Clinical trial NCT05509777: A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Official title: A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Inflammatory Bowel Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 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 SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0.
* 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.

Primary outcomes:
measure: 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
timeFrame: Baseline to Week 52
measure: Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving Clinical Response by PCDAI
timeFrame: Week 12
measure: Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)
timeFrame: Week 12
measure: Percentage of Participants Achieving Clinical Remission by PCDAI
timeFrame: Week 12
measure: Percentage of Participants Achieving Clinical Remission by CDAI
timeFrame: Week 12
measure: Percentage of Participants Achieving Endoscopic Response by SES-CD
timeFrame: Week 12
measure: Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52
timeFrame: Baseline to Week 52
measure: Change from Baseline in C-reactive Protein (CRP)
timeFrame: Baseline, Week 12
measure: Change from Baseline in CRP
timeFrame: Baseline, Week 52
measure: Change from Baseline in Fecal calprotectin
timeFrame: Baseline, Week 12
measure: Change from Baseline in Fecal calprotectin
timeFrame: Baseline, Week 52
measure: Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Participants Achieving Endoscopic Response
timeFrame: Week 52
measure: Percentage of Participants Achieving Clinical Remission by PCDAI
timeFrame: Week 52
measure: Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and PCDAI Clinical Remission without the use of Corticosteroids and who did not have Crohn's disease (CD)-Related Surgery at Week 52
timeFrame: Baseline to Week 52
measure: Pharmacokinetics (PK): Clearance of Mirikizumab
timeFrame: Baseline through Week 52
measure: Pharmacokinetics (PK): Volume of Distribution of Mirikizumab
timeFrame: Baseline through Week 52
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Children's Center for Digestive Health Care, LLC
state: Georgia
city: Indianapolis
country: United States
facility: Riley Childrens Hospital
state: Indiana
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Morristown
country: United States
facility: Atlantic Children's Health--Pediatric Gastroenterology
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian
state: New York
city: Dayton
country: United States
facility: Childrens Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Vienna
country: Austria
facility: AKH - Medizinische Universtität Wien
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande Do Sul
city: Votuporanga
country: Brazil
facility: Integral Pesquisa e Ensino
state: Sao Paulo
city: Campinas
country: Brazil
facility: Hospital PUC-CAMPINAS
state: São Paulo
city: Curitiba-PR
country: Brazil
facility: Hospital Pequeno Príncipe
city: Goiânia
country: Brazil
facility: Hospital das Clínicas - UFG (Universidade Federal de Goiás)
city: Santos Dumont
country: Brazil
facility: NDI - Nucleo de Doenças Infecciosas
city: Vancouver
country: Canada
facility: Children's & Women's Health Centre of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre (LHSC) - Victoria Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Lille Cedex
country: France
facility: Hopital Jeanne de Flandre - CHRU Lille
state: Nord
city: Amiens
country: France
facility: CHU AMIENS Picardie Site SUD CRC
city: Paris
country: France
facility: URC CIC
city: Paris
country: France
facility: Hôpital Robert Debré - Paris
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Israel
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
city: Jerusalem
country: Israel
facility: Shaare Zedek
city: Jerusalem
country: Israel
facility: Hadassah University Hospital, Ein Kerem,
city: Petah Tiqva
country: Israel
facility: Schneider Children's Medical Center
city: Bergamo
country: Italy
facility: Asst Papa Giovanni Xxiii Bergamo
city: Bologna
country: Italy
facility: Azienda USL di Bologna
city: Firenze
country: Italy
facility: SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)
city: Milano
country: Italy
facility: Ospedale dei Bambini Vittore Buzzi
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: Roma
country: Italy
facility: Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
state: Aomori Pref.
city: Kashiwa-shi
country: Japan
facility: Kokikai Tsujinaka Hospital Kashiwanoha
state: Chiba-Ken
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Yokohama-shi
country: Japan
facility: Yokohama City University Medical Center, Center of IBD
state: Kanagawa-Ken
city: Sendai-shi
country: Japan
facility: Miyagi Children's Hospital
state: Miyagi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development
state: Tokyo
city: Saga
country: Japan
facility: Saga University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
state: Gyeongsangbuk-do
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Korea
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
state: Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
state: Zuid-Holland
city: Nordbyagen
country: Norway
facility: Akershus Universitetssykehus
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord-Norge
city: Trondheim
country: Norway
facility: St-Olavs Hospital
city: Warszawa
country: Poland
facility: Instytut Pomnik-Centrum Zdrowia Dziecka
state: Masovian
city: Krakow
country: Poland
facility: Uniwersytecki Szpital Dziecięcy w Krakowie
city: Rzeszow
country: Poland
facility: Korczowski Bartosz, Gabinet Lekarski
city: Warszawa
country: Poland
facility: Warsaw IBD Point Profesor Kierkus
city: Braga
country: Portugal
facility: Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar de São João, E.P.E.
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Whitechapel
country: United Kingdom
facility: Royal London Hospital
state: Greater London
city: London
country: United Kingdom
facility: Great Ormond Street Hospital For Children NHS Foundation Trust
state: London, City Of
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Children and Young People
state: Lothian Region
city: Headington
country: United Kingdom
facility: Oxford University Hospitals NHS trust John Radcliffe hospital
state: Oxford
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
state: South Yorkshire
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: