An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination with Mirikizumab for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis
Key facts
- Where
- Budapest, Budapest III, Gyongyos, Szeged és Szekesfehervar, MagyarországSee the 6 sites
- Phase
- 2. fázis
Where in Magyarország
- Semmelweis EgyetemBudapest, MagyarországNo longer taking part
- Clinexpert Kft.Budapest III, MagyarországNo longer taking part
- Obudai Egeszseguegyi Centrum Kft.Budapest III, MagyarországNo longer taking part
- Clinexpert Gyoengyoes Kft.Gyongyos, MagyarországNo longer taking part
- University of SzegedSzeged, MagyarországNo longer taking part
- Fejer Varmegyei Szent Gyoergy Egyetemi Oktato KorhazSzekesfehervar, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly & Co.
- Trial code
- EU 2023-507853-13-00
- Record updated
- 2026. november 10.
- Original description
To determine whether eltrekibart alone is superior to placebo in inducing clinical remission in participants with moderately to severely active UCRead full original descriptionShow less
I7P-MC-DSAG - An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination with Mirikizumab for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis
To determine whether eltrekibart alone is superior to placebo in inducing clinical remission in participants with moderately to severely active UC
Inclusion: 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: Have received anti-IL-23p19 or anti-IL-12p40 antibodies in the past; Have experienced a thrombotic event within 24 weeks before baseline; Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study; Have a current diagnosis of Crohn’s Disease or certain other inflammatory gastrointestinal diseases; Have a history of certain adenomas, dysplasia’s, or malignancies.