LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEli Lilly and Company

About this trial

The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).

Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.

Eligibility criteria

Qualifiers

Have had an established diagnosis of UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC

Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1.

Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization

Are up-to-date on colorectal cancer surveillance per local society guidelines

Disqualifiers

Have a current diagnosis of

Crohn's disease

Inflammatory Bowel Disease (IBD) unclassified (formerly known as indeterminate colitis), or

primary sclerosing cholangitis

Trial design

Treatments tested in this trial

  • LY4268989
  • Mirikizumab
  • LY4268989 Placebo

Treatment groups

252 Participants
are divided into 2 treatment groups

Sponsors and collaborators