Shine-2
Research type
Research Study
Full title
A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age with Moderately to Severely Active Ulcerative Colitis
IRAS ID
1008243
Contact name
Lilly Clinical Trials info desk Lilly Clinical Trials info desk
Sponsor organisation
Eli Lilly & Co
Clinicaltrials.gov Identifier
Research summary
The target group for this trial are children and adolescents (age range from 2years to 18years) with moderate to severe Colitis ulcerosa. This study is being conducted to confirm how the children and adolescent body interacts with the study medication and the safety and efficacy of Mirikizumab, an experimental not yet approved medication. The study drug has been tested before in other trials, and risk and burdens will be outlined in the consent form of this trial. The study is open label, so the study doctor and the patient will know that they receive the study drug.
The study will have 4 study periods
• Period I: screening for up to 28 days
• Period II: mirikizumab open-label induction for 12 weeks
• Period III: mirikizumab open-label maintenance for 40 weeks
• Period IV: safety follow-up for approximately 16 weeks after the last treatment visit
Patients that will benefit from the study will have the chance to receive the medication in an extension study, currently planned for another 3years after end of this study.REC name
HSC REC A
REC reference
23/NI/0143
Date of REC Opinion
1 Feb 2024
REC opinion
Further Information Favourable Opinion