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.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

90

Study ID:

NCT05509777

Recruitment Status:

Recruiting

Sponsor:

Eli Lilly and Company

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There are 87 Locations for this study

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University of California San Diego
La Jolla California, 92093, United States More Info
Jeannie Huang
Principal Investigator
Cedars Sinai Medical Center
Los Angeles California, 90048, United States More Info
David Ziring
Principal Investigator
University of California-San Francisco-Mission Bay
San Francisco California, 94143, United States More Info
Sofia Verstraete
Principal Investigator
Connecticut Children's Medical Center
Hartford Connecticut, 06106, United States More Info
Jeffrey Hyams
Principal Investigator
Nicklaus Children's Hospital
Miami Florida, 33155, United States More Info
Lina Maria Felipez
Principal Investigator
The Emory Clinic Emory University
Atlanta Georgia, 30322, United States More Info
subra kugathasan
Principal Investigator
Children's Center for Digestive Health Care, LLC
Atlanta Georgia, 30342, United States More Info
Jeffrey Lewis
Principal Investigator
Riley Childrens Hospital
Indianapolis Indiana, 46202, United States More Info
Steven Steiner
Principal Investigator
Boston Children's Hospital
Boston Massachusetts, 02115, United States More Info
Athos Bousvaros
Principal Investigator
Atlantic Health System
Morristown New Jersey, 07960, United States More Info
Oren Koslowe
Principal Investigator
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
New York New York, 10021, United States More Info
Contact
646-962-7162
Aliza Solomon
Principal Investigator
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States More Info
David Dunkin
Principal Investigator
Columbia University Medical Center/New York Presbyterian
New York New York, 10032, United States More Info
Joseph Picoraro
Principal Investigator
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Jessica Barry
Principal Investigator
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States More Info
Arthur Kastl
Principal Investigator
Cook Children's Medical Center
Fort Worth Texas, 76104, United States More Info
Clifton Huang
Principal Investigator
Texas Children's Hospital -Research Resource Office
Houston Texas, 77030, United States More Info
Lina Karam
Principal Investigator
University of Vermont Medical Center
Burlington Vermont, 05401, United States More Info
Jillian Sullivan
Principal Investigator
Seattle Children's Hospital
Seattle Washington, 98105, United States More Info
Contact
206-987-1293
Ghassan Wahbeh
Principal Investigator
The Children's Hospital at Westmead
Westmead New South Wales, 2145, Australia More Info
Shoma Dutt
Principal Investigator
Mater Hospital Brisbane
South Brisbane Queensland, 4101, Australia More Info
Jakob Begun
Principal Investigator
Women'S and Children'S Hospital, Adelaide
North Adelaide South Australia, 5006, Australia More Info
Richard Couper
Principal Investigator
Perth Children's Hospital
Nedlands Western Australia, 6009, Australia More Info
Zubin Grover
Principal Investigator
AKH - Medizinische Universtität Wien
Vienna , 1090, Austria More Info
Wolf-Dietrich Huber
Principal Investigator
UZ Leuven
Leuven Brabant, 3000, Belgium More Info
Ilse Hoffman
Principal Investigator
Cliniques universitaires Saint-Luc
Brussels , 1200, Belgium More Info
Francoise Smets
Principal Investigator
Universitair Ziekenhuis Brussel
Brussel , 1090, Belgium More Info
Elisabeth De Greef
Principal Investigator
Universitair Ziekenhuis Antwerp
Gent , 9000, Belgium More Info
Pauline De Bruyne
Principal Investigator
Núcleo de Doenças Infecciosas/CBM/UFES
Vitória Espírito Santo, 29040, Brazil More Info
Ana Daniela Izoton de Sadovsky
Principal Investigator
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia Goiás, 74605, Brazil More Info
Naflesia Bezerra Oliveira Correa
Principal Investigator
Associação Hospitalar de Proteção à Infância Dr. Raul Carneiro
Curitiba Paraná, 80250, Brazil More Info
Sabine Kruger Truppel
Principal Investigator
Hospital das Clinicas da FMRP
Sao Paulo Paraná, 14048, Brazil More Info
Regina Sawamura
Principal Investigator
Hospital da Criança Santo Antônio - Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre Rio Grande Do Sul, 90035, Brazil More Info
Cristina Targa Ferreira
Principal Investigator
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
Campinas Sao Paulo, 13060, Brazil More Info
Joaquim Simoes Neto
Principal Investigator
Integral Pesquisa e Ensino
Votuporanga São Paulo, 15501, Brazil More Info
Herlon Escorsi Valerio
Principal Investigator
Children's & Women's Health Centre of British Columbia
Vancouver British Columbia, V6H 3, Canada More Info
Kevan Jacobson
Principal Investigator
IWK Health Centre
Halifax Nova Scotia, B3K 6, Canada More Info
Anthony Otley
Principal Investigator
London Health Sciences Centre (LHSC) - Victoria Hospital
London Ontario, N6A 5, Canada More Info
Dhandapani Ashok
Principal Investigator
The Hospital for Sick Children
Toronto Ontario, M5G 1, Canada More Info
Anne Griffiths
Principal Investigator
CHU Amiens - Hopital NORD
Amines Cedex1, 80054, France More Info
Djeddi Djamal-Dine
Principal Investigator
Hopital Jeanne de Flandre - CHRU Lille
Lille Cedex Nord, 59037, France More Info
Delphine Ley
Principal Investigator
Hôpital Necker - Enfants Malades
Paris , 75015, France More Info
Frank Ruemmele
Principal Investigator
Hôpital Robert Debré - Paris
Paris , 75019, France More Info
Jérôme Viala
Principal Investigator
Soroka Medical Center
Beer-Sheva HaDarom, 84101, Israel More Info
Baruch Yerushalmi
Principal Investigator
Rambam Health Care Campus
Haifa , 31096, Israel More Info
Ramit Magen Rimon
Principal Investigator
Shamir Medical Center (Assaf Harofeh)
Israel , 70300, Israel More Info
EFRAT BROIDE
Principal Investigator
Shaare Zedek
Jerusalem , 91031, Israel More Info
Dan Turner
Principal Investigator
Hadassah University Hospital, Ein Kerem
Jerusalem , 91120, Israel More Info
Contact
+972528709824
Zev Davidovics
Principal Investigator
Schneider Children's Medical Center
Petah-Tikva , 49202, Israel More Info
Contact
+972-39253039
Dror Shouval
Principal Investigator
Asst Papa Giovanni Xxiii Bergamo
Bergamo , 24127, Italy More Info
Naire Sansotta
Principal Investigator
Azienda USL di Bologna
Bologna , 40124, Italy More Info
Patrizia Alvisi
Principal Investigator
SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)
Firenze , 50139, Italy More Info
Paolo Lionetti
Principal Investigator
Ospedale Pediatrico Bambino Gesù
Roma , 00165, Italy More Info
Fiammetta Bracci
Principal Investigator
Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)
Roma , CAP 0, Italy More Info
Marina Aloi
Principal Investigator
Hirosaki University Hospital
Hirosaki Aomori Pref., 036, Japan More Info
Hirotake Sakuraba
Principal Investigator
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi Chiba-Ken, 277-0, Japan More Info
Ken Takeuchi
Principal Investigator
Yokohama City University Medical Center, Center of IBD
Yokohama-shi Kanagawa-Ken, 232-0, Japan More Info
Reiko Kunisaki
Principal Investigator
Miyagi Children's Hospital
Sendai-shi Miyagi, 989 3, Japan More Info
Daiki Abukawa
Principal Investigator
Juntendo University Hospital
Bunkyo-ku Tokyo, 113-8, Japan More Info
Takahiro Kudo
Principal Investigator
National Center For Child Health And Development
Setagaya-ku Tokyo, 154, Japan More Info
Katsuhiro Arai
Principal Investigator
Saga University Hospital
Saga , 849-8, Japan More Info
Toshihiko Kakiuchi
Principal Investigator
Severance Hospital, Yonsei University Health System
Seoul Korea, 03722, Korea, Republic of More Info
Hong Koh
Principal Investigator
Inje University Haeundae Paik Hospital
Busan Kwangyǒkshi, 48108, Korea, Republic of More Info
Tae-oh Kim
Principal Investigator
Kyungpook National University Chilgok Hospital
Daegu Kwangyǒkshi, 41404, Korea, Republic of More Info
Ben Kang
Principal Investigator
Seoul National University Hospital
Seoul Seoul-teukbyeolsi [Seoul], 03080, Korea, Republic of More Info
Jin Soo Moon
Principal Investigator
Samsung Medical Center
Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of More Info
Mi Jin Kim
Principal Investigator
Erasmus Medisch Centrum
Rotterdam , 3015 , Netherlands More Info
Lissy De Ridder
Principal Investigator
Akershus Universitetssykehus
Nordbyagen , 1478, Norway More Info
Christopher Inchley
Principal Investigator
Oslo University Hospital
Oslo , 0424, Norway More Info
Gori Perminow
Principal Investigator
Universitetssykehuset Nord-Norge
Tromsø , 9038, Norway More Info
Lene Nymo Trulsen
Principal Investigator
St-Olavs Hospital
Trondheim , 7030, Norway More Info
Henrik Dollner
Principal Investigator
Instytut Pomnik-Centrum Zdrowia Dziecka
Warszawa Masovian, 04-73, Poland More Info
Jaroslaw Kierkus
Principal Investigator
Uniwersytecki Szpital Dziecięcy w Krakowie
Krakow , 30 66, Poland More Info
Kinga Kowalska Duplaga
Principal Investigator
Korczowski Bartosz, Gabinet Lekarski
Rzeszow , 35-30, Poland More Info
Bartosz Korczowski
Sub-Investigator
Warsaw IBD Point Profesor Kierkus
Warszawa , 00-72, Poland More Info
Monika Meglicka
Principal Investigator
Hospital de Braga
Braga , 4710-, Portugal More Info
Filipa Neiva
Principal Investigator
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisboa , 1649-, Portugal More Info
Ana Isabel Lopes
Principal Investigator
Centro Hospitalar de São João, E.P.E.
Porto , 4200 , Portugal More Info
Eunice Trindade
Principal Investigator
Corporacio Sanitaria Parc Tauli
Sabadell Barcelona, 08208, Spain More Info
Diana Garcia Tirado
Principal Investigator
Hospital Universitario Reina Sofia
Cordoba , 14004, Spain More Info
Rafael Gonzlez de Caldas
Principal Investigator
Hospital Sant Joan de Deu
Esplugues de Llobregat , 08950, Spain More Info
Francisco Javier Martin Carpi
Principal Investigator
Hospital Universitari i Politecnic La Fe
València , 46026, Spain More Info
Marisa Isabel Iborra Colomino
Principal Investigator
John Radcliffe Hospital
Oxford Gb-oxf, OX3 9, United Kingdom More Info
Lucy Howarth
Principal Investigator
Royal London Hospital
Whitechapel Greater London, E1 1F, United Kingdom More Info
Ahmed Kadir
Principal Investigator
Royal Manchester Children's Hospital
Manchester Greater Manchester, M13 9, United Kingdom More Info
Andrew Fagbemi
Principal Investigator
Royal Hospital for Children and Young People
Edinburgh Lothian Region, EH16 , United Kingdom More Info
Richard Russell
Principal Investigator
Sheffield Children's Hospital
Sheffield South Yorkshire, S10 2, United Kingdom More Info
Akshay Kapoor
Principal Investigator
Great Ormond Street Hospital for Children
London , WC1N , United Kingdom More Info
Kelsey Jones
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

90

Study ID:

NCT05509777

Recruitment Status:

Recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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