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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• UCSF Medical Center at Mission Bay
  San Francisco, California, United States Recruiting
• Connecticut Children's Medical Center
  Hartford, Connecticut, United States Recruiting
• Emory University School of Medicine
  Atlanta, Georgia, United States Recruiting
• Children's Center for Digestive Health Care, LLC
  Atlanta, Georgia, United States Recruiting
• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• Massachusetts General Hospital
  Waltham, Massachusetts, United States Recruiting

+19 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ath-063: Testing a new treatment for moderately to severely active ulcerative colitis in patients who have tried other biologics

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• Lyophilized fecal microbiota transplant for adults with active ulcerative colitis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.