Phase 3
Completed N=150
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
Crohn's Disease · Complex Perianal Fistula
Source: ClinicalTrials.gov NCT04075825 ↗
Enrolled (actual)
150
Serious AEs
16.7%
Results posted
Apr 2025
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 40; 43 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
40; 43 | — |
| PRIMARY Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) |
14; 11 | — |
| PRIMARY Number of Participants With Specific Adverse Events of Special Interest (AESIs) |
3; 7; 1; 3; 6; 7 | — |
| SECONDARY Percentage of Participants Who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) |
36.49; 50.00; 31.08; 43.42 | — |
| SECONDARY Percentage of Participants Who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) |
40.54; 56.58; 32.43; 47.37 | — |
| SECONDARY Percentage of Participants With Relapse at Week 156 After Achieving Combined Remission at Week 52 of ADMIRE-CD II |
54.76; 42.50 | — |
| SECONDARY Percentage of Participants Who Achieve Combined Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study) |
29.73; 36.84 | — |
| SECONDARY Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156 |
9.62; 7.02 | — |
| SECONDARY Change From Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 |
1.53; 1.25; -0.67; -0.56; -0.67; -0.50 | — |
| SECONDARY Change From Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 |
1.25; 1.06; -0.49; -0.54; -0.56; -0.45 | — |
Eligibility Criteria
Inclusion Criteria
- Has participated in and completed the ADMIRE-CD II (NCT03279081) study (i.e., did not discontinue).
Exclusion Criteria
- Has been more than 3 months since the participant completed the ADMIRE-CD II study.
Data sourced from ClinicalTrials.gov (NCT04075825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.