Phase
Condition
Gastrointestinal Diseases And Disorders
Ulcerative Colitis
Inflammatory Bowel Disease
Treatment
Mirikizumab
Clinical Study ID
Ages 2-19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants from originating studies (I6T-MC-AMBA [NCT05784246], I6T-MC-AMBU [NCT04004611], I6T-MC-AMAM [NCT03926130]) , I6T-MC-AMAY [NCT05509777]) who would, inthe opinion of the investigator, derive clinical benefit from further treatment withmirikizumab
Participants from prior studies who have completed assessments and procedures atlast visit of originating study and remain on study drug treatment.
Female participants must agree to contraception requirements.
Exclusion
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 StudyAMAZ that continued treatment with mirikizumab would present an unreasonable riskfor the participant.
Participants must not have had permanently or temporarily stopped study drug in theoriginating study, such that restarting mirikizumab would pose an unacceptable riskfor the participant in Study AMAZ.
Participants must not have an unstable or uncontrolled illness that wouldpotentially affect participant safety.
Participants must not be enrolled in the study if, for any reason, being in thestudy 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.
Study Design
Connect with a study center
Medizinische Universität Wien
Vienna, 1090
AustriaSite Not Available
UZ Gent
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
Cliniques universitaires Saint-Luc
Brussels, 1200
BelgiumSite Not Available
UZ Brussel
Brussels, 1090
BelgiumSite Not Available
UZ Brussel
Brussels 2800866, 1090
BelgiumSite Not Available
Antwerp University Hospital
Edegem, 2650
BelgiumSite Not Available
UZ Gent
Ghent, 9000
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumActive - Recruiting
Hospital Universitario Cassiano Antonio de Moraes
Vitoria, Espírito Santo 29040-091
BrazilSite Not Available
Universidade Federal de Goias
Goiania, Goiás 74605-020
BrazilSite Not Available
Centro de Pesquisa Sao Lucas
Campinas, 13060-803
BrazilSite Not Available
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
Curitiba, 80250-060
BrazilSite Not Available
Universidade Federal de Goias
Goiânia, 74605-020
BrazilSite Not Available
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90050-170
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre 3452925, 90050-170
BrazilSite Not Available
Hospital Universitario Cassiano Antonio de Moraes
Vitória, 29040-091
BrazilSite Not Available
Integral Pesquisa e Ensino
Votuporanga, 15500-269
BrazilSite Not Available
Integral Pesquisa e Ensino
Votuporanga 3444864, 15501-405
BrazilSite Not Available
London Health Sciences Centre
London, N6A 5W9
CanadaSite Not Available
The Hospital for Sick Children
Toronto, M5G 1X8
CanadaActive - Recruiting
Hôpital Jeanne de Flandre
Lille, Nord-Pas-de-Calais 59000
FranceSite Not Available
CHU d'Amiens-Picardie - Hôpital Sud
Amiens, Somme 80054
FranceSite Not Available
Hôpital Armand Trousseau
Paris, 75012
FranceSite Not Available
Hôpital Universitaire Necker Enfants Malades
Paris 2988507, 75015
FranceSite Not Available
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, 55131
GermanyActive - Recruiting
Dr. von Haunersches Kinderspital
Munich, 80337
GermanyActive - Recruiting
Schneider Children's Medical Center
Petah-Tikva, HaMerkaz 49202
IsraelSite Not Available
Yitzhak Shamir Medical Center
Zerifin, HaMerkaz 70300
IsraelSite Not Available
Rambam Health Care Campus
Haifa, 3109601
IsraelSite Not Available
Hadassah Medical Center
Jerusalem, 9112001
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem, 9013102
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem 281184, 9013102
IsraelSite Not Available
Schneider Children's Medical Center
Petah Tikva, 49202
IsraelActive - Recruiting
Yitzhak Shamir Medical Center
Ẕerifin, 70300
IsraelActive - Recruiting
Policlinico Umberto I
Roma, Lazio 00161
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
Firenze, Toscana 50139
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
ItalySite Not Available
Ospedale Maggiore Azienda USL di Bologna
Bologna, 40133
ItalySite Not Available
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, 50139
ItalyActive - Recruiting
Ospedale dei Bambini Vittore Buzzi
Milan, 20154
ItalyActive - Recruiting
AOU Policlinico Umberto I
Roma, 00161
ItalyActive - Recruiting
Ospedale Pediatrico Bambino Gesù IRCCS
Rome, 00165
ItalySite Not Available
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-8431
JapanActive - Recruiting
Tokyo Medical And Dental University Medical Hospital
Bunkyō, Tokyo 113-8519
JapanActive - Recruiting
Tokyo Medical and Dental University Hospital
Bunkyō, Tokyo 113-8519
JapanActive - Recruiting
Institute of Science Tokyo Hospital
Bunkyō, 113-8519
JapanActive - Recruiting
Juntendo University Hospital
Bunkyō City, 113-8431
JapanActive - Recruiting
Tsujinaka Hospital - Kashiwanoha
Kashiwa, 273-0011
JapanActive - Recruiting
Kobe University Hospital
Kobe, 650-0017
JapanSite Not Available
National Center for Child Health and Development
Tokyo, 157-8535
JapanSite Not Available
Yokohama City University Medical Center
Yokohama, 232-0024
JapanActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu, Kwangyǒkshi 41404
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul] 06351
Korea, Republic ofActive - Recruiting
Kyungpook National University Chilgok Hospital
Deagu, 41404
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Amsterdam UMC, locatie AMC
Amsterdam, Noord-Holland 1105 AZ
NetherlandsSite Not Available
Erasmus Medisch Centrum
Rotterdam, 3015 GD
NetherlandsSite Not Available
Akershus Universitetssykehus
Lørenskog, 1478
NorwaySite Not Available
Oslo Universitetssykehus Ullevål
Oslo, 0450
NorwaySite Not Available
Universitetssykehuset Nord-Norge HF
Tromsø, 9038
NorwaySite Not Available
St. Olavs Hospital
Trondheim, 7030
NorwaySite Not Available
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warszawa, Mazowieckie 04-501
PolandActive - Recruiting
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302
PolandActive - Recruiting
Twoja Przychodnia SCM
Szczecin, 71-434
PolandActive - Recruiting
Centrum Zdrowia Dziecka w Warszawie
Warsaw, 04-730
PolandActive - Recruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, 04-501
PolandActive - Recruiting
Centrum Zdrowia Dziecka w Warszawie
Warsaw 756135, 04-730
PolandActive - Recruiting
Centrum Medyczne Oporów
Wroclaw, 52-416
PolandActive - Recruiting
2Ca Braga
Braga, 4710-243
PortugalSite Not Available
Centro Hospitalar de Sao Joao - Hospital de Sao Joao
Porto, 4200-319
PortugalActive - Recruiting
Kyungpook National University Chilgok Hospital
Deagu, 41404
South KoreaActive - Recruiting
Samsung Medical Center
Seoul, 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul, 03080
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848, 06351
South KoreaActive - Recruiting
Hospital Universitario Reina Sofia
Cordoba, Andalucía 14004
SpainSite Not Available
Hospital Universitario Reina Sofia
Córdoba, 14004
SpainSite Not Available
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950
SpainSite Not Available
Hospital Universitari Parc Tauli
Sabadell, 08208
SpainSite Not Available
Hospital Universitari i Politecnic La Fe
Valencia, 46026
SpainActive - Recruiting
Royal London Hospital
London, E1 1BB
United KingdomSite Not Available
The John Radcliffe Hospital
Oxford, OX3 9DU
United KingdomSite Not Available
Sheffield Children's Hospital
Sheffield, S10 2TH
United KingdomActive - Recruiting
UCSF Medical Center at Mission Bay
San Francisco, California 94158
United StatesActive - Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut 06106
United StatesActive - Recruiting
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia 30342
United StatesActive - Recruiting
Children's Center for Digestive Healthcare
Atlanta, Georgia 30342
United StatesSite Not Available
Emory University School of Medicine
Atlanta, Georgia 30322
United StatesActive - Recruiting
The Hospital for Sick Children
Atlanta, Georgia 30342
United StatesSite Not Available
Emory University School of Medicine
Atlanta 4180439, Georgia 4197000 30322
United StatesActive - Recruiting
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
MGH for Children - Waltham
Waltham, Massachusetts 02451
United StatesActive - Recruiting
Massachusetts General Hospital
Waltham, Massachusetts 02451
United StatesActive - Recruiting
Washington University School of Medicine
St Louis, Missouri 63110
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Cook Children's Medical Center
Fort Worth, Texas 76104
United StatesActive - Recruiting
Pediatric Specialists of Virginia
Fairfax, Virginia 22031
United StatesSite Not Available
Children's Specialty Group, PPLC
Norfolk, Virginia 23507
United StatesActive - Recruiting

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