No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 – 19
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for children with ulcerative colitis or Crohn's disease who have participated in earlier studies of mirikizumab. Participants will take mirikizumab and will have regular visits over about 172 weeks to check their health and response to the treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have taken part in previous studies of mirikizumab
I have completed my last visit in the previous study
I am a female and I agree to use contraception
You may not be able to join if
I have had a serious or ongoing health issue from the last study
I have had to stop treatment with mirikizumab in my previous study
I have an uncontrolled illness that could affect my safety
I would be unsafe or my results would be unclear if I joined this study
I have not removed adenomatous polyps
I am pregnant or breastfeeding
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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City
State
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Status
Eligibility 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
* Partici…
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.
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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