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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis, Ulcerative Colitis Chronic

In brief

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).

Key facts

Study ID

NCT06598943

Run by

Eli Lilly and Company

People needed

143

Starts

2024-10-10

Expected to finish

2028-09-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Smart Medical Research - Jackson Heights — Jackson Heights, New York, United States (enrolling)
• Digestive Disease Medicine of Central New York — Utica, New York, United States (enrolling)
• Avicenna Clinical Research - SW Gastroenterology — Oak Lawn, Illinois, United States (enrolling)
• Ellipsis Research Group — Brooklyn, New York, United States (enrolling)
• Valley View Research — Garden Grove, California, United States (enrolling)
• Pioneer Clinical Research NY — New York, New York, United States (enrolling)
• Applied Research Center of Arkansas — Little Rock, Arkansas, United States (enrolling)
• International Center for Research LLC — Tampa, Florida, United States (enrolling)
• Southern California GI and Liver Centers (SCLC) — Coronado, California, United States (enrolling)
• Gastroenterology Associates of Western Michigan, P.L.C. — Wyoming, Michigan, United States (enrolling)
• Om Research LLC — Victorville, California, United States (enrolling)
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (enrolling)
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States (enrolling)
• Om Research, LLC — Lancaster, California, United States (enrolling)
• United Medical Doctors — Los Alamitos, California, United States (enrolling)
• Erick Alayo Medical Corp/Gastro SB Clinic — Chula Vista, California, United States (enrolling)
• Well Pharma Medical Research Corp. — Miami, Florida, United States (enrolling)
• Clinnova Research — Orange, California, United States (enrolling)
• Prospective Research Innovations — Rancho Cucamonga, California, United States (enrolling)
• Orlando Health Digestive Health Institute — Orlando, Florida, United States (enrolling)
• Clinical Trials Management Services, LLC — Thousand Oaks, California, United States (enrolling)
• Nodal Medical Center — Tampa, Florida, United States (enrolling)
• Research Bay,Inc. — Tampa, Florida, United States (enrolling)
• GCP Clinical Research, LLC — Tampa, Florida, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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