Phase
Condition
Crohn's Disease
Ulcerative Colitis
Ulcers
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, Wien 1090
AustriaSite Not Available
Antwerp University Hospital
Edegem, Antwerpen 2650
BelgiumSite Not Available
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région De 1200
BelgiumSite Not Available
UZ Brussel
Brussels, Bruxelles-Capitale, Région De 1090
BelgiumSite Not Available
UZ Gent
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
UZ Leuven
Leuven, Vlaams-Brabant 3000
BelgiumSite Not Available
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
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
Curitiba, Paraná 80250-060
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90050-170
BrazilSite Not Available
Centro de Pesquisa Sao Lucas
Campinas, São Paulo 13060-803
BrazilSite Not Available
Integral Pesquisa e Ensino
Votuporanga, São Paulo 15501-405
BrazilSite Not Available
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, 75015
FranceSite Not Available
Dr. von Haunersches Kinderspital
Munich, Bayern 80337
GermanySite Not Available
HELIOS Klinikum Wuppertal
Wuppertal, Nordrhein-Westfalen 42283
GermanySite Not Available
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rheinland-Pfalz 55131
GermanySite Not Available
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, HaTsafon 3109601
IsraelSite Not Available
Hadassah Medical Center
Jerusalem, Yerushalayim 9112001
IsraelSite Not Available
Shaare Zedek Medical Center
Jerusalem, Yerushalayim 9013102
IsraelSite Not Available
AOU Policlinico Umberto I
Roma, Lazio 00161
ItalyActive - Recruiting
Policlinico Umberto I
Roma, Lazio 00161
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Lombardia 24127
ItalySite Not Available
Ospedale dei Bambini Vittore Buzzi
Milan, Milano 20154
ItalySite Not Available
Ospedale Pediatrico Bambino Gesù IRCCS
Rome, Roma 00165
ItalySite Not Available
Azienda Ospedaliera Universitaria Meyer IRCCS
Firenze, Toscana 50139
ItalySite Not Available
Ospedale Maggiore Azienda USL di Bologna
Bologna, 40133
ItalySite Not Available
Tsujinaka Hospital - Kashiwanoha
Kashiwa, Chiba 273-0011
JapanActive - Recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-8431
JapanActive - Recruiting
Institute of Science Tokyo Hospital
Bunkyō, Tokyo 113-8519
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
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
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul] 03080
Korea, Republic ofActive - Recruiting
Kyungpook National University Chilgok Hospital
Deagu, Taegu-Kwangyǒkshi 41404
Korea, Republic ofActive - Recruiting
Kyungpook National University Chilgok Hospital
Taegu, Taegu-Kwangyǒkshi 41404
Korea, Republic ofSite Not Available
Amsterdam UMC, locatie AMC
Amsterdam, Noord-Holland 1105 AZ
NetherlandsSite Not Available
Erasmus Medisch Centrum
Rotterdam, Zuid-Holland 3015 GD
NetherlandsSite Not Available
Centrum Zdrowia Dziecka w Warszawie
Warsaw, Mazowieckie 04-730
PolandActive - Recruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warszawa, Mazowieckie 04-501
PolandSite Not Available
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Podkarpackie 35-302
PolandActive - Recruiting
Twoja Przychodnia SCM
Szczecin, Zachodniopomorskie 71-434
PolandSite Not Available
Hospital Universitario Reina Sofia
Cordoba, Andalucía 14004
SpainSite Not Available
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona] 08950
SpainSite Not Available
Hospital Universitari Parc Tauli
Sabadell, Barcelona [Barcelona] 08208
SpainSite Not Available
Hospital Universitari i Politecnic La Fe
Valencia, València 46026
SpainSite Not Available
Hospital Universitari i Politecnic La Fe
València, 46026
SpainSite Not Available
The John Radcliffe Hospital
Oxford, England OX3 9DU
United KingdomSite Not Available
Sheffield Children's Hospital
Sheffield, S10 2TH
United KingdomSite Not Available
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
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Boston's Childrens Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
MGH for Children - Waltham
Waltham, Massachusetts 02451
United StatesActive - Recruiting
Massachusetts General Hospital
Waltham, Massachusetts 02451
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Cook Children's Medical Center
Fort Worth, Texas 76104
United StatesActive - Recruiting
Pediatric Specialists of Virginia
Fairfax, Virginia 22031
United StatesActive - Recruiting
Children's Hospital of The King's Daughters
Norfolk, Virginia 23507
United StatesSite Not Available
Children's Specialty Group, PPLC
Norfolk, Virginia 23507
United StatesActive - Recruiting
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