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

April 16, 2024 updated by: Eli Lilly and Company

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

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.

Study Overview

Status

Recruiting

Conditions

Ulcerative Colitis

Intervention / Treatment

Drug: Mirikizumab

Study Type

Interventional

Enrollment (Estimated)

1063

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

Argentina
- Ciudad Autónoma De Buenos Aires
  - Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1128AAF
    - Recruiting
    - Mautalen Salud e investigación
    - Principal Investigator:
      
      Emiliano Pablo Tron
  - Quilmes, Ciudad Autónoma De Buenos Aires, Argentina, 1879
    - Recruiting
    - CER medical Institute
    - Principal Investigator:
      
      EDGARDO DANIEL GIMENEZ
- Santa Fe
  - Rosario, Santa Fe, Argentina, S2000DEG
    - Completed
    - Fundacion Estudios Clinicos
- Tucumán
  - SAN M. DE Tucuman, Tucumán, Argentina, T4000AXL
    - Recruiting
    - Centro Medico Privado de Reumatologia
    - Principal Investigator:
      
      Eduardo Ezequiel Martinez
  - San Miguel de Tucumán, Tucumán, Argentina, 4000
    - Recruiting
    - C.I.C.E. 9 de Julio
    - Principal Investigator:
      
      Abel Luis Novillo
Australia
- Queensland
  - Brisbane, Queensland, Australia, 4102
    - Recruiting
    - Princess Alexandra Hospital
    - Principal Investigator:
      
      Gerald Holtmann
  - Brisbane, Queensland, Australia, 4101
    - Recruiting
    - Mater Misericordiae Limited
    - Principal Investigator:
      
      Jakob Begun
  - Maroochydore, Queensland, Australia, 4558
    - Recruiting
    - Coastal Digestive Health
    - Principal Investigator:
      
      Hansjoerg Seltenreich
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Recruiting
    - Royal Adelaide Hospital
    - Principal Investigator:
      
      Abdul Shaikh
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Recruiting
    - Box Hill Hospital
    - Principal Investigator:
      
      Abhinav Vasudevan
  - Fitzroy, Victoria, Australia, 3065
    - Recruiting
    - St Vincent's hospital
    - Contact:
      
      Phone Number: 61392313580
    - Principal Investigator:
      
      John Nik Sheng Ding
  - Parkville, Victoria, Australia, 3050
    - Recruiting
    - The Royal Melbourne Hospital
    - Principal Investigator:
      
      Finlay Alistair Macrae
Austria
- - Salzburg, Austria, 5020
    - Recruiting
    - Uniklinikum Salzburg
    - Principal Investigator:
      
      Sonja Heeren
- Tirol
  - Innsbruck, Tirol, Austria, 6020
    - Recruiting
    - Medizinische Universitaet Innsbruck
    - Principal Investigator:
      
      Robert Koch
- Wien
  - Vienna, Wien, Austria, 1090
    - Recruiting
    - Medizinische Universitat Wien
    - Principal Investigator:
      
      Walter Reinisch
Belgium
- Oost-Vlaanderen
  - Gent, Oost-Vlaanderen, Belgium, 9000
    - Active, not recruiting
    - UZ Gent
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - Active, not recruiting
    - UZ Leuven
- Wallonne, Région
  - Tournai, Wallonne, Région, Belgium, 7500
    - Recruiting
    - Centre Hospitalier de Wallonie Picarde - Site Notre Dame
    - Principal Investigator:
      
      souhail saikali
Canada
- Alberta
  - Edmonton, Alberta, Canada, T5R 1W2
    - Not yet recruiting
    - West Edmonton Diabetes Center
    - Contact:
      
      Phone Number: 7809301915
    - Principal Investigator:
      
      Allen Lim
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Recruiting
    - Vancouver General Hospital
    - Principal Investigator:
      
      Bill Salh
  - Vancouver, British Columbia, Canada, V5Z 2K5
    - Recruiting
    - GIRI GI Research Institute - Vancouver
    - Principal Investigator:
      
      Greg Rosenfeld
  - Victoria, British Columbia, Canada, V8V 3M9
    - Recruiting
    - PerCuro Clinical Research
    - Principal Investigator:
      
      Dustin Loomes
- Ontario
  - London, Ontario, Canada, N6A 5W9
    - Recruiting
    - Victoria Hospital
    - Contact:
      
      Phone Number: 5196675977
    - Principal Investigator:
      
      Terry Ponich
  - London, Ontario, Canada, N6A 5A5
    - Recruiting
    - University Hospital - London Health Sciences Centre (IBD Clinical Trials)
    - Principal Investigator:
      
      Vipul Jairath
- Quebec
  - Montreal, Quebec, Canada, H3G 1A4
    - Recruiting
    - Montreal General Hospital
    - Principal Investigator:
      
      Waqqas Afif
  - Montreal, Quebec, Canada, H1T 2M4
    - Recruiting
    - CIUSSS de l'Est-de-l'Île-de-Montréal
    - Principal Investigator:
      
      Guy Aumais
China
- - Liaocheng, China, 252000
    - Recruiting
    - Liaocheng People's Hospital
    - Principal Investigator:
      
      Peng Yan
- Anhui
  - Hefei, Anhui, China, 230022
    - Recruiting
    - The First Affiliated Hospital of Anhui Medical University
    - Principal Investigator:
      
      Naizhong Hu
  - Hefei, Anhui, China, 230071
    - Recruiting
    - Anhui Provincial Hospital
    - Principal Investigator:
      
      Kaiguang Zhang
- Chongqing
  - Chongqing, Chongqing, China, 400038
    - Not yet recruiting
    - Southwest Hospital of Third Military Medical University
    - Principal Investigator:
      
      Lei Chen
- Fuzhou
  - Fujian, Fuzhou, China, 350005
    - Recruiting
    - The First Affiliated Hospital of Fujian Medical University
    - Principal Investigator:
      
      Chengdang Wang
- Guangdong
  - Guangzhou, Guangdong, China, 510655
    - Recruiting
    - The Sixth Affiliated Hospital of Sun Yat-sen University
    - Principal Investigator:
      
      Xiang Gao
- Hainan
  - Haikou, Hainan, China, 570311
    - Not yet recruiting
    - Hainan General Hospital
    - Principal Investigator:
      
      Cheng Lan
- Hebei
  - Shijiazhuang, Hebei, China, 050000
    - Recruiting
    - The Second Afilliated Hospital of Hebei Medical University
    - Principal Investigator:
      
      Xiaolan Zhang
    - Contact:
      
      Phone Number: 8631166002162
- Henan
  - Zhengzhou, Henan, China, 450014
    - Not yet recruiting
    - The Second Affiliated Hospital of Zhengzhou University
    - Principal Investigator:
      
      Baisui Feng
- Hubei
  - Wuhan, Hubei, China, 430060
    - Recruiting
    - Renmin Hospital of Wuhan University
    - Contact:
      
      Phone Number: 862788041911
    - Principal Investigator:
      
      Yijuan Ding
  - Wuhan, Hubei, China, 430022
    - Recruiting
    - Wuhan Union Hospital
    - Principal Investigator:
      
      Liang Ru Zhu
  - Wuhan, Hubei, China, 430030
    - Recruiting
    - Tongji Hospital Tongji Medical,Science & Technology
    - Principal Investigator:
      
      Mei Liu
- Hunan
  - Changsha, Hunan, China, 410008
    - Recruiting
    - Xiangya Hospital Central South University
    - Principal Investigator:
      
      Meihua Xu
  - Zhuzhou, Hunan, China, 412007
    - Not yet recruiting
    - ZhuZhou Central Hospital
    - Principal Investigator:
      
      Dajun Wu
- Jiangsu
  - Changzhou, Jiangsu, China
    - Not yet recruiting
    - Changzhou No.2 People's Hospital
    - Contact:
      
      Phone Number: 0086051988104931
    - Principal Investigator:
      
      Wenjia LIU
  - Nanjing, Jiangsu, China, 210009
    - Recruiting
    - Zhongda Hospital Southeast University
    - Principal Investigator:
      
      Ruihua Shi
  - Nanjing, Jiangsu, China, 210029
    - Not yet recruiting
    - Jiangsu Province Hospital
    - Principal Investigator:
      
      Guoxin Zhang
  - Nanjing, Jiangsu, China, 210000
    - Recruiting
    - Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
    - Principal Investigator:
      
      Lei Wang
  - Nanjing, Jiangsu, China, 211100
    - Recruiting
    - Nanjing Medical University - Nanjing Jiangning Hospital
    - Principal Investigator:
      
      Jianning Wang
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - Not yet recruiting
    - The First Affiliated Hospital of NanChang University
    - Principal Investigator:
      
      Youxiang Chen
  - Pingxiang, Jiangxi, China, 337055
    - Not yet recruiting
    - Jiangxi Pingxiang People's Hospital
    - Principal Investigator:
      
      Li Xing
- Jilin
  - Jilin, Jilin, China, 132011
    - Recruiting
    - Center-Jilin Center Hospital
    - Principal Investigator:
      
      Dongming Wang
- Shandong
  - Jinan, Shandong, China, 250001
    - Not yet recruiting
    - Shandong Provincial Hospital
    - Principal Investigator:
      
      Hongwei Xu
  - Liaocheng, Shandong, China, 252000
    - Recruiting
    - People's Hospital of Liaocheng City
    - Principal Investigator:
      
      yanqing Li
  - Qingdao, Shandong, China, 266003
    - Recruiting
    - The Affiliated Hospital of Qingdao University
    - Principal Investigator:
      
      Xueli Ding
  - Taian, Shandong, China, 271000
    - Recruiting
    - Taian City Central Hospital
    - Principal Investigator:
      
      Qingcai Wang
- Shanghai
  - Shanghai, Shanghai, China, 200001
    - Recruiting
    - Renji Hospital Shanghai Jiao Tong University School of Medicine
    - Principal Investigator:
      
      Zhihua Ran
  - Shanghai, Shanghai, China
    - Recruiting
    - Shanghai Jiaotong University School of Medicine Ruijin Hospital
    - Principal Investigator:
      
      Jie Zhong
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - Recruiting
    - West China Hospital of Sichuan University
    - Principal Investigator:
      
      Yufang WANG
- Yunnan
  - Kunming, Yunnan, China, 650032
    - Recruiting
    - First Affiliated Hospital of Kunming Medical University
    - Principal Investigator:
      
      hairong zhang
  - Kunming, Yunnan, China, 650034
    - Recruiting
    - The First People's Hospital of Yunnan Province
    - Principal Investigator:
      
      Zhengji Song
- Zhejiang
  - Hangzhou, Zhejiang, China, 310016
    - Recruiting
    - Sir Run Run Shaw Hospital
    - Principal Investigator:
      
      Qian Cao
    - Contact:
      
      Phone Number: 0571-87887885
  - Hangzhou, Zhejiang, China, 310003
    - Recruiting
    - The First Affiliated Hospital, Zhejiang University
    - Principal Investigator:
      
      Chunxiao Chen
  - Hangzhou, Zhejiang, China, 310052
    - Recruiting
    - The Second Affiliated Hospital of Zhejiang University School of Medicine
    - Principal Investigator:
      
      Yan Chen
  - Wenzhou, Zhejiang, China, 315100
    - Recruiting
    - The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
    - Principal Investigator:
      
      Xuanping Xia
Czechia
- - Olomouc, Czechia, 779 00
    - Recruiting
    - PreventaMed
    - Principal Investigator:
      
      Jiri Pumprla
  - Praha 8, Czechia, 186 00
    - Active, not recruiting
    - Mediendo
  - Praha 9, Czechia
    - Active, not recruiting
    - ISCARE klinické centrum
- Brno-město
  - Brno, Brno-město, Czechia, 636 00
    - Recruiting
    - Vojenska nemocnice Brno
    - Principal Investigator:
      
      David Stepek
  - Brno, Brno-město, Czechia, 656 91
    - Active, not recruiting
    - Fakultni nemocnice u sv. Anny v Brne
- Hradec Králové
  - Hradec Kralove, Hradec Králové, Czechia, 500 12
    - Active, not recruiting
    - Hepato-gastroenterologie HK
- Olomoucký Kraj
  - Olomouc, Olomoucký Kraj, Czechia, 779 00
    - Active, not recruiting
    - MUDr. Gregar, s.r.o.
- Plzeň-město
  - Pilsen, Plzeň-město, Czechia, 312 00
    - Completed
    - A-Shine
Denmark
- Hovedstaden
  - Copenhagen, Hovedstaden, Denmark, 2730
    - Recruiting
    - Herlev and Gentofte Hospital
    - Principal Investigator:
      
      Jakob Benedict Seidelin
- Sjælland
  - Køge, Sjælland, Denmark, 4600
    - Recruiting
    - Sjællands Universitetshospital Køge
    - Principal Investigator:
      
      Lars Munck
- Syddanmark
  - Nyborg, Syddanmark, Denmark, 5800
    - Completed
    - Sygehusenheden Nyborg
France
- - Paris, France, 75010
    - Active, not recruiting
    - Hôpital Saint-Louis
- Alpes-Maritimes
  - Nice, Alpes-Maritimes, France, 06202
    - Active, not recruiting
    - Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
- Alsace
  - Strasbourg, Alsace, France, 67091
    - Active, not recruiting
    - CHU Strasbourg-Hautepierre
- Aquitaine
  - Pessac, Aquitaine, France, 33600
    - Active, not recruiting
    - CHU Bordeaux Haut-Leveque
- Centre
  - Chambray Les Tours, Centre, France, 37170
    - Active, not recruiting
    - CHRU Troussau
- Hauts-de-Seine
  - Neuilly-sur-Seine, Hauts-de-Seine, France, 92200
    - Active, not recruiting
    - Centres Médico Chirurgicaux - Clinique Ambroise Paré
- Languedoc-Roussillon
  - Montpellier, Languedoc-Roussillon, France, 34295
    - Active, not recruiting
    - CHU Saint Eloi
- Loire
  - Saint Priest En Jarez, Loire, France, 42270
    - Active, not recruiting
    - Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
- Lorraine
  - Vandoeuvre lès Nancy, Lorraine, France, 54511
    - Active, not recruiting
    - Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
- Nord
  - Lille, Nord, France, 59037
    - Active, not recruiting
    - Hopital Claude Huriez - CHU de Lille
- Pyrénées-Atlantiques
  - Pau, Pyrénées-Atlantiques, France, 64000
    - Active, not recruiting
    - Centre Hospitalier de Pau
- Rhône
  - Pierre-Bénite, Rhône, France, 69310
    - Active, not recruiting
    - Centre Hospitalier Lyon Sud
- Somme
  - Amiens, Somme, France, 80054
    - Completed
    - CHU d'Amiens-Picardie - Hôpital Sud
Georgia
- - Tbilisi, Georgia, 0112
    - Completed
    - LLC Arensia Exploratory Medicine
Germany
- - Berlin, Germany, 14163
    - Completed
    - Krankenhaus Waldfriede
  - Berlin, Germany, 12203
    - Recruiting
    - Charite Universitätsmedizin Berlin Campus Benjamin Franklin
    - Principal Investigator:
      
      Britta Siegmund
  - Brandenburg, Germany, 14770
    - Recruiting
    - Städtisches Klinikum Brandenburg
    - Principal Investigator:
      
      Stefan Lueth
  - Hamburg, Germany, 20251
    - Recruiting
    - HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
    - Principal Investigator:
      
      Stefanie Howaldt
- Rheinland-Pfalz
  - Ludwigshafen, Rheinland-Pfalz, Germany, 67067
    - Recruiting
    - Haus der Gesundheit
    - Principal Investigator:
      
      Peter Uebel
- Sachsen-Anhalt
  - Halle, Sachsen-Anhalt, Germany, 6120
    - Recruiting
    - Universitätsklinikum Halle
    - Principal Investigator:
      
      Jens Walldorf
  - Halle (Saale), Sachsen-Anhalt, Germany, 06108
    - Recruiting
    - Studiengesellschaft BSF Unternehmergesellschaft
    - Principal Investigator:
      
      Lars Fechner
Hungary
- - Budapest, Hungary, 1088
    - Recruiting
    - Semmelweis University
    - Principal Investigator:
      
      Zsolt Tulassay
  - Békéscsaba, Hungary, 5600
    - Recruiting
    - Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
    - Principal Investigator:
      
      Marta Varga
  - Miskolc, Hungary, 3526
    - Recruiting
    - Endomedix Diagnosztikai Központ - Miskolc
    - Principal Investigator:
      
      Tunde Kristof
- Csongrád
  - Szeged, Csongrád, Hungary, 6725
    - Recruiting
    - Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
    - Principal Investigator:
      
      Zoltan Szepes
- Győr-Moson-Sopron
  - Győr, Győr-Moson-Sopron, Hungary, 9024
    - Recruiting
    - Petz Aladár Egyetemi Oktató Kórház
    - Principal Investigator:
      
      Gyula Pecsi
- Komárom-Esztergom
  - Tatabánya, Komárom-Esztergom, Hungary, H-2800
    - Recruiting
    - Clinexpert Tatabánya Ltd.
    - Principal Investigator:
      
      Tamás Toth
- Pest
  - Vác, Pest, Hungary, 2600
    - Recruiting
    - Javorszky Odon Korhaz
    - Principal Investigator:
      
      Tibor Szaloki
- Tolna
  - Szekszárd, Tolna, Hungary, 7100
    - Recruiting
    - CLINFAN Szolgáltató Kft
    - Principal Investigator:
      
      Agnes Salamon
India
- Gujarat
  - Ahmedabad, Gujarat, India, 382428
    - Active, not recruiting
    - Apollo Hospitals Ahmedabad
  - Rajkot, Gujarat, India, 360005
    - Active, not recruiting
    - Shree Giriraj Multispeciality Hospital
  - Surat, Gujarat, India, 395002
    - Active, not recruiting
    - Nirmal Hospital
- Karnataka
  - Bangalore, Karnataka, India, 560054
    - Active, not recruiting
    - M S Ramaiah Medical College and Hospitals
- Maharashtra
  - Nagpur, Maharashtra, India, 440010
    - Active, not recruiting
    - Midas Multispeciality Hospital Pvt.Ltd.
  - Pune, Maharashtra, India, 411001
    - Completed
    - Grant Medical Foundation - Ruby Hall Clinic
  - Wardha, Maharashtra, India, 442004
    - Active, not recruiting
    - Acharya Vinoba Bhave Rural Hospital
- Punjab
  - Ludhiana, Punjab, India, 141001
    - Completed
    - Dayanand Medical College and Hospital
- Rajasthan
  - Jaipur, Rajasthan, India, 302006
    - Active, not recruiting
    - SR Kalla Memorial Gastro & General Hospital
- Telangana
  - Hyderabad, Telangana, India, 500058
    - Active, not recruiting
    - Owaisi Hospital and Research Center
  - Secunderabad, Telangana, India, 500003
    - Active, not recruiting
    - Gandhi Hospital
- Uttar Pradesh
  - Noida, Uttar Pradesh, India, 201301
    - Active, not recruiting
    - Fortis Hospital
Ireland
- - Dublin, Ireland, D9
    - Completed
    - Beaumont Hospital, Dublin
Israel
- HaDarom
  - Be'er Sheva, HaDarom, Israel, 8410101
    - Recruiting
    - Soroka Medical Center
    - Principal Investigator:
      
      Arik Segal
- HaMerkaz
  - Rehovot, HaMerkaz, Israel, 7610001
    - Completed
    - Kaplan Medical Center
  - Zerifin, HaMerkaz, Israel, 70300
    - Recruiting
    - Yitzhak Shamir Medical Center
    - Principal Investigator:
      
      Haim Shirin
- HaTsafon
  - Nahariya, HaTsafon, Israel, 2210001
    - Recruiting
    - Galilee Medical Center
    - Principal Investigator:
      
      Nimer Assy
- Tell Abīb
  - Tel Aviv, Tell Abīb, Israel, 6423906
    - Recruiting
    - Sourasky Medical Center
    - Principal Investigator:
      
      Sigal Fishman
- Yerushalayim
  - Jerusalem, Yerushalayim, Israel, 9778419
    - Recruiting
    - Shaare Zedek Medical Center
    - Principal Investigator:
      
      Eran Goldin
Italy
- - Catanzaro, Italy, 88100
    - Completed
    - Azienda Ospedaliera Mater Domini
  - Genova, Italy, 16132
    - Recruiting
    - Ospedale San Martino
    - Principal Investigator:
      
      MARIA CATERINA PARODI
  - Torino, Italy, 10128
    - Recruiting
    - Ospedale Mauriziano
    - Principal Investigator:
      
      Marco Daperno
- Lazio
  - Roma, Lazio, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli
    - Principal Investigator:
      
      Antonio Gasbarrini
  - Roma, Lazio, Italy, 00133
    - Recruiting
    - Fondazione Policlinico Tor Vergata
    - Principal Investigator:
      
      Giovanni Monteleone
- Lombardia
  - Rozzano, Lombardia, Italy, 20089
    - Recruiting
    - Humanitas
    - Principal Investigator:
      
      Alessandro Armuzzi
- Milano
  - Rho, Milano, Italy, 20017
    - Recruiting
    - Ospedale di Circolo
    - Principal Investigator:
      
      Simone Saibeni
- Roma
  - Rome, Roma, Italy, 00157
    - Recruiting
    - Ospedale Sandro Pertini
    - Principal Investigator:
      
      Roberta Pica
- Toscana
  - Pisa, Toscana, Italy, 56124
    - Recruiting
    - Azienda Ospedaliera Universitaria Pisana
    - Principal Investigator:
      
      Nicola De Bortoli
Japan
- - Fukuoka, Japan, 814-0180
    - Completed
    - Fukuoka University Hospital
  - Kagoshima, Japan, 892-0846
    - Completed
    - Sameshima Hospital
  - Kyoto, Japan, 612-8555
    - Completed
    - National Hospital Organization Kyoto Medical Center
  - Okayama, Japan, 700-8558
    - Completed
    - Okayama University Hospital
  - Osaka, Japan, 530-0011
    - Completed
    - Infusion Clinic
  - Osaka, Japan, 540-0006
    - Completed
    - National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
  - Saga, Japan, 840-8571
    - Completed
    - Saga-Ken Medical Center Koseikan
  - Saitama, Japan, 336-0963
    - Active, not recruiting
    - Tokitokai Tokito Clinic
  - Tokyo, Japan, 169-0073
    - Completed
    - Tokyo Yamate Medical Center
  - Toyama, Japan, 930-8550
    - Completed
    - Toyama Prefectural Central Hospital
- Aomori
  - Hirosaki, Aomori, Japan, 036-8545
    - Active, not recruiting
    - National Hospital Organization Hirosaki National Hospital
- Chiba
  - Sakura, Chiba, Japan, 285-0841
    - Completed
    - Toho University Sakura Medical Center
- Fukoka
  - Kitakyusyu-shi, Fukoka, Japan, 802-0077
    - Completed
    - Kitakyushu Municipal Medical Center
- Fukuoka-Ken
  - Kurume-shi, Fukuoka-Ken, Japan, 839 0809
    - Completed
    - Hidaka Coloproctology Clinic
- Gunma
  - Maebashi, Gunma, Japan, 371-8511
    - Completed
    - Gunma University Hospital
  - Takasaki, Gunma, Japan, 370-0829
    - Completed
    - National Hospital Organization Takasaki General Medical Centar
- Hokkaido
  - Asahikawa, Hokkaido, Japan, 070-8610
    - Completed
    - Asahikawa City Hospital
  - Sapporo, Hokkaido, Japan, 065-0033
    - Completed
    - Tokushukai Sapporo Higashi Tokushukai Hospital
  - Sapporo-shi, Hokkaido, Japan, 060 0033
    - Completed
    - Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
  - Sapporo-shi, Hokkaido, Japan, 004 0041
    - Completed
    - Tokushukai Sapporo Tokushukai Hospital
- Hyogo
  - Nishinomiya, Hyogo, Japan, 663-8501
    - Completed
    - Hyogo College of Medicine
- Hyogo-Ken
  - Kobe-shi, Hyogo-Ken, Japan, 650 0015
    - Active, not recruiting
    - Aoyama Clinic GI Endoscopy & IBD Center
- Ibaraki
  - Higashiibaraki, Ibaraki, Japan, 311-3117
    - Completed
    - Mito Medical Center
- Kagawa
  - Takamatsu, Kagawa, Japan, 760-8557
    - Completed
    - Kagawa Prefectural Central Hospital
- Kanagawa
  - Kamakura, Kanagawa, Japan, 247-0056
    - Active, not recruiting
    - Ofuna Central Hospital
  - Kawasaki, Kanagawa, Japan, 210-0013
    - Completed
    - Kawasaki Municipal Hospital
  - Yokohama, Kanagawa, Japan, 220-0041
    - Active, not recruiting
    - Matsushima Hospital
  - Yokohama, Kanagawa, Japan, 232-0024
    - Completed
    - Yokohama City University Medical Center
  - Yokohama, Kanagawa, Japan, 234-0032
    - Completed
    - Showa University Northern Yokohama Hospital
- Mie
  - Tsu, Mie, Japan, 514-8507
    - Completed
    - Mie University Hospital
- Miyagi
  - Sendai, Miyagi, Japan, 981-3213
    - Completed
    - Takagi Clinic - Sendai
- Niigata
  - Nagaoka-shi, Niigata, Japan, 940-8653
    - Active, not recruiting
    - Nagaoka Chuo General Hospital
- Oita-Ken
  - Oita-shi, Oita-Ken, Japan, 870 0823
    - Completed
    - Ishida Clinic of IBD and Gastroenterology
- Osaka
  - Fujiidera, Osaka, Japan, 583-0027
    - Completed
    - Sai Gastroenterologist Proctology
- Saitama-Ken
  - Kumagaya-shi, Saitama-Ken, Japan, 360-8567
    - Active, not recruiting
    - Kumagaya General Hospital
- Shizuoka
  - Hamamatsu, Shizuoka, Japan, 432-8061
    - Active, not recruiting
    - Matsuaikai Matsuda Hospital
- Tochigi
  - Shimotsuke, Tochigi, Japan, 329-0498
    - Completed
    - Jichi Medical University Hospital
- Tokyo
  - Bunkyō, Tokyo, Japan, 113-8519
    - Completed
    - Tokyo Medical And Dental University Medical Hospital
  - Chiyoda-ku, Tokyo, Japan, 101-8643
    - Completed
    - Mitsui Memorial Hospital
  - Koto-ku, Tokyo, Japan, 135 8577
    - Completed
    - Showa University Koto Toyosu Hospital
  - Minato-Ku, Tokyo, Japan, 108 8642
    - Completed
    - Kitasato University Kitasato Institute Hospital
  - Shinjyuku-ku, Tokyo, Japan, 162-8655
    - Completed
    - Center Hospital of the National Center for Global Health and Medicine
Korea, Republic of
- Kang-won-do
  - Wonju, Kang-won-do, Korea, Republic of, 26426
    - Active, not recruiting
    - Yonsei University-Wonju Severance Christian Hospital
- Kyǒngsangbuk-do
  - Gyeongsan-si, Kyǒngsangbuk-do, Korea, Republic of, 42415
    - Active, not recruiting
    - Yeungnam Univeristy Medical Center
- Pusan-Kwangyǒkshi
  - Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 49201
    - Active, not recruiting
    - Dong-A University Hospital
  - Haeundae-gu, Pusan-Kwangyǒkshi, Korea, Republic of, 48108
    - Active, not recruiting
    - Inje University Haeundae Paik Hospital
- Seoul-teukbyeolsi [Seoul]
  - Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
    - Recruiting
    - Asan Medical Center
    - Principal Investigator:
      
      Sang Hyoung Park
  - Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 02447
    - Active, not recruiting
    - Kyung Hee University Hospital
  - Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 3181
    - Active, not recruiting
    - Kangbuk Samsung Hospital
  - Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 6351
    - Recruiting
    - Samsung Medical Center
    - Principal Investigator:
      
      YoungHo Kim
- Taejǒn-Kwangyǒkshi
  - Daejeon, Taejǒn-Kwangyǒkshi, Korea, Republic of, 34943
    - Active, not recruiting
    - The Catholic University of Korea, Daejeon St. Mary's Hospital
Latvia
- - Riga, Latvia, 1079
    - Completed
    - Digestive Diseases Center "Gastro"
  - Riga, Latvia, LV1079
    - Completed
    - RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia
- Rīga
  - Riga, Rīga, Latvia, LV-1002
    - Active, not recruiting
    - Pauls Stradins Clinical Univeristy Hospital
Lithuania
- - Kaunas, Lithuania, 50009
    - Recruiting
    - Hospital of Lithuanian University of Health Sciences Kaunas
    - Principal Investigator:
      
      Gediminas Kiudelis
  - Klaipeda, Lithuania, 92231
    - Recruiting
    - Republic Hospital of Klaipeda
    - Contact:
      
      Phone Number: 37062046677
    - Principal Investigator:
      
      Arunas Kancauskas
  - Vilnius, Lithuania, LT-08661
    - Recruiting
    - Vilnius University hospital Santaros klinikos
    - Principal Investigator:
      
      Edita Kazenaite
- Klaipėdos Miestas
  - Klaipeda, Klaipėdos Miestas, Lithuania, 92288
    - Recruiting
    - Klaipeda University Hospital
    - Principal Investigator:
      
      Giedrius Simulionis
- Panevėžio Apskritis
  - Panevezys, Panevėžio Apskritis, Lithuania, LT-35144
    - Recruiting
    - Respublikine Panevezio Ligonine
    - Principal Investigator:
      
      Darius Kriukas
Malaysia
- - Kelantan, Malaysia, 16150
    - Recruiting
    - Hospital Universiti Sains Malaysia
    - Contact:
      
      Phone Number: 6097676595
    - Principal Investigator:
      
      Yeong Yeh Lee
  - Kuala Lumpur, Malaysia, 59100
    - Not yet recruiting
    - University Malaya Medical Centre
    - Contact:
      
      Phone Number: 6042225768
    - Principal Investigator:
      
      Choon Kin Lee
  - Selangor, Malaysia, 43000
    - Recruiting
    - Hospital Serdang
    - Contact:
      
      Phone Number: 60196662174
    - Principal Investigator:
      
      Rosaida Hj Md Said
- Kedah
  - Alor Star, Kedah, Malaysia, 05460
    - Not yet recruiting
    - Hospital Sultanah Bahiyah
    - Contact:
      
      Phone Number: 6047406227
    - Principal Investigator:
      
      Muhammad Radzi Bin Abu Hassan
- Kelantan
  - Kota Bahru, Kelantan, Malaysia, 15586
    - Not yet recruiting
    - Hospital Raja Perempuan Zainab II
    - Contact:
      
      Phone Number: 60139395880
    - Principal Investigator:
      
      Norasiah Binti Abu Bakar
- Kuala Lumpur
  - Cheras, Kuala Lumpur, Malaysia, 56000
    - Not yet recruiting
    - Pusat Perubatan University Kebangsaan Malaysia
    - Contact:
      
      Phone Number: 60124500026
    - Principal Investigator:
      
      Raja Affendi Bin Raja Ali
- Wilayah Persekutuan Kuala Lumpur
  - Lembah Pantai, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - University Malaya Medical Centre
    - Principal Investigator:
      
      Ida Normiha Hilmi
Mexico
- - Chihuahua, Mexico, 31203
    - Recruiting
    - Scientia Investigacion Clinica S.C.
    - Principal Investigator:
      
      Gaspar Iglesias
  - Veracruz, Mexico, 91900
    - Recruiting
    - Sociedad de Metabolsimo y Corazón S.C.
    - Principal Investigator:
      
      Aracely Cruz Palacios
- Sinaloa
  - Culiacán, Sinaloa, Mexico, 80230
    - Completed
    - Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
Moldova, Republic of
- - Chisinau, Moldova, Republic of, MD2025
    - Recruiting
    - Republican Clinical Hospital
    - Contact:
      
      Phone Number: 1137379689636
    - Principal Investigator:
      
      Elina Berliba
Netherlands
- - Utrecht, Netherlands, 3584 CX
    - Active, not recruiting
    - Universitair Medisch Centrum Utrecht
- Noord-Brabant
  - Tilburg, Noord-Brabant, Netherlands, 5022 GC
    - Active, not recruiting
    - ETZ Elisabeth
  - Uden, Noord-Brabant, Netherlands, 5406 PT
    - Completed
    - Ziekenhuis Bernhoven
- Noord-Holland
  - Amsterdam, Noord-Holland, Netherlands, 1105 AZ
    - Active, not recruiting
    - Amsterdam UMC, Locatie AMC
Poland
- Dolnośląskie
  - Wroclaw, Dolnośląskie, Poland, 53-114
    - Completed
    - Lexmedica
  - Wroclaw, Dolnośląskie, Poland, 53-333
    - Recruiting
    - Ars-Medica
    - Principal Investigator:
      
      Barbara Wozniak-Stolarska
- Kujawsko-pomorskie
  - Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
    - Completed
    - Centrum Medyczne Pratia Bydgoszcz
  - Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
    - Recruiting
    - Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
    - Principal Investigator:
      
      Maria Klopocka
  - Torun, Kujawsko-pomorskie, Poland, 87-100
    - Recruiting
    - Gastromed
    - Principal Investigator:
      
      Marcin Zmudzinski
- Lubelskie
  - Lublin, Lubelskie, Poland, 20-582
    - Recruiting
    - ZOZ Gastromed
    - Principal Investigator:
      
      Wit Cezary Danilkiewicz
  - Lublin, Lubelskie, Poland, 20-954
    - Recruiting
    - Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
    - Principal Investigator:
      
      Halina Cichoz-Lach
  - Zamosc, Lubelskie, Poland, 22-400
    - Recruiting
    - ETG Zamosc
    - Principal Investigator:
      
      Katarzyna Wojcik
- Mazowieckie
  - Warsaw, Mazowieckie, Poland, 03-580
    - Recruiting
    - NZOZ Vivamed
    - Principal Investigator:
      
      Robert Petryka
  - Warsaw, Mazowieckie, Poland, 00-728
    - Recruiting
    - WIP Warsaw IBD Point Profesor Kierkus
    - Principal Investigator:
      
      Jaroslaw Kierkus
  - Warszawa, Mazowieckie, Poland, 00-189
    - Recruiting
    - Centrum Zdrowia MDM
    - Principal Investigator:
      
      Michal Lawinski
- Małopolskie
  - Krakow, Małopolskie, Poland, 31-506
    - Recruiting
    - Topolowa Medicenter
    - Principal Investigator:
      
      Zbigniew Wylegala
  - Krakow, Małopolskie, Poland, 31-009
    - Recruiting
    - Gabinet Endoskopii Przewodu Pokarmowego
    - Principal Investigator:
      
      Piotr Walczak
  - Nowy Targ, Małopolskie, Poland, 34-400
    - Completed
    - Medicenter Nowy Targ
  - Wadowice, Małopolskie, Poland, 34-100
    - Recruiting
    - Nzoz Formed
    - Principal Investigator:
      
      Beata Mroziak
  - Warsaw, Małopolskie, Poland, 02-507
    - Recruiting
    - Centralny Szpital Kliniczny MSWiA w Warszawie
    - Principal Investigator:
      
      Grazyna Rydzewska
- Podkarpackie
  - Rzeszow, Podkarpackie, Poland, 35-068
    - Recruiting
    - Centrum Medyczne LUX MED - Rzeszow
    - Principal Investigator:
      
      Lucja Puszko
- Pomorskie
  - Sopot, Pomorskie, Poland, 81-756
    - Recruiting
    - Endoskopia Sp. z.o.o.
    - Principal Investigator:
      
      Marek Horynski
- Warmińsko-mazurskie
  - Elblag, Warmińsko-mazurskie, Poland, 02-300
    - Recruiting
    - Szpital Miejski im. Jana Pawła II w Elblagu
    - Principal Investigator:
      
      Krzysztof Niezgoda
  - Olsztyn, Warmińsko-mazurskie, Poland, 11-041
    - Recruiting
    - Wojewodzki Szpital Specjalistyczny w Olsztynie
    - Principal Investigator:
      
      Tomasz Arlukowicz
- Zachodniopomorskie
  - Szczecin, Zachodniopomorskie, Poland, 71-685
    - Recruiting
    - SONOMED Centrum Medyczne
    - Principal Investigator:
      
      Anna Wiechowska-Kozlowska
  - Szczecin, Zachodniopomorskie, Poland, 71-434
    - Recruiting
    - Twoja Przychodnia - Szczecinskie Centrum Medyczne
    - Principal Investigator:
      
      Beata Gawdis-Wojnarska
- Śląskie
  - Bedzin, Śląskie, Poland, 42-500
    - Completed
    - Promedica Dental Clinic
  - Katowice, Śląskie, Poland, 40-659
    - Recruiting
    - All-Medicus
    - Principal Investigator:
      
      Aldona Mularczyk
Romania
- - Bucuresti, Romania, 12015
    - Recruiting
    - S.C. Centrul Medical Medicum SRL
    - Principal Investigator:
      
      Theodor Voiosu
- Bihor
  - Oradea, Bihor, Romania, 410469
    - Recruiting
    - Spitalul Pelican
    - Principal Investigator:
      
      Suta Alin Horea
- București
  - Bucharest, București, Romania, 013812
    - Recruiting
    - Spitalul de Oncologie Monza
    - Principal Investigator:
      
      EUGENIU ION CRACIUN
  - Bucuresti, București, Romania, 20125
    - Recruiting
    - Spitalul Clinic Colentina
    - Principal Investigator:
      
      Bogdan Mateescu
  - Bucuresti, București, Romania, 30463
    - Recruiting
    - CCBR Clinical Research
    - Principal Investigator:
      
      Daniela Bartos
Russian Federation
- - Saint Petersburg, Russian Federation, 193015
    - Active, not recruiting
    - North-Western State Medical University named after I.I.Mechnikov
- Altayskiy Kray
  - Barnaul, Altayskiy Kray, Russian Federation, 656038
    - Active, not recruiting
    - Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"
- Irkutskaya Oblast'
  - Irkutsk, Irkutskaya Oblast', Russian Federation, 664079
    - Active, not recruiting
    - Scientific Centre of Reconstructive and Restorative Surgery
- Kareliya, Respublika
  - Petrozavodsk, Kareliya, Respublika, Russian Federation, 620109
    - Active, not recruiting
    - Karelia Republican Hospital V.A. Baranova
- Kemerovskaya Oblast'
  - Kemerovo, Kemerovskaya Oblast', Russian Federation, 620109
    - Active, not recruiting
    - Kemerovo Regional Clinical Hospital
- Leningradskaya Oblast'
  - Saint Petersburg, Leningradskaya Oblast', Russian Federation, 191104
    - Active, not recruiting
    - City Mariinskaya Hospital
- Nizhegorodskaya Oblast'
  - Nizhny Novgorod, Nizhegorodskaya Oblast', Russian Federation, 603140
    - Recruiting
    - Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
    - Principal Investigator:
      
      Natalia Alexandrovna Eremina
  - Nizhny Novgorod, Nizhegorodskaya Oblast', Russian Federation, 603126
    - Active, not recruiting
    - Nizhny Novgorod Regional Hospital N.A. Semashko
- Novosibirskaya Oblast'
  - Novosibirsk, Novosibirskaya Oblast', Russian Federation, 630117
    - Active, not recruiting
    - Research Institute of Physiology and Fundamental Medicine
  - Novosibirsk, Novosibirskaya Oblast', Russian Federation, 630008
    - Active, not recruiting
    - Medical Center SibNovoMed
- Rostovskaya Oblast'
  - Rostov-on-Don, Rostovskaya Oblast', Russian Federation, 344022
    - Completed
    - Rostov State Medical University
- Sankt-Peterburg
  - Saint Petersburg, Sankt-Peterburg, Russian Federation, 195271
    - Recruiting
    - Clinical Hospital "RZhD-Medicine"
    - Principal Investigator:
      
      Victor Borisovich Shunkov
  - Saint Petersburg, Sankt-Peterburg, Russian Federation, 196143
    - Active, not recruiting
    - Scientific research center ECO-security
  - Saint Petersburg, Sankt-Peterburg, Russian Federation, 197110
    - Completed
    - Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31
  - Saint-Petersburg, Sankt-Peterburg, Russian Federation, 197022
    - Active, not recruiting
    - First Pavlov State Medical University of Saint Petersburg
- Stavropol'skiy Kray
  - Stavropol, Stavropol'skiy Kray, Russian Federation, 355017
    - Completed
    - Stavropol State Medical University
- Sverdlovskaya Oblast'
  - Ekaterinburg, Sverdlovskaya Oblast', Russian Federation, 620109
    - Active, not recruiting
    - MO New Hospital
- Tatarstan, Respublika
  - Kazan, Tatarstan, Respublika, Russian Federation, 420064
    - Active, not recruiting
    - Kazan State Medical University
- Udmurtskaya Respublika
  - Izhevsk, Udmurtskaya Respublika, Russian Federation, 426061
    - Active, not recruiting
    - Alliance Biomedical URAL Group
- Yaroslavskaya Oblast'
  - Yaroslavl, Yaroslavskaya Oblast', Russian Federation, 150030
    - Active, not recruiting
    - SHI of Yaroslavl Region Clinical Hospital #8
Serbia
- Beograd
  - Belgrade, Beograd, Serbia, 11000
    - Recruiting
    - Clinical Hospital Center Zvezdara
    - Principal Investigator:
      
      Petar Svorcan
  - Belgrade, Beograd, Serbia, 11080
    - Completed
    - Clinical Center Bezanijska Kosa
- Vojvodina
  - Sombor, Vojvodina, Serbia, 25000
    - Recruiting
    - Regional Hospital Dr Radivoj Simonovic Sombor
    - Principal Investigator:
      
      Mileva Lovric Jovanovic
  - Sremska Mitrovica, Vojvodina, Serbia, 22000
    - Recruiting
    - Sremska Mitrovica Health Centre
    - Principal Investigator:
      
      Gordana Mitic
  - Zrenjanin, Vojvodina, Serbia, 23000
    - Recruiting
    - General Hospital "Djordje Joanovic"
    - Principal Investigator:
      
      Tatjana Latinovic Radakovic
- Šumadijski Okrug
  - Kragujevac, Šumadijski Okrug, Serbia, 34000
    - Recruiting
    - Clinical Center Kragujevac
    - Principal Investigator:
      
      Natasa Zdravkovic-Petrovic
Slovakia
- Banskobystrický Kraj
  - Banská Bystrica, Banskobystrický Kraj, Slovakia, 97517
    - Active, not recruiting
    - Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
- Bratislavský Kraj
  - Bratislava, Bratislavský Kraj, Slovakia, 811 09
    - Active, not recruiting
    - Univerzitná nemocnica Bratislava - Nemocnica Ružinov
- Nitriansky Kraj
  - Nitra, Nitriansky Kraj, Slovakia, 949 01
    - Active, not recruiting
    - KM Management
- Prešovský Kraj
  - Prešov, Prešovský Kraj, Slovakia, 080 01
    - Completed
    - Gastro
  - Vranov N. Toplou, Prešovský Kraj, Slovakia, 093 01
    - Active, not recruiting
    - Endomed, s.r.o.
Spain
- - Alicante, Spain, 3004
    - Completed
    - Instituto de Ciencias Médicas
  - Huelva, Spain, 21005
    - Completed
    - Hospital Universitario Juan Ramon Jimenez
  - Madrid, Spain, 28046
    - Active, not recruiting
    - Hospital Universitario La Paz
- Cantabria
  - Santander, Cantabria, Spain, 39008
    - Active, not recruiting
    - Hospital Universitario Marqués de Valdecilla
- Girona [Gerona]
  - Girona, Girona [Gerona], Spain, 17007
    - Active, not recruiting
    - Hospital Universitari de Girona Doctor Josep Trueta
- Las Palmas
  - Las Palmas De GC, Las Palmas, Spain, 35019
    - Active, not recruiting
    - Hospital Universitario de Gran Canaria Doctor Negrín
- Madrid
  - Fuenlabrada, Madrid, Spain, 28942
    - Active, not recruiting
    - Hospital Universitario de Fuenlabrada
- València
  - Sagunto, València, Spain, 46520
    - Active, not recruiting
    - Hospital de Sagunto y C.E.
Switzerland
- - Berne, Switzerland, 3010
    - Recruiting
    - Inselspital Bern
    - Principal Investigator:
      
      Benjamin Misselwitz
  - Zürich, Switzerland, 8091
    - Recruiting
    - Universitätsspital Zürich
    - Principal Investigator:
      
      Luc Biedermann
- Berne
  - Bern, Berne, Switzerland, 3012
    - Recruiting
    - Gastroenterologische Praxis Balsiger, Seibold & Partner
    - Principal Investigator:
      
      Frank Seibold
- Sankt Gallen
  - st.Gallen, Sankt Gallen, Switzerland, 9007
    - Recruiting
    - Cantonal Hospital St.Gallen
    - Principal Investigator:
      
      Stephan Brand
Taiwan
- - Taichung, Taiwan, 40447
    - Recruiting
    - China Medical University Hospital
    - Principal Investigator:
      
      Jen-Wei Chou
  - Taipei, Taiwan, 10002
    - Recruiting
    - National Taiwan University Hospital
    - Principal Investigator:
      
      Chia-Hung Tu
Turkey
- - Antalya, Turkey, 7100
    - Recruiting
    - Antalya Egitim ve Arastırma Hastanesi
    - Principal Investigator:
      
      ayhan cekin
  - Kocaeli, Turkey, 41380
    - Completed
    - Kocaeli Üniversitesi
  - Mersin, Turkey, 33110
    - Active, not recruiting
    - Mersin University
- İzmir
  - Bornova, İzmir, Turkey, 35100
    - Recruiting
    - Ege Universitesi Hastanesi
    - Principal Investigator:
      
      Nalan Gulsen Unal
Ukraine
- - Kyiv, Ukraine, 2091
    - Recruiting
    - Medical Center Ok!Clinic+
    - Principal Investigator:
      
      Nataliia Tsarynna
  - Kyiv, Ukraine, 04106
    - Recruiting
    - Kiev Regional Clinical Hospital No. 1
    - Principal Investigator:
      
      Svitlana Danyliuk
  - Kyiv, Ukraine, 4078
    - Recruiting
    - Kyiv Regional Clinical Hospital
    - Principal Investigator:
      
      Tetiana Lohdanidi
- Ivano-Frankivska Oblast
  - Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76008
    - Recruiting
    - Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"
    - Principal Investigator:
      
      Vira Vyshyvanyuk
- Kharkivska Oblast
  - Kharkiv, Kharkivska Oblast, Ukraine, 61037
    - Completed
    - City Clinical Hospital No. 2
  - Kharkiv, Kharkivska Oblast, Ukraine, 61039
    - Recruiting
    - L.T. Mala National Institute of Therapy of NAMS of Ukraine
    - Principal Investigator:
      
      Oleksiy Gridnyev
- Khersonska Oblast
  - Kherson, Khersonska Oblast, Ukraine, 73000
    - Completed
    - Kherson City Clinical Hospital
- Kirovohradska Oblast
  - Kropyvnytskyi, Kirovohradska Oblast, Ukraine, 25006
    - Recruiting
    - Private Enterprise Private Manufacturing Company Acinus
    - Principal Investigator:
      
      Viktoriia Shevchuk
- Kyiv
  - Kiev, Kyiv, Ukraine, 4050
    - Recruiting
    - Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
    - Principal Investigator:
      
      Oksana Gerasymenko
- Lvivska Oblast
  - Lviv, Lvivska Oblast, Ukraine, 79000
    - Completed
    - Lviv Railway Clinical Hospital
  - Lviv, Lvivska Oblast, Ukraine, 79010
    - Recruiting
    - Lviv Regional Clinical Hospital - Lviv National Medical University named Danylo Galician
    - Principal Investigator:
      
      Yaroslav Zborivskyy
    - Contact:
      
      Phone Number: +380679029773
  - Lviv, Lvivska Oblast, Ukraine, 79000
    - Recruiting
    - Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
    - Principal Investigator:
      
      Valeriy Vdovychenko
- Odeska Oblast
  - Odesa, Odeska Oblast, Ukraine, 65025
    - Recruiting
    - Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
    - Principal Investigator:
      
      Olena Levchenko
- Poltavska Oblast
  - Poltava, Poltavska Oblast, Ukraine, 36000
    - Completed
    - Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
- Vinnytska Oblast
  - Vinnytsia, Vinnytska Oblast, Ukraine, 21009
    - Recruiting
    - Medical Clinical Investigational Center of Medical Center Health Clinic
    - Principal Investigator:
      
      Oleksandr Golovchenko
  - Vinnytsya, Vinnytska Oblast, Ukraine, 21018
    - Recruiting
    - VNMU
    - Principal Investigator:
      
      Mykola Stanislavchuk
  - Vinnytsya, Vinnytska Oblast, Ukraine, 21000
    - Recruiting
    - City Clinical Hospital #1, Vinnitsya National Medical University
    - Principal Investigator:
      
      Valerii Ivanov
    - Contact:
      
      Phone Number: 38067 955 47 88
- Zakarpatska Oblast
  - Uzhgorod, Zakarpatska Oblast, Ukraine, 88000
    - Recruiting
    - Transcarpathian Regional Hospital im.Andriya Novak
    - Principal Investigator:
      
      Yaroslava Rishko
- Zaporizka Oblast
  - Zaporizhia, Zaporizka Oblast, Ukraine, 69076
    - Recruiting
    - Diaservis - Medical and Diagnostic Center
    - Principal Investigator:
      
      Oleksandr Oliinyk
  - Zaporizhzhia, Zaporizka Oblast, Ukraine, 69076
    - Recruiting
    - Diacenter
    - Principal Investigator:
      
      Viacheslav Vasilievich Neshta
United Kingdom
- Great Britain
  - Bury, Great Britain, United Kingdom, BL9 7TD
    - Completed
    - Fairfield General Hospital
- London, Ci
  - London, London, Ci, United Kingdom, NW1 2PG
    - Recruiting
    - Guy's & St Thomas' NHS Foundation Trust
    - Principal Investigator:
      
      Peter Irving
- Oxfordshire
  - Oxford, Oxfordshire, United Kingdom, OX3 9DU
    - Recruiting
    - The John Radcliffe Hospital
    - Principal Investigator:
      
      Simon Travis
- Waltham Forest
  - London, Waltham Forest, United Kingdom, E1 1RD
    - Recruiting
    - Barts Health Nhs Trust
    - Principal Investigator:
      
      Syed Samiul Hoque
United States
- Alabama
  - Dothan, Alabama, United States, 36305
    - Recruiting
    - Digestive Health Specialists
    - Principal Investigator:
      
      Paul Lamb
- Arizona
  - Litchfield Park, Arizona, United States, 85340
    - Recruiting
    - Research Solutions of Arizona
    - Principal Investigator:
      
      Connie Hsu
  - Phoenix, Arizona, United States, 85008
    - Recruiting
    - Valleywise Health Medical Center
    - Principal Investigator:
      
      Indu Srinivasan
- California
  - Arcadia, California, United States, 91006
    - Completed
    - InSite Digestive Health Care
  - Berkeley, California, United States, 94705
    - Recruiting
    - Care Access - Berkeley
    - Principal Investigator:
      
      MARK KOGAN
  - Lancaster, California, United States, 93534
    - Recruiting
    - Om Research LLC
    - Principal Investigator:
      
      Jatinder S Pruthi
  - Northridge, California, United States, 91324
    - Recruiting
    - California Medical Research Associates
    - Principal Investigator:
      
      Calin Arimie
  - Rialto, California, United States, 92377
    - Completed
    - Inland Empire Clinical Trials, LLC
  - San Diego, California, United States, 92103
    - Completed
    - Clinical Applications Laboratories, Inc.
- Florida
  - Hialeah, Florida, United States, 33012
    - Completed
    - Direct Helpers Research Center
  - Jacksonville, Florida, United States, 32256
    - Recruiting
    - Encore Borland-Groover Clinical Research
    - Principal Investigator:
      
      Mark R. Fleisher
  - Miami, Florida, United States, 33156
    - Recruiting
    - Research Associates of South Florida
    - Principal Investigator:
      
      Javier Sobrado
  - Miami Lakes, Florida, United States, 33016
    - Recruiting
    - Wellness Clinical Research
    - Principal Investigator:
      
      Lucky Flores
  - Orlando, Florida, United States, 32803
    - Recruiting
    - AdventHealth Orlando
    - Contact:
      
      Phone Number: 407-303-2570
    - Principal Investigator:
      
      Ilan Aharoni
  - Orlando, Florida, United States, 32818
    - Completed
    - Clintheory Healthcare
  - Pensacola, Florida, United States, 32503
    - Recruiting
    - Gastroenterology Associates of Pensacola, PA
    - Principal Investigator:
      
      Frederic Newman
    - Contact:
      
      Phone Number: 850-436-4536
  - Zephyrhills, Florida, United States, 33542-7505
    - Recruiting
    - Florida Medical Clinic LLC
    - Contact:
      
      Phone Number: 813-780-8368
    - Principal Investigator:
      
      Mark Eisner
- Georgia
  - Atlanta, Georgia, United States, 30327
    - Recruiting
    - Digestive Healthcare of Georgia
    - Principal Investigator:
      
      Michael R Galambos
- Illinois
  - Evanston, Illinois, United States, 60201
    - Recruiting
    - NorthShore University HealthSystem - Evanston Hospital
    - Principal Investigator:
      
      Ioannis Economou
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Recruiting
    - Indiana University Health University Hospital
    - Principal Investigator:
      
      Sashidhar Sagi
- Kansas
  - Topeka, Kansas, United States, 66606
    - Completed
    - Cotton O'Neil Digestive Health Center
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Recruiting
    - GI Alliance Research Baton Rouge
    - Principal Investigator:
      
      Michael Barker
    - Contact:
      
      Phone Number: 7850 225-927-1190
  - Monroe, Louisiana, United States, 71201
    - Recruiting
    - Delta Research Partners
    - Principal Investigator:
      
      Henry Hill Hinkle III
  - New Orleans, Louisiana, United States, 70125
    - Recruiting
    - Nola Research Works, LLC
    - Contact:
      
      Phone Number: 504-891-3613
    - Principal Investigator:
      
      Vivek Huilgol
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Completed
    - University of Michigan
  - Chesterfield, Michigan, United States, 48047
    - Recruiting
    - Clinical Research Institute of Michigan, LLC
    - Principal Investigator:
      
      Ronald Fogel
  - Novi, Michigan, United States, 48377
    - Recruiting
    - Henry Ford Medical Center - Columbus Center
    - Principal Investigator:
      
      Nirmal Kaur
  - Wyoming, Michigan, United States, 49519
    - Recruiting
    - West Michigan Clinical Research Center
    - Principal Investigator:
      
      Allan Coates
- Minnesota
  - Plymouth, Minnesota, United States, 55446
    - Recruiting
    - MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
    - Principal Investigator:
      
      Robert McCabe
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599-7080
    - Recruiting
    - Clinical & Translational Research Center (CTRC)
    - Principal Investigator:
      
      Animesh Jain
- Ohio
  - Poland, Ohio, United States, 44514
    - Recruiting
    - Care Access - Youngstown
    - Principal Investigator:
      
      Sayed M. Yossef
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104-5008
    - Recruiting
    - The University of Oklahoma Health Sciences Center
    - Principal Investigator:
      
      Ijlal Akbar Ali
  - Oklahoma City, Oklahoma, United States, 73118
    - Recruiting
    - Central Sooner Research - Oklahoma - Northwest 47th Street
    - Principal Investigator:
      
      Robert Gordon
- Pennsylvania
  - Pottsville, Pennsylvania, United States, 17901
    - Recruiting
    - Care Access - Pottsville
    - Principal Investigator:
      
      Glenn Freed
  - Wyomissing, Pennsylvania, United States, 19610
    - Recruiting
    - Digestive Disease Associates
    - Principal Investigator:
      
      Nirav Shah
- South Dakota
  - Sioux Falls, South Dakota, United States, 57108
    - Completed
    - Midwest Medical Care
- Texas
  - Fort Worth, Texas, United States, 76104
    - Recruiting
    - Texas Digestive Disease Consultants
    - Principal Investigator:
      
      Timothy Ritter
  - Garland, Texas, United States, 75044
    - Recruiting
    - GI Alliance
    - Principal Investigator:
      
      Harry Sarles
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Gastroenterology Research of San Antonio
    - Principal Investigator:
      
      Nicholas Martinez
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Southern Star Research Institute
    - Principal Investigator:
      
      Jeff Bullock
  - Southlake, Texas, United States, 76092
    - Recruiting
    - GI Alliance
    - Principal Investigator:
      
      Timothy Ritter
- Utah
  - Ogden, Utah, United States, 84403
    - Recruiting
    - Care Access - Ogden
    - Principal Investigator:
      
      Chad Gonzales
- Virginia
  - Roanoke, Virginia, United States, 24014
    - Recruiting
    - Carilion Clinic
    - Principal Investigator:
      
      Paul Yeaton
- Washington
  - Tacoma, Washington, United States, 98405
    - Recruiting
    - Washington Gastroenterology - Tacoma
    - Principal Investigator:
      
      William H Holderman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria
- Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) who have had at least one study drug administration and have not had early termination of study drug.
- Female participants must agree to contraception requirements.
Exclusion Criteria
- Participants must not have developed a new condition, including cancer in the originator study.
- Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
- Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
- Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mirikizumab Mirikizumab administered subcutaneously (SC).	Drug: Mirikizumab Administered SC. Other Names: LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Clinical Remission Time Frame: Week 52	Clinical remission based on the modified Mayo Score (MMS).	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Endoscopic Remission Time Frame: Week 52	Endoscopic remission based on the MMS Endoscopic Subscore (ES).	Week 52
Percentage of Participants in Corticosteroid-free Remission Time Frame: Week 52	Participants in corticosteroid-free remission.	Week 52
Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52 Time Frame: Week 52	Endoscopic remission based on the MMS ES and histologic remission based on histologic disease activity index.	Week 52
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.	Baseline to Week 52
UC Symptoms: Numeric Rating Score Time Frame: Week 160	UC symptoms based on numeric rating score.	Week 160
Percentage of Participants Who are Hospitalized Due to UC Time Frame: Baseline to Week 160	Participants who are hospitalized due to UC.	Baseline to Week 160
Percentage of Participants Who Undergo UC Surgeries Including Colectomy Time Frame: Baseline to Week 160	Participants who undergo UC surgeries including colectomy.	Baseline to Week 160

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2018

Primary Completion (Estimated)

July 7, 2026

Study Completion (Estimated)

December 20, 2027

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

May 7, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Inflammatory Bowel Disease

Other Study ID Numbers

16596
I6T-MC-AMAP (Other Identifier: Eli Lilly and Company)
2017 004092 31 (EudraCT Number)
2023-507657-15-00 (Other Identifier: EUCTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on Mirikizumab

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