Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06598943

A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis

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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CIPREC, CABA, Argentina

Loading trial locations.

About this study

The study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eltrekibart

Drug

Administered

Other names: LY3041658

Mirikizumab

Drug

Administered

Other names: LY3074828

Placebo

Drug

Administered

Primary outcomes

  1. Percentage of Participants Achieving Clinical Remission

    Time frame: Week 12

    Percentage of Participants Achieving Clinical Remission

Secondary outcomes

  1. Percentage of Participants Achieving Clinical Response

    Time frame: Week 12

    Percentage of Participants Achieving Clinical Response

  2. Percentage of Participants Achieving Endoscopic Improvement

    Time frame: Week 12

    Percentage of Participants Achieving Endoscopic Improvement

  3. Percentage of Participants Achieving Endoscopic Remission

    Time frame: Week 12

    Percentage of Participants Achieving Endoscopic Remission

  4. Percentage of Participants Achieving Clinical Remission

    Time frame: Week 52

    Percentage of Participants Achieving Clinical Remission

  5. Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement

    Time frame: Week 12

    Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement

  6. Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score

    Time frame: Baseline, Week 12

    Change From Baseline to Week 12 in IBDQ Total Score

  7. Pharmacokinetics (PK): Trough concentrations at Steady State (Ctrough ss) of Eltrekibart

    Time frame: Week 12

    PK: Ctrough ss of Eltrekibart

  8. PK: Ctrough ss of Mirikizumab

    Time frame: Week 12

    PK: Ctrough ss of Mirikizumab

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.