Status:
RECRUITING
A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
Lead Sponsor:
Eli Lilly and Company
Conditions:
Ulcerative Colitis
Ulcerative Colitis Chronic
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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).
Detailed Description
The study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06598943
Start Date
October 10 2024
End Date
September 1 2028
Last Update
December 24 2025
Active Locations (207)
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1
AZ Gastro Care - Chandler
Chandler, Arizona, United States, 85225
2
Applied Research Center of Arkansas
Little Rock, Arkansas, United States, 72205
3
Preferred Research Partners
Little Rock, Arkansas, United States, 72211
4
Erick Alayo Medical Corp/Gastro SB Clinic
Chula Vista, California, United States, 91910