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Lilly's Mirikizumab Helped Patients with Crohn's Disease Achieve Long-Term Remission in Phase 3 Trial

Published: 2023-10-12 10:45:00 ET
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Mirikizumab demonstrated clinical remission and endoscopic response for patients with moderately to severely active Crohn's disease through 52 weeks

The study achieved the coprimary endpoints and all major secondary endpoints versus placebo

This successful Phase 3 trial will be the basis of global regulatory submissions for Crohn's disease

INDIANAPOLIS, Oct. 12, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that mirikizumab (an investigational interleukin-23p19 antagonist) met the co-primary and all major secondary endpoints compared to placebo in VIVID-1, a Phase 3 study evaluating the safety and efficacy of mirikizumab for the treatment of adults with moderately to severely active Crohn's disease. The double-blind, treat-through trial included mirikizumab, placebo and active control (ustekinumab) arms.

Crohn's disease is a form of inflammatory bowel disease (IBD) that can cause systemic inflammation manifested as abdominal pain, diarrhea, fever and weight loss. It can lead to intestinal obstruction, fibrosis and other complications.

In VIVID-1, all patients in the active treatment arms from the 12-week induction period continued with their original therapy into the maintenance portion of the study up to Week 52. Placebo patients who did not achieve clinical response at Week 12 (nonresponders) were switched to blinded mirikizumab treatment.

The study included co-primary endpoints, which were:

  • Proportion of participants achieving clinical response by patient reported outcomes (PRO)* at Week 12 and clinical remission (defined as a Crohn's Disease Activity Index [CDAI] Total Score