CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
Darvadstrocel +1 morebiological
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.

Search/NCT04075825
NCT04075825Phase 3Completed
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A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study

Takeda·interventional·Posted Sep 3, 2019·Updated Apr 23, 2025

In Brief

A Phase 3 clinical trial evaluating Placebo and Darvadstrocel for Crohn's Disease and Complex Perianal Fistula. Completed, enrolled 150 participants across 58 sites in 9 countries.

Detailed Summary

The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease, Complex Perianal Fistula
CountriesBelgium, Czechia, France, Hungary, Israel, Italy, Poland, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 3, 2019
Enrollment StartNov 5, 2019
Primary CompletionApr 2, 2024
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 6.8 years ago

Interventions

Placeboother

Darvadstrocel placebo-matching eASCs intralesional injection received in previous ADMIRE-CD II study. No drug administration in this study.

Darvadstrocelbiological

Allogenic expanded adipose-derived stem cells (eASCs) 5 million cells/ml - suspension for injection darvadstrocel received in previous ADMIRE-CD II study. No drug administration in this study.