Phase 3b LUCENT-URGE is the first study in inflammatory bowel disease to assess bowel urgency across three measures — severity, frequency and stool deferral time — reflecting the spectrum of its burden on patients
By Week 12, patients experienced a 55% reduction in daily episodes of bowel urgency from baseline, with severity reduced by more than half by Week 28
At Week 28, nearly one-third of patients were able to delay using the restroom for at least 15 minutes after feeling urgency, up from 4% at baseline
New data from Eli Lilly and Company (NYSE: LLY) showed Omvoh-treated patients with moderately to severely active ulcerative colitis (UC) and bowel urgency experienced early improvements in bowel urgency severity, frequency and stool deferral time by Week 12. These outcomes continued to improve through 28 weeks. The Phase 3b single-arm, open-label LUCENT-URGE study was specifically designed to assess bowel urgency and is the first in inflammatory bowel disease to include the novel endpoints of bowel urgency frequency and stool deferral time to more fully capture the patient experience. These results will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place Oct. 24-29 in Phoenix.1
“For many people with ulcerative colitis, the unpredictable and immediate need to find a restroom can be stressful and disrupt everyday activities, often forcing them to map restroom locations or to avoid important events,” said David Rubin, M.D., Professor of Medicine and Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine. “These data build on prior Phase 3 and long-term results demonstrating Omvoh can reduce bowel urgency and help people regain control over a symptom that has often dictated their daily life.”
In LUCENT-URGE, the following results were observed:1
- Bowel urgency severity: Bowel urgency severity was reduced by 52% at Week 28, with the average Urgency Numeric Rating Scale (UNRS) score dropping from 6.9 at baseline to 3.7 at Week 12 and 3.3 at Week 28.
- Bowel urgency frequency: Patients reported a 55% reduction from baseline in the number of times they experienced bowel urgency per day, from 6.9 times per day at baseline to 3.1 at Week 12, which was maintained at Week 28.
- Stool deferral time: The proportion of patients who were able to delay a bowel movement for at least 15 minutes or experienced no urgency in the previous 24 hours increased from 4.1% at baseline to 15.7% at Week 12 and 29.7% at Week 28, allowing them more time to reach a restroom.
Clinical, endoscopic and histologic improvements were consistent with previously disclosed LUCENT Phase 3 trial data. The safety profile in patients with moderately to severely active UC was consistent with the known safety profile of Omvoh with no new safety signals observed. In LUCENT-URGE, 5.2% of patients reported a serious adverse event, while 4.7% discontinued treatment due to an adverse event.1
“Lilly is continuing to drive novel science in the study and treatment of bowel urgency because comprehensive control of ulcerative colitis must reflect the daily realities patients face, including the constant calculations and compromises they often make to navigate bowel urgency and its challenges,” said Mark Genovese, M.D., senior vice president of Lilly Immunology development. “With Omvoh, we are delivering on our commitment to provide better patient outcomes.”
The results from LUCENT-URGE build on the learnings from Lilly’s CONFIDE study, which highlighted the often-overlooked burden of bowel urgency and other daily challenges faced by people living with UC. Lilly also recently disclosed four-year final data from LUCENT-3 in UC, including long-term outcomes in bowel urgency severity.
Lilly is advancing combination studies of mirikizumab aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies in UC with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with LY4268989 (MORF-057) (NCT07186101), an oral α4β7 integrin inhibitor. Lilly is also advancing novel science to uncover the potential of incretins in immunology and has initiated the COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) trials evaluating the efficacy and safety of treating adults with UC or Crohn’s disease and obesity with the concomitant use of mirikizumab with an incretin-based therapy. In addition, a trial of mirikizumab in pediatric patients is ongoing in UC (NCT05784246).
Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn’s disease in adults and has been approved in 45 countries around the world.
