A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

Official title

A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease

Overview

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.

Interventions

• Drug Mirikizumab
  Administered SC
• Drug Mirikizumab
  Administered IV

Primary outcome measures

• Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission [Time frame: Week 52]
• Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission [Time frame: Week 52]

Secondary outcome measures (12)

• Percentage of Participants with UC in MMS Clinical Response [Time frame: Week 52]
• Percentage of Participants with CD in PCDAI Clinical Response [Time frame: Week 52]
• Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response [Time frame: Week 52]
• Percentage of Participants with UC in PUCAI Clinical Remission [Time frame: Week 52]
• Percentage of Participants with UC in Endoscopic Remission [Time frame: Week 52]
• Percentage of Participants with CD in Endoscopic Remission [Time frame: Week 52]
• Percentage of Participants with UC in Endoscopic Response [Time frame: Week 52]
• Percentage of Participants with CD in Endoscopic Response [Time frame: Week 52]
• Percentage of Participants with UC in having Endoscopic Subscore = 0 [Time frame: Week 52]
• Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission [Time frame: Week 52]
• Percentage of Participants with CD Achieving Histologic Remission [Time frame: Week 52]
• Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery [Time frame: Week 52]

Eligibility criteria

Inclusion criteria

• Participants from originating studies (I6T-MC-AMBA \[NCT05784246\], I6T-MC-AMBU \[NCT04004611\], I6T-MC-AMAM \[NCT03926130\]) , I6T-MC-AMAY \[NCT05509777\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
• Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
• Female participants must agree to contraception requirements.

Exclusion criteria

• Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.
• Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.
• Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
• Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.
• Participants must not have adenomatous polyps that have not been removed.
• Participants must not be pregnant or breastfeeding.

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 · 11 centers

• UCSF Medical Center at Mission Bay — San Francisco
• Connecticut Children's Medical Center — Hartford
• Emory University School of Medicine — Atlanta
• Children's Center for Digestive Health Care, LLC — Atlanta
• Boston Children's Hospital — Boston
• Massachusetts General Hospital — Waltham
• Washington University School of Medicine — St Louis
• Icahn School of Medicine at Mount Sinai — New York
• … and 3 more centers

Brazil · 7 centers

• Centro de Pesquisa Sao Lucas — Campinas
• Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância — Curitiba
• Universidade Federal de Goias — Goiânia
• Hospital de Clinicas de Porto Alegre — Porto Alegre
• Irmandade da Santa Casa de Misericórdia de Porto Alegre — Porto Alegre
• Hospital Universitario Cassiano Antonio de Moraes — Vitória
• Integral Pesquisa e Ensino — Votuporanga

Israel · 6 centers

• Soroka Medical Center — Beersheba
• Rambam Health Care Campus — Haifa
• Shaare Zedek Medical Center — Jerusalem
• Hadassah Medical Center — Jerusalem
• Schneider Children's Medical Center — Petah Tikva
• Yitzhak Shamir Medical Center — Ẕerifin

Italy · 6 centers

• Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII — Bergamo
• Ospedale Maggiore Azienda USL di Bologna — Bologna
• Azienda Ospedaliera Universitaria Meyer IRCCS — Florence
• Ospedale dei Bambini Vittore Buzzi — Milan
• AOU Policlinico Umberto I — Roma
• Ospedale Pediatrico Bambino Gesù IRCCS — Rome

Japan · 6 centers

• Institute of Science Tokyo Hospital — Bunkyō
• Juntendo University Hospital — Bunkyō City
• Tsujinaka Hospital - Kashiwanoha — Kashiwa
• Kobe University Hospital — Kobe
• National Center for Child Health and Development — Tokyo
• Yokohama City University Medical Center — Yokohama

Belgium · 5 centers

• UZ Brussel — Brussels
• Cliniques universitaires Saint-Luc — Brussels
• Antwerp University Hospital — Edegem
• UZ Gent — Ghent
• UZ Leuven — Leuven

Poland · 5 centers

• Korczowski Bartosz, Gabinet Lekarski — Rzeszów
• Twoja Przychodnia SCM — Szczecin
• Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś — Warsaw
• Centrum Zdrowia Dziecka w Warszawie — Warsaw
• Centrum Medyczne Oporów — Wroclaw

Norway · 4 centers

• Akershus Universitetssykehus — Lørenskog
• Oslo Universitetssykehus Ullevål — Oslo
• Universitetssykehuset Nord-Norge HF — Tromsø
• St. Olavs Hospital — Trondheim

Spain · 4 centers

• Hospital Universitario Reina Sofia — Córdoba
• Hospital Sant Joan de Déu — Esplugues de Llobregat
• Hospital Universitari Parc Tauli — Sabadell
• Hospital Universitari i Politecnic La Fe — Valencia

South Korea · 3 centers

• Kyungpook National University Chilgok Hospital — Deagu
• Seoul National University Hospital — Seoul
• Samsung Medical Center — Seoul

United Kingdom · 3 centers

• Royal London Hospital — London
• The John Radcliffe Hospital — Oxford
• Sheffield Children's Hospital — Sheffield

Canada · 2 centers

• London Health Sciences Centre — London
• The Hospital for Sick Children — Toronto

Germany · 2 centers

• Universitätsmedizin Johannes Gutenberg Universität Mainz — Mainz
• Dr. von Haunersches Kinderspital — Munich

Portugal · 2 centers

• 2Ca Braga — Braga
• Centro Hospitalar de Sao Joao - Hospital de Sao Joao — Porto

Austria · 1 center

• Medizinische Universität Wien — Vienna

Netherlands · 1 center

• Erasmus Medisch Centrum — Rotterdam

Identifiers

NCT: NCT04844606 · 16633 · I6T-MC-AMAZ · 2020-005311-49 · ISA-1 UC · ISA-2 CD · ISA-3 UC · ISA-4 CD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗