Mirikizumab
DrugAdministered SC
Other names: LY3074828
NCT Number: NCT04844606
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.
Interested in participating?
Request Info2 year–19 year
All sexes
Interventional
Phase 3
Medizinische Universität Wien, Vienna, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered SC
Other names: LY3074828
Time frame: Week 52
Clinical Remission based on the MMS
Time frame: Week 52
Clinical Remission based on the PCDAI
Time frame: Week 52
Clinical Response based on the MMS
Time frame: Week 52
Clinical Response based on the PCDAI
Time frame: Week 52
Clinical Response based on the PUCAI
Time frame: Week 52
Clinical Response based on the PUCAI
Time frame: Week 52
Endoscopic Remission based on the Endoscopic Subscore (ES)
Time frame: Week 52
Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD)
Time frame: Week 52
Endoscopic Response in Participants based on the ES
Time frame: Week 52
Endoscopic Response based on the SES-CD
Time frame: Week 52
Endoscopic Remission when ES = 0
Time frame: Week 52
Histologic remission based on histology scoring and endoscopic remission based on endoscopy score
Time frame: Week 52
Histologic remission based on histology scoring
Time frame: Week 52
Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery
Time frame: Week 52
Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery)
Time frame: Week 0 to Week 52
Time frame: Week 52
Time frame: Baseline, Week 0 to Week 52
Contact information is provided by the study sponsor or research team.
Physicians interested in becoming principal investigators please contact
CONTACT
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Eli Lilly and Company
Industry
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
Acronym: SHINE-ON
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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