主方案 (AMAZ):Mirikizumab (LY3074828) 在患有溃疡性结肠炎或克罗恩病 (SHINE-ON) 的儿科参与者中的研究 (SHINE-ON)
用于评估 Mirikizumab 在患有中度至重度溃疡性结肠炎或克罗恩病的儿童和青少年中的长期疗效和安全性的 3 期、多中心、开放标签、长期扩展研究的主方案
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- 电话号码:1-317-615-4559
- 邮箱:LillyTrials@Lilly.com
研究联系人备份
- 姓名:Physicians interested in becoming principal investigators please contact
- 邮箱:clinical_inquiry_hub@lilly.com
学习地点
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Beersheba、以色列、8410101
- 尚未招聘
- Soroka Medical Center
-
接触:
- 电话号码:+97286400693
-
首席研究员:
- Gadi Howard
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Haifa、以色列、3109601
- 尚未招聘
- Rambam Health Care Campus
-
首席研究员:
- Ramit Magen Rimon
-
接触:
- 电话号码:972-4-7774381
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Jerusalem、以色列、9112001
- 招聘中
- Hadassah Medical Center
-
首席研究员:
- Zev Davidovics
-
接触:
- 电话号码:+97226778718
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Jerusalem、以色列、9013102
- 招聘中
- Shaare Zedek Medical Center
-
首席研究员:
- Dan Turner
-
接触:
- 电话号码:+97226666482
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Petah Tikva、以色列、49202
- 招聘中
- Schneider Children's Medical Center
-
首席研究员:
- Dror Shouval
-
接触:
- 电话号码:972039253674
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Tsrifin、以色列、70300
- 招聘中
- Yitzhak Shamir Medical Center
-
首席研究员:
- EFRAT BROIDE
-
接触:
- 电话号码:972-8-934-9793
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-
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London、加拿大、N6A 5W9
- 尚未招聘
- London Health Sciences Centre
-
接触:
- 电话号码:519-685-8500
-
首席研究员:
- Dhandapani Ashok
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Toronto、加拿大、M5G 1X8
- 招聘中
- The Hospital for Sick Children
-
首席研究员:
- Thomas Walters
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-
-
-
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Vienna、奥地利、1090
- 尚未招聘
- Medizinische Universität Wien
-
首席研究员:
- Wolf-Dietrich Huber
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-
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Campinas、巴西、13060-803
- 尚未招聘
- Centro de Pesquisa Sao Lucas
-
首席研究员:
- Joaquim Simoes Neto
-
接触:
- 电话号码:19 3252-5611
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Curitiba、巴西、80250-060
- 尚未招聘
- Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
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首席研究员:
- Sabine Truppel
-
接触:
- 电话号码:+554121083861
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Goiânia、巴西、74605-020
- 尚未招聘
- Universidade Federal de Goias
-
首席研究员:
- Naflesia O. Correa
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Porto Alegre、巴西、90035-903
- 尚未招聘
- Hospital de Clinicas de Porto Alegre
-
接触:
- 电话号码:+5551999199815
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首席研究员:
- Luciana Harlacher
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Porto Alegre、巴西、90050-170
- 尚未招聘
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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首席研究员:
- Vanessa Scheffer
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Vitória、巴西、29040-091
- 尚未招聘
- Hospital Universitario Cassiano Antonio de Moraes
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接触:
- 电话号码:+55 27 999720299
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首席研究员:
- Ana Daniela Sadovsky
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Votuporanga、巴西、15500-269
- 尚未招聘
- Integral Pesquisa e Ensino
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首席研究员:
- HERLON VALÉRIO
-
接触:
- 电话号码:+5517997472217
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Mainz、德国、55131
- 招聘中
- Universitätsmedizin Johannes Gutenberg Universität Mainz
-
首席研究员:
- Stephan Gehring
-
接触:
- 电话号码:00496131175839
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Munich、德国、80337
- 招聘中
- Dr. von Haunersches Kinderspital
-
首席研究员:
- Tobias Schwerd
-
接触:
- 电话号码:004989440057931
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Bergamo、意大利、24127
- 尚未招聘
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
-
首席研究员:
- Naire Sansotta
-
接触:
- 电话号码:0352673856
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Bologna、意大利、40133
- 尚未招聘
- Ospedale Maggiore Azienda USL di Bologna
-
首席研究员:
- Patrizia Alvisi
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Florence、意大利、50139
- 招聘中
- Azienda Ospedaliera Universitaria Meyer IRCCS
-
首席研究员:
- Paolo Lionetti
-
接触:
- 电话号码:055 56621
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Milan、意大利、20154
- 招聘中
- Ospedale dei Bambini Vittore Buzzi
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首席研究员:
- Lorenzo Norsa
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接触:
- 电话号码:00390263631
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Roma、意大利、00161
- 招聘中
- AOU Policlinico Umberto I
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首席研究员:
- Salvatore Oliva
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接触:
- 电话号码:0039 0649979330
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Rome、意大利、00165
- 尚未招聘
- Ospedale Pediatrico Bambino Gesù IRCCS
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首席研究员:
- Fiammetta Bracci
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接触:
- 电话号码:0039 06 68592243
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Lørenskog、挪威、1478
- 尚未招聘
- Akershus Universitetssykehus
-
首席研究员:
- Christopher Inchley
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Oslo、挪威、0450
- 尚未招聘
- Oslo Universitetssykehus Ullevål
-
首席研究员:
- Gori Perminow
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Tromsø、挪威、9038
- 尚未招聘
- Universitetssykehuset Nord-Norge HF
-
首席研究员:
- Lene Nymo Trulsen
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接触:
- 电话号码:95821317
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Trondheim、挪威、7030
- 尚未招聘
- St. Olavs Hospital
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接触:
- 电话号码:72574658
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首席研究员:
- Henrik Døllner
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Bunkyō、日本、113-8519
- 招聘中
- Institute of Science Tokyo Hospital
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首席研究员:
- Masakazu Nagahori
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接触:
- 电话号码:81120023812
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Bunkyō City、日本、113-8431
- 招聘中
- Juntendo University Hospital
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首席研究员:
- Takahiro Kudo
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接触:
- 电话号码:81120023812
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Kashiwa、日本、273-0011
- 招聘中
- Tsujinaka Hospital - Kashiwanoha
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首席研究员:
- Ken Takeuchi
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接触:
- 电话号码:81120023812
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Kobe、日本、650-0017
- 招聘中
- Kobe University Hospital
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接触:
- 电话号码:81120023812
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首席研究员:
- Tomoko Horinouchi
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Tokyo、日本、157-8535
- 招聘中
- National Center for Child Health and Development
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首席研究员:
- Katsuhiro Arai
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接触:
- 电话号码:81120023812
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Yokohama、日本、232-0024
- 招聘中
- Yokohama City University Medical Center
-
首席研究员:
- Reiko Kunisaki
-
接触:
- 电话号码:81120023812
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Brussels、比利时、1200
- 尚未招聘
- Cliniques universitaires Saint-Luc
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首席研究员:
- Isabelle Scheers
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Brussels、比利时、1090
- 招聘中
- UZ Brussel
-
首席研究员:
- Elisabeth De Greef
-
接触:
- 电话号码:3224749399
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Edegem、比利时、2650
- 尚未招聘
- Antwerp University Hospital
-
首席研究员:
- Els Van de Vijver
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接触:
- 电话号码:3238215524
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Ghent、比利时、9000
- 招聘中
- UZ Gent
-
首席研究员:
- Pauline De Bruyne
-
接触:
- 电话号码:3293323966
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Leuven、比利时、3000
- 招聘中
- UZ Leuven
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首席研究员:
- Ilse Hoffman
-
接触:
- 电话号码:003216343343
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Rzeszów、波兰、35-302
- 招聘中
- Korczowski Bartosz, Gabinet Lekarski
-
首席研究员:
- Bartosz Korczowski
-
接触:
- 电话号码:604481752
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Szczecin、波兰、71-434
- 招聘中
- Twoja Przychodnia SCM
-
首席研究员:
- Beata Gawdis-Wojnarska
-
接触:
- 电话号码:48 91 433 29 19
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Warsaw、波兰、04-730
- 招聘中
- Centrum Zdrowia Dziecka w Warszawie
-
首席研究员:
- Jaroslaw Kierkus
-
接触:
- 电话号码:500111648
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Warsaw、波兰、04-501
- 招聘中
- Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
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首席研究员:
- Monika Meglicka
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Wroclaw、波兰、52-416
- 招聘中
- Centrum Medyczne Oporów
-
首席研究员:
- Radoslaw Kempinski
-
接触:
- 电话号码:71 712 70 77
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California
-
San Francisco、California、美国、94158
- 招聘中
- UCSF Medical Center at Mission Bay
-
首席研究员:
- Sofia Verstraete
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Connecticut
-
Hartford、Connecticut、美国、06106
- 招聘中
- Connecticut Children's Medical Center
-
首席研究员:
- Jeffrey Hyams
-
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Georgia
-
Atlanta、Georgia、美国、30322
- 招聘中
- Emory University School of Medicine
-
首席研究员:
- subra kugathasan
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Atlanta、Georgia、美国、30342
- 招聘中
- Children's Center for Digestive Health Care, LLC
-
首席研究员:
- Jeffery Lewis
-
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Massachusetts
-
Boston、Massachusetts、美国、02115
- 招聘中
- Boston Children's Hospital
-
接触:
- 电话号码:617-355-6058
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首席研究员:
- Athos Bousvaros
-
Waltham、Massachusetts、美国、02451
- 招聘中
- Massachusetts General Hospital
-
首席研究员:
- Jess Kaplan
-
-
Missouri
-
St Louis、Missouri、美国、63110
- 招聘中
- Washington University School of Medicine
-
首席研究员:
- Charles Samson
-
接触:
- 电话号码:314-454-6173
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-
New York
-
New York、New York、美国、10029
- 招聘中
- Icahn School of Medicine at Mount Sinai
-
接触:
- 电话号码:212-241-5415
-
首席研究员:
- David Dunkin
-
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Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- 尚未招聘
- Children's Hospital of Philadelphia (CHOP)
-
首席研究员:
- Arthur Kastl
-
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Texas
-
Fort Worth、Texas、美国、76104
- 招聘中
- Cook Children's Medical Center
-
接触:
- 电话号码:682-885-1990
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首席研究员:
- Clifton Huang
-
-
Virginia
-
Fairfax、Virginia、美国、22031
- 尚未招聘
- Pediatric Specialists of Virginia
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首席研究员:
- Peter Lee
-
接触:
- 电话号码:703-876-2788
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-
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London、英国、E1 1BB
- 尚未招聘
- Royal London Hospital
-
首席研究员:
- Ahmed Kadir
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Oxford、英国、OX3 9DU
- 尚未招聘
- The John Radcliffe Hospital
-
首席研究员:
- Lucy Howarth
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Sheffield、英国、S10 2TH
- 招聘中
- Sheffield Children's Hospital
-
首席研究员:
- Akshay Kapoor
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-
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Rotterdam、荷兰、3015 GD
- 尚未招聘
- Erasmus Medisch Centrum
-
首席研究员:
- Lissy De Ridder
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Braga、葡萄牙、4710-243
- 尚未招聘
- 2Ca Braga
-
首席研究员:
- Filipa Neiva
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Lisbon、葡萄牙、1649-035
- 尚未招聘
- Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
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首席研究员:
- Luis Rodrigues
-
接触:
- 电话号码:00351217805229
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Porto、葡萄牙、4200-319
- 招聘中
- Centro Hospitalar de Sao Joao - Hospital de Sao Joao
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首席研究员:
- Eunice Trindade
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Córdoba、西班牙、14004
- 尚未招聘
- Hospital Universitario Reina Sofia
-
首席研究员:
- RAFAEL MARCHAL
-
接触:
- 电话号码:34957010350
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Esplugues de Llobregat、西班牙、08950
- 尚未招聘
- Hospital Sant Joan de Déu
-
首席研究员:
- Javier Martín de Carpi
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Sabadell、西班牙、08208
- 尚未招聘
- Hospital Universitari Parc Tauli
-
首席研究员:
- Diana García
-
接触:
- 电话号码:(+34) 937458305
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Valencia、西班牙、46026
- 招聘中
- Hospital Universitari i Politecnic La Fe
-
首席研究员:
- Marisa Iborra Colomino
-
接触:
- 电话号码:961244055
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Deagu、韩国、41404
- 招聘中
- Kyungpook National University Chilgok Hospital
-
首席研究员:
- Ben Kang
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Seoul、韩国、03080
- 招聘中
- Seoul National University Hospital
-
首席研究员:
- Jin Soo Moon
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Seoul、韩国、06351
- 招聘中
- Samsung Medical Center
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首席研究员:
- Yon Ho Choe
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants from originating studies (I6T-MC-AMBA [NCT05784246], I6T-MC-AMBU [NCT04004611], I6T-MC-AMAM [NCT03926130]) , I6T-MC-AMAY [NCT05509777]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
- Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
- Female participants must agree to contraception requirements.
Exclusion Criteria:
- Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.
- Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.
- Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
- Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.
- Participants must not have adenomatous polyps that have not been removed.
- Participants must not be pregnant or breastfeeding.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Mirikizumab Dose 1 for UC
Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight. |
Administered SC
其他名称:
Administered IV
其他名称:
|
|
实验性的:Mirikizumab Dose 2 for UC
Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
Administered SC
其他名称:
Administered IV
其他名称:
|
|
实验性的:Mirikizumab Dose 3 for UC
Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
Administered SC
其他名称:
Administered IV
其他名称:
|
|
实验性的:Mirikizumab Dose 4 for CD
Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
Administered SC
其他名称:
Administered IV
其他名称:
|
|
实验性的:Mirikizumab Dose 5 for CD
Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
Administered SC
其他名称:
Administered IV
其他名称:
|
|
实验性的:Mirikizumab Dose 6 for CD
Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
Administered SC
其他名称:
Administered IV
其他名称:
|
|
实验性的:Mirikizumab Dose 7 for UC or CD
Intravenous (IV) rescue dosing, if response is lost. |
Administered SC
其他名称:
Administered IV
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission
大体时间:Week 52
|
Clinical Remission based on the MMS |
Week 52
|
|
Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
大体时间:Week 52
|
Clinical Remission based on the PCDAI |
Week 52
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
是时候在UC进入研究的参与者中首次服用皮质类固醇
大体时间:第0周至第52周
|
第0周至第52周
|
|
|
通过PCDAI和内窥镜反应实现临床缓解的参与者的百分比
大体时间:第52周
|
第52周
|
|
|
C反应蛋白的基线随时间的变化,高灵敏度(HSCRP)
大体时间:基线,第0周至第52周
|
基线,第0周至第52周
|
|
|
Percentage of Participants with UC in MMS Clinical Response
大体时间:Week 52
|
Clinical Response based on the MMS |
Week 52
|
|
Percentage of Participants with CD in PCDAI Clinical Response
大体时间:Week 52
|
Clinical Response based on the PCDAI |
Week 52
|
|
Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
大体时间:Week 52
|
Clinical Response based on the PUCAI |
Week 52
|
|
Percentage of Participants with UC in PUCAI Clinical Remission
大体时间:Week 52
|
Clinical Response based on the PUCAI |
Week 52
|
|
Percentage of Participants with UC in Endoscopic Remission
大体时间:Week 52
|
Endoscopic Remission based on the Endoscopic Subscore (ES) |
Week 52
|
|
Percentage of Participants with CD in Endoscopic Remission
大体时间:Week 52
|
Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD) |
Week 52
|
|
Percentage of Participants with UC in Endoscopic Response
大体时间:Week 52
|
Endoscopic Response in Participants based on the ES |
Week 52
|
|
Percentage of Participants with CD in Endoscopic Response
大体时间:Week 52
|
Endoscopic Response based on the SES-CD |
Week 52
|
|
Percentage of Participants with UC in having Endoscopic Subscore = 0
大体时间:Week 52
|
Endoscopic Remission when ES = 0 |
Week 52
|
|
Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission
大体时间:Week 52
|
Histologic remission based on histology scoring and endoscopic remission based on endoscopy score |
Week 52
|
|
Percentage of Participants with CD Achieving Histologic Remission
大体时间:Week 52
|
Histologic remission based on histology scoring |
Week 52
|
|
Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery
大体时间:Week 52
|
Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery |
Week 52
|
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Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery
大体时间:Week 52
|
Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery) |
Week 52
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合作者和调查者
调查人员
- 研究主任:Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 16633
- I6T-MC-AMAZ (其他标识符:Eli Lilly and Company)
- 2020-005311-49 (EudraCT编号)
- ISA-1 UC (其他标识符:Eli Lilly and Company)
- ISA-2 CD (其他标识符:Eli Lilly and Company)
- ISA-3 UC (其他标识符:Eli Lilly and Company)
- ISA-4 CD (其他标识符:Eli Lilly and Company)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD 共享时间框架
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD 共享访问标准
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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