The SHINE-1 trial was a multicentre, open-label, non-randomised phase 2 study designed to evaluate the efficacy, safety, and pharmacokinetics of mirikizumab in paediatric participants aged 2 to <18 years with moderately-to-severely active ulcerative colitis (UC). Mirikizumab is a humanised immunoglobulin G4 monoclonal antibody that targets the p19 subunit of IL-23, a cytokine implicated in inflammatory pathways.
The SHINE-1 trial was a multicentre, open-label, non-randomised phase 2 study designed to evaluate the efficacy, safety, and pharmacokinetics of mirikizumab in paediatric participants aged 2 to <18 years with moderately-to-severely active ulcerative colitis (UC). Mirikizumab is a humanised immunoglobulin G4 monoclonal antibody that targets the p19 subunit of IL-23, a cytokine implicated in inflammatory pathways. The study enrolled 26 participants from Canada, Israel, Japan, South Korea, and the USA who had inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, biologics, or JAK inhibitors.
Participants received intravenous mirikizumab induction doses at weeks 0, 4, and 8, followed by subcutaneous maintenance doses for responders. At week 12, 69.2% of participants achieved clinical response by modified Mayo score (mMS), with 38.5% achieving clinical remission. By week 52, 53.8% maintained mMS-based clinical response, while 38.5% achieved clinical remission without corticosteroid use or UC-related surgery. Endoscopic remission, histologic-endoscopic mucosal improvement, and symptomatic remission were also observed.
Mirikizumab demonstrated a favourable safety profile, with most adverse events being mild or moderate. Serious adverse events occurred in 12% of participants, with one leading to study discontinuation. These findings support further investigation of mirikizumab for paediatric UC treatment.
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