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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Ulcerative Colitis Chronic; Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Eltrekibart; Drug: Mirikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06598943

I7P-MC-DSAG (Other Identifier)

18751

Details and patient eligibility

About

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).

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 4 patient groups

Eltrekibart + Placebo

Experimental group

Description:

Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.

Treatment:

Drug: Mirikizumab

Drug: Eltrekibart

Drug: Placebo

Mirikizumab + Placebo

Experimental group

Description:

Participants will receive mirikizumab and placebo or mirikizumab.

Treatment:

Drug: Mirikizumab

Drug: Placebo

Eltrekibart + Mirikizumab

Experimental group

Description:

Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.

Treatment:

Drug: Mirikizumab

Drug: Eltrekibart

Placebo

Experimental group

Description:

Participants will receive placebo or mirikizumab.

Treatment:

Drug: Mirikizumab

Drug: Placebo