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Taking peoplePhase 2

Tests eltrekibart, alone or with mirikizumab, for ulcerative colitis

Tests eltrekibart alone or with mirikizumab in adults with moderately to severely active ulcerative colitis.

Key facts

Who runs it
Eli Lilly & Co.
Where
Copenhagen Nv and Herlev, DenmarkSee the 2 sitesAlso in 13 other countries, 107 sites
Trial code
Registry title
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
Status
Recruiting
Phase
Phase 2
People taking part
587 people, planned
Started
25 Feb 2025
Expected to end
16 Sept 2028
Type of study
Interventional
Record updated
11 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderately to severely active ulcerative colitis who did not respond well to earlier treatment.

Age
18 years or older
Sex
All sexes
Disease stage
Moderately to severely active ulcerative colitis, diagnosed at least 3 months before the start.
Earlier treatment
Must have had an inadequate response, loss of response or intolerance to at least one conventional medicine (including corticosteroids) or one advanced therapy (including biologics, JAK inhibitors or S1P immunomodulators). Must be on a stable dose of certain oral UC medicines. Must not have had anti-IL-23p19 or anti-IL-12p40 antibodies before.

Main reasons for not taking part

  • Past treatment with anti-IL-23p19 or anti-IL-12p40 antibodies
  • A blood clot (thrombotic event) within 24 weeks before the start
  • Current Crohn's disease or certain other inflammatory bowel diseases
  • Certain abdominal surgeries within the past 3 months, or likely to need surgery for UC during the study
  • History of certain adenomas, dysplasias or cancers

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Denmark

Also in 13 other countries, 107 sites

  • Region HovedstadenCopenhagen Nv, DenmarkNo longer taking part
  • Region HovedstadenHerlev, DenmarkNo longer taking part

About the trial

What the trial wants to find out

To determine whether eltrekibart alone is superior to placebo in inducing clinical remission in participants with moderately to severely active UC

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests eltrekibart, alone or with mirikizumab, for ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
11 November 2026