臨床研究等提出・公開システム

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)

I6T-MC-AMAN

Eli Lilly Japan K.K.

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Eli Lilly Japan K.K.

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+81-120-023-812

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completed

Oct. 22, 2018

Interventional

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study

treatment purpose

3

-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.

-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).

Both

Ulcerative Colitis

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

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : intravenous injection

efficacy
Percentage of Participants With Clinical Remission at Week 12

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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June. 12, 2018