I6T-MC-AMAN

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224155

Enrollment

1160

Registered

2018-11-22

Start date

2018-10-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

investigational material(s) Generic name etc : LY3074828 INN of investigational material : mirikizumab Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
efficacy Percentage of Participants With Clinical Remission at Week 12	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics -Percentage of Participants With Clinical Response at Week 12 -Percentage of Participants With Endoscopic Remission at Week 12 -Percentage of Participants With Symptomatic Remission at Week 12 -Percentage of Participants With Symptomatic Response at Week 12 -Percentage of Participants With Histologic Remission at Week 12 -Percentage of Participants With Endoscopic Response at Week 12 -Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) -Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score -Change From Baseline to Week 12 in Fecal Calprotectin -Pharmacokinetics (PK): Clearance of Mirikizumab	—

Measure

Time frame

safety efficacy pharmacokinetics -Percentage of Participants With Clinical Response at Week 12 -Percentage of Participants With Endoscopic Remission at Week 12 -Percentage of Participants With Symptomatic Remission at Week 12 -Percentage of Participants With Symptomatic Response at Week 12 -Percentage of Participants With Histologic Remission at Week 12 -Percentage of Participants With Endoscopic Response at Week 12 -Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) -Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score -Change From Baseline to Week 12 in Fecal Calprotectin -Pharmacokinetics (PK): Clearance of Mirikizumab

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Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026