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Evaluating Mirikizumab for Children with Ulcerative Colitis or Crohn's Disease

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

Phase 3 Interventional Eli Lilly and Company · NCT04844606

This study is testing if a medication called mirikizumab can help children with ulcerative colitis or Crohn's disease feel better over a long period of time.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment150 (estimated)
Ages2 Years to 19 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsmirikizumab
Locations66 sites (San Francisco, California and 65 other locations)
Trial IDNCT04844606 on ClinicalTrials.gov

What this trial studies

This study aims to assess the long-term effectiveness of mirikizumab in pediatric patients suffering from ulcerative colitis or Crohn's disease. Over approximately 172 weeks, participants will undergo up to 44 visits to monitor their response to the treatment. The study includes children who have previously participated in related studies and are deemed likely to benefit from continued treatment with mirikizumab. The goal is to gather comprehensive data on the drug's efficacy and safety in this specific population.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients who have previously participated in related studies and are expected to benefit from ongoing treatment with mirikizumab.

Not a fit: Patients who have experienced serious adverse events in prior studies or who have had their treatment with mirikizumab stopped may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of ulcerative colitis and Crohn's disease in children.

How similar studies have performed: Other studies have shown promising results with similar treatments for inflammatory bowel diseases, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

San Francisco, California and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative ColitisUlcerative Colitis ChronicInflammatory Bowel DiseasesCrohn's DiseasePediatric Ulcerative ColitisPediatric Crohn's DiseasePediatric UCPediatric CD
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.