At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 28 enrolled
Drug / intervention
E6011 2 mg/kg +3 moredrug
Likely dose
E6011 2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease
In Brief
A Phase 2 clinical trial evaluating E6011 2 mg/kg, E6011 5 mg/kg, and 2 other interventions for Crohn's Disease. Completed, enrolled 28 participants across 17 sites.
Detailed Summary
This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate mainly the safety and tolerability of 12-week repeated intravenous administration of E6011. A total of 24 subjects will enroll into four cohorts. Six subjects per cohort will receive repeated intravenous administration of E6011.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartApr 2014
Primary CompletionJan 2017
Study CompletionNov 2017
TodayJul 2026
First PostedJan 17, 2014
Enrollment StartApr 5, 2014
Primary CompletionJan 6, 2017
Study CompletionNov 27, 2017
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.5 years ago
Interventions
E6011 2 mg/kgdrug
E6011 5 mg/kgdrug
E6011 10 mg/kgdrug
E6011 15 mg/kgdrug