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

NCT06598943

RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Ulcerative Colitis, Ulcerative Colitis Chronic

Interventions: Eltrekibart, Mirikizumab, Placebo

Countries: United States, Argentina, Belgium, Canada, Colombia, Croatia, Czechia, Denmark

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (207)
  • Chandler, Arizona, United States
  • Little Rock, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Chula Vista, California, United States
  • Coronado, California, United States
  • Garden Grove, California, United States
  • Lancaster, California, United States
  • Los Alamitos, California, United States
  • Orange, California, United States
  • Rancho Cucamonga, California, United States
  • Thousand Oaks, California, United States
  • Victorville, California, United States
  • Colorado Springs, Colorado, United States
  • Hamden, Connecticut, United States
  • Clermont, Florida, United States
  • Doral, Florida, United States
  • Lakewood Rch, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Orange Park, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Chicago, Illinois, United States
  • Oak Lawn, Illinois, United States
  • Metairie, Louisiana, United States
  • Wyoming, Michigan, United States
  • + 177 more on CT.gov