Eli Lilly said Omvoh met the primary endpoint in a Phase 3 study of children and adolescents with moderately to severely active ulcerative colitis, with half of initial treatment responders achieving clinical remission after one year.
The company plans to submit the SHINE-2 findings to regulators worldwide to seek an expansion of Omvoh’s approved use. The drug, also known as mirikizumab, is currently approved for adults with ulcerative colitis and Crohn’s disease.
SHINE-2 was a single-arm, open-label study involving patients aged 6 to 17. It had no placebo or active-treatment comparison group.
Overall, 81% of participants achieved a clinical response after 12 weeks of initial treatment. The reported one-year efficacy results apply to those responders, rather than all enrolled patients.
At Week 52, 50% of responders achieved clinical remission without corticosteroids or surgery. Symptomatic remission occurred in 71.2%, while 53.8% showed endoscopic improvement and 44.2% achieved endoscopic remission. Clinical response persisted in 73.1%.
The study included patients with substantial disease burden: 54% had previously experienced biologic treatment failure, and half entered with severe disease activity.
Lilly reported no new safety signals through one year. Common adverse events included upper respiratory infections, injection-site reactions, ulcerative colitis, headache, nasopharyngitis and anemia.
Four patients, or 6.3%, experienced serious adverse events, none considered treatment-related. Two discontinued treatment because of ulcerative colitis flares. No deaths, malignancies, opportunistic infections or growth-related safety concerns were reported.
The results were presented at United European Gastroenterology Week 2026. Omvoh’s safety and effectiveness in pediatric patients remain under evaluation in clinical studies.
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