 |
| 244 | Juntendo University Hospital | Bunkyo-ku | Tokyo | Japan | 113-8431 |
| 245 | Tokyo Medical and Dental University Hospital | Bunkyō | Tokyo | Japan | 113-8519 |
| 246 | Showa University Koto Toyosu Hospital | Koto-ku | Tokyo | Japan | 135 8577 |
| 247 | Kitasato University Kitasato Institute Hospital | Minato-Ku | Tokyo | Japan | 108 8642 |
| 248 | Kyorin University Hospital | Mitaka | Tokyo | Japan | 181-8611 |
| 249 | JHCO Tokyo Yamate Medical Center | Shinjuku-ku | Tokyo | Japan | 169-0073 |
| 250 | Fukuoka University Hospital | Fukuoka | Japan | 814-0180 | |
| 251 | Hiroshima University Hospital | Hiroshima | Japan | 734-8551 | |
| 252 | Sameshima Hospital | Kagoshima | Japan | 892-0846 | |
| 253 | National Hospital Organization Kyoto Medical Center | Kyoto | Japan | 612-8555 | |
| 254 | Okayama University Hospital | Okayama | Japan | 700-8558 | |
| 255 | Tokitokai Tokito Clinic | Saitama | Japan | 336-0963 | |
| 256 | Toyama Prefectural Central Hospital | Toyama | Japan | 930-8550 | |
| 257 | Severance Hospital, Yonsei University Health System | Wonju-si | Gangwon-do | Korea, Republic of | 26426 |
| 258 | Kyung Hee University Hospital | Seoul | Korea | Korea, Republic of | 02447 |
| 259 | Dong-A University Hospital | Busan | Pusan-Kwangyǒkshi | Korea, Republic of | 49201 |
| 260 | Kangbuk Samsung Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 03181 |
| 261 | Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 05505 |
| 262 | Samsung Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 06351 |
| 263 | The Catholic University of Korea, Daejeon St. Mary's Hospital | Daejeon | Taejǒn-Kwangyǒkshi | Korea, Republic of | 34943 |
| 264 | Inje University Haeundae Paik Hospital | Busan | Korea, Republic of | 48108 | |
| 265 | Yeungnam Univeristy Medical Center | Daegu | Korea, Republic of | 42415 | |
| 266 | Pauls Stradins Clinical Univeristy Hospital | Riga | Rīga | Latvia | LV-1002 |
| 267 | Digestive Diseases Center "Gastro" | Riga | Latvia | 1079 | |
| 268 | Riga Eastern Clinical University Hospital | Riga | Latvia | LV-1038 | |
| 269 | Respublikine Panevezio ligonine | Panevezys | Panevėžio Apskritis | Lithuania | LT-35144 |
| 270 | Hospital of Lithuanian University of Health Sciences Kaunas | Kaunas | Lithuania | 50009 | |
| 271 | Republic Hospital of Klaipeda | Klaipeda | Lithuania | 92231 | |
| 272 | Klaipeda Seamen's Hospital | Klaipeda | Lithuania | 92288 | |
| 273 | Vilnius University Hospital Santariskiu Clinics | Vilnius | Lithuania | LT-08661 | |
| 274 | Universiti Sains Malaysia | Kubang Kerian | Kelantan | Malaysia | 16150 |
| 275 | University Malaya Medical Centre | Lembah Pantai | Kuala Lumpur | Malaysia | 59100 |
| 276 | Hospital Ampang | Ampang | Selangor | Malaysia | 68000 |
| 277 | Centro de Investigación Clínica Acelerada | Mexico City | Distrito Federal | Mexico | 07020 |
| 278 | Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. | Zapopan | Jalisco | Mexico | 45030 |
| 279 | Centro Para el Desarrollo de la Medicina y de Asistencia Med | Culiacan | Sinaloa | Mexico | 80230 |
| 280 | Scientia Investigacion Clinica S.C. | Chihuahua | Mexico | 31203 | |
| 281 | Sociedad de Metabolismo y Corazon | Veracruz | Mexico | 91900 | |
| 282 | St Elisabeth Ziekenhuis | Tilburg | Noord Brabant | Netherlands | 5022 GC |
| 283 | Amsterdam UMC, locatie AMC | Amsterdam | Noord-Holland | Netherlands | 1105 AZ |
| 284 | Bernhoven Ziekenhuis | Uden | Netherlands | 5406 PT | |
| 285 | UMC Utrecht, Dept. of Internal Medicine, MDL | Utrecht | Netherlands | 3584 CX | |
| 286 | LexMedica | Wroclaw | Dolnośląskie | Poland | 53-114 |
| 287 | Szpital Uniwersytecki Nr 2 w Bydgoszczy | Bydgoszcz | Kujawsko-pomorskie | Poland | 85-168 |
| 288 | Centrum Medyczne Pratia Bydgoszcz | Bydgoszcz | Kujawsko-pomorskie | Poland | 85-796 |
| 289 | ZOZ Gastromed | Lublin | Lubelskie | Poland | 20-582 |
| 290 | Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie | Lublin | Lubelskie | Poland | 20-954 |
| 291 | NZOZ Vivamed | Warsaw | Mazowieckie | Poland | 03-580 |
| 292 | Topolowa Medicenter | Krakow | Małopolskie | Poland | 31-506 |
| 293 | Medicenter Nowy Targ | Nowy Targ | Małopolskie | Poland | 34-400 |
| 294 | NZOZ Formed | Wadowice | Małopolskie | Poland | 34-100 |
| 295 | Endoskopia Sp. z.o.o. | Sopot | Pomorskie | Poland | 81-756 |
| 296 | SONOMED Centrum Medyczne | Szczecin | Zachodniopomorskie | Poland | 71-685 |
| 297 | All-Medicus | Katowice | Poland | 40-660 | |
| 298 | Wojewodzki Specjalistyczny Szpital w Olsztynie | Olsztyn | Poland | 10-561 | |
| 299 | Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | Poland | 71-434 | |
| 300 | Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii | Torun | Poland | 87-100 | |
| 301 | Warsaw IBD Point Profesor Kierkus | Warszawa | Poland | 00-728 | |
| 302 | Centrum Zdrowia MDM | Warszawa | Poland | 00635 | |
| 303 | Centrum Medyczne NeuroProtect | Warszawa | Poland | 01-697 | |
| 304 | PlanetMed Sp.z o.o. | Wroclaw | Poland | 52-210 | |
| 305 | ETG Zamość | Zamosc | Poland | 22-400 | |
| 306 | Promedica Dental Clinic | Bedzin | Śląskie | Poland | 42-500 |
| 307 | KO-Med Centrum Medyczne | Straszów | Świętokrzyskie | Poland | 28-200 |
| 308 | CCBR Clinical Research | Bucharest | București | Romania | 030463 |
| 309 | MedLife Grivita | Bucuresti | Romania | 010719 | |
| 310 | Spitalul Clinic Colentina | Bucuresti | Romania | 020125 | |
| 311 | Institutul Clinic Fundeni | Bucuresti | Romania | 022328 | |
| 312 | Hifu Terramed Conformal SRL | Bucuresti | Romania | 031864 | |
| 313 | Spital Pelican Oradea | Oradea | Romania | 410469 | |
| 314 | Scientific Centre of Reconstructive and Restorative Surgery | Irkutsk | Irkutskaya Oblast' | Russian Federation | 664079 |
| 315 | Karelia Republican Hospital V.A. Baranova | Petrozavodsk | Kareliya, Respublika | Russian Federation | 185019 |
| 316 | Nizhny Novgorod Regional Hospital N.A. Semashko | Nizhny Novgorod | Nizhegorodskaya Oblast' | Russian Federation | 603126 |
| 317 | Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod | Nizhny Novgorod | Nizhegorodskaya Oblast' | Russian Federation | 603140 |
| 318 | Novosibirski Gastrocenter | Novosibirsk | Novosibirskaya Oblast' | Russian Federation | 630007 |
| 319 | Rostov State Medical University | Rostov-on-Don | Rostovskaya Oblast' | Russian Federation | 344091 |
| 320 | Scientific research center ECO-security | Saint Petersburg | Sankt-Peterburg | Russian Federation | 196143 |
| 321 | Multidisciplinary Medical Clinic "Anthurium" | Barnaul | Russian Federation | 656043 | |
| 322 | Medical and Sanitary Division of Severstal | Cherepovets | Russian Federation | 162600 | |
| 323 | LLC MA New Hospital | Ekaterinburg | Russian Federation | 620109 | |
| 324 | Alliance Biomedical URAL Group | Izhevsk | Russian Federation | 426061 | |
| 325 | Clinical Trials Center of Medical Institute | Kaliningrad | Russian Federation | 236035 | |
| 326 | State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan" | Kazan | Russian Federation | 420064 | |
| 327 | SIH Kemerovo Regional Clinical Hosptial | Kemerovo | Russian Federation | 650066 | |
| 328 | Medical rehabilitation center | Moscow | Russian Federation | 125367 | |
| 329 | LLC "Medicine Center SibNovoMed" | Novosibirsk | Russian Federation | 630005 | |
| 330 | Clinical Diagnostic Center Ultramed | Omsk | Russian Federation | 644024 | |
| 331 | Saint Petersburg State Medical University n.a. Pavlov I.P. | Saint Petersburg | Russian Federation | 197022 | |
| 332 | Pokrovskaya Municipal Hospital | Saint-Petersburg | Russian Federation | 195067 | |
| 333 | Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways" | Saint-Petersburg | Russian Federation | 195271 | |
| 334 | SBIH City Clinical Hospital #31 | Saint-Petersburg | Russian Federation | 197110 | |
| 335 | Medical Institute REAVIZ | Samara | Russian Federation | 443001 | |
| 336 | City Mariinskaya Hospital | St. Petersburg | Russian Federation | 191104 | |
| 337 | Stavropol State Medical University | Stavropol | Russian Federation | 355018 | |
| 338 | Yaroslavl Municipal HI Clinical Hospital #8 | Yaroslavl | Russian Federation | 150030 | |
| 339 | Clinical Hospital Center Zvezdara | Belgrade | Beograd | Serbia | 11000 |
| 340 | University Medical Center "Bezanijska kosa" | Belgrade | NAP | Serbia | 11080 |
| 341 | Regional Hospital Dr Radivoj Simonovic Sombor | Sombor | Vojvodina | Serbia | 25000 |
| 342 | Sremska Mitrovica Health Centre | Sremska Mitrovica | Vojvodina | Serbia | 22000 |
| 343 | General Hospital "Djordje Joanovic" | Zrenjanin | Vojvodina | Serbia | 23000 |
| 344 | Clinical Center Kragujevac Gastroenterohepatology Clinic | Kragujevac | Serbia | 34000 | |
| 345 | KM Management | Nitra | Nitriansky Kraj | Slovakia | 949 01 |
| 346 | Gastro | Prešov | Prešovský Kraj | Slovakia | 080 01 |
| 347 | Endomed, s.r.o. | Vranov N. Toplou | Prešovský Kraj | Slovakia | 093 01 |
| 348 | Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica | Banska Bystrica | Slovakia | 975 17 | |
| 349 | Univerzitna nemocnica Bratislava | Bratislava | Slovakia | 82007 | |
| 350 | Hospital Universitario Virgen Del Rocio | Sevilla | Andalucía | Spain | 41013 |
| 351 | Hospital Universitario Central de Asturias | Oviedo | Asturias | Spain | 33011 |
| 352 | Hospital Universitari Son Espases | Palma de Mallorca | Baleares Islands | Spain | 07120 |
| 353 | Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | Spain | 39008 |
| 354 | Hospital De Fuenlabrada | Fuenlabrada | Madrid | Spain | 28942 |
| 355 | Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo | Sagunto | Valencia | Spain | 46520 |
| 356 | Instituto de Ciencias Médicas | Alicante | Spain | 3004 | |
| 357 | Hospital Universitari de Girona | Girona | Spain | 17007 | |
| 358 | Hospital Universitario Juan Ramon Jimenez | Huelva | Spain | 21005 | |
| 359 | Complexo Hospitalario Universitario A Coruña, CHUAC | La Coruña | Spain | 15006 | |
| 360 | Hospital De Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria | Spain | 35010 | |
| 361 | Hospital Universitario La Paz | Madrid | Spain | 28046 | |
| 362 | Gastroenterologische Praxis Balsiger, Seibold & Partner | Bern | Berne | Switzerland | 3012 |
| 363 | Inselspital Bern | Berne | Switzerland | 3010 | |
| 364 | Kantonsspital St.Gallen | St.Gallen | Switzerland | 9007 | |
| 365 | UniversitätsSpital Zürich | Zürich | Switzerland | 8091 | |
| 366 | China Medical University Hospital | Taichung | Taiwan | 40447 | |
| 367 | Health management center | Taipei | Taiwan | 10002 | |
| 368 | Antalya Egitim ve Arastırma Hastanesi | Kocaeli | Antalya | Turkey | 7100 |
| 369 | Acibadem Universitesi - Acibadem Kozyatagi Hastanesi | Kadıkoy | Istanbul | Turkey | 34734 |
| 370 | Kocaeli University Medical Faculty Hospital | Izmit | Kocaeli | Turkey | 41380 |
| 371 | Mersin University Medical Faculty | Yenişehir | Mersin | Turkey | 33110 |
| 372 | Ege University Medicine of Faculty | Izmir | Turkey | 35100 | |
| 373 | Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk | Ivano-Frankivsk Region | Ukraine | 76008 |
| 374 | City Clinical Hospital No. 2 | Kharkiv | Kharkivska Oblast | Ukraine | 61037 |
| 375 | Kherson City Clinical Hospital | Kherson | Khersonska Oblast | Ukraine | 73000 |
| 376 | Medical Center of Limited Liability Company "Medical Center "Consilium Medical" | Kiev | Kyiv | Ukraine | 4050 |
| 377 | Lviv Railway Clinical Hospital | Lviv | Lvivska Oblast | Ukraine | 79000 |
| 378 | Lviv Regional Endocrinology Dispensary | Lviv | Lvivska Oblast | Ukraine | 79000 |
| 379 | Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital" | Lviv | Lvivska Oblast | Ukraine | 79000 |
| 380 | Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho | Poltava | Poltavska Oblast | Ukraine | 36000 |
| 381 | Diaservis - Medical and Diagnostic Center | Zaporizhia | Zaporizka Oblast | Ukraine | 69076 |
| 382 | Kharkiv City Student Hospital | Kharkiv | Ukraine | 61002 | |
| 383 | GI L.T. Malaya TI Namsu | Kharkiv | Ukraine | 61039 | |
| 384 | Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus | Kropyvnytskyi | Ukraine | 25006 | |
| 385 | Kyiv Municipal Clinical Hospital #1 | Kyiv | Ukraine | 02091 | |
| 386 | Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary" | Kyiv | Ukraine | 04078 | |
| 387 | Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary" | Kyiv | Ukraine | 04107 | |
| 388 | Communal Enterprise "Odesa Regional Clinical Hospital" | Odesa | Ukraine | 65000 | |
| 389 | A. Novak Transcarpathian Regional Clinical Hospital | Uzhgorod | Ukraine | 88000 | |
| 390 | Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU | Vinnytsia | Ukraine | 21005 | |
| 391 | MCIC MC LLC Health Clinic | Vinnytsia | Ukraine | 21009 | |
| 392 | CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM | Vinnytsia | Ukraine | 21029 | |
| 393 | M.I. Pyrogov Regional Clinical Hospital | Vinnytsya | Ukraine | 21018 | |
| 394 | Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2 | Zaporizhzhia | Ukraine | 69104 | |
| 395 | Queens Hospital | Romford | Essex | United Kingdom | RM7 0AG |
| 396 | Fairfield General Hospital | Bury | Great Britain | United Kingdom | BL9 7TD |
| 397 | St Thomas' Hospital | Great Maze Pond | London | United Kingdom | SE1 9RT |
| 398 | Whipps Cross University Hospital | London | Surrey | United Kingdom | E11 1NR |
| 399 | Morriston Hospital | Swansea | Swansea [Abertawe Gb-ata] | United Kingdom | SA6 6SG |
| 400 | St James's University Hospital | Leeds | Vinnytsia | United Kingdom | LS9 7TF |
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:
NCT03524092
Other Study ID Numbers:
- 16823
- I6T-MC-AMBG
- 2017-003238-96
First Posted:
May 14, 2018
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 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: