A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis (LUCENT-ACT)

Lilly

Status and phase: Withdrawn; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo SC; Drug: Mirikizumab SC; Drug: Vedolizumab IV; Drug: Mirikizumab IV; Drug: Placebo IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT04469062

16825

2019-001653-99 (EudraCT Number)

I6T-MC-AMBI (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have a diagnosis of UC for at least 3 months prior to baseline
• Participants must have a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS)
• Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC
• Participants must, if female, meet the contraception requirements

Exclusion criteria

• Participants must not have a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis)
• Participants must not have had a previous colectomy
• Participants must not have current evidence of toxic megacolon
• Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab
• Participants must not have prior clinical failure or intolerance to anti-IL12p40 antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab) within 4 weeks prior to screening endoscopy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

Mirikizumab

Experimental group

Description:

Mirikizumab administered intravenously (IV) and subcutaneously (SC).

Treatment:

Drug: Mirikizumab IV

Drug: Mirikizumab SC

Vedolizumab

Active Comparator group

Description:

Vedolizumab administered IV.

Treatment:

Drug: Vedolizumab IV

Placebo

Placebo Comparator group

Description:

Placebo administered SC and IV.

Treatment:

Drug: Placebo IV

Drug: Placebo SC