Table 1.
Treatment‐emergent adverse events
| SAD study | ||||||||
|---|---|---|---|---|---|---|---|---|
| Preferred term, n (%), (number of events) | Placebo (n = 12) | Evobrutinib | ||||||
| 25 mg (n = 6) | 50 mg (n = 6) | 100 mg (n = 6) | 200 mg (n = 6) | 350 mg (n = 6) | 500 mg (n = 6) | Pooled active (n = 36) | ||
| Overall total | 4 (33.3) (6) | 0 (0.0) | 3 (50.0) (6) | 1 (16.7) (1) | 2 (33.3) (4) | 1 (16.7) (1) | 2 (33.3) (3) | 9 (25.0) (15) |
| Headache | 1 (8.3) (1) | 0 (0.0) | 1 (16.7) (2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) (1) | 2 (5.6) (3) |
| Contact dermatitis | 0 (0.0) | 0 (0.0) | 2 (33.3) (2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (5.6) (2) |
| Amylase increased | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) (1) | 0 (0.0) | 0 (0.0) | 1 (2.8) (1) |
| Back pain | 0 (0.0) | 0 (0.0) | 1 (16.7) (1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.8) (1) |
| Dizziness | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) (1) | 0 (0.0) | 0 (0.0) | 1 (2.8) (1) |
| Dry eye | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) (1) | 1 (2.8) (1) |
| Dyspepsia | 0 (0.0) | 0 (0.0) | 1 (16.7) (1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.8) (1) |
| Excoriation | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) (1) | 0 (0.0) | 0 (0.0) | 1 (2.8) (1) |
| Lipase increased | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) (1) | 0 (0.0) | 0 (0.0) | 1 (2.8) (1) |
| Multiple injuries | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) (1) | 0 (0.0) | 1 (2.8) (1) |
| Nasal congestion | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) (1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.8) (1) |
| Odynophagia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) (1) | 1 (2.8) (1) |
| Abdominal pain | 1 (8.3) (1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Application site pruritus (due to ECG stickers) | 1 (8.3) (1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Dry mouth | 1 (8.3) (1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Noncardiac chest pain | 1 (8.3) (1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| URTI | 1 (8.3) (1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| MAD study | |||||
|---|---|---|---|---|---|
| Preferred term, n (%), (number of events) | Placebo (n = 9) | Evobrutinib | |||
| 25 mg (n = 9) | 75 mg (n = 9) | 200 mg (n = 9) | Pooled active (n = 27) | ||
| Overall total | 2 (22.2) (2) | 3 (33.3) (6) | 7 (77.8) (14) | 3 (33.3) (3) | 13 (48.1) (23) |
| Headache | 1 (11.1) (1) | 1 (11.1) (1) | 2 (22.2) (2) | 0 (0.0) | 3 (11.1) (3) |
| Application site irritation | 0 (0.0) | 0 (0.0) | 1 (11.1) (1) | 1 (11.1) (1) | 2 (7.4) (2) |
| Fatigue | 0 (0.0) | 0 (0.0) | 2 (22.2) (2) | 0 (0.0) | 2 (7.4) (2) |
| URTI | 0 (0.0) | 0 (0.0) | 1 (11.1) (1) | 1 (11.1) (1) | 2 (7.4) (2) |
| Abdominal pain | 0 (0.0) | 0 (0.0) | 1 (11.1) (2) | 0 (0.0) | 1 (3.7) (2) |
| Nausea | 0 (0.0) | 0 (0.0) | 1 (11.1) (2) | 0 (0.0) | 1 (3.7) (2) |
| Abdominal discomfort | 0 (0.0) | 1 (11.1) (1) | 0 (0.0) | 0 (0.0) | 1 (3.7) (1) |
| Complex regional pain | 0 (0.0) | 1 (11.1) (1) | 0 (0.0) | 0 (0.0) | 1 (3.7) (1) |
| Constipation | 0 (0.0) | 0 (0.0) | 1 (11.1) (1) | 0 (0.0) | 1 (3.7) (1) |
| Dry throat | 0 (0.0) | 0 (0.0) | 1 (11.1) (1) | 0 (0.0) | 1 (3.7) (1) |
| Excoriation | 0 (0.0) | 1 (11.1) (1) | 0 (0.0) | 0 (0.0) | 1 (3.7) (1) |
| Muscle spasms | 0 (0.0) | 0 (0.0) | 1 (11.1) (1) | 0 (0.0) | 1 (3.7) (1) |
| Muscle strain | 0 (0.0) | 1 (11.1) (1) | 0 (0.0) | 0 (0.0) | 1 (3.7) (1) |
| Rhinorrhea | 1 (11.1) (1) | 1 (11.1) (1) | 0 (0.0) | 0 (0.0) | 1 (3.7) (1) |
| Sneezing | 0 (0.0) | 0 (0.0) | 1 (11.1) (1) | 0 (0.0) | 1 (3.7) (1) |
| Toothache | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (11.1) (1) | 1 (3.7) (1) |
ECG, electrocardiogram; MAD, multiple ascending dose; SAD, single ascending dose; URTI, upper respiratory tract infection.