NCT06598943 A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
| NCT ID | NCT06598943 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Eli Lilly and Company |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2024-10-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
✉ LillyTrials@Lilly.com📞 1-317-615-4559
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY DIRECTOR
Eli Lilly and Company
Frequently Asked Questions
Who can join the NCT06598943 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06598943 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06598943 currently recruiting?
Yes, NCT06598943 is actively recruiting participants. Contact the research team at LillyTrials@Lilly.com for enrollment information.
Where is the NCT06598943 trial being conducted?
This trial is being conducted at Chandler, United States, Little Rock, United States, Little Rock, United States, Chula Vista, United States and 11 additional locations.
Who is sponsoring the NCT06598943 clinical trial?
NCT06598943 is sponsored by Eli Lilly and Company. The principal investigator is Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) at Eli Lilly and Company. The trial plans to enroll 140 participants.
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