A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Recruiting · NCT04844606 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
2 Years to 19 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 9 US states.
- UCSF Medical Center at Mission Bay - San Francisco, California, United States
- UCSF Medical Center at Mission Bay - San Francisco, California, United States
- Connecticut Children's Medical Center - Hartford, Connecticut, United States
- Connecticut Children's Medical Center - Hartford, Connecticut, United States
- Emory University School of Medicine - Atlanta, Georgia, United States
- Children's Center for Digestive Health Care, LLC - Atlanta, Georgia, United States
- Emory University School of Medicine - Atlanta, Georgia, United States
- Children's Center for Digestive Health Care, LLC - Atlanta, Georgia, United States
- Boston Children's Hospital - Boston, Massachusetts, United States
- Boston Children's Hospital - Boston, Massachusetts, United States
- Massachusetts General Hospital - Waltham, Massachusetts, United States
- Massachusetts General Hospital - Waltham, Massachusetts, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Children's Hospital of Philadelphia (CHOP) - Philadelphia, Pennsylvania, United States
- Children's Hospital of Philadelphia (CHOP) - Philadelphia, Pennsylvania, United States
- Cook Children's Medical Center - Fort Worth, Texas, United States
- Cook Children's Medical Center - Fort Worth, Texas, United States
- Pediatric Specialists of Virginia - Fairfax, Virginia, United States
- Pediatric Specialists of Virginia - Fairfax, Virginia, United States
- Soroka Medical Center - Beersheba, Israel
- Soroka Medical Center - Beersheba, Israel
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Bergamo, Italy
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Bergamo, Italy
- Ospedale Maggiore Azienda USL di Bologna - Bologna, Italy
- Ospedale Maggiore Azienda USL di Bologna - Bologna, Italy
- 2Ca Braga - Braga, Portugal
- 2Ca Braga - Braga, Portugal
- UZ Brussel - Brussels, Belgium
- Cliniques universitaires Saint-Luc - Brussels, Belgium
- UZ Brussel - Brussels, Belgium
- Cliniques universitaires Saint-Luc - Brussels, Belgium
- Institute of Science Tokyo Hospital - Bunkyō, Japan
- Institute of Science Tokyo Hospital - Bunkyō, Japan
- Juntendo University Hospital - Bunkyō City, Japan
- Juntendo University Hospital - Bunkyō City, Japan
- Centro de Pesquisa Sao Lucas - Campinas, Brazil
- Centro de Pesquisa Sao Lucas - Campinas, Brazil
- Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância - Curitiba, Brazil
- Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância - Curitiba, Brazil
- Hospital Universitario Reina Sofia - Córdoba, Spain
- Hospital Universitario Reina Sofia - Córdoba, Spain
- Kyungpook National University Chilgok Hospital - Deagu, South Korea
- Kyungpook National University Chilgok Hospital - Deagu, South Korea
- Antwerp University Hospital - Edegem, Belgium
- Antwerp University Hospital - Edegem, Belgium
- Hospital Sant Joan de Déu - Esplugues de Llobregat, Spain
- Hospital Sant Joan de Déu - Esplugues de Llobregat, Spain
- Azienda Ospedaliera Universitaria Meyer IRCCS - Florence, Italy
- Azienda Ospedaliera Universitaria Meyer IRCCS - Florence, Italy
- UZ Gent - Ghent, Belgium
- UZ Gent - Ghent, Belgium
- Universidade Federal de Goias - Goiânia, Brazil
- Universidade Federal de Goias - Goiânia, Brazil
- Rambam Health Care Campus - Haifa, Israel
- Rambam Health Care Campus - Haifa, Israel
- Shaare Zedek Medical Center - Jerusalem, Israel
- Hadassah Medical Center - Jerusalem, Israel
Showing 60 of 136 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →