Phase 3
N=150
Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
Crohn's Disease · Complex Perianal Fistula
Bottom Line
View on ClinicalTrials.gov: NCT04075825 ↗Enrolled (actual)
150
Serious AEs
16.7%
Results posted
Apr 2025
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 40; 43 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Other); Darvadstrocel (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Apr 2024
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 | — |
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.
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.