Table 1.
Baseline characteristics.
| Total Safety Population, n | 17 |
| Enrolment by country | |
| The Netherlands | 6 |
| Croatia | 7 [6 in Efficacy Population] |
| Sweden | 2 |
| Italy | 2 |
| Sex, n [% male] | 13 [76.5] |
| Ethnicity, n [% Caucasian] | 14 [82.4] |
| Mean age, years [range] | 35.4 [21.0–62.0] |
| Mean age at CD diagnosis, years [range] | 23.5 [14.2–57.0] |
| Mean CD duration, years [range] | 12.2 [4.7–25.2] |
| Mean height, cm [SD; range] | 174.7 [5.8; 162.5–186.0] |
| Mean weight, kg [SD; range] | 67.1 [11.7; 50.0–88.7] |
| Mean BMI, kg/m2 [SD; range] | 22.0 [4.0; 16.8–29.0] |
| Number of prior biologics [SD; range] | 2.2 [1.4; 1–6] |
| Number of patients on biologics at baseline | 4 |
| Number of patients with prior bowel resection | 7 |
| Number of patients with prior or current perianal fistula | 5 |
| Number of patients with confirmed colonic involvement | 17 |
| Number of patients with confirmed ileal involvement | 11 |
| Total Efficacy Population, n | 16 |
| CDAI [SD] | 306.4 [59.4] |
| SES-CD [SD] | 20.2 [6.8] |
| Faecal calprotectin [SD] | 5054.4 [5062.54] |
| High-sensitivity CRP, mg/L [SD] | 4.4 [3.4] |
Abbreviations: BMI: Body Mass Index, CD = Crohn’s Disease, CDAI = Crohn’s Disease Activity Index, CRP = C-Reactive Protein.