A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company
About this trial
The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).
Eligibility criteria
Qualifiers
Have had an established diagnosis of UC of ≥3 months in duration before baseline.
Have moderately to severely active UC as assessed by the UC disease activity score.
Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators).
Are on a stable dose of certain oral UC medications (including corticosteroids).
Disqualifiers
Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past.
Have experienced a thrombotic event within 24 weeks before baseline.
Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases.
Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.
Trial design
Treatments tested in this trial
- Eltrekibart
- Mirikizumab
- Placebo
Treatment groups
140 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov