Darvadstrocel shows 48.8% combined remission in Crohn's perianal fistulas, not superior to placebo

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Gastroenterology Published June 1, 2026 Medically reviewed June 1, 2026 Study authors: Colombel Jean-Frédéric, Garcia Olmo Damian, Chen Szu-Ta, Serclova Zuzana, Schwartz David A, Wexner S… PubMed ↗ NCT03279081 ↗ DOI ↗ By Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

Key Takeaway

Note that darvadstrocel did not show a statistically significant benefit over placebo for combined remission in Crohn's perianal fistulas at 24 weeks.

This Phase 3, double-blind, randomized, placebo-controlled trial evaluated darvadstrocel, a dispersion of 120 × 10 stem cells in 24 mL sterile buffered solution, in adults with Crohn's disease and complex perianal fistulas with ≤2 internal openings and ≤3 external openings and inadequate response to immunosuppressive agents or biologics. The study enrolled 568 patients randomized 1:1 to darvadstrocel (n=283) or placebo (n=285) across sites in Europe, Israel, and North America, with a follow-up to week 24.

The primary outcome was combined remission (closure of all treated external openings and absence of collections >2 cm) at week 24. This occurred in 138 of 283 patients (48.8%) in the darvadstrocel group versus 132 of 285 (46.3%) in the placebo group. The estimated treatment difference was 2.4% (95% CI, -5.8 to 10.6; P = .571), indicating no statistically significant difference. Secondary outcomes of clinical remission at week 24 and time to clinical remission also showed no significant differences (P = .515 and P = .374, respectively).

Safety was similar between groups. Treatment-emergent adverse events were experienced by 203 of 278 patients (73.0%) receiving darvadstrocel and 201 of 274 (73.4%) receiving placebo. No new safety signals were identified for darvadstrocel. Serious adverse events and discontinuations were not reported.

Key limitations include the lack of reported funding or conflicts, and the study population was specific to patients with inadequate response to prior therapies. The findings suggest that darvadstrocel does not offer a statistically significant advantage over placebo for achieving combined remission in this patient population at 24 weeks.

Study Details

Study typeRct

Sample sizen = 283

EvidenceLevel 2

PublishedJun 2026

PMID41790076

TrialNCT03279081

View Original Abstract ↓

BACKGROUND & AIMS: The ADMIRE CD trial demonstrated the efficacy and safety of darvadstrocel in patients with complex perianal fistulas from Europe and Israel. The efficacy and safety of darvadstrocel in an expanded patient population was investigated. METHODS: ADMIRE CD II (ClinicalTrials.gov, Number: NCT03279081) was a phase 3, double-blind, randomized, placebo-controlled trial conducted in Europe, Israel, and North America. Adults with Crohn's disease and complex perianal fistulas with ≤2 internal openings and ≤3 external openings and inadequate response to immunosuppressive agents or biologics were randomized 1:1 to receive darvadstrocel (a dispersion of 120 × 10 stem cells in 24 mL sterile buffered solution) or placebo. Both groups underwent curettage and closure of the internal opening. The primary endpoint was combined remission (closure of all treated external openings and absence of collections >2 cm) at week 24. RESULTS: Overall, 568 patients were randomized to receive darvadstrocel (n = 283) or placebo (n = 285); 249 and 246, respectively, completed the trial. At week 24, combined remission was achieved in 138 of 283 (48.8%) patients in the darvadstrocel group and 132 of 285 (46.3%) in the placebo group (estimated treatment difference: 2.4%; 95% CI, -5.8 to 10.6; P = .571). There were no significant differences in key secondary endpoints for darvadstrocel vs placebo (clinical remission at week 24 [P = .515] and time to clinical remission [P = .374]). Treatment-emergent adverse events were infrequent and experienced by similar proportions of patients receiving darvadstrocel (203/278 [73.0%]) and placebo (201/274 [73.4%]). CONCLUSIONS: ADMIRE CD II did not meet its primary endpoint of combined remission at week 24, with no statistically significant difference between darvadstrocel and placebo. No new safety signals were identified for darvadstrocel. CLINICALTRIALS: gov, Number: NCT002209456.