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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03519945
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This study 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
Ulcerative Colitis Drug: Mirikizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
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 : July 18, 2018
Estimated Primary Completion Date : August 23, 2023
Estimated Study Completion Date : August 23, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mirikizumab
Mirikizumab administered subcutaneously (SC).
Drug: Mirikizumab
Administered SC.
Other Name: LY3074828




Primary Outcome Measures :
  1. Percentage of Participants in Clinical Remission [ Time Frame: Week 52 ]
    Clinical remission based on the modified Mayo Score (MMS).


Secondary Outcome Measures :
  1. Percentage of Participants in Endoscopic Remission [ Time Frame: Week 52 ]
    Endoscopic remission based on the MMS Endoscopic Subscores (ES).

  2. Percentage of Participants in Corticosteroid-free Remission [ Time Frame: Week 52 ]
    Percentage of participants in corticosteroid-free remission.

  3. Percentage of Participants with Mucosal Healing at Week 52 [ Time Frame: Week 52 ]
    Mucosal healing based on a histologic disease activity index.

  4. Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score [ Time Frame: Baseline to Week 52 ]
    Health Related Quality of Life based on IBDQ score.

  5. UC Symptoms: Numeric Rating Score [ Time Frame: Week 160 ]
    UC symptoms based on numeric rating score.

  6. Percentage of Participants Who are Hospitalized Due to UC [ Time Frame: Baseline to Week 160 ]
    Percentage of participants who are hospitalized due to UC.

  7. Percentage of Participants Who Undergo UC Surgeries Including Colectomy [ Time Frame: Baseline to Week 160 ]
    Percentage of participants who undergo UC surgeries including colectomy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Inclusion Criteria

    • Participants from Study AMAC (NCT02589665) or AMBG (NCT #:TBD) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519945


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

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Locations
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United States, Alabama
Digestive Health Specialists of the Southeast Not yet recruiting
Dothan, Alabama, United States, 36305
Contact    334-836-3341      
Principal Investigator: Paul Lamb         
United States, California
University of California San Diego Not yet recruiting
La Jolla, California, United States, 92093
Contact    858-657-5284      
Principal Investigator: William J Sandborn         
Inland Empire Liver Foundation Recruiting
Rialto, California, United States, 92377
Contact    909-883-2999      
Principal Investigator: Zeid Kayali         
Clinical Applications Laboratories, Inc. Not yet recruiting
San Diego, California, United States, 92103
Contact    619-260-1012      
Principal Investigator: Vijayalakshmi S Pratha         
United States, Florida
Wellness Clinical Research Recruiting
Hialeah Gardens, Florida, United States, 33012
Contact    786-483-7856      
Principal Investigator: Lucky Flores         
Nature Coast Clinical Research, LLC Recruiting
Inverness, Florida, United States, 34452
Contact    352-341-2100      
Principal Investigator: Paul A Hellstern         
Borland Groover Clinic Recruiting
Jacksonville, Florida, United States, 32256 6004
Contact    904-398-3262      
Principal Investigator: Mark R Fleisher         
Research Associates of South Florida, LLC Not yet recruiting
Miami, Florida, United States, 33156
Contact    786-476-8790      
Principal Investigator: Javier Sobrado         
Gastroenterology Associates of Pensacola, PA Not yet recruiting
Pensacola, Florida, United States, 32503
Contact    850-436-4536      
Principal Investigator: Frederic Newman         
United States, Georgia
Digestive Healthcare of Georgia Not yet recruiting
Atlanta, Georgia, United States, 30309
Contact    404-355-3200      
Principal Investigator: Michael R Galambos         
United States, Kansas
Cotton-O'Neil Clinical Research Center, Digestive Health Not yet recruiting
Topeka, Kansas, United States, 66606
Contact    785-270-4852      
Principal Investigator: Thomas C Welton         
United States, Louisiana
Delta Research Partners LLC Recruiting
Monroe, Louisiana, United States, 71201
Contact    318-283-2177      
Principal Investigator: Bal Raj Bhandari         
United States, Michigan
University of Michigan Completed
Ann Arbor, Michigan, United States, 48109
Clinical Research Institute of Michigan, LLC Recruiting
Chesterfield, Michigan, United States, 48047
Contact    586-598-3329      
Principal Investigator: Ronald P Fogel         
Gastroenterology Associates of Western Michigan, P.L.C. Not yet recruiting
Wyoming, Michigan, United States, 49529
Contact    616-328-5344      
Principal Investigator: Allan G Coates         
United States, Minnesota
Minnesota Gastroenterology, P.A. Recruiting
Plymouth, Minnesota, United States, 55446
Contact    612-870-5599      
Principal Investigator: Robert P McCabe         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact    212-831-4900      
Principal Investigator: Simon Lichtiger         
United States, North Carolina
University of North Carolina Center for Inflammatory Bowel Disease Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact    919-843-3873      
Principal Investigator: Animesh Jain         
United States, Pennsylvania
Care Access Research LLC Recruiting
Pottsville, Pennsylvania, United States, 17901
Contact    570-478-5120      
Principal Investigator: Glenn Freed         
United States, Tennessee
Gastro One Not yet recruiting
Germantown, Tennessee, United States, 38138
Contact    901-309-6035      
Principal Investigator: Ziad H Younes         
United States, Texas
Digestive Health Associates of Texas Not yet recruiting
Garland, Texas, United States, 75044
Contact    972-265-8201      
Principal Investigator: Harry Sarles         
Biopharma Informatic, Inc. Not yet recruiting
Houston, Texas, United States, 77084
Contact    2819443610      
Principal Investigator: James Arthur Maher         
Gastroenterology Research of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact    210-615-3848      
Principal Investigator: Nicholas P Martinez         
Texas Digestive Disease Consultants Not yet recruiting
Southlake, Texas, United States, 76092
Contact    940-367-2316      
Principal Investigator: Timothy Ritter         
Texas Digestive Disease Consultants Not yet recruiting
Southlake, Texas, United States, 76092
Contact    817-424-1525      
Principal Investigator: Timothy Ritter         
United States, Utah
Care Access Research - Salt Lake City Not yet recruiting
Ogden, Utah, United States, 84403
Contact    908-941-2273      
Principal Investigator: Chad Gonzales         
Care Access Research - Salt Lake City Recruiting
Salt Lake City, Utah, United States, 84124
Contact    801-893-1788      
Principal Investigator: Peder J Pedersen         
Argentina
Hospital Italiano de Buenos Aires Not yet recruiting
Caba, Buenos Aires, Argentina, C1181ACH
Contact    541149590200      
Principal Investigator: Juan De Paula         
Glenny Corp SA- BIOCLINICA Argentina Recruiting
Caba, Buenos Aires, Argentina, C1430CKE
Contact    541145445522      
Principal Investigator: Rafael Escobar Fernandez         
CER Instituto Medico Not yet recruiting
Quilmes, Buenos Aires, Argentina, B1878DVC
Contact    541143509600      
Principal Investigator: Edgardo Gimenez         
Instituto de Investigaciones Clinicas Quilmes Not yet recruiting
Quilmes, Buenos Aires, Argentina, B1878GEG
Contact    541142531337      
Principal Investigator: Paola Adami         
Fundación de Estudios Clínicos Not yet recruiting
Rosario, Santa Fe, Argentina, S2000DEJ
Contact    543415290086      
Principal Investigator: Martin Camilo Azum         
Mautalen Salud e Investigación - Servicio de Endocrinología Recruiting
Ciudad Autonoma De Buenos Air, Argentina, C1128AAF
Contact    541145143410      
Principal Investigator: Emiliano Tron         
Australia, Queensland
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact    61731767792      
Principal Investigator: Gerald Holtmann         
Australia, Victoria
St Vincents Hospital Melbourne Recruiting
Fitzroy, Victoria, Australia, 3065
Contact    61392313580      
Principal Investigator: John Nik Sheng Ding         
Austria
AKH - Gastroenterologie und Hepatologie - Interne Medizin III Not yet recruiting
Wien, Vienna, Austria, 1090
Contact    43014040047440      
Principal Investigator: Walter Reinisch         
Medizinische Universität Innsbruck Not yet recruiting
Innsbruck, Austria, 6020
Contact    435125040      
Principal Investigator: Robert Koch         
Universitätsklinikum Salzburg Not yet recruiting
Salzburg, Austria, 5020
Contact    435725525402      
Principal Investigator: Sonja Gassner         
KH der Barmherzigen Schwestern Wien BetriebsGesmbH Not yet recruiting
Wien, Austria, 1060
Contact    431599882119      
Principal Investigator: Franz Pfeffel         
Belgium
AZ Klina Not yet recruiting
Brasschaat, Belgium, 2930
Contact    3236505053      
Principal Investigator: Jos Callens         
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Contact    3293325166      
Principal Investigator: Triana Lobaton         
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
Contact    3216348856      
Principal Investigator: Marc Ferrante         
Canada, British Columbia
Fraser Clinical Trials, Inc. Not yet recruiting
New Westminster, British Columbia, Canada, V3L 3W4
Contact    6045228899      
Principal Investigator: Kenneth Atkinson         
The Gordon and Leslie Diamond Health Care Centre Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact    6048755224      
Principal Investigator: Baljinder Salh         
GI Research Institute Recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Contact    6046886332      
Principal Investigator: Gregory Rosenfeld         
Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact    2263776579      
Principal Investigator: Vipul Jairath         
Canada, Quebec
CIUSS-de-L'Est-de-l'île-de-Montréal-Hôpital Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact    5142523400      
Principal Investigator: Guy Aumais         
McGill University Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact    5149341934      
Principal Investigator: Waqqas Afif         
Croatia
University Hospital Center Osijek Not yet recruiting
Osijek, Croatia, 31000
Contact    38531511101      
Principal Investigator: Vladimir Borzan         
CHC Zagreb Not yet recruiting
Zagreb, Croatia, 10000
Contact    38512388888      
Principal Investigator: Zeljko Krznaric         
Clinical Hospital Sveti Duh Not yet recruiting
Zagreb, Croatia, 10000
Contact    38513712226      
Principal Investigator: Marinko Marusic         
Polyclinic Bonifarm Not yet recruiting
Zagreb, Croatia, 10000
Contact    38516461170      
Principal Investigator: Katja Grubelic Ravic         
University Hospital Center Sestre Milosrdnice Not yet recruiting
Zagreb, Croatia, 10000
Contact    385994430566      
Principal Investigator: Vedran Tomasic         
Czechia
Hepato-gastroenterologie HK, s.r.o. Recruiting
Hradec Kralove, Czechia, 50012
Contact    420495404485      
Principal Investigator: Tomas Vanasek         
Gregar s.r.o. Not yet recruiting
Olomouc, Czechia, 779 00
Contact    420777284842      
Principal Investigator: Jan Gregar         
PreventaMed, s.r.o. Not yet recruiting
Olomouc, Czechia, 779 00
Contact    420585225504      
Principal Investigator: Jiri Pumprla         
A-Shine s.r.o. Not yet recruiting
Plzen, Czechia, 31200
Contact    420777242101      
Principal Investigator: Lubos Janu         
Denmark
Nyborg Sygehus - OUH Recruiting
Nyborg, Denmark, 5800
Contact    4563312906      
Principal Investigator: Claus Aalykke         
France
CHRU de Montpellier-Hopital St Eloi Recruiting
Montpellier, France, 34295
Contact    33467337064      
Principal Investigator: Romain Altwegg         
CHU de Nice Hopital de L'Archet Not yet recruiting
Nice cedex 3, France, 06202
Contact    33492036168      
Principal Investigator: Xavier Hebuterne         
CHU St Etienne Hopital Nord Recruiting
Saint Etienne Cedex 2, France, 42055
Contact    33477828320      
Principal Investigator: Xavier Roblin         
Georgia
LLC ARENSIA Exploratory Medicine Recruiting
Tbilisi, Georgia, 0112
Contact    995599171517      
Principal Investigator: Konstantine Maisaia         
Germany
Universitätsklinikum Ulm Not yet recruiting
Ulm, Baden-Württemberg, Germany, 89081
Contact    4973150044501      
Principal Investigator: Jochen Klaus         
Klinikum Augsburg Not yet recruiting
Augsburg, Bavaria, Germany, 86156
Contact    4982140001      
Principal Investigator: Elisabeth Schnoy         
Medizinische Hochschule Hannover Not yet recruiting
Hannover, Niedersachsen, Germany, 30625
Contact    495115329427      
Principal Investigator: Ursula Seidler         
Martin-Luther-Universität Halle-Wittenberg Not yet recruiting
Halle (Saale), Sachsen-Anhalt, Germany, 06120
Contact    493455572668      
Principal Investigator: Jens Walldorf         
Gastroenterologische Praxis Dres Behrens, Steudel, Fechner Not yet recruiting
Halle (Saale), Saxony-Anhalt, Germany, 06108
Contact    49345299760      
Principal Investigator: Lars Fechner         
Charité Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 10117
Contact    4930450 665214      
Principal Investigator: Anja Schirbel         
Charité Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 13353
Contact    004930450514358      
Principal Investigator: Britta Siegmund         
Krankenhaus Waldfriede e. V. Not yet recruiting
Berlin, Germany, 14163
Contact    4930818108509      
Principal Investigator: Carsten Büning         
Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen Not yet recruiting
Hamburg, Germany, 20251
Contact    4940423265150      
Principal Investigator: Stefanie Howaldt         
INLUGA im Haus der Gesundheit Not yet recruiting
Ludwigshafen, Germany, 67067
Contact    4962159570060      
Principal Investigator: Peter Uebel         
Gastro Campus Research GbR Not yet recruiting
Münster, Germany, 48159
Contact    492512846680      
Principal Investigator: Michael Linnepe         
Praxiszentrum Alte Maelzerei Not yet recruiting
Regensburg, Germany, 93053
Contact    49941920600      
Principal Investigator: Florian Obermeier         
Hungary
Dr. Rethy Pal Korhaz es Rendelointezet Recruiting
Bekescsaba, Bekes, Hungary, 5600
Contact    36309159350      
Principal Investigator: Marta Varga         
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo I. Belgyogyaszat Recruiting
Budapest, Hungary, 1125
Contact    3614584533      
Principal Investigator: Gabor Tamas Toth         
SZTE I. sz. Belgyogyaszati Klinika Recruiting
Szeged, Hungary, 6720
Contact    3662545185      
Principal Investigator: Zoltan Szepes         
Clinfan Szolgaltato Kft. Recruiting
Szekszard, Hungary, 7100
Contact    3674501500      
Principal Investigator: Agnes Salamon         
Javorszky Odon Hospital Recruiting
Vac, Hungary, 2600
Contact    3627620620      
Principal Investigator: Tibor Szaloki         
India
Sunshine Hospital Not yet recruiting
Hyderabad, Andhra Pradesh, India, 500003
Contact    09391075600      
Principal Investigator: Ravi Shankar         
Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre Recruiting
Hyderabad, Andhra Pradesh, India, 500058
Contact    91 9347364790      
Principal Investigator: Mohammed Aejaz Habeeb         
Gandhi Hospital Not yet recruiting
Secunderabad, AP, India, 500048
Contact    04027505566      
Principal Investigator: Shravan Porika         
Institute of Digestive and Liver Diseases Recruiting
Guwahati, Assam, India, 781 006
Contact    919864094739      
Principal Investigator: Bhabadev Goswami         
Escorts Heart Institute and Research Centre Ltd Recruiting
New Delhi, Delhi, India, 110 025
Contact    9111268254213      
Principal Investigator: Mukul Rastogi         
Sir Ganga Ram Hospital Not yet recruiting
New Delhi, Delhi, India, 110060
Contact    91115735205      
Principal Investigator: Naresh Bansal         
Apollo Research and Innovations, Apollo Hospitals International Ltd Not yet recruiting
Gandhinagar, Gujarat, India, 382428
Contact    917966701843      
Principal Investigator: Shravan Bohra         
Shree Giriraj Hospital Not yet recruiting
Rajkot, Gujarat, India, 360005
Contact    912812587087      
Principal Investigator: Chetan Mehta         
Nirmal Hospital Private Limited Recruiting
Surat, Gujarat, India, 395002
Contact    919408042224      
Principal Investigator: Saumin Shah         
Bangalore Medical College and Research Institute Not yet recruiting
Bangalore, Karnataka, India, 560 002
Contact    +91 80 26706264      
Principal Investigator: Parvesh Kumar Jain         
M S Ramaiah Medical College Hospital Recruiting
Bangalore, Karnataka, India, 560054
Contact    9845156811      
Principal Investigator: Avinash Balekuduru         
Lokmanya Hospital Not yet recruiting
Mumbai, Maharashtra, India, 400022
Principal Investigator: Akash Shukla         
Fortis Hospital Not yet recruiting
Mumbai, Maharashtra, India, 400078
Contact    919324684736      
Principal Investigator: Nulan Desai         
Poona Medical Foundation. Ruby Hall Clinic Not yet recruiting
Pune, Maharashtra, India, 411 001
Contact    +91-20-266455495      
Principal Investigator: Nitin Pai         
K E M Hospital and Research Centre Not yet recruiting
Pune, Maharashtra, India, 411011
Contact    918554999974      
Principal Investigator: Bharat Kalambe         
Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital Not yet recruiting
Wardha, Maharashtra, India, 442004
Contact    (07152) - 287701      
Principal Investigator: Vijendra Kirnake         
Midas Multispecilaity Hopsital Pvt Ltd Recruiting
Ramdaspeth, Nagpur, India, 440010
Contact    91 7720033280      
Principal Investigator: Shrikant Mukewar         
Dayanand Medical College Not yet recruiting
Ludhiana, Punjab, India, 141001
Contact    9111612481522      
Principal Investigator: Ajit Sood         
S.R. Kalla Hospital Recruiting
Jaipur, Rajasthan, India, 302001
Contact    91 9829050622      
Principal Investigator: Mukesh Kalla         
Osmania Medical College & Hospital Recruiting
Hyderabad, Telangana, India, 500012
Contact    09949043290      
Principal Investigator: Ramesh Kumar         
Asian Institute of Gastroenterology Recruiting
Hyderabad, Telangana, India, 500032
Contact    040424442222      
Principal Investigator: Rupa Banerjee         
King George Medical University Not yet recruiting
Lucknow, Uttar Pradesh, India, 226003
Contact    09335920302      
Principal Investigator: Abhijit Chandra         
Post Graduate Institute of Medical Education & Research Not yet recruiting
Chandigarh, India, 160012
Contact    911722747585      
Principal Investigator: Saroj Kant Sinha         
Fortis Hospital Recruiting
Delhi, India
Contact    9810154088      
Principal Investigator: Ajay Bhalla         
Ireland
Beaumont Hospital Not yet recruiting
Dublin, Ireland, DUBLIN 9
Contact    35318377755      
Principal Investigator: Aoibhlinn O'Toole         
Israel
Soroka Medical Center Not yet recruiting
Beer Sheva, Israel, 8410101
Contact    972507413471      
Principal Investigator: Arik Segal         
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 3810101
Contact    97246304582      
Principal Investigator: Baruch Ovadia         
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Contact    97226666064      
Principal Investigator: Eran Goldin         
Galilee Medical Center Department of Internal Medicine A Not yet recruiting
Nahariya, Israel, 22100
Contact    97249107748      
Principal Investigator: Nimer Assy         
Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 5265601
Contact    97235302197      
Principal Investigator: Adi Lahat-Zok         
Kaplan Medical Center Not yet recruiting
Rehovot, Israel, 7610001
Contact    97289441587      
Principal Investigator: Ehud Melzer         
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 6423906
Contact    97236973896      
Principal Investigator: Sigal Fishman         
Italy
Presidio di Rho Not yet recruiting
Rho, Milano, Italy, 20017
Contact    393479030959      
Principal Investigator: Simone Saibeni         
Istituto Clinico Humanitas Not yet recruiting
Rozzano, Milano, Italy, 20089
Contact    390282245555      
Principal Investigator: Silvio Danese         
Istituto Mangiagalli Not yet recruiting
Milano, MI, Italy, 20122
Contact    393288372003      
Principal Investigator: Flavio Caprioli         
Ospedale Sandro Pertini Recruiting
Roma, RM, Italy, 00157
Contact    390641434453      
Principal Investigator: Roberta Pica         
Spedali Civili - Universita degli Studi Not yet recruiting
Brescia, Italy, 25123
Contact    390303995243      
Principal Investigator: Chiara Ricci         
Policlinico Mater Domini Not yet recruiting
Catanzaro, Italy, 88100
Contact    3909613647113      
Principal Investigator: Francesco Luzza         
Azienda Ospedaliera Universitaria Policlinico de Modena Not yet recruiting
Modena, Italy, 41124
Contact    00390594225308      
Principal Investigator: Erica Villa         
Azienda Ospedlaliero-Univeristaria Pisana - Ospedale di Cisanello - Gastroenterologia Not yet recruiting
Pisa, Italy, 56124
Contact    39050997385      
Principal Investigator: Santino Marchi         
A.O. San Giovanni di Dio e Ruggi D'Aragona Not yet recruiting
Salerno, Italy, 84131
Contact    39089965032      
Principal Investigator: Carolina Ciacci         
Japan
Aichi Medical University Hospital Recruiting
Nagakute-shi, Aichi-ken, Japan, 480-1195
Contact    81878113333      
Principal Investigator: Makoto Sasaki         
Fujita Health University Hospital Not yet recruiting
Toyoake-shi, Aichi-ken, Japan, 470-1192
Contact    81562932111      
Principal Investigator: Naoki Omiya         
NHO Hirosaki National Hospital Not yet recruiting
Hirosaki-shi, Aomori-Ken, Japan, 036 8545
Contact    81172324311      
Principal Investigator: Yo Ishiguro         
Toho University School of Medicine, Sakura Hospital Not yet recruiting
Sakura, Chiba, Japan, 285-8741
Contact    81434628811      
Principal Investigator: Katsuyoshi Matsuoka         
Kitakyushu Municipal Medical Center Not yet recruiting
Kitakyusyu-shi, Fukoka, Japan, 802-0077
Contact    81935411831      
Principal Investigator: Hirotada Akiho         
Fukuoka University Chikushi Hospital Not yet recruiting
Chikushino-shi, Fukuoka-Ken, Japan, 818 8502
Contact    81929211011      
Principal Investigator: Fumihito Hirai         
Yukinoseibokai St. Mary's Hospital Recruiting
Kurume-shi, Fukuoka-Ken, Japan, 830 8543
Contact    81942353322      
Principal Investigator: Hiroshi Kawano         
Hidaka Coloproctology Clinic Not yet recruiting
Kurume-shi, Fukuoka-Ken, Japan, 839 0809
Contact    81942447737      
Principal Investigator: Hisamitsu Hidaka         
Gunma University Hosptial Not yet recruiting
Maebashi, Gunma, Japan, 371-8511
Contact    81272207111      
Principal Investigator: Toshio Uraoka         
Takasaki General Medical Center Not yet recruiting
Takasaki, Gunma, Japan, 370-0829
Contact    81273225901      
Principal Investigator: Tomohiro Kudo         
NHO Mito Medical Center Not yet recruiting
Ibaraki-machi, HigaShiibaraki-Gun, Japan, 311 3193
Contact    81292407711      
Principal Investigator: Hiroyasu Ishida         
Hiroshima University Hospital Not yet recruiting
Hiroshima-shi, Hiroshima-ken, Japan, 734-8551
Contact    81822575555      
Principal Investigator: Shinji Tanaka         
Tokushukai Sapporo Tokushukai Hospital Recruiting
Sapporo-shi, Hokkaido, Japan, 004 0041
Contact    81118901110      
Principal Investigator: Toshifumi Ashida         
Keijinkai Teine Keijinkai Hospital Not yet recruiting
Sapporo-shi, Hokkaido, Japan, 0068555
Contact    81116818111      
Principal Investigator: Tokuma Tanuma         
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital Recruiting
Sapporo-shi, Hokkaido, Japan, 060 0033
Contact    81120360605      
Principal Investigator: Satoshi Motoya         
Tokushukai Sapporo Higashi Tokushukai Hospital Not yet recruiting
Sapporo-shi, Hokkaido, Japan, 065 0033
Contact    81117221110      
Principal Investigator: Atsuo Maemoto         
Aoyama Clinic GI Endoscopy & IBD Center Not yet recruiting
Kobe-shi, Hyogo-Ken, Japan, 650 0015
Contact    81783666810      
Principal Investigator: Nobuo Aoyama         
The Hospital of Hyogo College of Medecine Recruiting
Nishinomiya, Hyogo, Japan, 663-8501
Contact    81120360605      
Principal Investigator: Shiro Nakamura         
Takamatsu Red Cross Hospital Not yet recruiting
Takamatsu, Kagawa, Japan, 760-0017
Contact    81878317101      
Principal Investigator: Mitsushige Shibatoge         
Kagawa Prefectural Central Hospital Not yet recruiting
Takamatsu, Kagawa, Japan, 760-8557
Contact    81878113333      
Principal Investigator: Tomoki Inaba         
Sameshima Hospital Recruiting
Kagoshima-shi, Kagoshima, Japan, 892-0846
Contact    81120360605      
Principal Investigator: Yukinori Sameshima         
Kitasato University Hospital Not yet recruiting
Sagamihara-shi, Kanagawa-ken, Japan, 252-0375
Contact    81427788111      
Principal Investigator: Kaoru Yokoyama         
Sankikai Yokohama Shin midori General Hospital Not yet recruiting
Yokohama-shi, Kanagawa-Ken, Japan, 226 0025
Contact    81459842400      
Principal Investigator: Nobutsuna Kuwamoto         
Gokeikai Ofuna Chuo Hospital Recruiting
Kamakura-shi, Kanagawa, Japan, 247-0056
Contact    81120360605      
Principal Investigator: Yutaka Endo         
Kawasaki Municipal Kawasaki Hospital Recruiting
Kawasaki, Kanagawa, Japan, 210-0013
Contact    81120360605      
Principal Investigator: Hanae Takagi         
Matsushima Clinic Recruiting
Yokohama, Kanagawa, Japan, 220 0045
Contact    81120360605      
Principal Investigator: Kouichi Nakajima         
Showa University Northern Yokohama Hospital Not yet recruiting
Yokohama, Kanagawa, Japan, 224-8503
Contact    81459497000      
Principal Investigator: Noriyuki Ogata         
Yokohama City University Medical Center Not yet recruiting
Yokohama, Kanagawa, Japan, 232-0024
Contact    81452615656      
Principal Investigator: Reiko Kunisaki         
NHO Kyoto Medical Center Not yet recruiting
Kyoto-shi, Kyoto, Japan, 612 8555
Contact    81756419161      
Principal Investigator: Shinji Katsushima         
Mie University Hospital Not yet recruiting
Tsu, Mie, Japan, 514-8507
Contact    81120360605      
Principal Investigator: Noriyuki Horiki         
Takagi Clinic Recruiting
Sendai-shi, Miyagi-Ken, Japan, 981 3213
Contact    81 223793811      
Principal Investigator: Sho Takagi         
Nagaoka Chuo General Hospital Not yet recruiting
Nagaoka-shi, Niigata, Japan, 940-8653
Contact    81 258353700      
Principal Investigator: Takashi Tomidokoro         
Ishida Clinic of IBD and Gastroenterology Not yet recruiting
Oita-shi, Oita-Ken, Japan, 870 0823
Contact    81975295777      
Principal Investigator: Tetsuya Ishida         
Shinseikai Sai Gastroenterology, proctology Not yet recruiting
Fujidera-shi, Osaka Fu, Japan, 583 0027
Contact    817055525570      
Principal Investigator: Souken Sai         
Osaka University Hospital Not yet recruiting
Suita-shi, Osaka-Fu, Japan, 5650871
Contact    81120360605      
Principal Investigator: Hideki Iijima         
Kinshukai Infusion Clinic Recruiting
Osaka-shi, Osaka, Japan, 530 0011
Contact    81120360605      
Principal Investigator: Hiroaki Ito         
NHO Osaka National Hospital Not yet recruiting
Osaka-shi, Osaka, Japan, 540 0006
Contact    81669421331      
Principal Investigator: Hisashi Ishida         
Saga-Ken Medical Center Koseikan Recruiting
Saga-shi, Saga, Japan, 840 8571
Contact    81120360605      
Principal Investigator: Shinichi Ogata         
Kumagaya General Hospital Not yet recruiting
Kumagaya-shi, Saitama-Ken, Japan, 360-8567
Contact    81 929211011      
Principal Investigator: Takeshi Ishikawa         
Tokitokai Tokito Clinic Recruiting
Saitama-shi, Saitama-Ken, Japan, 336 0963
Contact    81 488786411      
Principal Investigator: Satoki Tokito         
Matsuaikai Matsuda Hospital Not yet recruiting
Hamamatsu-shi, Shizuoka-Ken, Japan, 4328061
Contact    81534485121      
Principal Investigator: Kazuhiko Kawakami         
Jichi Medical University Hospital Not yet recruiting
Shimotsuke, Tochigi, Japan, 329-0498
Contact    81285442111      
Principal Investigator: Keijiro Sunada         
Center Hospital of the National Center for Global Health and Medicine Not yet recruiting
Shinjuku-ku, Tokyo-To, Japan, 162 8655
Contact    81 332027181      
Principal Investigator: Junichi Akiyama         
Juntendo University Hospital Not yet recruiting
Bunkyo-ku, Tokyo, Japan, 113-8431
Contact    81338133111      
Principal Investigator: Tomoyoshi Shibuya         
Tokyo Medical And Dental University Hospital Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8519
Contact    81120360605      
Principal Investigator: Toshimitsu Fujii         
Showa University Koto Toyosu Hospital Not yet recruiting
Koto-ku, Tokyo, Japan, 135 8577
Contact    81362046000      
Principal Investigator: Naoyuki Uragami         
Kitasato University Kitasato Institute Hospital Not yet recruiting
Minato-Ku, Tokyo, Japan, 108 8642
Contact    81334446161      
Principal Investigator: Masaru Nakano         
Kyorin University Hospital Recruiting
Mitaka, Tokyo, Japan, 181-8611
Contact    81120360605      
Principal Investigator: Tadakazu Hisamatsu         
JHCO Tokyo Yamate Medical Center Recruiting
Shinjuku-ku, Tokyo, Japan, 169-0073
Contact    81120360605      
Principal Investigator: Naoki Yoshimura         
Toyama Prefectural Central Hospital Recruiting
Toyama-Shi, Toyama, Japan, 930-8550
Contact    81120360605      
Principal Investigator: Koichiro Matsuda         
Kumamoto University Hospital Not yet recruiting
Kumamoto, Japan, 860-8556
Contact    81963442111      
Principal Investigator: Hideaki Naoe         
Okayama University Hospital Not yet recruiting
Okayama, Japan, 700-8558
Contact    81862237151      
Principal Investigator: Sakiko Hiraoka         
Korea, Republic of
Kyung Hee University Hospital Not yet recruiting
Seoul, Korea, Korea, Republic of, 02447
Contact    8229588147      
Principal Investigator: Hyo-Jong Kim         
Kangbuk Samsung Hosp Not yet recruiting
Seoul, Korea, Republic of, 03181
Contact    82220018555      
Principal Investigator: Dong ll Park         
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of, 05505
Contact    820230105768      
Principal Investigator: Sang Hyoung Park         
Latvia
Pauls Stradins Kliniska Universitates Slimnica Recruiting
Riga, Latvia, LV-1002
Contact    3717069509      
Principal Investigator: Juris Pokrotnieks         
Health Center 4, Affiliate Diagnostic Center Recruiting
Riga, Latvia, LV-1003
Contact    37126588961      
Principal Investigator: Hosams Abu Meri         
Digestive Diseases Center "Gastro" Recruiting
Riga, Latvia, LV-1006
Contact    37129245443      
Principal Investigator: Ivars Tolmanis         
Riga Eastern Clinical University Hospital Recruiting
Riga, Latvia, LV-1038
Contact    37129527746      
Principal Investigator: Aleksejs Derovs         
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Recruiting
Kaunas, Lithuania, 50161
Contact    37068568861      
Principal Investigator: Gediminas Kiudelis         
Hospital of Lithuanian University of Health Sciences Kaunas Not yet recruiting
Kaunas, Lithuania, 50161
Contact    3707730709      
Principal Investigator: Gediminas Kiudelis         
Republic Hospital of Klaipeda Recruiting
Klaipeda, Lithuania, 92231
Contact    37062046677      
Principal Investigator: Arunas Kancauskas         
Klaipeda Seamen's Hospital Recruiting
Klaipeda, Lithuania, 92288
Contact    37068712367      
Principal Investigator: Giedrius Simulionis         
Respublikine Panevezio Ligonine Recruiting
Panevezys, Lithuania, LT-35144
Contact    37067035353      
Principal Investigator: Darius Kriukas         
Vilniaus Universiteto Ligonines Santariskiu Klinikos Recruiting
Vilnius, Lithuania, LT-08661
Contact    37068825454      
Principal Investigator: Edita Kazenaite         
Vilnius University Hospital Santariskiu Clinics Not yet recruiting
Vilnius, Lithuania, LT-08661
Contact    37068761398      
Principal Investigator: Ieva Stundiene         
Malaysia
Hospital Sultanah Bahiyah Not yet recruiting
Alor Star, Kedah, Malaysia, 05460
Contact    6047406227      
Principal Investigator: Muhammad Radzi Bin Abu Hassan         
Hospital Raja Perempuan Zainab II Not yet recruiting
Kota Bahru, Kelantan, Malaysia, 15586
Contact    60139395880      
Principal Investigator: Norasiah Binti Abu Bakar         
Hospital Ampang Not yet recruiting
Ampang, Selangor, Malaysia, 68000
Contact    60 193 141 698      
Principal Investigator: Rosaida Hj Md Said         
Pusat Perubatan University Kebangsaan Malaysia Not yet recruiting
Cheras, Kuala Lumpur, Malaysia, 56000
Contact    60124500026      
Principal Investigator: Raja Affendi Bin Raja Ali         
Hospital Universiti Sains Malaysia Not yet recruiting
Kelantan, Malaysia, 16150
Contact    6097676595      
Principal Investigator: Yeong Yeh Lee         
University Malaya Medical Centre Not yet recruiting
Kuala Lumpur, Malaysia, 59100
Contact    6042225768      
Principal Investigator: Choon Kin Lee         
University Malaya Medical Centre Not yet recruiting
Kuala Lumpur, Malaysia, 59100
Contact    60379492966      
Principal Investigator: Ida Normiha Hilmi         
Mexico
Clinicos Asociados BOCM, S.C. Not yet recruiting
Mexico, DF, Mexico, 03300
Contact    525556014596      
Principal Investigator: Pedro López Fournier         
Centro de Investigación Clínica Acelerada Not yet recruiting
Mexico City, Distrito Federal, Mexico, 07020
Contact    57813954      
Principal Investigator: Emilio Fernando Bermudez Villegas         
Clinical Research Institute S C Not yet recruiting
Tlalnepantla, Edo De Mex, Mexico, 54055
Contact    53627780      
Principal Investigator: Leticia Marin Chavez         
Investigación Biomédica para el Desarrollo de Fármacos SA de Not yet recruiting
Zapopan, Jalisco, Mexico, 45030
Contact    523315220008      
Principal Investigator: Roberto Ulises Cruz Neri         
Christus Muguerza Sur S.A. de C.V. Not yet recruiting
Monterrey, Nuevo León, Mexico, 64908
Contact    83179977      
Principal Investigator: Eduardo Mendoza Fuerte         
Centro Para el Desarrollo de la Medicina y de Asistencia Med Not yet recruiting
Culiacan, Sinaloa, Mexico, 80230
Contact    016677215355      
Principal Investigator: Efren Gallardo         
Scientia Investigacion Clinica S.C. Not yet recruiting
Chihuahua, Mexico, 31203
Contact    6146883416      
Principal Investigator: Gaspar Iglesias Miramontes         
Sociedad de Metabolismo y Corazon S.C. Not yet recruiting
Veracruz, Mexico, 91900
Contact    522299323157      
Principal Investigator: Aracely Cruz Palacios         
Moldova, Republic of
Republican Clinical Hospital Recruiting
Chisinau, Moldova, Republic of, MD2025
Contact    1137379689636      
Principal Investigator: Elina Berliba         
Netherlands
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact    31205666545      
Principal Investigator: Mark Lowenberg         
Amphia Ziekenhuis Not yet recruiting
Breda, Netherlands, 4818 CK
Contact    31765955511      
Principal Investigator: Alexander Bodelier         
Albert Schweitzer Ziekenhuis Not yet recruiting
Dordrecht, Netherlands, 3318 AT
Contact    31786523221      
Principal Investigator: Frank Wolfhagen         
ETZ Elisabeth Not yet recruiting
Tilburg, Netherlands, 5022 GC
Contact    31132218466      
Principal Investigator: Robert Laheij         
Bernhoven Uden Not yet recruiting
Uden, Netherlands, 5406 PT
Contact    31413401932      
Principal Investigator: Ingrid Gisbertz         
Universitair Medisch Centrum Utrecht Not yet recruiting
Utrecht, Netherlands, 3584
Contact    31887556276      
Principal Investigator: Herma Fidder         
Poland
Promedica S.C Not yet recruiting
Bedzin, Poland, 42-500
Contact    0048322971991      
Principal Investigator: Lukasz Firkowski         
Szpital Uniwersytecki nr 2 im. dr J. Biziela Recruiting
Bydgoszcz, Poland, 85-168
Contact    48523655106      
Principal Investigator: Maria Klopocka         
Centrum Medyczne Pratia Bydgoszcz Not yet recruiting
Bydgoszcz, Poland, 85-796
Contact    0048604937500      
Principal Investigator: Marcin Sobon         
Szpital Miejski Sw. Jana Pawla II Recruiting
Elblag, Poland, 82-300
Contact    48606204848      
Principal Investigator: Krzysztof Niezgoda         
NZOZ ALL-MEDICUS, Zaklad Gastroenterologii Recruiting
Katowice, Poland, 40-659
Contact    48602372597      
Principal Investigator: Maciej Gonciarz         
Indywidualna Specjalistyczna Praktyka Lekarska Not yet recruiting
Knurow, Poland, 44-190
Contact    48605521824      
Principal Investigator: Maciej Zymla         
Topolowa Medicenter Not yet recruiting
Krakow, Poland, 31-506
Contact    48604550763      
Principal Investigator: Zbigniew Wylegala         
Gabinet Endoskopii Przewodu Pokarmowego Recruiting
Krakow, Poland, 31009
Contact    48124212520      
Principal Investigator: Piotr Walczak         
NZOZ Gastromed Recruiting
Lublin, Poland, 20-582
Contact    48795404502      
Principal Investigator: Wit Danilkiewicz         
Samodzielny Publiczny Szpital Kliniczny nr 4 Not yet recruiting
Lublin, Poland, 20-954
Contact    0048817244672      
Principal Investigator: Halina Cichoz-Lach         
Wojewodzki Specjalistyczny Szpital w Olsztynie Not yet recruiting
Olsztyn, Poland, 10-561
Contact    0048895386557      
Principal Investigator: Tomasz Arlukowicz         
Centrum Medyczne Lux Med Poradnia Gastroenterologii Recruiting
Rzeszow, Poland, 35-068
Contact    48608446952      
Principal Investigator: Lucja Puszko         
Endoskopia sp z o. o Recruiting
Sopot, Poland, 81-756
Contact    48585552631      
Principal Investigator: Marek Horynski         
KO-MED Centra Kliniczne Staszow Not yet recruiting
Staszow, Poland, 28-200
Contact    48158641234      
Principal Investigator: Jacek Kieltucki         
Twoja Przychodnia-Szczecinskie Centrum Medyczne Not yet recruiting
Szczecin, Poland, 71-434
Contact    0048914332919      
Principal Investigator: Beata Gawdis-Wojnarska         
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED Not yet recruiting
Szczecin, Poland, 71-685
Contact    0048914842147      
Principal Investigator: Anna Wiechowska-Kozlowska         
Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii Not yet recruiting
Torun, Poland, 87-100
Contact    0048790800856      
Principal Investigator: Marcin Zmudzinski         
Nzoz Formed Not yet recruiting
Wadowice, Poland, 34-100
Contact    48338233255      
Principal Investigator: Beata Mroziak         
Centrum Zdrowia Matki, Dziecka i Mlodziezy Not yet recruiting
Warszawa, Poland, 00-635
Contact    48226580456      
Principal Investigator: Jaroslaw Kierkus         
Centralny Szpital Kliniczny MSWia Klinika Dermatologiczna Not yet recruiting
Warszawa, Poland, 02-507
Contact    48225081240      
Principal Investigator: Grazyna Rydzewska-Wyszkowska         
Vivamed Recruiting
Warszawa, Poland, 03-580
Contact    48601322352      
Principal Investigator: Robert Edward Petryka         
PlanetMed Sp.z o.o. Not yet recruiting
Wroclaw, Poland, 52-210
Contact    0048713738929      
Principal Investigator: Barbara Wozniak-Stolarska         
LexMedica Osrodek Badan Klinicznych Not yet recruiting
Wroclaw, Poland, 53-114
Contact    0048713397227      
Principal Investigator: Jerzy Rozciecha         
ETG Zamosc Not yet recruiting
Zamosc, Poland, 22-400
Contact    0048721055855      
Principal Investigator: Katarzyna Wojcik         
Romania
SC Pelican SRL Not yet recruiting
Oradea, Bihor, Romania, 410469
Contact    40359804343      
Principal Investigator: Alin-Horea Suta         
Clinica Hifu Terra Med Conformal Not yet recruiting
Bucharest 3, Bucharest, Romania, 031864
Contact    40217786903      
Principal Investigator: Theodor-Alexandru Voiosu         
Spitalul Clinic Judetean de Urgenta Targu Mures Not yet recruiting
Targu Mures, Mures, Romania, 540136
Contact    40212750500      
Principal Investigator: Simona Bataga         
SC Med Life SA Not yet recruiting
Bucuresti, Romania, 010719
Contact    40212094040      
Principal Investigator: Ion-Eugeniu Craciun         
Centrul Medical Unirea SRL Not yet recruiting
Bucuresti, Romania, 014461
Contact    40724229028      
Principal Investigator: Camelia Chioncel         
Institutul Clinic Fundeni Not yet recruiting
Bucuresti, Romania, 022328
Contact    40212750500      
Principal Investigator: Liliana Simona Gheorghe         
Institutul Clinic Fundeni Not yet recruiting
Bucuresti, Romania, 022328
Contact    40212750500      
Principal Investigator: George Stancu         
Spitalul Clinic Colentina Not yet recruiting
Bucuresti, Romania, 21155
Contact    40213173245      
Principal Investigator: Radu B Mateescu         
Policlinica CCBR S.R.L. Not yet recruiting
Bucuresti, Romania, 30463
Contact    40213401425      
Principal Investigator: Daniela Bartos         
Russian Federation
Multidisciplinary Medical Clinic "Anthurium" Not yet recruiting
Barnaul, Russian Federation, 656043
Contact    73852441030      
Principal Investigator: Galina Chumakova         
Medical and Sanitary Division of Severstal Not yet recruiting
Cherepovets, Russian Federation, 162600
Contact    78202534985      
Principal Investigator: Denis Medvedev         
LLC MA New Hospital Not yet recruiting
Ekaterinburg, Russian Federation, 620109
Contact    73433555657      
Principal Investigator: Denis Nikolin         
Irkutsk State Medical Academy of Continuing Education Not yet recruiting
Irkutsk, Russian Federation, 664049
Contact    73952460318      
Principal Investigator: Olga Fedorishina         
LLC Alliance Biomedical - Ural Group Not yet recruiting
Izhevsk, Russian Federation, 426061
Contact    73412271789      
Principal Investigator: Liudmila Odnopozova         
Clinical Trials Center of Medical Institute Not yet recruiting
Kaliningrad, Russian Federation, 236035
Contact    74012313339      
Principal Investigator: Vladimir Rafalskiy         
Kazan State Medical University Not yet recruiting
Kazan, Russian Federation, 420012
Contact    78432367972      
Principal Investigator: Rustem Abdulkhakov         
SIH Kemerovo Regional Clinical Hosptial Not yet recruiting
Kemerovo, Russian Federation, 650066
Contact    79059495995      
Principal Investigator: Irina Khodareva         
Kuban State Medical University-Clinics of KSMU Not yet recruiting
Krasnodar, Russian Federation, 350072
Contact    78619911010      
Principal Investigator: Vladimir Onopriev         
Treatment and Rehabilitation Center of the Ministry of Health of the RF Not yet recruiting
Moscow, Russian Federation, 125367
Contact    74991934080      
Principal Investigator: Igor Nikitin         
SBIH of Moscow "City Clinical Hospital #24 " Not yet recruiting
Moscow, Russian Federation, 127015
Contact    74957283226      
Principal Investigator: Eduard Burnevich         
Nizhegorodskiy Regional Clinical Hospital N.A.Semashko Not yet recruiting
Nizhniy Novgorod, Russian Federation, 603126
Contact    78314389352      
Principal Investigator: Olga Alexeeva         
NHI Road Clinical Hospital on Gorkiy station of public corporation Russian Railways Not yet recruiting
Nizhniy Novgorod, Russian Federation, 603140
Contact    79101472875      
Principal Investigator: Natalia Eremina         
LLC "Medicine Center SibNovoMed" Not yet recruiting
Novosibirsk, Russian Federation, 630005
Contact    73832240619      
Principal Investigator: Marina Osipenko         
Ultramed Not yet recruiting
Omsk, Russian Federation, 644024
Contact    79139886912      
Principal Investigator: Valentina Molostova         
Republican Hospital named after V.A. Baranov Not yet recruiting
Petrozavodsk, Russian Federation, 185019
Contact    79114123729      
Principal Investigator: Olga Barysheva         
Rostov State Medical University Not yet recruiting
Rostov-on-Don, Russian Federation, 344022
Contact    78632504160      
Principal Investigator: Alexey Yakovlev         
City Hospital of Saint Martyr Elizabeth Not yet recruiting
Saint Petersburg, Russian Federation, 193257
Contact    78125551765      
Principal Investigator: Anatoly Pershko         
SPb SBIH "City Mariinskaya Hospital" Not yet recruiting
Saint-Petersburg, Russian Federation, 194104
Contact    78126050303      
Principal Investigator: Gonchar         
LLC Gastroenterology Centre Expert Not yet recruiting
Saint-Petersburg, Russian Federation, 197110
Contact    78126023544      
Principal Investigator: Sabir Mekhtiev         
SBIH City Clinical Hospital #31 Not yet recruiting
Saint-Petersburg, Russian Federation, 197110
Contact    78122357165      
Principal Investigator: Oksana Shchukina         
Medical Institute REAVIZ Not yet recruiting
Samara, Russian Federation, 443001
Contact    78462502503      
Principal Investigator: Elena Bunkova         
Academician I.P. Pavlov First St-Petersburg State Medical University Not yet recruiting
St-Petersburg, Russian Federation, 197022
Contact    79219131328      
Principal Investigator: Vasiliy Trofimov         
GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health Not yet recruiting
St. Petersburg, Russian Federation, 195067
Contact    79616127712      
Principal Investigator: Igor Bakulin         
Railway clinical hospital Not yet recruiting
St. Petersburg, Russian Federation, 195271
Contact    78125430155      
Principal Investigator: Viktor Shunkov         
LLC Scientific Research Centre EKO-Bezopasnost Not yet recruiting
St. Petersburg, Russian Federation, 196143
Contact    79219502991      
Principal Investigator: Konstantin Zakharov         
Stavropol State Medical Academy Not yet recruiting
Stavropol, Russian Federation, 355017
Contact    78652714835      
Principal Investigator: Vladimir Pavlenko         
SHI of Yaroslavl Region Clinical Hospital #8 Not yet recruiting
Yaroslavl, Russian Federation, 150030
Contact    74852445404      
Principal Investigator: Andrey Arshinov         
Saudi Arabia
King Fahad Specialist Hospital—Dammam Not yet recruiting
Dammam, Saudi Arabia, 31444
Contact    9665138442222      
Principal Investigator: Turki Al Ameel         
Serbia
Clinical Center Bezanijska Kosa Not yet recruiting
Belgrade, NAP, Serbia, 11000
Contact    381641608353      
Principal Investigator: Mirjana Cvetkovic         
Clinical Center of Serbia Not yet recruiting
Belgrade, Serbia, 11000
Contact    381113615575      
Principal Investigator: Dragan Popovic         
Clinical Center Zvezdara Not yet recruiting
Belgrade, Serbia, 11000
Contact    381608839217      
Principal Investigator: Petar Svorcan         
Military Medical Academy Not yet recruiting
Belgrade, Serbia, 11000
Contact    381113672457      
Principal Investigator: Dino Tarabar         
Military Medical Academy Not yet recruiting
Belgrade, Serbia, 11000
Contact    886975056026      
Principal Investigator: Radoje Doder         
Clinical Hospital Center Kragujevac Not yet recruiting
Kragujevac, Serbia, 34000
Contact    381642926143      
Principal Investigator: Slavko Knezevic         
Clinical Center Nis Not yet recruiting
Nis, Serbia, 18000
Contact    381184537344      
Principal Investigator: Aleksandar Nagorni         
General Hospital Dr Radivoj Simonovic Not yet recruiting
Sombor, Serbia, 25000
Contact    381642453707      
Principal Investigator: Mileva Lovric Jovanovic         
General Hospital Sremska Mitrovica Not yet recruiting
Sremska Mitrovica, Serbia, 22000
Contact    381643427353      
Principal Investigator: Gordana Mitic         
Clinical Center Zemun Not yet recruiting
Zemun, Serbia, 11080
Contact    381113772666      
Principal Investigator: Predrag Dugalic         
General Hospital "Djordje Joanovic" Not yet recruiting
Zrenjanin, Serbia, 23000
Contact    381606076527      
Principal Investigator: Tatjana Radakovic         
Slovakia
Univerzitna nemocnica Nemocnica Stare Mesteo Not yet recruiting
Bratislava, Slovakia, 813 69
Principal Investigator: Ludovit Lukac         
Univerzitna nemocnica Bratislava Ruzinov Not yet recruiting
Bratislava, Slovakia, 82007
Contact    421233221111      
Principal Investigator: Tibor Hlavaty         
KM Management spol. s r.o. Gastroenterologicke a hepatologicke centrum Not yet recruiting
Nitra, Slovakia, 94901
Principal Investigator: Milos Gregus         
GASTRO I., s.r.o. Not yet recruiting
Presova, Slovakia, 08001
Principal Investigator: Ivan Bunganic         
Endomed, s.r.o.- Gastroenterologicka ambulancia Not yet recruiting
Vranov N. Toplou, Slovakia, 09301
Contact    421905271215      
Principal Investigator: Miroslav Fedurco         
Spain
Hospital Universitario Marques De Valdecilla Not yet recruiting
Santander, Cantabria, Spain, 39008
Contact    34942202680      
Principal Investigator: Javier Crespo Garcia         
Instituto de Ciencias medicas Not yet recruiting
Alicante, Spain, 03004
Contact    0034966592350      
Principal Investigator: Luis de Teresa Parreño         
Hospital General Juan Ramón Jiménez Not yet recruiting
Huelva, Spain, 21005
Contact    34959016726      
Principal Investigator: Juan María Vazquez Morón         
Complexo Hospitalario Universitario A Coruña, CHUAC Not yet recruiting
La Coruña, Spain, 15006
Contact    34654844101      
Principal Investigator: Maria Teresa Diz-Lois Palomares         
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain, 28046
Contact    34912071741      
Principal Investigator: Maria Dolores Martin Arranz         
Hospital Universitario Virgen del Rocio Not yet recruiting
Sevilla, Spain, 41013
Contact    34955012065      
Principal Investigator: Maria Dolores De La Cruz Ramirez         
Switzerland
Kantonsspital St. Gallen Not yet recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Contact    41714943040      
Principal Investigator: Stephan Brand         
Inselspital Bern Not yet recruiting
Bern, Switzerland, 3010
Contact    41316323813      
Principal Investigator: Pascal Juillerat         
Praxis Balsiger, Seibold & Partner und Crohn-Colitis-Zentrum Not yet recruiting
Bern, Switzerland, 3012
Contact    41313023234      
Principal Investigator: Frank Seibold         
Universitätsspital Zürich Not yet recruiting
Zürich, Switzerland, 8091
Contact    41442551111      
Principal Investigator: Luc Biedermann         
Taiwan
Changhua Christian Hospital Not yet recruiting
Changhua, Taiwan, 500
Contact    886917150852      
Principal Investigator: Hsu-Heng Yen         
Kaohsiung Medical University Chung-Ho Memorial Hospital Not yet recruiting
Kaohsiung, Taiwan, 80756
Contact    88673121101 ext. 7451      
Principal Investigator: Yu-Chung Su         
Chang Gung Memorial Hospital - Kaohsiung Not yet recruiting
Kaohsiung, Taiwan, 83301
Contact    88677317123 ext 8301      
Principal Investigator: Wei-Chen Tai         
Chung Shan Medical University Hospital Not yet recruiting
Taichung City, Taiwan, 40201
Contact    886424739595      
Principal Investigator: Ching-Pin Lin         
China Medical University Hospital Not yet recruiting
Taichung, Taiwan, 40447
Contact    886422052121 ext. 2222      
Principal Investigator: Jen-Wei Chou         
MacKay Memorial Hospital Not yet recruiting
Taipei City, Taiwan, 10449
Contact    8862254335353993      
Principal Investigator: cheng-Hsin Chu         
Taipei Medical University Hospital Not yet recruiting
Taipei City, Taiwan, 11031
Contact    886972652529      
Principal Investigator: Po-Li Wei         
Health management center Not yet recruiting
Taipei, Taiwan, 10048
Contact    886223123456 ext.63675      
Principal Investigator: Chia-Hung Tu         
Taipei Veterans General Hospital Not yet recruiting
Taipei, Taiwan, 11217
Contact    886228712121 ext.2147      
Principal Investigator: Jiing-Chyuan Luo         
Turkey
Hacettepe University Faculty of Medicine Not yet recruiting
Ankara, Turkey, 06100
Contact    00903124423715      
Principal Investigator: Halis Simsek         
Ankara Gazi State Hospital Not yet recruiting
Ankara, Turkey, 6560
Contact    4444848      
Principal Investigator: Tarkan Karakan         
Gaziantep University Medical Faculty Not yet recruiting
Gaziantep, Turkey, 27310
Contact    905052760075      
Principal Investigator: Bugra Tolga Konduk         
Acibadem Fulya Hospital Not yet recruiting
Istanbuk, Turkey, 34349
Contact    902123064444      
Principal Investigator: Hulya Hamzaoglu         
Acibadem Kozyatagi Hospital Not yet recruiting
Istanbul, Turkey, 34668
Contact    902165714444      
Principal Investigator: Can Gonen         
Kocaeli University Medical Faculty Hospital Not yet recruiting
Izmit, Turkey, 41380
Contact    902623037525      
Principal Investigator: Sadettin Hulagu         
Mersin University Not yet recruiting
Mersin, Turkey, 33343
Contact    032424100022565      
Principal Investigator: Engin Altintas         
Ukraine
Ivano-Frankivsk State Medical University Not yet recruiting
Ivano-Frankivsk, Ukraine, 76018
Contact    380342528211      
Principal Investigator: Vira Vyshyvaniuk         
Communal Institution of Healthcare War Veterans Regional Hospital Not yet recruiting
Kharkiv, Ukraine, 61019
Contact    380577152575      
Principal Investigator: Oleksii Oparin         
CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2 Not yet recruiting
Kharkiv, Ukraine, 61037
Contact    380577387273      
Principal Investigator: Olena Datsenko         
GI L.T. Malaya TI Namsu Not yet recruiting
Kharkiv, Ukraine, 61039
Contact    380573739050      
Principal Investigator: Oleksiy Gridnyev         
CI Kherson CCH Not yet recruiting
Kherson, Ukraine, 73000
Contact    38055225238      
Principal Investigator: Alla Malytska         
ACINUS Medical and Diagnostic Center Not yet recruiting
Kropyvnytskyi, Ukraine, 25006
Contact    380522366001      
Principal Investigator: Viktorya Shevchuk         
International Institute of Clinical Trials LLC Not yet recruiting
Kyiv, Ukraine, 02091
Contact    380800211298      
Principal Investigator: Inna Markevych         
Medical Centre CONSILIUM MEDICAL Not yet recruiting
Kyiv, Ukraine, 04050
Contact    380442074927      
Principal Investigator: Oksana Gerasymenko         
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary" Not yet recruiting
Kyiv, Ukraine, 04078
Contact    380444435702      
Principal Investigator: Tetiana Lohdanidi         
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary" Not yet recruiting
Kyiv, Ukraine, 04107
Contact    380442370286      
Principal Investigator: Svitlana Danyliuk         
Lviv Regional Clinical Hospital Not yet recruiting
Liviv, Ukraine, 79010
Contact    380322755611      
Principal Investigator: Yaroslav Zborivskyy         
Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC Ukrainian Railway Sta Not yet recruiting
Lviv, Ukraine, 79007
Contact    38032264308      
Principal Investigator: Olha Ivanishyn         
Communal City Clinical Emergency Hospital, Danylo Galytskyy Lviv National Medical University Not yet recruiting
Lviv, Ukraine, 79059
Contact    380322527590      
Principal Investigator: Valeriy Vdovychenko         
Odesa Regional Clinical Hospital Not yet recruiting
Odesa, Ukraine, 65117
Contact    380503907846      
Principal Investigator: Olena Levchenko         
Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo, Ukr.med.stom.acad. Not yet recruiting
Poltava, Ukraine, 36011
Contact    380532225607      
Principal Investigator: Igor Skrypnyk         
SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU Not yet recruiting
Uzhgorod, Ukraine, 88009
Contact    380505710797      
Principal Investigator: Ivan Chopey         
A. Novak Transcarpathian Regional Clinical Hospital Not yet recruiting
Uzhgorod, Ukraine, 88018
Contact    380312615101      
Principal Investigator: Yaroslava Rishko         
Medical Center "Health Clinic" LLC Not yet recruiting
Vinnitsa, Ukraine, 21009
Contact    380432538157      
Principal Investigator: Oleksandr Golovchenko         
Private Small Enterprise, Medical Center Pulse Not yet recruiting
Vinnytsia, Ukraine, 21001
Contact    380680020996      
Principal Investigator: Natalya Kizlova         
Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU Not yet recruiting
Vinnytsia, Ukraine, 21005
Contact    380432550794      
Principal Investigator: Valerii Ivanov         
Vinnytsia M.I. Pyrogov NMU Ch of internal medicine #1 Not yet recruiting
Vinnytsia, Ukraine, 21018
Contact    380506986684      
Principal Investigator: Mykola Stanislavchuk         
LEC Scient.&Research Instit.of Invalid Rehabiltation Not yet recruiting
Vinnytsia, Ukraine, 21029
Contact    380432511276      
Principal Investigator: Oksana Zaporozhets         
MCIC MC LLC Health Clinic Not yet recruiting
Vinnytsia, Ukraine, 21029
Contact    380432437212      
Principal Investigator: Halyna Tomashkevych         
Diaservis Ltd Not yet recruiting
Zaporizhzhia, Ukraine, 69035
Contact    380676190303      
Principal Investigator: Oleksandr Oliinyk         
Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2 Not yet recruiting
Zaporizhzhia, Ukraine, 69104
Contact    380612965685      
Principal Investigator: Viacheslav Neshta         
United Kingdom
John Radcliffe Hospital Recruiting
Headington, Oxfordshire, United Kingdom, OX3 9DU
Contact    441865228753      
Principal Investigator: Simon Travis         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03519945     History of Changes
Other Study ID Numbers: 16596
I6T- MC-AMAP ( Other Identifier: Eli Lilly and Company )
2017 004092 31 ( EudraCT Number )
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.


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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:
Inflammatory Bowel Disease

Additional relevant MeSH terms:
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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases