Cure8 trial brief
This trial is testing whether continued mirikizumab treatment helps children and teens with ulcerative colitis or Crohn’s disease achieve and maintain remission over the long term. Results could expand pediatric treatment options if the drug is shown to be effective and safe.
Pediatric patients with UC or Crohn’s disease (and their caregivers) who participated in prior mirikizumab studies, pediatric gastroenterologists, clinical researchers in IBD, and families exploring trial participation.
This is a Phase 3 interventional trial (AMAZ) testing long-term mirikizumab in children and adolescents with ulcerative colitis or Crohn’s disease. The study plans ~172 weeks of follow-up, up to 150 participants, subcutaneous and IV mirikizumab dosing (weight-based), and primary endpoints of clinical remission at Week 52 using MMS for UC and PCDAI for CD.
Eligibility focuses on pediatric participants (2–19 years) rolling over from specified originating mirikizumab studies; usual exclusions include pregnancy, unresolved serious adverse events from the originating study, and unstable illness. The record is a trial registry entry (Phase 3, recruiting) rather than a report of results.
It describes the design, interventions (SC and IV mirikizumab dosing), planned outcomes (Week 52 remission measures), sites, and key inclusion/exclusion criteria. It does not provide efficacy or safety results.
If you are a caregiver or clinician considering this trial, the registry shows it is intended for pediatric patients already participating in prior mirikizumab studies who may benefit from continued treatment; check the full ClinicalTrials.gov entry and contact study sites for up-to-date eligibility and safety information.
This is a trial registry record (Phase 3, recruiting) and does not report study results. The study enrolls pediatric participants who come from specific prior mirikizumab studies; it does not represent an open enrollment trial for all pediatric IBD patients. Details such as safety outcomes and efficacy will only be known after the study reports results.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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