The trial is taking place at:
R

Research Associates of South Florida | Miami, FL

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

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Lilly

Status and phase

Active, not recruiting
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

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

Trial documents
3

Trial contacts and locations

506

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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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