Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease (Pediatric)
Colic
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
Medizinische Universität Wien
Vienna 2761369, 1090
AustriaSite Not Available
Cliniques universitaires Saint-Luc
Brussels, 1200
BelgiumSite Not Available
UZ Brussel
Brussels, 1090
BelgiumSite Not Available
Cliniques universitaires Saint-Luc
Brussels 2800866, 1200
BelgiumSite Not Available
UZ Brussel
Brussels 2800866, 1090
BelgiumSite Not Available
Antwerp University Hospital
Edegem, 2650
BelgiumSite Not Available
Antwerp University Hospital
Edegem 2799007, 2650
BelgiumSite Not Available
UZ Gent
Gent, 9000
BelgiumSite Not Available
UZ Gent
Ghent, 9000
BelgiumSite Not Available
UZ Gent
Ghent 2797656, 9000
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumActive - Recruiting
UZ Leuven
Leuven 2792482, 3000
BelgiumSite Not Available
Centro de Pesquisa Sao Lucas
Campinas, 13060-803
BrazilSite Not Available
Centro de Pesquisa Sao Lucas
Campinas 3467865, 13060-803
BrazilSite Not Available
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
Curitiba, 80250-060
BrazilSite Not Available
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
Curitiba 3464975, 80250-060
BrazilSite Not Available
Universidade Federal de Goias
Goiania, 74605-020
BrazilSite Not Available
Universidade Federal de Goias
Goiânia, 74605-020
BrazilSite Not Available
Universidade Federal de Goias
Goiânia 3462377, 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
Hospital de Clinicas de Porto Alegre
Porto Alegre 3452925, 90035-903
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
Vitoria, 29040-091
BrazilSite Not Available
Hospital Universitario Cassiano Antonio de Moraes
Vitória, 29040-091
BrazilSite Not Available
Hospital Universitario Cassiano Antonio de Moraes
Vitória 3444924, 29040-091
BrazilSite Not Available
Integral Pesquisa e Ensino
Votuporanga, 15500-269
BrazilSite Not Available
Integral Pesquisa e Ensino
Votuporanga 3444864, 15500-269
BrazilSite Not Available
London Health Sciences Centre
London, N6A 5W9
CanadaSite Not Available
London Health Sciences Centre
London 6058560, N6A 5W9
CanadaSite Not Available
The Hospital for Sick Children
Toronto, M5G 1X8
CanadaSite Not Available
The Hospital for Sick Children
Toronto 6167865, M5G 1X8
CanadaSite Not Available
CHU d'Amiens-Picardie - Hôpital Sud
Amiens, 80054
FranceSite Not Available
CHU d'Amiens-Picardie - Hôpital Sud
Amiens 3037854, 80054
FranceSite Not Available
Hôpital Jeanne de Flandre
Lille, 59000
FranceSite Not Available
Hôpital Jeanne de Flandre
Lille 2998324, 59000
FranceSite Not Available
Hôpital Armand Trousseau
Paris, 75012
FranceSite Not Available
Hôpital Universitaire Necker Enfants Malades
Paris, 75015
FranceSite Not Available
Hôpital Armand Trousseau
Paris 2988507, 75012
FranceSite Not Available
Hôpital Universitaire Necker Enfants Malades
Paris 2988507, 75015
FranceSite Not Available
HELIOS Klinikum Wuppertal
Wuppertal, Nordrhein-Westfalen 42283
GermanySite Not Available
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, 55131
GermanyActive - Recruiting
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz 2874225, 55131
GermanySite Not Available
Dr. von Haunersches Kinderspital
Munich, 80337
GermanyActive - Recruiting
Dr. von Haunersches Kinderspital
Munich 2867714, 80337
GermanySite Not Available
Rambam Health Care Campus
Haifa, 3109601
IsraelSite Not Available
Rambam Health Care Campus
Haifa 294801, 3109601
IsraelSite Not Available
Hadassah Medical Center
Jerusalem, 9112001
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem, 9013102
IsraelSite Not Available
Hadassah Medical Center
Jerusalem 281184, 9112001
IsraelSite Not Available
Shaare Zedek Medical Center
Jerusalem 281184, 9013102
IsraelSite Not Available
Schneider Children's Medical Center
Petah Tikva, 49202
IsraelActive - Recruiting
Schneider Children's Medical Center
Petah Tikva 293918, 49202
IsraelSite Not Available
Schneider Children's Medical Center
Petah-Tikva, 49202
IsraelSite Not Available
Yitzhak Shamir Medical Center
Zerifin, 70300
IsraelSite Not Available
Yitzhak Shamir Medical Center
Ẕerifin, 70300
IsraelActive - Recruiting
Yitzhak Shamir Medical Center
Ẕerifin 293084, 70300
IsraelSite Not Available
Policlinico Umberto I
Roma, Lazio 00161
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
ItalySite Not Available
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo 3182164, 24127
ItalySite Not Available
Ospedale Maggiore Azienda USL di Bologna
Bologna, 40133
ItalySite Not Available
Ospedale Maggiore Azienda USL di Bologna
Bologna 3181928, 40133
ItalySite Not Available
Azienda Ospedaliera Universitaria Meyer IRCCS
Firenze, 50139
ItalySite Not Available
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, 50139
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence 3176959, 50139
ItalySite Not Available
Ospedale dei Bambini Vittore Buzzi
Milan, 20154
ItalyActive - Recruiting
Ospedale dei Bambini Vittore Buzzi
Milan 3173435, 20154
ItalySite Not Available
AOU Policlinico Umberto I
Roma, 00161
ItalyActive - Recruiting
AOU Policlinico Umberto I
Roma 8957247, 00161
ItalySite Not Available
Ospedale Pediatrico Bambino Gesù IRCCS
Rome, 00165
ItalySite Not Available
Ospedale Pediatrico Bambino Gesù IRCCS
Rome 3169070, 00165
ItalySite Not Available
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
Juntendo University Hospital
Bunkyo-ku, 113-8431
JapanSite Not Available
Institute of Science Tokyo Hospital
Bunkyō, 113-8519
JapanActive - Recruiting
Institute of Science Tokyo Hospital
Bunkyō 11077909, 113-8519
JapanSite Not Available
Juntendo University Hospital
Bunkyō City, 113-8431
JapanActive - Recruiting
Juntendo University Hospital
Bunkyō City 11790632, 113-8431
JapanSite Not Available
Tsujinaka Hospital - Kashiwanoha
Kashiwa, 273-0011
JapanActive - Recruiting
Tsujinaka Hospital - Kashiwanoha
Kashiwa 1859924, 273-0011
JapanSite Not Available
National Center for Child Health and Development
Tokyo, 157-8535
JapanSite Not Available
National Center for Child Health and Development
Tokyo 1850147, 157-8535
JapanSite Not Available
Yokohama City University Medical Center
Yokohama, 232-0024
JapanSite Not Available
Yokohama City University Medical Center
Yokohama 1848354, 232-0024
JapanSite Not Available
Kyungpook National University Chilgok Hospital
Daegu, Kwangyǒkshi 41404
Korea, Republic ofSite Not Available
Kyungpook National University Chilgok Hospital
Taegu, Taegu-Kwangyǒkshi 41404
Korea, Republic ofSite Not Available
Kyungpook National University Chilgok Hospital
Deagu, 41404
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Amsterdam UMC, locatie AMC
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Amsterdam UMC, locatie AMC
Amsterdam 2759794, 1105 AZ
NetherlandsSite Not Available
Erasmus Medisch Centrum
Rotterdam, 3015 GD
NetherlandsSite Not Available
Erasmus Medisch Centrum
Rotterdam 2747891, 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
St. Olavs Hospital
Trondheim 3133880, 7030
NorwaySite Not Available
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302
PolandActive - Recruiting
Korczowski Bartosz, Gabinet Lekarski
Rzeszów 759734, 35-302
PolandSite Not Available
Twoja Przychodnia SCM
Szczecin, 71-434
PolandActive - Recruiting
Twoja Przychodnia SCM
Szczecin 3083829, 71-434
PolandSite Not Available
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
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw 756135, 04-501
PolandSite Not Available
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warszawa, 04-501
PolandSite Not Available
Centrum Medyczne Oporów
Wroclaw, 52-416
PolandActive - Recruiting
Centrum Medyczne Oporów
Wroclaw 3081368, 52-416
PolandSite Not Available
2Ca Braga
Braga, 4710-243
PortugalSite Not Available
2Ca Braga
Braga 2742032, 4710-243
PortugalSite Not Available
Centro Hospitalar de Sao Joao - Hospital de Sao Joao
Porto, 4200-319
PortugalActive - Recruiting
Centro Hospitalar de Sao Joao - Hospital de Sao Joao
Porto 2735943, 4200-319
PortugalSite Not Available
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
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaSite Not Available
Hospital Universitario Reina Sofia
Cordoba, 14004
SpainSite Not Available
Hospital Universitario Reina Sofia
Córdoba, 14004
SpainSite Not Available
Hospital Universitario Reina Sofia
Córdoba 2519240, 14004
SpainSite Not Available
Hospital Sant Joan de Déu
Esplugues de Llobregat, 08950
SpainSite Not Available
Hospital Sant Joan de Déu
Esplugues de Llobregat 3122826, 08950
SpainSite Not Available
Hospital Universitari Parc Tauli
Sabadell, 08208
SpainSite Not Available
Hospital Universitari Parc Tauli
Sabadell 3111199, 08208
SpainSite Not Available
Hospital Universitari i Politecnic La Fe
Valencia, 46026
SpainSite Not Available
Hospital Universitari i Politecnic La Fe
Valencia 2509954, 46026
SpainSite Not Available
Hospital Universitari i Politecnic La Fe
València, 46026
SpainSite Not Available
Royal London Hospital
London, E1 1BB
United KingdomSite Not Available
Royal London Hospital
London 2643743, E1 1BB
United KingdomSite Not Available
The John Radcliffe Hospital
Oxford, OX3 9DU
United KingdomSite Not Available
The John Radcliffe Hospital
Oxford 2640729, OX3 9DU
United KingdomSite Not Available
Sheffield Children's Hospital
Sheffield, S10 2TH
United KingdomActive - Recruiting
Sheffield Children's Hospital
Sheffield 2638077, S10 2TH
United KingdomSite Not Available
UCSF Medical Center at Mission Bay
San Francisco, California 94158
United StatesActive - Recruiting
UCSF Medical Center at Mission Bay
San Francisco 5391959, California 5332921 94158
United StatesSite Not Available
Connecticut Children's Medical Center
Hartford, Connecticut 06106
United StatesActive - Recruiting
Connecticut Children's Medical Center
Hartford 4835797, Connecticut 4831725 06106
United StatesSite Not Available
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
Children's Center for Digestive Health Care, LLC
Atlanta 4180439, Georgia 4197000 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
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
Boston Children's Hospital
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Massachusetts General Hospital
Waltham 4954380, Massachusetts 6254926 02451
United StatesSite Not Available
Washington University School of Medicine
St Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Cook Children's Medical Center
Fort Worth, Texas 76104
United StatesActive - Recruiting
Cook Children's Medical Center
Fort Worth 4691930, Texas 4736286 76104
United StatesSite Not Available
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
Pediatric Specialists of Virginia
Fairfax 4758023, Virginia 6254928 22031
United StatesSite Not Available

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