Mirikizumab posts one-year phase 3 results in paediatric ulcerative colitis
Lilly says half of the children who responded to induction with Omvoh were in clinical remission at one year. The SHINE-2 study had no control arm, so its result rests on a comparison with adult data.
In brief
Lilly's single-arm SHINE-2 study found 50% clinical remission at week 52 with mirikizumab in children and adolescents with ulcerative colitis.
- SHINE-2 enrolled 63 patients aged four to 17, and 54% had previously failed a biologic.
- Half of the 52 patients who responded at week 12 were in clinical remission at week 52.
- Omvoh is not approved for children, and Lilly plans to submit the data to regulators worldwide.
Eli Lilly has reported that mirikizumab, sold for adults as Omvoh, met the primary endpoint of a one-year phase 3 study in children and adolescents with ulcerative colitis. The results from SHINE-2 were announced on 19 October 2026 and presented as a late-breaking oral at UEG Week in Barcelona.
Lilly describes Omvoh as the first IL-23p19 inhibitor to report one-year phase 3 results in paediatric ulcerative colitis. The drug is approved for adults in 47 countries. Its safety and effectiveness have not been established in children, and Lilly says it plans to submit the data to regulators around the world.
The study
SHINE-2 was a single-arm, open-label, multicentre study of 63 patients aged four to 17. Half had severe disease on the Pediatric Ulcerative Colitis Activity Index, and 54% had previously failed a biologic. Patients received three intravenous induction doses, four weeks apart, of 300 mg if they weighed more than 40 kg or 5 mg/kg if they weighed 40 kg or less. Lilly reported a clinical response in 81% at week 12, and the 52 responders, aged six to 17, moved to subcutaneous maintenance every four weeks through to week 52.
One-year results
Among those 52 responders, 50% were in clinical remission at week 52, and the same proportion were in corticosteroid-free remission without surgery. Clinical response was seen in 73.1%, symptomatic remission reached 71.2%, endoscopic improvement 53.8% and endoscopic remission 44.2%.
Across all 63 patients, four (6.3%) had serious adverse events, none judged related to treatment, and two (3.2%) stopped because of a colitis flare. Lilly reported no deaths, malignancies, opportunistic infections or growth-related safety concerns.
With no placebo arm, the headline result depends on how far adult data can stand in for a control group.
Reading the numbers
The primary analysis used a borrowed benchmark. The lower bound of the paediatric 80% credible interval, 42.8%, exceeded the upper bound of the 90% credible interval for adults on placebo in LUCENT-2, 32.6%. Lilly also set the result beside the 50.7% remission rate among adult week 12 responders treated with Omvoh in that trial, while cautioning that this is not a direct comparison.
Designs of this kind reflect the difficulty of randomising children with active disease to placebo, and they lean on the extrapolation from adults that regulators increasingly accept. They also leave limits. The data have not yet been published in a peer-reviewed journal, and Contemporary Pediatrics noted that the sample is too small to detect uncommon adverse events. Only patients who responded early entered the one-year analysis, so the 50% figure should not be read as a rate for all children who start treatment.
What comes next
Patients completing the study may enter the SHINE-ON long-term extension, which should provide the longer follow-up that matters for a therapy likely to be used for years. Lilly is also running a phase 3 programme in paediatric Crohn's disease. How regulators weigh a single-arm package of this size will be the next test.
