The trial is taking place at:
W

West Michigan Clinical Research Center | Wyoming, MI

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

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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)

160 participants in 1 patient group

Mirikizumab
Experimental group
Description:
Participants will receive mirikizumab intravenously (IV) and mirikizumab subcutaneously (SC).
Treatment:
Drug: Mirikizumab

Trial contacts and locations

158

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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