A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcer… (NCT06598943) | Clinical Trial Compass
RecruitingPhase 2
A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
United States140 participantsStarted 2024-10-10
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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).
* Must meet contraception requirements.
Exclusion Criteria:
* 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.
* Have a history of certain adenomas, dysplasia's, or malignancies.
What they're measuring
1
Percentage of Participants Achieving Clinical Remission
Timeframe: Week 12
Trial details
NCT IDNCT06598943
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-12
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or