A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 2)
I6T-MC-AMBG
Eli Lilly Japan K.K.
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+81-120-023-812
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Eli Lilly Japan K.K.
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+81-120-023-812
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completed
Feb. 27, 2019
1044
Interventional
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study
treatment purpose
3
-Have completed Study AMAN, 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.
-Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN.
-Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN, 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 .
-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.
-Participants who initiate a new prohibited medication during the induction study AMAN.
-Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
18age old over
80age old under
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, Subcutaneous injection
control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -
efficacy
Percentage of Participants in Clinical Remission [ Time Frame: Week 40 ]
safety
efficacy
pharmacokinetics
-Percentage of Participants in Endoscopic Remission [ Time Frame: Week 40 ]
-Percentage of Participants with Histologic Remission [ Time Frame: Week 40 ]
-Percentage of Participants in Symptomatic Remission [ Time Frame: Week 40 ]
-Percentage of Participants in Endoscopic Response [ Time Frame: Week 40 ]
-Percentage of Participants in Clinical Response [ Time Frame: Week 40 ]
-Change from Baseline to Week 40 in Health Related Quality of Life [ Time Frame: Baseline, Week 40 ]
-Change from Baseline to Week 40 in Fecal Calprotectin [ Time Frame: Baseline, Week 40 ]
-Change from Baseline to Week 40 in Ulcerative Colitis (UC) Symptoms: Numeric Rating Score (NRS) [ Time Frame: Baseline, Week 40 ]
-Percentage of Participants Hospitalized for UC [ Time Frame: Week 40 ]
-Pharmacokinetics (PK): Clearance of Mirikizumab [ Time Frame: Weeks 0, 4, 12, 24, and 40 ]
Eli Lilly Japan K.K.
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Kawasaki Municipal Hospital Institutional Review Board
