A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's Disease
- Registration Number
- NCT02249078
- Lead Sponsor
- Eisai Inc.
- Brief Summary
This is a multicenter, Phase 1b, randomized, double-blind, placebo-controlled, sequential-cohort, multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of 3 subcutaneous and 1 intravenous dose of E6011 in subjects with active Crohn's disease (CD). Thirty-two subjects will be randomized to one of 4 dose cohorts (8 per cohort) and will receive E6011 or placebo for 10 weeks. The first 3 cohorts will receive E6011 or placebo via subcutaneous injection and the last cohort will receive E6011 or placebo by intravenous injection. The ratio of E6011 to placebo within each cohort will be 3:1. The study has 2 phases: Prerandomization and Randomization.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 E6011 200 mg subcutaneous once every 2 weeks with initial double dose (400 mg total) Cohort 1 E6011 100 mg subcutaneous once every 2 weeks with initial double dose (200 mg total) Cohort 3 E6011 400 mg subcutaneous once every 2 weeks with initial double dose (800 mg total) Placebo Placebo Placebo 2-mL vial solution for injection Cohort 4 E6011 10 mg/kg IV at Day 1, Day 8, Day 15, and every 2 weeks thereafter
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a measure of the short-term safety and tolerability of E6011 Up to 3 years The short-term safety and tolerability of subcutaneous (SC) and intravenous (IV) doses of E6011 compared to placebo in subjects with active CD. Safety assessments will consist of monitoring and recording all AEs and SAEs; regulatory monitoring of hematology, blood chemistry, and urine values; periodic measurement vital signs and ECGs; and performance of physical examinations.
- Secondary Outcome Measures
Name Time Method The number of screen positives, confirm positives, and relative anti-E6011 levels measured in blood samples from participants. Up to 3 years Change from baseline in the percentage of immunohistochemical staining for the CX3CR1+ protein in intestinal tissue over time. Up to 3 years Concentration of E6011 measured over time in blood samples. Up to 3 years The number and percentage of participants with anti-E6011 antibodies detected in blood samples over time. Up to 3 years