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

Overview

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.

Interventions

• Drug Mirikizumab
  Administered IV or SC

Primary outcome measures

• 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]
• 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]

Secondary outcome measures (12)

• Percentage of Participants Achieving Clinical Response by PCDAI [Time frame: Week 12]
• Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI) [Time frame: Week 12]
• Percentage of Participants Achieving Clinical Remission by PCDAI [Time frame: Week 12]
• Percentage of Participants Achieving Clinical Remission by CDAI [Time frame: Week 12]
• Percentage of Participants Who Achieve PCDAI Clinical Response at Week 12 and PCDAI Clinical Remission and Endoscopic Remission at Week 52 [Time frame: Baseline to Week 52]
• Percentage of Participants Who Achieve PCDAI Clinical Remission and Endoscopic Remission at Week 52 [Time frame: Week 52]
• Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52 [Time frame: Baseline to Week 52]
• Change from Baseline in C-reactive Protein (CRP) [Time frame: Baseline, Week 12]
• Change from Baseline in CRP [Time frame: Baseline, Week 52]
• Change from Baseline in Fecal calprotectin [Time frame: Baseline, Week 12]
• Change from Baseline in Fecal calprotectin [Time frame: Baseline, Week 52]
• Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52 [Time frame: Baseline to Week 52]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 15 centers

• Cedars Sinai Medical Center — Los Angeles
• Connecticut Children's Medical Center — Hartford
• Emory University — Atlanta
• Children's Center for Digestive Health Care, LLC — Atlanta
• Riley Childrens Hospital — Indianapolis
• Boston Children's Hospital — Boston
• Atlantic Children's Health--Pediatric Gastroenterology — Morristown
• Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) — New York
• … and 7 more centers

Japan · 12 centers

• Juntendo University Hospital — Bunkyō City
• Hirosaki University Hospital — Hirosaki
• Kagoshima University Hospital — Kagoshima
• Kokikai Tsujinaka Hospital Kashiwanoha — Kashiwa-shi
• Kobe University Hospital — Kobe
• Saga University Hospital — Saga
• Miyagi Children's Hospital — Sendai
• National Center for Child Health and Development — Setagaya-ku
• … and 4 more centers

Brazil · 7 centers

• Hospital PUC-CAMPINAS — Campinas
• Hospital Pequeno Príncipe — Curitiba-PR
• Hospital das Clínicas - UFG (Universidade Federal de Goiás) — Goiânia
• Hospital de Clínicas de Porto Alegre — Porto Alegre
• Irmandade da Santa Casa de Misericórdia de Porto Alegre — Porto Alegre
• NDI - Nucleo de Doenças Infecciosas — Santos Dumont
• Integral Pesquisa e Ensino — Votuporanga

Israel · 6 centers

• Soroka Medical Center — Beersheba
• Shamir Medical Center (Assaf Harofeh) — Israel
• Shaare Zedek — Jerusalem
• Hadassah University Hospital, Ein Kerem, — Jerusalem
• Schneider Children's Medical Center — Petah Tikva
• Kaplan Medical Center, Pediatric Gastroenterology Dept. — Rehovot

Italy · 6 centers

• Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. Arrigo — Alessandria
• Asst Papa Giovanni Xxiii Bergamo — Bergamo
• Azienda USL di Bologna — Bologna
• SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH cen — Florence
• Ospedale dei Bambini Vittore Buzzi — Milan
• Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica) — Roma

United Kingdom · 6 centers

• Royal Hospital for Children and Young People — Edinburgh
• Oxford University Hospitals NHS trust John Radcliffe hospital — Headington
• Great Ormond Street Hospital For Children NHS Foundation Trust — London
• Manchester University NHS Foundation Trust — Manchester
• Sheffield Children's Hospital — Sheffield
• … and 1 more center

South Korea · 5 centers

• Inje University Haeundae Paik Hospital — Busan
• Kyungpook National University Chilgok Hospital — Daegu
• Severance Hospital, Yonsei University Health System — Seoul
• Samsung Medical Center — Seoul
• Seoul National University Hospital — Seoul

Belgium · 4 centers

• Universitair Ziekenhuis Brussel — Brussels
• Cliniques universitaires Saint-Luc — Brussels
• Universitair Ziekenhuis Gent — Ghent
• UZ Leuven — Leuven

Canada · 4 centers

• IWK Health Centre — Halifax
• London Health Sciences Centre (LHSC) - Victoria Hospital — London
• The Hospital for Sick Children — Toronto
• Children's & Women's Health Centre of British Columbia — Vancouver

Norway · 4 centers

• Akershus Universitetssykehus — Nordbyagen
• Oslo University Hospital — Oslo
• Universitetssykehuset Nord-Norge — Tromsø
• St-Olavs Hospital — Trondheim

Poland · 3 centers

• Korczowski Bartosz, Gabinet Lekarski — Rzeszów
• Warsaw IBD Point Profesor Kierkus — Warsaw
• Instytut Pomnik-Centrum Zdrowia Dziecka — Warsaw

Portugal · 3 centers

• Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga) — Braga
• Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria — Lisbon
• Centro Hospitalar de São João, E.P.E. — Porto

Spain · 3 centers

• Hospital Universitario Reina Sofia — Córdoba
• Corporacio Sanitaria Parc Tauli — Sabadell
• Hospital Universitari i Politecnic La Fe — Valencia

Austria · 1 center

• AKH - Medizinische Universtität Wien — Vienna

France · 1 center

• URC CIC — Paris

Netherlands · 1 center

• Erasmus Medisch Centrum — Rotterdam

Identifiers

NCT: NCT05509777 · 16632 · I6T-MC-AMAY · MACARONI-23 · PLATFORMPBCRD3001 · I6T-MC-PIBD · 2024-511472-32-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗