Baseline (n=265)* | Month 30 (n=120)* | Month 60 (n=17)* | |||||||
---|---|---|---|---|---|---|---|---|---|
CAN dose category1 | < SD | SD | > SD | < SD | SD | > SD | < SD | SD | > SD |
n (% of patients) | 8 (3.3) | 152 (63.1) | 81 (33.6) | 19 (18.3) | 28 (26.9) | 57 (54.8) | 2 (13.3) | 1 (6.7) | 12 (80.0) |
Investigator’s assessment of disease activity (PGA), n (% of patients) | |||||||||
Absent | 29 (59.2) | 9 (25.7) | 28 (37.8) | 13 (76.5) | 4 (66.7) | 22 (62.9) | n.a. | n.a. | n.a. |
Mild/moderate | 15 (30.6) | 25 (71.4) | 40 (54.1) | 4 (23.5) | 2 (33.3) | 13 (37.1) | |||
Severe | 3 (6.1) | 0 (0.0) | 4 (5.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |||
Not done | 2 (4.1) | 1 (2.9) | 2 (2.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |||
Missing | 20 | 38 | 21 | 12 | 22 | 23 | |||
Patient’s assessment of disease activity | |||||||||
(VAS score 0-10), median | 2.0 | 2.0 | 3.0 | 1.0 | 2.0 | 1.0 | 2.0 | n.a. | 1.0 |
(min.; max.), n | (0.0;10.0, n=66 | (0.0; 10.0), n=71 | (0.0; 10.0), n=93 | (0.0; 9.0), n=27 | (0.0; 6.0), n=26 | 0.0; 8.0), n=49 | (0.0; 5.0), n=3 | (0.0; 4.0), n=12 | |
Safety (interim analysis cut-off date December 2023), all patients (N=268) | |||||||||
< SD (n=69) | SD (n=73) | > SD (n=95) | Dose missing (n=31) | ||||||
Patients with nsADR, n (%) | 17 (24.6) | 15 (20.5) | 42 (44.2) | 8 (25.8) | |||||
Patients with SADR, n (%) | 5 (7.2)# | 0 (0.0) | 8 (8.4)# | 1 (3.2) |