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Eltrekibart + Mirikizumab for Ulcerative Colitis

Phase 2
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have moderately to severely active UC as assessed by the UC disease activity score
Are on a stable dose of certain oral UC medications
Must not have
Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past
Have a history of certain adenomas, dysplasias, or malignancies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52

Summary

This trial aims to see if eltrekibart and mirikizumab are safe and effective in treating adults with moderate to severe ulcerative colitis.

Who is the study for?
Adults with moderate to severe ulcerative colitis (UC) who haven't responded well to conventional treatments or advanced therapies can join. They must be on a stable oral UC medication dose, have had UC for at least 3 months, and follow contraception rules. People with Crohn's Disease, past anti-IL therapy, certain gastrointestinal diseases, recent thrombotic events or surgeries aren't eligible.
What is being tested?
The trial is testing the safety and effectiveness of two drugs: Eltrekibart and Mirikizumab against a placebo in adults with active UC. Participants will receive one of these medications or a placebo to see which is better at managing their symptoms.
What are the potential side effects?
Possible side effects may include immune system reactions like infections due to drug-induced immunosuppression, infusion-related reactions such as fever or chills during administration of the drugs, and potential gastrointestinal disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My ulcerative colitis is moderate to severe.
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I am on a stable dose of my ulcerative colitis medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been treated with anti-IL-23p19 or anti-IL-12p40 antibodies before.
Select...
I have a history of specific types of growths or cancers.
Select...
I have been diagnosed with Crohn's Disease or a similar inflammatory bowel condition.
Select...
I have not had major abdominal surgery in the last 3 months and do not expect to need surgery for UC during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
PK: Ctrough ss of Mirikizumab
Percentage of Participants Achieving Clinical Remission
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment2 Interventions
Participants will receive placebo or mirikizumab.
Group II: Mirikizumab + PlaceboExperimental Treatment2 Interventions
Participants will receive mirikizumab and placebo or mirikizumab.
Group III: Eltrekibart + PlaceboExperimental Treatment3 Interventions
Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
Group IV: Eltrekibart + MirikizumabExperimental Treatment2 Interventions
Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Mirikizumab
2020
Completed Phase 3
~6070

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,675 Previous Clinical Trials
3,463,843 Total Patients Enrolled
11 Trials studying Colitis
4,347 Patients Enrolled for Colitis
Study DirectorEli Lilly and Company
1,388 Previous Clinical Trials
427,238 Total Patients Enrolled
9 Trials studying Colitis
4,097 Patients Enrolled for Colitis
~93 spots leftby Dec 2027
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