Clinical Trials in Italy / NCT06598943
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
Condition(s) studied
Ulcerative ColitisUlcerative Colitis Chronic
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
On this site
📄 Omvoh (mirikizumab) drug profile →More Eli Lilly and Company trials in Italy
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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