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

Description

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).

Conditions

Ulcerative Colitis, Ulcerative Colitis Chronic

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Lancaster

Om Research, LLC, Lancaster, California, United States, 93534

Los Alamitos

United Medical Doctors, Los Alamitos, California, United States, 90720-3433

Orange

Clinnova Research, Orange, California, United States, 92868-4402

Rancho Cucamonga

Prospective Research Innovations, Rancho Cucamonga, California, United States, 91730-4850

Colorado Springs

Peak Gastroenterology Associates, Colorado Springs, Colorado, United States, 80907-6262

Hamden

Medical Research Center of Connecticut, LLC, Hamden, Connecticut, United States, 06518-3602

Orange Park

Digestive Disease Consultants DDCJAX, Orange Park, Florida, United States, 32073-4752

Tampa

International Center for Research LLC, Tampa, Florida, United States, 33614

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Wyoming

Gastroenterology Associates of Western Michigan, P.L.C., Wyoming, Michigan, United States, 49519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2028-09