Clinical Trial

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

Dimensions: NCT03518086

Investigators

Scott Lee (30)
So, Kenji (41)
So, Kenji (43)
Lei Chen (58)
Gao, Xiang (59)
Wei, Po-Li (61)
Shen, Hong (64)
Ruihua Shi (65)
Peng Yan (70)
Zheng, Jie (71)
Zhihua Ran (72)
Yao, Ping (74)
Yan Chen (77)
Cao, Qian (79)
Yi Jiang (80)
Simon, M (98)
Jochen Klaus (103)
Stefan Lüth (104)
Segal, Arik (116)
Ehud Melzer (120)
Haim Shirin (122)
Ran, Zhi Hua (127)
Villa, Erica (129)
Naoki Omiya (137)
Yo Ishiguro (138)
Kawai, Mikio (149)
Hanae Takagi (153)
Toda, Nobuo (162)
Jonghun Lee (171)
Dongwoo Kim (173)
Shi, Rui-Hua (175)
So, Kenji (176)
Hyo-Jong Kim (177)
YoungHo Kim (179)
Tae-oh Kim (180)
JongPi Im (183)
Dong II Park (184)
Li, Yan-Qing (194)
Ran, Zhi Hua (221)
Wei-Chen Tai (229)
Yu-Cheng Su (230)
Jen-Wei Chou (232)
Po-Li Wei (235)
Halis Simsek (237)
Gonen, Can (240)
Leena Sinha (247)
Jimmy Limdi (249)
Mowat, Craig (251)
Hoque, Syed (252)

Affiliations

Organisations

  1. (1) Phoenix College, grid.459941.4
  2. (2) Maricopa Integrated Health System, grid.416426.3
  3. (3) University of California, San Diego, grid.266100.3
  4. (4) University of California, San Francisco, grid.266102.1
  5. (5) Prescott College, grid.423309.f
  6. (6) Northwestern University, grid.16753.36
  7. (7) NorthShore University HealthSystem, grid.240372.0
  8. (8) Indiana University – Purdue University Indianapolis, grid.257413.6
  9. (9) University of Kansas Medical Center, grid.412016.0
  10. (10) Texas Digestive Disease Consultants, grid.492969.9
  11. (11) Tulane University, grid.265219.b
  12. (12) New England Center for Clinical Research, grid.477695.e
  13. (13) Henry Ford Health System, grid.239864.2
  14. (14) Gastroenterology Associates Of Western Michigan, grid.477275.4
  15. (15) Minnesota Gastroenterology, grid.477550.4
  16. (16) Bozeman Health Deaconess Hospital, grid.490033.d
  17. (17) Capital Health Medical Center Hopewell, grid.489941.9
  18. (18) Holy Name Medical Center, grid.414324.4
  19. (19) Northwell Health, grid.416477.7
  20. (20) Clinical Research Associates, grid.506874.8
  21. (21) Cornell University, grid.5386.8
  22. (22) University of North Carolina System, grid.410711.2
  23. (23) University of Oklahoma Health Sciences Center, grid.266902.9
  24. (24) Vanderbilt University Medical Center, grid.412807.8
  25. (25) The University of Texas Medical Branch at Galveston, grid.176731.5
  26. (26) Digestive Health Associates of Texas, grid.488757.1
  27. (27) Baylor College of Medicine, grid.39382.33
  28. (28) Houston Methodist, grid.63368.38
  29. (29) Carilion Clinic, grid.413420.0
  30. (30) University of Washington Medical Center, grid.412623.0
  31. (31) Hospital Italiano de Buenos Aires, grid.414775.4
  32. (32) Hospital Privado, grid.413199.7
  33. (33) John Hunter Hospital, grid.414724.0
  34. (34) Royal Prince Alfred Hospital, grid.413249.9
  35. (35) Princess Alexandra Hospital, grid.412744.0
  36. (36) Royal Adelaide Hospital, grid.416075.1
  37. (37) Box Hill Hospital, grid.414580.c
  38. (38) Northern Hospital, grid.416536.3
  39. (39) The Alfred Hospital, grid.1623.6
  40. (40) Royal Melbourne Hospital, grid.416153.4
  41. (41) Royal Perth Hospital, grid.416195.e
  42. (42) Innsbruck Medical University, grid.5361.1
  43. (43) Universitätskliniken Salzburg, grid.413000.6
  44. (44) Medical University of Vienna, grid.22937.3d
  45. (45) Ghent University Hospital, grid.410566.0
  46. (46) AZ Klina, grid.420031.4
  47. (47) AZ Groeninge, grid.420028.c
  48. (48) Universitair Ziekenhuis Leuven, grid.410569.f
  49. (49) Heritage Medical Research Clinic, grid.500315.2
  50. (50) Victoria Hospital, grid.416847.8
  51. (51) Western University, grid.39381.30
  52. (52) McGill University Health Centre, grid.63984.30
  53. (53) Royal University Hospital, grid.412271.3
  54. (54) Anhui Provincial Hospital, grid.411395.b
  55. (55) First Affiliated Hospital of Anhui Medical University, grid.412679.f
  56. (56) Beijing Friendship Hospital, grid.411610.3
  57. (57) Xiangya Hospital Central South University, grid.452223.0
  58. (58) Southwest Hospital, grid.416208.9
  59. (59) Sixth Affiliated Hospital of Sun Yat-sen University, grid.488525.6
  60. (60) University of Hong Kong - Shenzhen Hospital, grid.440671.0
  61. (61) Hainan General Hospital, grid.459560.b
  62. (62) Huazhong University of Science and Technology, grid.33199.31
  63. (63) Nanjing Drum Tower Hospital, grid.428392.6
  64. (64) Jiangsu Province Hospital, grid.412676.0
  65. (65) Zhongda Hospital Southeast University, grid.452290.8
  66. (66) Nanjing Jiangning Hospital, grid.459788.f
  67. (67) Jiangxi Pingxiang People's Hospital, grid.452823.a
  68. (68) Second Affiliated Hospital of Dalian Medical University, grid.452828.1
  69. (69) Qilu Hospital of Shandong University, grid.452402.5
  70. (70) Liaocheng People's Hospital, grid.415912.a
  71. (71) Ruijin Hospital, grid.412277.5
  72. (72) Shanghai Jiao Tong University, grid.16821.3c
  73. (73) West China Hospital of Sichuan University, grid.412901.f
  74. (74) Xinjiang Medical University, grid.13394.3c
  75. (75) Kunming Medical University, grid.285847.4
  76. (76) First People's Hospital of Yunnan Province, grid.414918.1
  77. (77) Second Affiliated Hospital of Zhejiang University, grid.412465.0
  78. (78) First Affiliated Hospital Zhejiang University, grid.452661.2
  79. (79) Sir Run Run Shaw Hospital, grid.415999.9
  80. (80) Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, grid.417384.d
  81. (81) Tongji Hospital, grid.412793.a
  82. (82) Klinički bolnički centar Osijek, grid.412412.0
  83. (83) University Hospital Centre Zagreb, grid.412688.1
  84. (84) Fakultní nemocnice Královské Vinohrady, grid.412819.7
  85. (85) St. Anne´s University Hospital, grid.412752.7
  86. (86) Aalborg Hospital, grid.27530.33, North Denmark Region
  87. (87) Hospital of South West Jutland, grid.414576.5, Southern Denmark Region
  88. (88) Gentofte Hospital, grid.411646.0, Capital Region
  89. (89) Zealand University Hospital, grid.476266.7, Zealand Region
  90. (90) Hôpital d'Hautepierre, grid.412201.4
  91. (91) Hôpital Saint-Louis, grid.413328.f
  92. (92) Hôpital Claude Huriez, grid.413875.c
  93. (93) Hospices Civils de Lyon, grid.413852.9
  94. (94) Centre Hospitalier Universitaire Amiens-Picardie, grid.134996.0
  95. (95) Beaujon Hospital, grid.411599.1
  96. (96) Hôpital Saint Eloi, grid.414352.5
  97. (97) Hôpital l'Archet, grid.413770.6
  98. (98) Centre Hospitalier De Pau, grid.489904.8
  99. (99) Centre Hospitalier Universitaire de Bordeaux, grid.42399.35
  100. (100) Centre Hospitalier Universitaire de Poitiers, grid.411162.1
  101. (101) Hôpital Robert Debré, grid.413235.2
  102. (102) Centre Hospitalier Regional Universitaire De Dijon, grid.31151.37
  103. (103) University Hospital Ulm, grid.410712.1
  104. (104) Klinikum Brandenburg, grid.506532.7
  105. (105) Hannover Medical School, grid.10423.34
  106. (106) Martin Luther University Halle-Wittenberg, grid.9018.0
  107. (107) Charité, grid.6363.0
  108. (108) Krankenhaus Waldfriede, grid.492535.c
  109. (109) Békés Megyei Pándy Kálmán Kórház, grid.415438.f
  110. (110) Semmelweis University, grid.11804.3c
  111. (111) University of Debrecen, grid.7122.6
  112. (112) University of Szeged, grid.9008.1
  113. (113) Fortis Escorts Heart Institute, grid.417966.b
  114. (114) Sir Ganga Ram Hospital, grid.415985.4
  115. (115) Beaumont Hospital, grid.414315.6
  116. (116) Soroka Medical Center, grid.412686.f
  117. (117) Hillel Yaffe Medical Center, grid.414084.d
  118. (118) Meir Medical Center, grid.415250.7
  119. (119) Sheba Medical Center, grid.413795.d
  120. (120) Kaplan Medical Center, grid.415014.5
  121. (121) Tel Aviv Sourasky Medical Center, grid.413449.f
  122. (122) Assaf Harofeh Medical Center, grid.413990.6
  123. (123) Humanitas Research Hospital, grid.417728.f
  124. (124) Ospedale Sandro Pertini, grid.415113.3
  125. (125) Policlinico Tor Vergata, grid.413009.f
  126. (126) Spedali Civili di Brescia, grid.412725.7
  127. (127) Azienda Ospedaliero Universitario Mater Domini, grid.488515.5
  128. (128) Azienda Ospedaliero-Universitaria Careggi, grid.24704.35
  129. (129) Policlinico di Modena, grid.413363.0
  130. (130) Azienda Ospedaliera Universitaria Pisana, grid.144189.1
  131. (131) Agostino Gemelli University Polyclinic, grid.411075.6
  132. (132) Federico II University Hospital, grid.411293.c
  133. (133) Policlinico San Donato, grid.419557.b
  134. (134) A. O. Ordine Mauriziano di Torino, grid.414700.6
  135. (135) Ospedale Santa Maria della Misericordia di Udine, grid.411492.b
  136. (136) Aichi Medical University, grid.411234.1
  137. (137) Fujita Health University Hospital, grid.471500.7
  138. (138) Hirosaki National Hospital, grid.414152.7
  139. (139) Toho University, grid.265050.4
  140. (140) Kitakyushu Municipal Medical Center, grid.415388.3
  141. (141) Fukuoka University Tsukushi Hospital, grid.413918.6
  142. (142) St Mary's Hospital, grid.416532.7
  143. (143) Gunma University, grid.256642.1
  144. (144) National Hospital Organization Mito Medical Center, grid.410845.c
  145. (145) Hiroshima University Hospital, grid.470097.d
  146. (146) Asahikawa City Hospital, grid.413947.c
  147. (147) Sapporo Kosei General Hospital, grid.415268.c
  148. (148) Sapporo Higashi Tokushukai Hospital, grid.490419.1
  149. (149) Hyogo College of Medicine, grid.272264.7
  150. (150) Takamatsu Red Cross Hospital, grid.416853.d
  151. (151) Kagawa Prefectural Central Hospital, grid.414811.9
  152. (152) Kitasato Institute Hospital, grid.415395.f
  153. (153) Kawasaki Municipal Hospital, grid.415107.6
  154. (154) Showa University Northern Yokohama Hospital, grid.482675.a
  155. (155) Yokohama City University Medical Center, grid.413045.7
  156. (156) Kumamoto University Hospital, grid.411152.2
  157. (157) Kyoto Medical Center, grid.410835.b
  158. (158) Mie University Hospital, grid.412075.5
  159. (159) Osaka National Hospital, grid.416803.8
  160. (160) Osaka University Hospital, grid.412398.5
  161. (161) Jichi Medical University Hospital, grid.415016.7
  162. (162) Mitsui Memorial Hospital, grid.415980.1
  163. (163) Juntendo University Hospital, grid.411966.d
  164. (164) Tokyo Medical and Dental University Hospital, grid.474906.8
  165. (165) Showa University, grid.410714.7
  166. (166) Kyorin University Hospital, grid.459686.0
  167. (167) Tokyo Yamate Medical Center, grid.416089.2
  168. (168) Toyama Prefectural Central Hospital, grid.417235.6
  169. (169) Fukuoka University Hospital, grid.411556.2
  170. (170) Okayama University Hospital, grid.412342.2
  171. (171) Dong-A University Hospital, grid.412048.b
  172. (172) Yonsei University Health System, grid.413046.4
  173. (173) Korea University Medical Center, grid.411134.2
  174. (174) St. Vincent's Hospital, grid.416965.9
  175. (175) Ajou University Hospital, grid.411261.1
  176. (176) Hanyang University Guri Hospital, grid.412145.7
  177. (177) Kyung Hee University Medical Center, grid.411231.4
  178. (178) Asan Medical Center, grid.413967.e
  179. (179) Samsung Medical Center, grid.414964.a
  180. (180) Inje University Haeundae Paik Hospital, grid.411631.0
  181. (181) Kyungpook National University Medical Center, grid.477473.4
  182. (182) Yeungnam University Medical Center, grid.413040.2
  183. (183) Seoul National University Hospital, grid.412484.f
  184. (184) Kangbuk Samsung Hospital, grid.415735.1
  185. (185) Ewha Womans University Medical Center, grid.411076.5
  186. (186) Riga East University Hospital, grid.488518.8
  187. (187) Hospital of Lithuanian University of Health Sciences Kaunas Clinics, grid.48349.32
  188. (188) Vilnius University Hospital Santariskiu Klinikos, grid.426597.b
  189. (189) Hospital Sultanah Bahiyah, grid.452819.3
  190. (190) Hospital Raja Perempuan Zainab II, grid.500264.5
  191. (191) Universiti Sains Malaysia, grid.11875.3a
  192. (192) University Malaya Medical Centre, grid.413018.f
  193. (193) Hospital Pulau Pinang, grid.477137.1
  194. (194) University Kebangsaan Malaysia Medical Centre, grid.240541.6
  195. (195) Academic Medical Center, grid.5650.6
  196. (196) Amphia Ziekenhuis, grid.413711.1
  197. (197) Albert Schweitzer Ziekenhuis, grid.413972.a
  198. (198) University Medical Center Utrecht, grid.7692.a
  199. (199) Hospital Colentina, grid.414585.9
  200. (200) Institutul Clinic Fundeni, grid.415180.9
  201. (201) Rostov State Medical University, grid.445717.4
  202. (202) Russian Railways, grid.465426.7
  203. (203) Stavropol State Medical University, grid.414750.3
  204. (204) King Abdulaziz Medical City, grid.415254.3
  205. (205) Klinički centar Srbije, grid.418577.8
  206. (206) Klinički centar Kragujevac, grid.412710.1
  207. (207) Klinički centar Niš, grid.418653.d
  208. (208) University Hospital Bratislava, grid.412685.c
  209. (209) Hospital Universitario Virgen del Rocío, grid.411109.c
  210. (210) Central University Hospital of Asturias, grid.411052.3
  211. (211) Hospital Universitario Son Espases, grid.411164.7
  212. (212) Marqués de Valdecilla University Hospital, grid.411325.0
  213. (213) Hospital Universitario de Fuenlabrada, grid.411242.0
  214. (214) Complejo Hospitalario de Navarra, grid.497559.3
  215. (215) Hospital de Sagunto, grid.414561.3
  216. (216) Hospital San Pedro de Alcántara, grid.413393.f
  217. (217) Hospital Universitario Reina Sofía, grid.411349.a
  218. (218) Hospital Universitari de Girona Doctor Josep Trueta, grid.411295.a
  219. (219) Complexo Hospitalario Universitario A Coruña, grid.411066.4
  220. (220) Doctor Negrín University Hospital, grid.411250.3
  221. (221) Hospital Universitario La Paz, grid.81821.32
  222. (222) Hospital Clínico Universitario de Valencia, grid.411308.f
  223. (223) Hospital Universitario Río Hortega, grid.411280.e
  224. (224) Canton of St. Gallen-Hospital, grid.413349.8
  225. (225) University Hospital of Bern, grid.411656.1
  226. (226) University Hospital of Zurich, grid.412004.3
  227. (227) Taipei Medical University-Shuang Ho Hospital, grid.412955.e
  228. (228) Changhua Christian Hospital, grid.413814.b
  229. (229) Kaohsiung Chang Gung Memorial Hospital, grid.413804.a
  230. (230) Kaohsiung Medical University Chung-Ho Memorial Hospital, grid.412027.2
  231. (231) Chung Shan Medical University Hospital, grid.411645.3
  232. (232) China Medical University Hospital, grid.411508.9
  233. (233) Taipei Veterans General Hospital, grid.278247.c
  234. (234) Mackay Memorial Hospital, grid.413593.9
  235. (235) Taipei Medical University Hospital, grid.412897.1
  236. (236) Gazi University, grid.25769.3f
  237. (237) Hacettepe University, grid.14442.37
  238. (238) Antalya Eğitim ve Araştırma Hastanesi, grid.413819.6
  239. (239) Istanbul University Cerrahpaşa, grid.506076.2
  240. (240) Acıbadem University, grid.411117.3
  241. (241) University of Kocaeli, grid.411105.0
  242. (242) Mersin University, grid.411691.a
  243. (243) Gaziantep University, grid.411549.c
  244. (244) Ege University, grid.8302.9
  245. (245) Dokuz Eylül Üniversitesi Hastanesi, grid.412164.4
  246. (246) Royal Berkshire Hospital, grid.416094.e
  247. (247) Queen's Hospital, grid.415588.5
  248. (248) Royal Hampshire County Hospital, grid.416128.8
  249. (249) Fairfield General Hospital, grid.414732.7
  250. (250) St Thomas' Hospital, grid.425213.3
  251. (251) Ninewells Hospital, grid.416266.1
  252. (252) Whipps Cross University Hospital, grid.439471.c
  253. (253) St James's University Hospital, grid.443984.6
  254. (254) Morriston Hospital, grid.416122.2
  255. (255) Queen Elizabeth Hospital Birmingham, grid.415490.d

Sponsors/collaborators

Abstract

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Methods

Condition: Ulcerative Colitis

Intervention: Administered IV

Recruitment information

Gender: All

Trial period

2018-2021

Phase

Phase 3

Research Categories

Main Subject Area

Fields of Research

External sources

Access at Registry