Clinical trial • Phase III • Gastroenterology

MIRIKIZUMAB for Crohn's disease

Phase III trial of MIRIKIZUMAB for Crohn's disease.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Crohn's disease
Trial Stage
Phase III
Drug Modality
Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
03-07-2024
First CTIS Authorization Date
31-07-2024

Trial design

Randomised, placebo (adult placebo) - comparator described as adult placebo; no dose or schedule specified in the available record-controlled Phase III trial across 31 sites in Italy, Netherlands, Portugal and others.

Randomised
Yes
Comparator
Placebo (adult placebo) - comparator described as adult placebo; no dose or schedule specified in the available record
Target Sample Size
58
Trial Duration For Participant
364

Eligibility

Recruits 58 paediatric patients.

Vulnerable Population
Pediatric participants are included. Assent and parental/guardian consent procedures are implemented: multiple age-specific assent forms and parental/guardian informed consent forms are provided (documents for ages/groups such as 2-5 years, 6-11 years, 12-17 years, parental/guardian forms, and 'Turning 18' forms). Consent/assent documentation is available in multiple languages as supplied in trial documents (English, French, Dutch, Polish, Portuguese, Spanish, Italian, Norwegian).

Inclusion criteria

  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Participants must have moderately to severely active CD (as defined by a baseline PCDAI score ≥30)."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Participants must have a prior or current CD medication history that includes either inadequate response, loss of response to or failure to tolerate current treatment immunomodulators or with oral or IV corticosteroids or have received biologic therapy/JAK inhibitor for the treatment of CD and have a documented history of inadequate response, loss of response (LOR), or intolerance to the biologic therapy/JAK inhibitor."}

Exclusion criteria

  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Participants must not have an abscess."}
  • {"criterion_text":"- Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 [ Time Frame: Baseline to Week 52 ] Clinical response based on PCDAI, and endoscopic response based on SES-CD","definition_or_measurement_approach":"Clinical response based on PCDAI; endoscopic response based on SES-CD; Time Frame: Baseline to Week 52"}
  • {"endpoint_text":"- Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52 [ Time Frame: Baseline to Week 52 ] Clinical response based on PCDAI, and clinical remission based on PCDAI","definition_or_measurement_approach":"Clinical response and clinical remission assessed using the Pediatric Crohn's Disease Activity Index (PCDAI); Time Frame: Baseline to Week 52"}

Recruitment

Planned Sample Size
58
Recruitment Window Months
52
Consent Approach
Informed consent is obtained from parents/legal guardians for pediatric participants; age-appropriate assent forms are used for children (documents available for age groups including 2-5 years, 6-11 years, 12-17 years). There are specific 'Turning 18' forms for participants reaching adulthood. Subject information and consent/assent materials are provided in multiple languages (English, French, Dutch, Polish, Portuguese, Spanish, Italian, Norwegian) as shown in the submitted ICF and assent documents.

Geography

Total Number Of Sites
31
Total Number Of Participants
30

Italy

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
19-08-2024
Processing Time Days
33
Number Of Sites
7
Number Of Participants
5

Sites

Site Name
ASST Fatebenefratelli Sacco
Department Name
Gastroenterologia e Nutrizione
Principal Investigator Name
Lorenzo Norsa
Principal Investigator Email
lorenzo.norsa@asst-fbf-sacco.it
Contact Person Name
Lorenzo Norsa
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
OU di Epatologia, Gastroenterologia e Nutrizione
Principal Investigator Name
Fiammetta Bracci
Principal Investigator Email
fiammetta.bracci@opbg.net
Contact Person Name
Fiammetta Bracci
Contact Person Email
fiammetta.bracci@opbg.net
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Gastroenterologia ed Epotologia Pediatrica
Principal Investigator Name
Salvatore Oliva
Principal Investigator Email
salvatore.oliva@uniroma1.it
Contact Person Name
Salvatore Oliva
Contact Person Email
salvatore.oliva@uniroma1.it
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
Pediatrics Unit
Principal Investigator Name
Enrico Felici
Principal Investigator Email
enrico.felici@ospedale.al.it
Contact Person Name
Enrico Felici
Contact Person Email
enrico.felici@ospedale.al.it
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
Pediatria
Principal Investigator Name
Patrizia Alvisi
Principal Investigator Email
patrizia.alvisi@ausl.bologna.it
Contact Person Name
Patrizia Alvisi
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Epatologia e Gastroenterologia Pediatrica e dei Trapianti
Principal Investigator Name
Naire Sansotta
Principal Investigator Email
nsansotta@asst-pg23.it
Contact Person Name
Naire Sansotta
Contact Person Email
nsansotta@asst-pg23.it
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
Gastroenterologia e Nutrizione
Principal Investigator Name
Paolo Lionetti
Principal Investigator Email
paolo.lionetti@unifi.it
Contact Person Name
Paolo Lionetti
Contact Person Email
paolo.lionetti@unifi.it

Netherlands

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
31-07-2024
Processing Time Days
14
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Gastroenterology
Principal Investigator Name
Johanna Escher
Principal Investigator Email
j.escher@erasmusmc.nl
Contact Person Name
Johanna Escher
Contact Person Email
j.escher@erasmusmc.nl

Portugal

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
28-08-2024
Processing Time Days
42
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Serviço de Pediatria
Principal Investigator Name
Eunice Trindade
Principal Investigator Email
eunice_trindade@netcabo.pt
Contact Person Name
Eunice Trindade
Contact Person Email
eunice_trindade@netcabo.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Serviço de Pediatria
Principal Investigator Name
Luís Rodrigues
Principal Investigator Email
luisnorterodrigues@gmail.com
Contact Person Name
Luís Rodrigues
Contact Person Email
luisnorterodrigues@gmail.com
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Serviço de Pediatria
Principal Investigator Name
Filipa Neiva
Principal Investigator Email
ana.neiva@hb.min-saude.pt
Contact Person Name
Filipa Neiva
Contact Person Email
ana.neiva@hb.min-saude.pt

France

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
06-08-2024
Processing Time Days
20
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Pediatric
Principal Investigator Name
Djamal-Dine DJEDDI
Principal Investigator Email
djeddi.djamal-dine@chu-amiens.fr
Contact Person Name
Djamal-Dine DJEDDI
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pediatric
Principal Investigator Name
Frank RUEMMELE
Principal Investigator Email
frank.ruemmele@aphp.fr
Contact Person Name
Frank RUEMMELE
Contact Person Email
frank.ruemmele@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Pediatric
Principal Investigator Name
Delphine LEY
Principal Investigator Email
delphine.ley@chu-lille.fr
Contact Person Name
Delphine LEY
Contact Person Email
delphine.ley@chu-lille.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pediatric
Principal Investigator Name
Jerome VIALA
Principal Investigator Email
jerome.viala@rdb.aphp.fr
Contact Person Name
Jerome VIALA
Contact Person Email
jerome.viala@rdb.aphp.fr

Spain

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
08-08-2024
Processing Time Days
22
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Hospital Universitario Reina Sofia
Department Name
Pediatric Gastroenterology
Principal Investigator Name
Rafael Gonzalez de Caldas Marchal
Principal Investigator Email
rgonzalezdecaldasmarchal@gmail.com
Contact Person Name
Rafael Gonzalez de Caldas Marchal
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Gastroenterology
Principal Investigator Name
Maria Isabel Iborra Colomino
Principal Investigator Email
marisaiborra@hotmail.com
Contact Person Name
Maria Isabel Iborra Colomino
Contact Person Email
marisaiborra@hotmail.com
Site Name
Parc Tauli Hospital Universitari
Department Name
Pediatric Gastroenterology
Principal Investigator Name
Diana Garcia Tirado
Principal Investigator Email
dgarcia@tauli.cat
Contact Person Name
Diana Garcia Tirado
Contact Person Email
dgarcia@tauli.cat

Poland

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
04-08-2024
Processing Time Days
18
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Centrum Medyczne Oporow
Principal Investigator Name
Radoslaw Kempinski
Principal Investigator Email
radoslaw.kempinski@cmoporow.com
Contact Person Name
Radoslaw Kempinski
Site Name
Medical Network Sp. z o.o.
Department Name
WIP Warsaw IBD Point Profesor Kierkuś
Principal Investigator Name
Monika Meglicka
Principal Investigator Email
m.meglicka@wip.waw.pl
Contact Person Name
Monika Meglicka
Contact Person Email
m.meglicka@wip.waw.pl
Site Name
Gabinet Lekarski Bartosz Korczowski
Principal Investigator Name
Bartosz Korczowski
Principal Investigator Email
korczowski@op.pl
Contact Person Name
Bartosz Korczowski
Contact Person Email
korczowski@op.pl
Site Name
Instytut Pomnik Centrum Zdrowia Dziecka
Department Name
Klinika Gastroenterologii, Hepatologii, Zaburzeń odżywiania i Pediatrii
Principal Investigator Name
Jarosław Kierkuś
Principal Investigator Email
j.kierkus@med-net.pl
Contact Person Name
Jarosław Kierkuś
Contact Person Email
j.kierkus@med-net.pl

Norway

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
05-08-2024
Processing Time Days
19
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Oslo University Hospital HF
Department Name
Doctor of Pediatric Medicine
Principal Investigator Name
Gori Perminow
Principal Investigator Email
goeper@ous-hf.no
Contact Person Name
Gori Perminow
Contact Person Email
goeper@ous-hf.no
Site Name
Akershus University Hospital
Department Name
Doctor of Medicine
Principal Investigator Name
Christopher Inchley
Principal Investigator Email
christopher.stephen.inchley@ahus.no
Contact Person Name
Christopher Inchley
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Doctor of Medicine
Principal Investigator Name
Lene Nymo Trulsen
Principal Investigator Email
lene.nymo.trulsen@unn.no
Contact Person Name
Lene Nymo Trulsen
Contact Person Email
lene.nymo.trulsen@unn.no
Site Name
St. Olavs Hospital HF
Department Name
Doctor of Medicine
Principal Investigator Name
Henrik Dollner
Principal Investigator Email
henrik.dollner@ntnu.no
Contact Person Name
Henrik Dollner
Contact Person Email
henrik.dollner@ntnu.no

Belgium

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
01-08-2024
Processing Time Days
15
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
UZ Brussel
Department Name
Pediatric gastroenterology
Principal Investigator Name
Elisabeth De Greef
Principal Investigator Email
elisabeth.degreef@uzbrussel.be
Contact Person Name
Elisabeth De Greef
Contact Person Email
elisabeth.degreef@uzbrussel.be
Site Name
UZ Leuven
Department Name
Pediatric gastroenterology
Principal Investigator Name
Ilse Hoffman
Principal Investigator Email
ilse.hoffman@uzleuven.be
Contact Person Name
Ilse Hoffman
Contact Person Email
ilse.hoffman@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Pediatric gastroenterology
Principal Investigator Name
Françoise Smets
Principal Investigator Email
francoise.smets@saintluc.uclouvain.be
Contact Person Name
Françoise Smets
Site Name
Universitair Ziekenhuis Gent
Department Name
Pediatric gastroenterology
Principal Investigator Name
Saskia Vande Velde
Principal Investigator Email
saskia.vandevelde@uzgent.be
Contact Person Name
Saskia Vande Velde
Contact Person Email
saskia.vandevelde@uzgent.be

Austria

Earliest CTIS Part Ii Submission Date
17-07-2024
Latest Decision Or Authorization Date
05-08-2024
Processing Time Days
19
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Pediatric Nephrology and Gastroenterology
Principal Investigator Name
Judith Pichler
Principal Investigator Email
judith.pichler@meduniwien.ac.at
Contact Person Name
Judith Pichler

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Third parties

  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"eCOA, ePRO - design and device provision","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Laboratory – sample collection and processing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA, ePRO - design and device provision","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eli Lilly & Co.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Laboratory – sample collection and processing","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Mirikizumab
Active Substance
MIRIKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
Authorised
Investigational Product Name
Mirikizumab
Active Substance
MIRIKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Authorisation Status
Authorised
Investigational Product Name
Mirikizumab
Active Substance
MIRIKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
CUTANEOUS USE
Route
CUTANEOUS USE
Authorisation Status
Authorised

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