A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

Lilly

Status and phase: Active, not recruiting; Phase 3

Conditions: Ulcerative Colitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03524092

16823

I6T-MC-AMBG (Other Identifier)

2017-003238-96 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 1,177 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,177 participants in 6 patient groups, including a placebo group

Maintenance Period: Miri Induction Responder (IR) - Placebo (PBO) Subcutaneous (SC)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo SC

Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC

Experimental group

Description:

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.

Treatment:

Drug: Mirikizumab SC

Maintenance Period: PBO IR - PBO SC

Other group

Description:

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.

Treatment:

Drug: Placebo SC

Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV

Other group

Description:

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.

Treatment:

Drug: Mirikizumab IV

Extended Induction: Induction Nonresponders - 300mg Miri IV

Other group

Description:

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.

Treatment:

Drug: Mirikizumab IV

Open Label Maintenance: Delayed Responders - 200 mg Miri SC

Other group

Description:

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.

Treatment:

Drug: Mirikizumab SC