Research in Context

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Mirikizumab in paediatric ulcerative colitis: phase 2 findings, not yet approved for children.

In the phase 2 SHINE-1 trial, mirikizumab was associated with improvements in clinical, endoscopic, histologic, and symptomatic outcomes and an acceptable safety profile among paediatric participants with ulcerative colitis after inadequate response, loss of response, or intolerance to prior therapies; the authors say findings support further evaluation for moderately-to-severely active disease in this population.

  • Jess L Kaplan, MD; Athos Bousvaros, MD; Dan Turner, MD; Marla Dubinsky, MD; Amy Larkin, BS; Jordan Johns, PhD; et al.

  • November 18, 2025

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Evidence before this study

Ulcerative colitis in paediatric patients poses significant morbidity, and existing treatments, particularly TNF inhibitors, have issues such as high discontinuation rates and safety concerns. Mirikizumab, an IL-23p19 monoclonal antibody, has demonstrated efficacy and safety in adults with moderately-to-severely active ulcerative colitis and Crohn's disease. In the phase 3 LUCENT-1 and LUCENT-2 trials, mirikizumab induced and maintained clinical remission versus placebo, with durable benefits confirmed in the long-term extension study (LUCENT-3). Its safety profile was consistent with other IL-23p19 inhibitors, supporting FDA and EMA approvals for ulcerative colitis and Crohn's disease. In an effort to shorten the delay between approval for adult use and for use in paediatric patients, we started a phase 2 clinical trial in paediatric patients to confirm modelled doses that would match the effective exposure in adults with ulcerative colitis.

Added value of this study

Results from the phase 2 SHINE-1 study showed that treatment with mirikizumab resulted in improved clinical, endoscopic, histologic, and symptomatic outcomes in paediatric participants with ulcerative colitis with inadequate response, loss of response, or intolerance to previous biologic, immunomodulator, or corticosteroid therapies. Mirikizumab also showed an acceptable safety profile.

Implications of all the available evidence

The efficacy and safety profile observed in this trial was similar to that reported in adults with ulcerative colitis treated with mirikizumab. This study supports further evaluation of mirikizumab for the treatment of moderately-to-severely active ulcerative colitis in the paediatric population.

Source: The Lancet Gastroenterology & Hepatology

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