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

Conditions

• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Mirikizumab SC — DRUG
  Administered SC
• Mirikizumab IV — DRUG
  Administered IV
• Placebo SC — DRUG
  Administered SC

Study Details

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).

Key Dates

First listed

May 14, 2018

Start date

Oct 19, 2018

Status verified

May 2026

Primary completion

Nov 3, 2021

Completion

Feb 17, 2025

Study Design

Enrollment

1,328 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.
• Experimental: 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.
• Experimental: Maintenance Period: Miri IR - PBO SC - ME2 Cohort
  Participants in the ME2 Cohort 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.
• Experimental: Maintenance Period: Miri IR - 200 mg Miri SC - ME2 Cohort
  Participants in the ME2 Cohort 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.
• Experimental: Maintenance Period: PBO IR - PBO SC - ME2 Cohort
  Participants in the ME2 Cohort 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.
• Experimental: Loss of Response (LOR) Rescue Period: LOR Cohort-300 mg Miri IV
  Participants who received blinded PBO SC or blinded 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.
• Experimental: LOR Rescue Period: LOR Cohort-300 mg Miri IV - ME2 Cohort
  Participants in the ME2 Cohort who received blinded PBO SC or blinded 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.
• Experimental: 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.
• Experimental: Extended Induction: Induction Nonresponders - 300mg Miri IV - ME2 Cohort
  Participants in the ME2 Cohort 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.
• Experimental: 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 or until early termination (rescue was not available for these participants).
• Experimental: Open Label Maintenance: Delayed Responders - 200 mg Miri SC - ME2 Cohort
  Participants in the ME2 Cohort 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 or until early termination (rescue was not available for these participants).

Primary Outcome Measure

Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders) [ Time Frame: Week 40 ]

Locations (57)

Find similar trials in Dothan, AL

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