At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 22 enrolled
Drug / intervention
Darvadstrocelbiological
Likely dose
Not stated in 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 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients With Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating Darvadstrocel for Complex Perianal Fistulas in Adult Participants With Crohn's Disease. Completed, enrolled 22 participants across 11 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of darvadstrocel for the treatment of complex perianal fistulas in adult participants with Crohn's disease over 24 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartMar 2019
Primary CompletionJul 2020
Study CompletionFeb 2023
TodayJul 2026
First PostedOct 16, 2018
Enrollment StartMar 6, 2019
Primary CompletionJul 20, 2020
Study CompletionFeb 10, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.7 years ago
Interventions
Darvadstrocelbiological
Darvadstrocel cell suspension for intralesional injection.