Omvoh meets primary endpoint in Phase 3 SHINE-2 study, the first IL-23p19 inhibitor to report one-year results in paediatric ulcerative colitis

Eli Lilly has reported positive late-breaking one year results from the Phase 3 SHINE-2 study of Omvoh (mirikizumab-mrkz) in children and adolescents aged 6 to 17 with moderately to severely active ulcerative colitis (UC). The single arm, open label study looked at clinical, symptomatic and endoscopic outcomes. At Week 12, 81 per cent of patients responded clinically to Omvoh induction. Among those responders, 50 per cent were in clinical remission at Week 52, meeting the primary endpoint. The results were presented in a late-breaking oral session at United European Gastroenterology Week 2026. Omvoh is the first IL-23p19 inhibitor to report one year Phase 3 results in paediatric UC.

In key secondary outcomes, 71.2 per cent of patients who responded to induction achieved symptomatic remission at one year, and 50 per cent achieved corticosteroid free clinical remission without surgery.

Omvoh is currently approved only for adults with moderately to severely active UC, and its safety and effectiveness in children are still being evaluated in clinical studies. Lilly plans to submit the SHINE-2 data to regulators around the world to support a possible label expansion. If approved, Omvoh would become the first IL-23p19 inhibitor indicated for paediatric UC.

Mark Genovese, M.D., senior vice president of Lilly Immunology development, said persistent bowel urgency, abdominal pain and unpredictability can put a normal childhood out of reach for young people with UC, particularly when symptoms return after earlier treatments. He noted that Omvoh is already approved in adults, and said Lilly looks forward to working with regulators to potentially offer it to children and adolescents who continue to face a heavy disease burden and unmet needs.

UC affects more than 26,000 children and adolescents in the US. Though relatively uncommon, onset in childhood is often more extensive and severe than disease that starts in adulthood. Up to half of children treated with corticosteroids become dependent on them, and up to one third need surgery within a year.

SHINE-2 enrolled a population with a high disease burden. Some 54 per cent of patients had previously failed treatment with a biologic, and half began the study with severe disease activity on the Pediatric Ulcerative Colitis Activity Index.

Marla C. Dubinsky, M.D., professor of paediatrics and medicine at the Icahn School of Medicine at Mount Sinai and chief of paediatric gastroenterology and nutrition at Mount Sinai Kravis Children’s Hospital, said every year spent relying on corticosteroids or facing the prospect of surgery can affect a child’s growth, development and quality of life. She said it is particularly meaningful that half of the responders reached corticosteroid free clinical remission without surgery at one year, given how many had already seen advanced therapies fail.

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