Eli Lilly and Company has reported positive one-year results from a Phase 3 trial of Omvoh (mirikizumab-mrkz) in children and adolescents aged 6 to 17 with moderately to severely active ulcerative colitis (UC), with half of patients who initially responded to treatment achieving clinical remission at Week 52.

 

The findings from the SHINE-2 study, presented as a late-breaking oral presentation at United European Gastroenterology (UEG) Week 2026, also showed sustained improvements across clinical, symptomatic and endoscopic outcomes.

 

In the single-arm, open-label study, 81% of patients achieved a clinical response after 12 weeks of Omvoh induction treatment. Among these responders, 50% achieved clinical remission at one year, meeting the study’s primary endpoint.

 

Omvoh is the first interleukin-23 p19 (IL-23p19) inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis.

 

The drug is currently approved for adults with moderately to severely active UC.

 

"For children and adolescents, the persistent bowel urgency, abdominal pain and unpredictability of ulcerative colitis can make a normal childhood feel out of reach, especially when symptoms return after previous treatments," said Mark Genovese, senior vice president of Lilly Immunology development. 

 

"Already approved for adults with ulcerative colitis, Omvoh is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis. We look forward to working with regulators to potentially make Omvoh available to children and adolescents living with this disease, who continue to face substantial disease burden and ongoing unmet needs."

 

The SHINE-2 trial enrolled a high-burden patient population with substantial unmet treatment needs. More than half of participants (54%) had previously experienced biologic treatment failure, while half entered the study with severe disease activity, as measured by the Pediatric Ulcerative Colitis Activity Index.

 

"For children with ulcerative colitis, every year spent relying on corticosteroids or facing the possibility of surgery can have important implications for growth, development and quality of life," said Marla C. Dubinsky, Professor of Pediatrics and Medicine at the Icahn School of Medicine at Mount Sinai, Chief of Pediatric Gastroenterology and Nutrition at Mount Sinai Kravis Children's Hospital. 

 

"Considering these challenges, the finding that half of the pediatric patients who responded to Omvoh achieved corticosteroid-free clinical remission without surgery at one year is particularly meaningful, especially in a population where many patients had previously experienced treatment failure with advanced therapies."

 

One-year results showed sustained improvements in patients aged 6 to 17 who responded to Omvoh induction treatment, with 50% achieving clinical remission, meeting the primary endpoint. And 50% achieving corticosteroid-free clinical remission without surgery.

 

The pediatric Week 52 clinical remission rate was similar to the 50.7% rate observed at Week 12 among adult responders treated with Omvoh in the LUCENT-2 study.

 

However, Lilly noted that this was a descriptive observation separate from the primary endpoint analysis and should not be interpreted as a direct comparison between the two studies.