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

Phase 2

Recruiting

• Conditions: Ulcerative Colitis; Ulcerative Colitis Chronic
• Interventions: Drug: Eltrekibart; Drug: Placebo; Drug: Mirikizumab

• Registration Number: NCT06598943
• Lead Sponsor: Eli Lilly and Company

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 screening.

Study Timeline

• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Study Start: 2024-10-10
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-25
• Primary Completion: 2027-12
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo or mirikizumab.
Eltrekibart + Placebo	Eltrekibart	Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
Eltrekibart + Placebo	Mirikizumab	Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
Eltrekibart + Placebo	Placebo	Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
Mirikizumab + Placebo	Placebo	Participants will receive mirikizumab and placebo or mirikizumab.
Eltrekibart + Mirikizumab	Eltrekibart	Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.
Mirikizumab + Placebo	Mirikizumab	Participants will receive mirikizumab and placebo or mirikizumab.
Placebo	Mirikizumab	Participants will receive placebo or mirikizumab.
Eltrekibart + Mirikizumab	Mirikizumab	Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Clinical Remission	Week 12	Percentage of Participants Achieving Clinical Remission

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Clinical Response	Week 12	Percentage of Participants Achieving Clinical Response
Percentage of Participants Achieving Endoscopic Improvement	Week 12	Percentage of Participants Achieving Endoscopic Improvement
Percentage of Participants Achieving Endoscopic Remission	Week 12	Percentage of Participants Achieving Endoscopic Remission
Percentage of Participants Achieving Clinical Remission	Week 52	Percentage of Participants Achieving Clinical Remission
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement	Week 12	Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement
Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score	Baseline, Week 12	Change From Baseline to Week 12 in IBDQ Total Score
Pharmacokinetics (PK): Trough concentrations at Steady State (Ctrough ss) of Eltrekibart	Week 12	PK: Ctrough ss of Eltrekibart
PK: Ctrough ss of Mirikizumab	Week 12	PK: Ctrough ss of Mirikizumab

Trial Locations

Locations (183)

Applied Research Center of Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Southern California GI and Liver Centers (SCLC); 🇺🇸 Coronado, 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

Peak Gastroenterology Associates; 🇺🇸 Colorado Springs, Colorado, United States

Medical Research Center of Connecticut, LLC; 🇺🇸 Hamden, Connecticut, United States

Well Pharma Medical Research Corp.; 🇺🇸 Miami, Florida, United States

Digestive Disease Consultants DDCJAX; 🇺🇸 Orange Park, Florida, United States

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