Additional Relevant Details
The ADMIRE-CD trial is a randomized, double-blind, placebo-controlled, Phase 3 study, designed to investigate the efficacy and safety of a single treatment of Cx601 for the treatment of complex perianal fistulas in Crohn’s disease patients. A significantly greater proportion of patients in the Cx601 group versus the placebo group achieved the primary endpoint of combined remission (defined as clinical assessment of closure of all treated external openings draining at baseline, despite gentle finger compression, and absence of collections >2cm confirmed by MRI) at week 24 in the ITT population 53 (50%) of 107 vs 36 of 105 (34%), respectively (97.5% CI 0.2–30.3; p=0.024) and the mITT population 53 (51%) of 103 vs 36 (36%) of 101 (0.5–31.2; p=0.021). These results were confirmed in the per-protocol population and in additional supportive and sensitivity analyses. This definition of remission is more stringent than those commonly used in clinical trials on perianal fistulizing disease, as it includes both clinical and radiological assessment by MRI.2,3Treatment-emergent adverse (non-serious and serious) and discontinuations due to adverse events were comparable between Cx601 and placebo arms.In addition, severity of perianal Crohn’s disease was assessed at baseline and all study visits with the Perianal Disease Activity Index (PDAI). In the mITT population, the PDAI score was similar in the Cx601 and the placebo groups at baseline. The improvement in PDAI with Cx601 was significantly greater than placebo at week 6, 12 and 18. In addition, the mean total PDAI score at week 24 with Cx601 (4.4) was close to the threshold for inactive perianal disease (PDAI<4) at which patients do not need medical or surgical treatment.