RECRUITING

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

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Conditions

Ulcerative ColitisUlcerative Colitis ChronicCXCR1/2 Ligand receptor antagonistIL-23 p19 antibodyGastrointestinal DiseasesInflammatory Bowel DiseasesDigestive System DiseasesColonic DiseasesIntestinal DiseasesColitisColitis, UlcerativeAnti-Inflammatory AgentsMirikizumabEltrekibartAdultModerate to Severe

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-10-10
Study Completion:2028-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06598943

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have had an established diagnosis of UC of ≥3 months in duration before baseline.
  2. * Have moderately to severely active UC as assessed by the UC disease activity score.
  3. * 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).
  4. * Are on a stable dose of certain oral UC medications (including corticosteroids).
  5. * Must meet contraception requirements.
  1. * Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past.
  2. * Have experienced a thrombotic event within 24 weeks before baseline.
  3. * Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases.
  4. * Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.
  5. * Have a history of certain adenomas, dysplasia's, or malignancies.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
ClinicalTrials.gov@lilly.com

Principal Investigator

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 Locations (Sites)

Om Research, LLC
Lancaster, California, 93534
United States
United Medical Doctors
Los Alamitos, California, 90720-3433
United States
Clinnova Research
Orange, California, 92868-4402
United States
Prospective Research Innovations
Rancho Cucamonga, California, 91730-4850
United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907-6262
United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518-3602
United States
Digestive Disease Consultants DDCJAX
Orange Park, Florida, 32073-4752
United States
International Center for Research LLC
Tampa, Florida, 33614
United States
Northwestern University
Chicago, Illinois, 60611
United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, 49519
United States
Ellipsis Research Group
Brooklyn, New York, 11215
United States
Smart Medical Research - Jackson Heights
Jackson Heights, New York, 11372
United States
Pioneer Clinical Research NY
New York, New York, 10012-3645
United States
Inquest Clinical Research
Baytown, Texas, 77521
United States
Intergrity Research
Houston, Texas, 77043
United States
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229
United States
Tyler Research Institute
Tyler, Texas, 75701
United States
Care Access-Ogden
Ogden, Utah, 84403
United States
Advanced Research Institute - South Ogden
Ogden, Utah, 84405
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-10
Study Completion Date2028-09

Study Record Updates

Study Start Date2024-10-10
Study Completion Date2028-09

Terms related to this study

Keywords Provided by Researchers

  • CXCR1/2 Ligand receptor antagonist
  • IL-23 p19 antibody
  • Gastrointestinal Diseases
  • Inflammatory Bowel Diseases
  • Digestive System Diseases
  • Colonic Diseases
  • Intestinal Diseases
  • Colitis
  • Colitis, Ulcerative
  • Anti-Inflammatory Agents
  • Mirikizumab
  • Eltrekibart
  • Adult
  • Moderate to Severe

Additional Relevant MeSH Terms

  • Ulcerative Colitis
  • Ulcerative Colitis Chronic