Try our mobile app

Mirikizumab Demonstrates Superiority over Placebo in Phase 3 Maintenance Study in Ulcerative Colitis, Supporting Regulatory Submissions in 2022

Published: 2021-12-14 22:00:00 ET
<<<  go to LLY company page

Significantly more patients treated with mirikizumab maintenance dosing achieved the primary endpoint of clinical remission at one year (52 weeks), and all key secondary endpoints were met

Mirikizumab is the first and only anti-IL23p19 to demonstrate maintenance of clinical remission in a Phase 3 study in UC

INDIANAPOLIS, Dec. 14, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that mirikizumab met the primary endpoint of clinical remission and all key secondary endpoints at one year in LUCENT-2, a Phase 3 maintenance study evaluating the efficacy and safety of mirikizumab for the treatment of patients with moderately-to-severely active ulcerative colitis (UC). Patients in this study were previously enrolled in a 12-week induction study, LUCENT-1. These results build on the positive outcomes from LUCENT-1.

In LUCENT-2, for patients who achieved clinical response with mirikizumab in the 12-week induction study and were re-randomized to mirikizumab maintenance dosing, a statistically higher proportion met the primary endpoint of clinical remission at one year compared to patients who were re-randomized to placebo (p