Home › Trials › NCT06598943

Testing new medications for ulcerative colitis

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

Phase 2 Interventional Eli Lilly and Company · NCT06598943

This study is testing two new medications to see if they can help adults with moderate to severe ulcerative colitis who haven't found relief from other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment140 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsmirikizumab
Locations207 sites (Chandler, Arizona and 206 other locations)
Trial IDNCT06598943 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of two medications, eltrekibart and mirikizumab, in adults suffering from moderately to severely active ulcerative colitis. Participants will undergo a screening process and, if eligible, will be treated over a period of approximately 69 weeks. The study aims to determine how well these treatments work for patients who have not responded adequately to existing therapies. The overall duration of the study is expected to last around 4-5 years.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed diagnosis of moderately to severely active ulcerative colitis who have not adequately responded to previous treatments.

Not a fit: Patients with Crohn's Disease or those who have received specific prior therapies targeting IL-23 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options for patients with ulcerative colitis who have not responded to current therapies.

How similar studies have performed: Other studies have shown promise with similar approaches targeting inflammatory pathways in ulcerative colitis, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Chandler, Arizona and 206 other locations

+157 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative ColitisUlcerative Colitis ChronicCXCR1/2 Ligand receptor antagonistIL-23 p19 antibodyGastrointestinal DiseasesInflammatory Bowel DiseasesDigestive System DiseasesColonic Diseases
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.