Table 1.
EDP1815 combined safety data summary in healthy volunteers, psoriasis, and atopic dermatitis.
| Adverse event | Skin challenge healthy volunteers | Psoriasis | Atopic dermatitis | |||||
|---|---|---|---|---|---|---|---|---|
| Placebo (n = 8) | Active Cohort 1 (n = 12) | Active Cohort 2 (n = 12) | Placebo (n = 10) | Active low dose (n = 8) | Active high dose (n = 12) | Placebo (n = 8) | Active (n = 16) | |
| Any TEAE | ||||||||
| Mild | 8 (100%) | 11 (92%) | 8 (67%) | 5 (50%) | 4 (50%) | 9 (75%) | 6 (75%) | 14 (88%) |
| Moderate | 0 | 1 (8%) | 0 | 5 (50%) | 1 (13%) | 3 (25%) | 3 (13%) | 3 (19%) |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Related TEAE | ||||||||
| Mild | 4 (50%) | 7 (58%) | 2 (17%) | 1 (10%) | 3 (38%) | 2 (17%) | 1 (13%) | 5 (31%) |
| Moderate | 0 | 0 | 0 | 2 (20%) | 0 | 1 (13%) | 0 | 0 |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse Event reported by 3 patients in either group | ||||||||
| Headache | 2 (25%) | 7 (58%) | 6 (50%) | 3 (30%) | 1 (13%) | 2 (17%) | 2 (25%) | 8 (50%) |
| Fatigue | 3 (38%) | 1 (8%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Myalgia | 2 (25%) | 4 (33%) | 2 (17%) | 0 | 0 | 0 | 0 | 0 |
| Viral Upper respiratory tract infection | 3 (38%) | 3 (25%) | 1 (8%) | 0 | 0 | 0 | 0 | 0 |
| Rash | 0 | 3 (25%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Abdominal pain upper | 0 | 3 (25%) | 0 | 0 | 0 | 1 (8%) | 0 | 0 |
| Abdominal pain | 1 (13%) | 0 | 0 | 0 | 0 | 0 | 0 | 3 (19%) |
| Diarrhea | 0 | 0 | 0 | 0 | 1 (13%) | 0 | 0 | 6 (38%) |
| Treatment Modification | ||||||||
| Discontinuation | – | – | – | 0 | 0 | 0 | 0 | 0 |
| Dose Interruption | – | – | – | 0 | 0 | 0 | 0 | 1 (6%) |
| Dose Reduction | – | – | – | 0 | 0 | 0 | 0 | 0 |
The preferred term was used to summarize the adverse events across the 3 groups. Different dictionaries may have been used between the healthy volunteer and psoriasis and atopic dermatitis study.