臨床研究等提出・公開システム

A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

I6T-MC-AMAP

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

Aug. 02, 2018

Interventional

A single-arm, outpatient, open-label, Phase 3, multicenter, long-term extension study evaluating the efficacy and safety of mirikizumab in patients with moderately to severely active UC who have participated in an originator mirikizumab UC study

treatment purpose

3

Inclusion Criteria
-Participants from Study AMAC or AMBG who have had at least one study drug administration and have not had early termination of study drug.
-Female participants must agree to contraception requirements.

-Participants must not have developed a new condition, including cancer in the originator study.
-Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
-Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
-Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.

Both

Ulcerative Colitis

investigational material(s)
Generic name etc : LY3074828
INN of investigational material : mirikizumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Mirikizumab administered subcutaneously (SC)

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

efficacy
Percentage of Participants in Clinical Remission

efficacy
-Percentage of Participants in Endoscopic Remission.
-Percentage of Participants in Corticosteroid-free Remission .
-Percentage of Participants with Mucosal Healing at Week 52.
-Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score .
-Percentage of Participants Who are Hospitalized Due to UC .
-Percentage of Participants Who Undergo UC Surgeries Including Colectomy

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June. 18, 2018