Multiple Sclerosis Clinical Trial
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn’s Disease
Summary
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.
Study periods for the intervention-specific appendix (ISA) will be as follows:
A 12-week induction period
A maintenance period from Week 12 to Week 52, and
A safety follow-up period up to 16 weeks.
The study will last about 74 weeks and may include up to 19 visits.
Full Description
Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.
Eligibility Criteria
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 must have moderately to severely active CD (as defined by a baseline PCDAI score >30).
Participants must have endoscopy with evidence of active CD defined as as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) during screening into this study.
Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.
Exclusion Criteria:
Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
Participants must not have an abscess.
Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.
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There are 87 Locations for this study
La Jolla California, 92093, United States More Info
Principal Investigator
Los Angeles California, 90048, United States More Info
Principal Investigator
San Francisco California, 94143, United States More Info
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Hartford Connecticut, 06106, United States More Info
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Miami Florida, 33155, United States More Info
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Atlanta Georgia, 30322, United States More Info
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Atlanta Georgia, 30342, United States More Info
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Indianapolis Indiana, 46202, United States More Info
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Boston Massachusetts, 02115, United States More Info
Principal Investigator
Morristown New Jersey, 07960, United States More Info
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New York New York, 10021, United States More Info
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New York New York, 10029, United States More Info
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New York New York, 10032, United States More Info
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Cleveland Ohio, 44195, United States More Info
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Philadelphia Pennsylvania, 19104, United States More Info
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Fort Worth Texas, 76104, United States More Info
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Houston Texas, 77030, United States More Info
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Burlington Vermont, 05401, United States More Info
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Seattle Washington, 98105, United States More Info
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Westmead New South Wales, 2145, Australia More Info
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South Brisbane Queensland, 4101, Australia More Info
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North Adelaide South Australia, 5006, Australia More Info
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Nedlands Western Australia, 6009, Australia More Info
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Vienna , 1090, Austria More Info
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Brussels , 1200, Belgium More Info
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Brussel , 1090, Belgium More Info
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Gent , 9000, Belgium More Info
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Vitória Espírito Santo, 29040, Brazil More Info
Principal Investigator
Goiânia Goiás, 74605, Brazil More Info
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Curitiba Paraná, 80250, Brazil More Info
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Sao Paulo Paraná, 14048, Brazil More Info
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Porto Alegre Rio Grande Do Sul, 90035, Brazil More Info
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Campinas Sao Paulo, 13060, Brazil More Info
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Votuporanga São Paulo, 15501, Brazil More Info
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Vancouver British Columbia, V6H 3, Canada More Info
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London Ontario, N6A 5, Canada More Info
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Toronto Ontario, M5G 1, Canada More Info
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Amines Cedex1, 80054, France More Info
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Lille Cedex Nord, 59037, France More Info
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Paris , 75015, France More Info
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Beer-Sheva HaDarom, 84101, Israel More Info
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Israel , 70300, Israel More Info
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Jerusalem , 91120, Israel More Info
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Petah-Tikva , 49202, Israel More Info
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Bergamo , 24127, Italy More Info
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Firenze , 50139, Italy More Info
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Roma , 00165, Italy More Info
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Roma , CAP 0, Italy More Info
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Hirosaki Aomori Pref., 036, Japan More Info
Principal Investigator
Kashiwa-shi Chiba-Ken, 277-0, Japan More Info
Principal Investigator
Yokohama-shi Kanagawa-Ken, 232-0, Japan More Info
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Sendai-shi Miyagi, 989 3, Japan More Info
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Bunkyo-ku Tokyo, 113-8, Japan More Info
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Setagaya-ku Tokyo, 154, Japan More Info
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Seoul Korea, 03722, Korea, Republic of More Info
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Busan Kwangyǒkshi, 48108, Korea, Republic of More Info
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Daegu Kwangyǒkshi, 41404, Korea, Republic of More Info
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Seoul Seoul-teukbyeolsi [Seoul], 03080, Korea, Republic of More Info
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Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of More Info
Principal Investigator
Rotterdam , 3015 , Netherlands More Info
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Nordbyagen , 1478, Norway More Info
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Tromsø , 9038, Norway More Info
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Warszawa Masovian, 04-73, Poland More Info
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Krakow , 30 66, Poland More Info
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Rzeszow , 35-30, Poland More Info
Sub-Investigator
Warszawa , 00-72, Poland More Info
Principal Investigator
Lisboa , 1649-, Portugal More Info
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Porto , 4200 , Portugal More Info
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Sabadell Barcelona, 08208, Spain More Info
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Cordoba , 14004, Spain More Info
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Esplugues de Llobregat , 08950, Spain More Info
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València , 46026, Spain More Info
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Oxford Gb-oxf, OX3 9, United Kingdom More Info
Principal Investigator
Whitechapel Greater London, E1 1F, United Kingdom More Info
Principal Investigator
Manchester Greater Manchester, M13 9, United Kingdom More Info
Principal Investigator
Edinburgh Lothian Region, EH16 , United Kingdom More Info
Principal Investigator
Sheffield South Yorkshire, S10 2, United Kingdom More Info
Principal Investigator
London , WC1N , United Kingdom More Info
Principal Investigator
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