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

RecruitingPhase 2

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

Who can join

Ages 18 to 75 · All sexes

Full 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.

About the study

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).

What is being tested

Sponsor: Eli Lilly and Company · Participants: 143 · Started: Oct 10, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06598943

Locations in the U.S.

ArizonaAZ Gastro Care - Chandler, Chandler (Not yet recruiting)
ArkansasApplied Research Center of Arkansas, Little Rock
Preferred Research Partners, Little Rock (Not yet recruiting)
CaliforniaErick Alayo Medical Corp/Gastro SB Clinic, Chula Vista
Southern California GI and Liver Centers (SCLC), Coronado
Valley View Research, Garden Grove
Om Research, LLC, Lancaster
United Medical Doctors, Los Alamitos
Clinnova Research, Orange
Prospective Research Innovations, Rancho Cucamonga
Clinical Trials Management Services, LLC, Thousand Oaks
Om Research LLC, Victorville
ColoradoPeak Gastroenterology Associates, Colorado Springs
ConnecticutMedical Research Center of Connecticut, LLC, Hamden
FloridaNovum Research, LLC, Clermont (Not yet recruiting)
I.V.A.M. Clinical & Investigational Center, LLC, Doral (Not yet recruiting)
Florida Research Institute, Lakewood Rch (Not yet recruiting)
Reserka, Miami (Not yet recruiting)
Well Pharma Medical Research Corp., Miami
Digestive Disease Consultants DDCJAX, Orange Park (Not yet recruiting)
AdventHealth Orlando, Orlando (Not yet recruiting)
Orlando Health Digestive Health Institute, Orlando
GCP Clinical Research, LLC, Tampa
International Center for Research LLC, Tampa
Nodal Medical Center, Tampa
Research Bay,Inc., Tampa
IllinoisNorthwestern University, Chicago (Not yet recruiting)
Avicenna Clinical Research - SW Gastroenterology, Oak Lawn
LouisianaClinical Trials Management, LLC, Metairie (Not yet recruiting)
MichiganGastroenterology Associates of Western Michigan, P.L.C., Wyoming
New YorkEllipsis Research Group, Brooklyn
Smart Medical Research - Jackson Heights, Jackson Heights
Pioneer Clinical Research NY, New York
Digestive Disease Medicine of Central New York, Utica
North CarolinaUniversity of North Carolina, Chapel Hill
OhioGCGA Physicians, LLC dba / Gastro Health Research, Cincinnati
NexGen Research, Lima
TexasInquest Clinical Research, Baytown
DHR Health Gastroenterology - Edinburg, Edinburg
Baylor College of Medicine, Houston
Intergrity Research, Houston
Gastroenterology Research of San Antonio, San Antonio
Tyler Research Institute, Tyler
UtahAdvanced Research Institute - South Ogden, Ogden
Care Access-Ogden, Ogden
WashingtonUniversity of Washington School Medicine, Seattle (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.