A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

Crohn's Disease Clinical Trial

— AMAY  

Official title:

A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509777
• Other study ID #: 16632
• Secondary ID: I6T-MC-AMAY2022-
• Status: Recruiting
• Phase: Phase 3
• Start date: March 13, 2024
• Est. completion date: October 10, 2027

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 10, 2027
• Est. primary completion date: July 18, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Mirikizumab
Administered IV or SC

Locations

Country	Name	City	State
Australia	Perth Children's Hospital	Nedlands	Western Australia
Australia	Women'S and Children'S Hospital, Adelaide	North Adelaide	South Australia
Australia	Mater Hospital Brisbane	South Brisbane	Queensland
Australia	The Children's Hospital at Westmead	Westmead	New South Wales
Austria	AKH - Medizinische Universtität Wien	Vienna
Belgium	Universitair Ziekenhuis Brussel	Brussel
Belgium	Cliniques universitaires Saint-Luc	Brussels
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	UZ Leuven	Leuven	Brabant
Brazil	HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas	Campinas	Sao Paulo
Brazil	Associação Hospitalar de Proteção à Infância Dr. Raul Carneiro	Curitiba	Paraná
Brazil	HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás	Goiânia	Goiás
Brazil	Hospital da Criança Santo Antônio - Irmandade da Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da FMRP	Sao Paulo	Paraná
Brazil	Núcleo de Doenças Infecciosas/CBM/UFES	Vitória	Espírito Santo
Brazil	Integral Pesquisa e Ensino	Votuporanga	São Paulo
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	London Health Sciences Centre (LHSC) - Victoria Hospital	London	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	Children's & Women's Health Centre of British Columbia	Vancouver	British Columbia
France	CHU Amiens - Hopital NORD	Amines	Cedex1
France	Hopital Jeanne de Flandre - CHRU Lille	Lille Cedex	Nord
France	Hôpital Robert Debré - Paris	Paris
France	URC CIC	Paris
Israel	Soroka Medical Center	Beer-Sheva	HaDarom
Israel	Rambam Health Care Campus	Haifa
Israel	Shamir Medical Center (Assaf Harofeh)	Israel
Israel	Hadassah University Hospital, Ein Kerem	Jerusalem
Israel	Shaare Zedek	Jerusalem
Israel	Schneider Children's Medical Center	Petah-Tikva
Italy	Asst Papa Giovanni Xxiii Bergamo	Bergamo
Italy	Azienda USL di Bologna	Bologna
Italy	SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)	Firenze
Italy	Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)	Roma
Italy	Ospedale Pediatrico Bambino Gesù	Roma
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	Hirosaki University Hospital	Hirosaki	Aomori Pref.
Japan	Kokikai Tsujinaka Hospital Kashiwanoha	Kashiwa-shi	Chiba-Ken
Japan	Saga University Hospital	Saga
Japan	Miyagi Children's Hospital	Sendai-shi	Miyagi
Japan	National Center For Child Health And Development	Setagaya-ku	Tokyo
Japan	Yokohama City University Medical Center, Center of IBD	Yokohama-shi	Kanagawa-Ken
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan	Kwangyokshi
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu	Kwangyokshi
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Korea
Netherlands	Erasmus Medisch Centrum	Rotterdam
Norway	Akershus Universitetssykehus	Nordbyagen
Norway	Oslo University Hospital	Oslo
Norway	Universitetssykehuset Nord-Norge	Tromsø
Norway	St-Olavs Hospital	Trondheim
Poland	Uniwersytecki Szpital Dzieciecy w Krakowie	Krakow
Poland	Korczowski Bartosz, Gabinet Lekarski	Rzeszow
Poland	Instytut Pomnik-Centrum Zdrowia Dziecka	Warszawa	Masovian
Poland	Warsaw IBD Point Profesor Kierkus	Warszawa
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria	Lisboa
Portugal	Centro Hospitalar de São João, E.P.E.	Porto
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital Sant Joan de Deu	Esplugues de Llobregat
Spain	Corporacio Sanitaria Parc Tauli	Sabadell	Barcelona
Spain	Hospital Universitari i Politecnic La Fe	València
United Kingdom	Royal Hospital for Children and Young People	Edinburgh	Lothian Region
United Kingdom	Great Ormond Street Hospital for Children	London
United Kingdom	Royal Manchester Children's Hospital	Manchester	Greater Manchester
United Kingdom	John Radcliffe Hospital	Oxford	Gb-oxf
United Kingdom	Sheffield Children's Hospital	Sheffield	South Yorkshire
United Kingdom	Royal London Hospital	Whitechapel	Greater London
United States	Children's Center for Digestive Health Care, LLC	Atlanta	Georgia
United States	The Emory Clinic Emory University	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Texas Children's Hospital -Research Resource Office	Houston	Texas
United States	Riley Childrens Hospital	Indianapolis	Indiana
United States	University of California San Diego	La Jolla	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Nicklaus Children's Hospital	Miami	Florida
United States	Atlantic Health System	Morristown	New Jersey
United States	Columbia University Medical Center/New York Presbyterian	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of California-San Francisco-Mission Bay	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  France,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical response based on PCDAI, and endoscopic response based on SES-CD.	Baseline to Week 52
Primary	Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52	Clinical response based on PCDAI, and clinical remission based on PCDAI.	Baseline to Week 52
Secondary	Percentage of Participants Achieving Clinical Response by PCDAI	Clinical response based on PCDAI.	Week 12
Secondary	Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)	Clinical response based on CDAI for participants =12 years of age	Week 12
Secondary	Percentage of Participants Achieving Clinical Remission by PCDAI	Clinical remission based on PCDAI.	Week 12
Secondary	Percentage of Participants Achieving Clinical Remission by CDAI	Clinical remission based on CDAI for participants =12 years of age.	Week 12
Secondary	Percentage of Participants Achieving Endoscopic Response by SES-CD	Endoscopic response based on SES-CD.	Week 12
Secondary	Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52		Baseline to Week 52
Secondary	Change from Baseline in C-reactive Protein (CRP)		Baseline, Week 12
Secondary	Change from Baseline in CRP		Baseline, Week 52
Secondary	Change from Baseline in Fecal calprotectin		Baseline, Week 12
Secondary	Change from Baseline in Fecal calprotectin		Baseline, Week 52
Secondary	Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52	Clinical response by PCDAI, CDAI for participants =12 years of age	Baseline to Week 52
Secondary	Percentage of Participants Achieving Endoscopic Response	Endoscopic response by SES-CD	Week 52
Secondary	Percentage of Participants Achieving Clinical Remission by PCDAI	Clinical remission based on PCDAI	Week 52
Secondary	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	Clinical response and clinical remission by PCDAI	Baseline to Week 52
Secondary	Pharmacokinetics (PK): Clearance of Mirikizumab		Baseline through Week 52
Secondary	Pharmacokinetics (PK): Volume of Distribution of Mirikizumab		Baseline through Week 52

External Links

•   A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease (AMAY)