An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

Lilly

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Mirikizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03518086

2017-003229-14 (EudraCT Number)

16591

I6T-MC-AMAN (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Enrollment: 1,281 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).
• Participants with a previous colectomy.
• Participants with current evidence of toxic megacolon.
• Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,281 participants in 4 patient groups, including a placebo group

Placebo Intravenous (IV) Every 4 Weeks (Q4W)

Placebo Comparator group

Description:

Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Treatment:

Drug: Placebo

300 Milligram (mg) Mirikizumab IV Q4W

Experimental group

Description:

300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Treatment:

Drug: Mirikizumab

Placebo IV Q4W Maximum Extended Enrollment (ME2)

Placebo Comparator group

Description:

Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Treatment:

Drug: Placebo

300 mg Mirikizumab IV Q4W ME2

Experimental group

Description:

300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Treatment:

Drug: Mirikizumab