Omvoh Achieves 50% Remission in Pediatric UC Trial

Eli Lilly and Company reported positive one-year results from the Phase 3 SHINE-2 study evaluating Omvoh (mirikizumab-mrkz), an interleukin-23 p19 (IL-23p19) inhibitor, in children and adolescents with moderately to severely active ulcerative colitis (UC). The study met its primary endpoint, with 50% of patients who responded to induction treatment achieving clinical remission at Week 52. The findings were presented as a late-breaking oral presentation at United European Gastroenterology (UEG) Week 2026.

Lilly plans to submit the data to global regulatory authorities to support a potential pediatric label expansion. Omvoh is currently approved for adults with moderately to severely active UC and Crohn’s disease, while its safety and effectiveness in pediatric patients remain under evaluation.

Phase 3 SHINE-2 Study Design and Efficacy Results

SHINE-2 (NCT05784246) was a multicenter, single-arm, open-label Phase 3 study that enrolled 63 participants aged 4–17 years. Patients received weight-based intravenous mirikizumab induction every four weeks for three doses: 300 mg for those weighing more than 40 kg and 5 mg/kg for those weighing 40 kg or less.

At Week 12, 52 patients who achieved a clinical response entered maintenance treatment. They received weight-based subcutaneous mirikizumab every four weeks through Week 52. The reported Week 52 efficacy analysis included these 52 responders aged 6–17 years, whereas safety analyses covered all 63 enrolled participants.

Overall, 81% of patients achieved a clinical response at Week 12. Among these responders, 50% achieved clinical remission at Week 52, meeting the study’s primary endpoint. The endpoint was assessed against a prespecified 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 was 42.8%, exceeding the upper bound of the 90% credible interval for the adult placebo benchmark of 32.6%.

Because SHINE-2 was a single-arm study, this benchmark-based assessment does not establish comparative efficacy against placebo in children.

At Week 52, additional outcomes among induction responders included a 50% rate of corticosteroid-free clinical remission without surgery, a 73.1% clinical response rate, 71.2% symptomatic remission, 53.8% endoscopic improvement and 44.2% endoscopic remission.

Clinical remission required a stool-frequency subscore of 0 or 1, a rectal-bleeding subscore of 0, and an endoscopic subscore of 0 or 1, excluding friability. Corticosteroid-free remission required no surgery and no corticosteroid use for at least 12 weeks before Week 52.

The pediatric Week 52 remission rate was numerically similar to the 50.7% remission rate reported at Week 12 among adult responders treated with Omvoh in LUCENT-2. Lilly described this as a descriptive observation, not a direct comparison between studies.

Safety Findings Through Week 52

The safety profile was consistent with Omvoh’s established adult safety profile, with no new safety signals identified. The most common treatment-emergent adverse events included upper respiratory tract infection, injection-site reactions, UC, headache, nasopharyngitis and anemia. Most events were mild to moderate.

Four patients (6.3%) experienced serious adverse events, none considered related to treatment. Two patients (3.2%) discontinued treatment because of a UC flare. No deaths, malignancies, opportunistic infections or growth-related safety concerns were reported through Week 52.

However, the relatively small study population and one-year follow-up limit conclusions about uncommon adverse events and longer-term pediatric safety.

 Pediatric Development and Regulatory Outlook

The SHINE-2 findings extend the assessment of mirikizumab beyond induction, providing one-year clinical, symptomatic and endoscopic outcomes in pediatric UC. The corticosteroid-free remission result is particularly relevant because it reflects disease control without surgery or recent corticosteroid use among induction responders.

The findings nevertheless require cautious interpretation. The efficacy results apply to patients who responded to induction and entered maintenance, rather than all enrolled participants. The single-arm design also limits comparisons with other advanced therapies.

Patients completing SHINE-2 may be eligible to continue in SHINE-ON, an ongoing long-term extension study evaluating mirikizumab in pediatric patients with UC or Crohn’s disease. The pediatric UC study is registered as NCT05784246, while Lilly is also evaluating mirikizumab in pediatric Crohn’s disease in a separate Phase 3 program.

Omvoh selectively targets the p19 subunit of IL-23, inhibiting a pathway involved in inflammatory bowel disease. If regulators approve pediatric use, it would become the first IL-23p19 inhibitor indicated for pediatric UC, according to Lilly. The SHINE-2 results support the company’s planned regulatory submissions, but pediatric approval has not yet been established.

Reference

Lilly’s Omvoh (mirikizumab-mrkz) meets primary endpoint of clinical remission and is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis, Lilly, 19 October 2026

A Study of Mirikizumab (LY3074828) in Pediatric Participants with Moderately to Severely or Active Ulcerative Colitis (SHINE-2), ClinicalTrials.gov ID NCT05784246