Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03706456 | Phase 3 Study of Cx601 in Participants With Complex Perianal Fistulising Crohn's Disease | PHASE3 | COMPLETED | 22 | — | — | Mar 6, 2019 | Feb 10, 2023 | Jun 10, 2024 | 11 | Japan |
Combined remission of perianal fistulising CD is defined as the clinically confirmed closure of all treated external openings that were draining at Screening despite gentle finger compression, and absence of collections \>2 cm in the treated fistulas, confirmed by central magnetic resonance imaging (MRI) assessment at Week 24 visit. In case of missing values, last observation carried forward (LOCF) method was applied. Percentages are rounded off to the nearest decimal point.
| Arm | Type | Description |
|---|---|---|
| Darvadstrocel 24 mL | EXPERIMENTAL | Darvadstrocel (Cx601) 24 mL suspension of 120 million cells of expanded allogeneic adipose-derived stem cells (eASC) as an intralesional injection, once on Day 1. |
| Name | Type | Description |
|---|---|---|
| Darvadstrocel | BIOLOGICAL | Darvadstrocel cell suspension for intralesional injection. |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with the protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any r...