A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Purpose

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).

Condition

  • Ulcerative Colitis

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug. - Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry. - If female, must meet the contraception requirements.

Exclusion Criteria

  • Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086). - Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG. - Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086). - Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086). - Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086). - Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Maintenance Period: Miri Induction Responder (IR) - Placebo (PBO) Subcutaneous (SC) 		Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.
  • Drug: Placebo SC
    Administered SC
Experimental
Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC 		Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
  • Drug: Mirikizumab SC
    Administered SC
    Other names:
    • LY3074828
Other
Maintenance Period: PBO IR - PBO SC 		Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
  • Drug: Placebo SC
    Administered SC
Other
Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV 		Participants who received PBO SC or 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.
  • Drug: Mirikizumab IV
    Administered IV
    Other names:
    • LY3074828
Other
Extended Induction: Induction Nonresponders - 300mg Miri IV 		Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.
  • Drug: Mirikizumab IV
    Administered IV
    Other names:
    • LY3074828
Other
Open Label Maintenance: Delayed Responders - 200 mg Miri SC 		Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40.
  • Drug: Mirikizumab SC
    Administered SC
    Other names:
    • LY3074828

More Details

Status
Active, not recruiting
Sponsor
Eli Lilly and Company

Study Contact