Phase
Condition
Inflammatory Bowel Disease
Colic
Bowel Dysfunction
Treatment
Mirikizumab
Clinical Study ID
Ages 2-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have a diagnosis of CD or fistulizing CD, with active colitis,ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic,and histologic criteria.
Participants have moderately to severely active CD (as defined by a baseline PCDAIscore ≥30).
Participants must have endoscopy with evidence of active CD defined as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receivingstudy intervention at Week 0.
Participants must have a documented history of inadequate response, loss of responseor intolerance to at least one medication used to treat CD, which may includeimmunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.
Exclusion
Exclusion Criteria:
Participants must not have complications of CD such as symptomatic strictures orstenosis, short gut syndrome, or any other manifestations that might be anticipatedto require surgery.
Participants must not have an abscess.
Participants must not have any kind of bowel resection within 26 weeks or any otherintra-abdominal surgery within 12 weeks of baseline.
Study Design
Study Description
Connect with a study center
The Children's Hospital at Westmead
Westmead, New South Wales 2145
AustraliaSite Not Available
Mater Hospital Brisbane
South Brisbane, Queensland 4101
AustraliaSite Not Available
Women'S and Children'S Hospital, Adelaide
North Adelaide, South Australia 5006
AustraliaSite Not Available
Perth Children's Hospital
Nedlands, Western Australia 6009
AustraliaSite Not Available
AKH - Medizinische Universtität Wien
Vienna, 1090
AustriaActive - Recruiting
Cliniques universitaires Saint-Luc
Bruxelles, Brussel 1200
BelgiumActive - Recruiting
UZ Leuven
Leuven, Vlaams-Brabant 3000
BelgiumActive - Recruiting
Universitair Ziekenhuis Brussel
Brussel, 1090
BelgiumActive - Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
BelgiumSite Not Available
Universitair Ziekenhuis Antwerp
Gent, 9000
BelgiumActive - Recruiting
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumActive - Recruiting
NDI - Nucleo de Doenças Infecciosas
Vitória, Espírito Santo 29040 091
BrazilSite Not Available
Núcleo de Doenças Infecciosas/CBM/UFES
Vitória, Espírito Santo 29040 091
BrazilActive - Recruiting
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, Goiás 74605 020
BrazilActive - Recruiting
Associação Hospitalar de Proteção à Infância Dr. Raul Carneiro
Curitiba, Paraná 80250 060
BrazilActive - Recruiting
Hospital Pequeno Príncipe
Curitiba, Paraná 80250 060
BrazilSite Not Available
Hospital das Clinicas da FMRP
Sao Paulo, Paraná 14051-140
BrazilSite Not Available
Hospital da Criança Santo Antônio - Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90035 074
BrazilActive - Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90050-170
BrazilActive - Recruiting
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
Campinas, Sao Paulo 13060-904
BrazilActive - Recruiting
Integral Pesquisa e Ensino
Votuporanga, Sao Paulo 15501 405
BrazilActive - Recruiting
Hospital PUC-CAMPINAS
Campinas, São Paulo 13060-904
BrazilActive - Recruiting
Hospital das Clinicas da FMRP
Ribeirao Preto, São Paulo 14048-900
BrazilSite Not Available
Hospital das Clinicas da FMRP
Ribeirão Preto, São Paulo 14051-140
BrazilSite Not Available
Hospital Pequeno Príncipe
Curitiba-PR, 80250-060
BrazilActive - Recruiting
Hospital das Clínicas - UFG (Universidade Federal de Goiás)
Goiânia, 74605-050
BrazilActive - Recruiting
NDI - Nucleo de Doenças Infecciosas
Santos Dumont, 29040-091
BrazilActive - Recruiting
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia V6H 3V4
CanadaSite Not Available
IWK Health Centre
Halifax, Nova Scotia B3K 6R8
CanadaSite Not Available
London Health Sciences Centre (LHSC) - Victoria Hospital
London, Ontario N6A 5W9
CanadaSite Not Available
The Hospital for Sick Children
Toronto, Ontario M5G 1X8
CanadaSite Not Available
CHU AMIENS Picardie Site SUD CRC
Amines, Cedex1 80054
FranceSite Not Available
CHU Amiens - Hopital NORD
Amines, Cedex1 80054
FranceActive - Recruiting
Hopital Jeanne de Flandre - CHRU Lille
Lille Cedex, Nord 59037
FranceActive - Recruiting
CHU AMIENS Picardie Site SUD CRC
Amiens, 80054
FranceActive - Recruiting
Hôpital Necker - Enfants Malades
Paris, 75015
FranceActive - Recruiting
Hôpital Robert Debré - Paris
Paris, 75019
FranceActive - Recruiting
URC CIC
Paris, 75015
FranceActive - Recruiting
Soroka Medical Center
Beer-Sheva, HaDarom 8410101
IsraelSite Not Available
Soroka Medical Center
Beer Sheva, 8410101
IsraelActive - Recruiting
Rambam Health Care Campus
Haifa, 3109601
IsraelSite Not Available
Shamir Medical Center (Assaf Harofeh)
Israel, 70300
IsraelActive - Recruiting
Hadassah University Hospital - Mount Scopus
Jerusalem, 9124001
IsraelSite Not Available
Hadassah University Hospital, Ein Kerem
Jerusalem, 9112001
IsraelSite Not Available
Hadassah University Hospital, Ein Kerem,
Jerusalem, 9112001
IsraelActive - Recruiting
Shaare Zedek
Jerusalem, 9103102
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
IsraelActive - Recruiting
Schneider Children's Medical Center
Petah Tiqva, 4920235
IsraelActive - Recruiting
Schneider Children's Medical Center
Petah-Tikva, 4920235
IsraelSite Not Available
Asst Papa Giovanni Xxiii Bergamo
Bergamo, 24127
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
ItalyActive - Recruiting
Azienda USL di Bologna
Bologna, 40133
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Firenze, 50139
ItalyActive - Recruiting
SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)
Firenze, 50139
ItalyActive - Recruiting
Ospedale dei Bambini Vittore Buzzi
Milano, 20154
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, 00161
ItalyActive - Recruiting
Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)
Roma, CAP 00161
ItalyActive - Recruiting
Ospedale Pediatrico Bambino Gesù
Roma, 00165
ItalyActive - Recruiting
Hirosaki University Hospital
Hirosaki, Aomori Pref. 036
JapanActive - Recruiting
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Chiba-Ken 277-0871
JapanActive - Recruiting
Kobe University Hospital
Kobe, Hyogo 650-0017
JapanSite Not Available
Yokohama City University Medical Center, Center of IBD
Yokohama-shi, Kanagawa-Ken 232-0024
JapanActive - Recruiting
Miyagi Children's Hospital
Sendai-shi, Miyagi 989 3126
JapanActive - Recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-8431
JapanActive - Recruiting
National Center For Child Health And Development
Setagaya-ku, Tokyo 154
JapanActive - Recruiting
National Center for Child Health and Development
Setagaya-ku, Tokyo 157-8535
JapanActive - Recruiting
Saga University Hospital
Saga, 849-8501
JapanActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu, Gyeongsangbuk-do 41404
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, Korea 06351
Korea, Republic ofActive - Recruiting
Inje University Haeundae Paik Hospital
Busan, Kwangyǒkshi 48108
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, Teukbyeolsi [Seoul] 3080
Korea, Republic ofActive - Recruiting
LIilly Korea Ltd
Seoul, 04637
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofActive - Recruiting
Erasmus Medisch Centrum
Rotterdam, Zuid-Holland 3015 CN
NetherlandsActive - Recruiting
Akershus Universitetssykehus
Nordbyagen, 01474
NorwayActive - Recruiting
Oslo University Hospital
Oslo, 0450
NorwayActive - Recruiting
Universitetssykehuset Nord-Norge
Tromsø, 9038
NorwayActive - Recruiting
St-Olavs Hospital
Trondheim, 7030
NorwayActive - Recruiting
Instytut Pomnik-Centrum Zdrowia Dziecka
Warszawa, Masovian 04-730
PolandActive - Recruiting
Uniwersytecki Szpital Dziecięcy w Krakowie
Krakow, 30 663
PolandActive - Recruiting
Korczowski Bartosz, Gabinet Lekarski
Rzeszow, 35-302
PolandActive - Recruiting
Warsaw IBD Point Profesor Kierkus
Warszawa, 00-728
PolandActive - Recruiting
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
Braga, 4710-243
PortugalActive - Recruiting
Hospital de Braga
Braga, 4710-243
PortugalSite Not Available
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisboa, 1649-035
PortugalActive - Recruiting
Centro Hospitalar de São João, E.P.E.
Porto, 4200 319
PortugalActive - Recruiting
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona 08950
SpainActive - Recruiting
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona 08208
SpainActive - Recruiting
Hospital Universitario Reina Sofia
Cordoba, 14004
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe
València, 46026
SpainActive - Recruiting
John Radcliffe Hospital
Oxford, Gb-oxf OX3 9DU
United KingdomActive - Recruiting
Oxford University Hospitals NHS trust John Radcliffe hospital
Oxford, Gb-oxf OX3 9DU
United KingdomSite Not Available
Royal London Hospital
Whitechapel, Greater London E1 1FR
United KingdomActive - Recruiting
Royal Manchester Children's Hospital
Manchester, Greater Manchester M13 9WL
United KingdomActive - Recruiting
Great Ormond Street Hospital For Children NHS Foundation Trust
London, London, City Of WC1N 3JH
United KingdomActive - Recruiting
Royal Hospital for Children and Young People
Edinburgh, Lothian Region EH16 4TJ
United KingdomActive - Recruiting
Oxford University Hospitals NHS trust John Radcliffe hospital
Headington, Oxford OX3 9DU
United KingdomActive - Recruiting
Sheffield Children's Hospital
Sheffield, South Yorkshire S10 2RX
United KingdomActive - Recruiting
Great Ormond Street Hospital for Children
London, WC1N 3JH
United KingdomActive - Recruiting
Manchester University NHS Foundation Trust
Manchester, M139WL
United KingdomActive - Recruiting
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United StatesSite Not Available
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas 72202
United StatesSite Not Available
University of California San Diego
La Jolla, California 92093
United StatesActive - Recruiting
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
University of California-San Francisco-Mission Bay
San Francisco, California 94158
United StatesSite Not Available
Connecticut Children's Medical Center
Hartford, Connecticut 06032
United StatesActive - Recruiting
Nicklaus Children's Hospital
Miami, Florida 33155
United StatesSite Not Available
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia 30342
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
The Emory Clinic Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
Riley Childrens Hospital
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Atlantic Children's Health--Pediatric Gastroenterology
Morristown, New Jersey 07960
United StatesSite Not Available
Atlantic Health System
Morristown, New Jersey 07960
United StatesSite Not Available
Columbia University Medical Center/New York Presbyterian
New York, New York 10032
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
New York, New York 10021-5663
United StatesActive - Recruiting
Weill Cornell Medicine
New York, New York 10021-5663
United StatesActive - Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Childrens Medical Center
Dayton, Ohio 45404
United StatesActive - Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19146
United StatesActive - Recruiting
Cook Children's Medical Center
Fort Worth, Texas 76104
United StatesActive - Recruiting
Texas Children's Hospital
Houston, Texas 77030
United StatesSite Not Available
Texas Children's Hospital -Research Resource Office
Houston, Texas 77030
United StatesActive - Recruiting
University of Vermont Medical Center
Burlington, Vermont 05401
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available
Children's Hospital of Wisconsin
Milwaukee, Wisconsin 53226 4874
United StatesSite Not Available
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