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Active, not recruiting Phase 2

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

NCT06598943 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2024-10-10
Last updated
2026-10-07

Condition(s) studied

Ulcerative ColitisUlcerative Colitis Chronic

Investigational drug(s) / intervention(s)

EltrekibartMirikizumab →Placebo

Eltrekibart: Administered

Mirikizumab: Administered

Placebo: Administered

Study summary

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Percentage of Participants Achieving Clinical Remission — Week 12
    Percentage of Participants Achieving Clinical Remission

Trial sites (207)

FacilityCityRegionStatus
AZ Gastro Care - Chandler Chandler Arizona
Applied Research Center of Arkansas Little Rock Arkansas
Preferred Research Partners Little Rock Arkansas
Erick Alayo Medical Corp/Gastro SB Clinic Chula Vista California
Southern California GI and Liver Centers (SCLC) Coronado California
Valley View Research Garden Grove California
Om Research, LLC Lancaster California
United Medical Doctors Los Alamitos California
Clinnova Research Orange California
Prospective Research Innovations Rancho Cucamonga California
Clinical Trials Management Services, LLC Thousand Oaks California
Om Research LLC Victorville California
Peak Gastroenterology Associates Colorado Springs Colorado
Medical Research Center of Connecticut, LLC Hamden Connecticut
Novum Research, LLC Clermont Florida
I.V.A.M. Clinical & Investigational Center, LLC Doral Florida
Florida Research Institute Lakewood Rch Florida
Well Pharma Medical Research Corp. Miami Florida
Reserka Miami Florida
Digestive Disease Consultants DDCJAX Orange Park Florida
Orlando Health Digestive Health Institute Orlando Florida
AdventHealth Orlando Orlando Florida
Nodal Medical Center Tampa Florida
Research Bay,Inc. Tampa Florida
GCP Clinical Research, LLC Tampa Florida
International Center for Research LLC Tampa Florida
Northwestern University Chicago Illinois
Avicenna Clinical Research - SW Gastroenterology Oak Lawn Illinois
Clinical Trials Management, LLC Metairie Louisiana
Gastroenterology Associates of Western Michigan, P.L.C. Wyoming Michigan
Ellipsis Research Group Brooklyn New York
Smart Medical Research - Jackson Heights Jackson Heights New York
Pioneer Clinical Research NY New York New York
Digestive Disease Medicine of Central New York Utica New York
University of North Carolina Chapel Hill North Carolina
GCGA Physicians, LLC dba / Gastro Health Research Cincinnati Ohio
NexGen Research Lima Ohio
Inquest Clinical Research Baytown Texas
DHR Health Gastroenterology - Edinburg Edinburg Texas
Baylor College of Medicine Houston Texas

+ 167 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06598943 on ClinicalTrials.gov ↗ ← All trials in Italy