Eli Lilly and Company has announced positive Phase 3 clinical trial results for Omvoh (mirikizumab-mrkz) in children and adolescents with moderately to severely active ulcerative colitis. The study found that half of the patients who initially responded to treatment achieved clinical remission after one year, meeting the trial’s primary endpoint.
The results come from the SHINE-2 study, which evaluated Omvoh in pediatric patients aged 6 to 17 years. Lilly announced the findings on October 19, 2026, and presented them at United European Gastroenterology (UEG) Week 2026.
Ulcerative colitis is a chronic inflammatory bowel disease that causes inflammation and ulcers in the lining of the large intestine. Symptoms can include abdominal pain, frequent bowel movements, rectal bleeding and an urgent need to use the bathroom. In children and adolescents, the disease can also affect growth, development and quality of life.
In the SHINE-2 trial, 81% of patients achieved a clinical response after 12 weeks of Omvoh induction treatment. Among those who responded and continued into the maintenance phase, 50% achieved clinical remission at Week 52.
The study also showed improvements across several other measures. At one year, 71.2% of patients who responded to induction treatment achieved symptomatic remission, while 50% achieved clinical remission without surgery and without corticosteroid use for at least 12 weeks before the assessment. Additionally, 53.8% achieved endoscopic improvement, and 44.2% achieved endoscopic remission.
The trial enrolled 63 patients, with 52 clinical responders entering the maintenance phase. The one-year efficacy results were assessed in this group, while safety results covered all enrolled patients.
Omvoh’s safety profile in children and adolescents was consistent with its established profile in adults, and no new safety concerns were identified through Week 52. Four patients experienced serious adverse events, none of which were considered related to the treatment. Two patients stopped treatment because of an ulcerative colitis flare, and no deaths or growth-related safety concerns were reported during the study period.
Omvoh is an interleukin-23 p19 (IL-23p19) inhibitor that works by blocking the IL-23 pathway, which plays a role in inflammation associated with inflammatory bowel disease. The medicine is currently approved in adults for moderately to severely active ulcerative colitis and Crohn’s disease.
However, Omvoh is not yet approved for pediatric patients, and its safety and effectiveness in this population have not been established. Lilly plans to submit the SHINE-2 findings to regulatory authorities worldwide to support a potential expansion of the drug’s approved use.
If approved for pediatric ulcerative colitis, Omvoh could become the first IL-23p19 inhibitor indicated for children and adolescents with the condition. The results offer encouraging evidence for a potential new treatment option for young patients, including those who have not responded adequately to previous advanced therapies.
Lilly continues to study mirikizumab in pediatric inflammatory bowel disease, including ongoing research in Crohn’s disease and long-term follow-up studies.