A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT-URGE)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Ulcerative Colitis Chronic; Ulcerative Colitis

Treatments: Drug: Mirikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05767021

18551

I6T-MC-AMBZ (Other Identifier)

2022-502393-16-00 (Other Identifier)

Details and patient eligibility

About

A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have an established diagnosis of UC for ≥3 months
• Have confirmed diagnosis of moderately for severely active UC
• Have current bowel urgency
• Have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic/Janus Kinase (JAK) inhibitor/sphingosine-1-phosphate (S1P) receptor modulator therapy for UC.

Exclusion criteria

• Have Crohn's disease (CD)
• Have inflammatory bowel disease-unclassified, formerly known as indeterminate colitis, or
• Have ulcerative proctitis, disease limited to the rectum, that is, distal to the recto-sigmoid junction, which lies approximately 10 to 15 centimeter (cm) from anal verge.
• Have an inherited immunodeficiency syndrome or a monogenic cause of UC-like colonic inflammation
• Have any history or current evidence of cancer of the gastrointestinal tract
• Have active tuberculosis
• Have HIV infection.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Mirikizumab

Experimental group

Description:

Participants will receive mirikizumab intravenously (IV) and mirikizumab subcutaneously (SC).

Treatment:

Drug: Mirikizumab

Drug: Mirikizumab