Indianapolis – October 19, 2026 -- Half of pediatric ulcerative colitis (UC) patients who responded to Eli Lilly's Omvoh (mirikizumab-mrkz) were in clinical remission at Week 52, meeting the primary endpoint of the Phase 3 SHINE-2 study. Lilly (NYSE: LLY) says Omvoh is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric UC, and it plans to submit the data to global regulators for a potential label expansion.
Lilly reports 81% induction response and 50% remission at one year
In the single-arm, open-label study, 81% of patients achieved clinical response at Week 12. Among the 52 responders, ages 6 to 17, 50% reached clinical remission at Week 52. The results were presented as a late-breaking oral presentation at United European Gastroenterology (UEG) Week 2026.
Secondary outcomes at Week 52 in responders were:
- 50% corticosteroid-free clinical remission without surgery
- 73.1% clinical response
- 71.2% symptomatic remission
- 53.8% endoscopic improvement
- 44.2% endoscopic remission
Study met its endpoint against a pre-specified adult placebo benchmark
The primary endpoint was judged against a benchmark derived from the adult placebo remission rate in the Phase 3 LUCENT-2 study. The lower bound of the 80% credible interval for pediatric remission (42.8%) exceeded the upper bound of the 90% credible interval for adult placebo remission (32.6%). The pediatric Week 52 remission rate was similar to the 50.7% seen in adult Week 12 responders in LUCENT-2. Lilly stresses this is a descriptive observation, not a direct cross-study comparison.
Trial enrolled 63 patients, 54% with prior biologic failure
SHINE-2 enrolled 63 participants, ages 4 to 17, who received weight-based intravenous induction every four weeks for three doses. Of these, 54% had previously failed biologic treatment, and half entered with severe disease on the Pediatric Ulcerative Colitis Activity Index. At Week 12, 52 responders moved to weight-based subcutaneous maintenance every four weeks through Week 52.
Marla C. Dubinsky of Mount Sinai Kravis Children's Hospital called the corticosteroid-free remission result "particularly meaningful" given how many patients had failed advanced therapies. She is a paid Lilly consultant.
Safety profile matches adult data with no new signals through Week 52
Four patients (6.3%) had a serious adverse event, and none was considered treatment-related. Two patients (3.2%) discontinued because of UC flare. No deaths, malignancies, opportunistic infections or growth-related safety concerns were reported. Safety results cover all 63 enrolled patients.
Pediatric UC affects more than 26,000 US children and adolescents
Up to half of children treated with corticosteroids become dependent on them, and up to one-third require surgery within a year. Omvoh is approved in 47 countries for adults with moderately to severely active UC and Crohn's disease. If approved for pediatric UC, it would be the first IL-23p19 inhibitor with that indication.
Lilly is also running a Phase 3 study in pediatric Crohn's disease (NCT05509777) and a long-term extension study in pediatric UC and Crohn's disease (NCT04844606). In adults, it is testing mirikizumab combinations with eltrekibart and zotemtegrast in UC, and with an FXR agonist in Crohn's disease. The COMMIT-UC and COMMIT-CD trials are evaluating mirikizumab alongside an incretin-based therapy in adults with UC or Crohn's disease who are obese or overweight.