A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
Recruiting · NCT06598943 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 15 US states.
- AZ Gastro Care - Chandler - Chandler, Arizona, United States
- Applied Research Center of Arkansas - Little Rock, Arkansas, United States
- Preferred Research Partners - Little Rock, Arkansas, United States
- Erick Alayo Medical Corp/Gastro SB Clinic - Chula Vista, California, United States
- Southern California GI and Liver Centers (SCLC) - Coronado, California, United States
- Valley View Research - Garden Grove, California, United States
- Om Research, LLC - Lancaster, California, United States
- United Medical Doctors - Los Alamitos, California, United States
- Clinnova Research - Orange, California, United States
- Prospective Research Innovations - Rancho Cucamonga, California, United States
- Clinical Trials Management Services, LLC - Thousand Oaks, California, United States
- Om Research LLC - Victorville, California, United States
- Peak Gastroenterology Associates - Colorado Springs, Colorado, United States
- Medical Research Center of Connecticut, LLC - Hamden, Connecticut, United States
- Novum Research, LLC - Clermont, Florida, United States
- I.V.A.M. Clinical & Investigational Center, LLC - Doral, Florida, United States
- Florida Research Institute - Lakewood Rch, Florida, United States
- Well Pharma Medical Research Corp. - Miami, Florida, United States
- Reserka - Miami, Florida, United States
- Digestive Disease Consultants DDCJAX - Orange Park, Florida, United States
- Orlando Health Digestive Health Institute - Orlando, Florida, United States
- AdventHealth Orlando - Orlando, Florida, United States
- Nodal Medical Center - Tampa, Florida, United States
- Research Bay,Inc. - Tampa, Florida, United States
- GCP Clinical Research, LLC - Tampa, Florida, United States
- International Center for Research LLC - Tampa, Florida, United States
- Northwestern University - Chicago, Illinois, United States
- Avicenna Clinical Research - SW Gastroenterology - Oak Lawn, Illinois, United States
- Clinical Trials Management, LLC - Metairie, Louisiana, United States
- Gastroenterology Associates of Western Michigan, P.L.C. - Wyoming, Michigan, United States
- Ellipsis Research Group - Brooklyn, New York, United States
- Smart Medical Research - Jackson Heights - Jackson Heights, New York, United States
- Pioneer Clinical Research NY - New York, New York, United States
- Digestive Disease Medicine of Central New York - Utica, New York, United States
- University of North Carolina - Chapel Hill, North Carolina, United States
- GCGA Physicians, LLC dba / Gastro Health Research - Cincinnati, Ohio, United States
- NexGen Research - Lima, Ohio, United States
- Inquest Clinical Research - Baytown, Texas, United States
- DHR Health Gastroenterology - Edinburg - Edinburg, Texas, United States
- Baylor College of Medicine - Houston, Texas, United States
- Intergrity Research - Houston, Texas, United States
- Gastroenterology Research of San Antonio - San Antonio, Texas, United States
- Tyler Research Institute - Tyler, Texas, United States
- Care Access-Ogden - Ogden, Utah, United States
- Advanced Research Institute - South Ogden - Ogden, Utah, United States
- University of Washington School Medicine - Seattle, Washington, United States
- Gazi University Medical Faculty Gazi Hospital - Ankara, Turkey (Türkiye)
- General Hospital of Athens 'Evangelismos' - Athens, Greece
- General Hospital of Athens Hippokratio - Athens, Greece
- Sotiria Thoracic Diseases Hospital of Athens - Athens, Greece
- Alexandra Hospital - Athens, Greece
- Universitätsklinikum Augsburg, III. Medizinische Klinik Studienzentrum - Augsburg, Germany
- Centro Medico Teknon - DIGESTIVO - Barcelona, Spain
- Clinical Center " Dr Dragisa Misovic Dedinje" - Belgrade, Serbia
- Clinical Hospital Center Bezanijska Kosa - Belgrade, Serbia
- Clinical Hospital Center Zvezdara - Belgrade, Serbia
- Clinical Hospital Centre Zemun - Belgrade, Serbia
- Military Medical Academy - Belgrade, Serbia
- Charité Campus Virchow-Klinikum - Berlin, Germany
- General Hospital Dr Andjelko Visic Bjelovar - Bjelovar, Croatia
Showing 60 of 207 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →