Table 1.
Demographics and general baseline characteristics (full analysis set)
| SHR0302 4 mg [n = 35] |
SHR0302 8 mg [n = 35] |
Placebo [n = 35] |
|
|---|---|---|---|
| Age, years | |||
| Mean (SD) | 38.5 (14.8) | 35.2 (14.8) | 30.3 (12.6) |
| Median (min, max) | 37.0 (18, 7) | 31.0 (19, 7) | 25.0 (18, 6) |
| Sex | |||
| Male [n (%)] | 20 (57.1) | 23 (65.7) | 26 (74.3) |
| Race | |||
| Asian [n (%)] | 35 (100.0) | 35 (100.0) | 35 (100.0) |
| Body height, cm | |||
| Mean (SD) | 167.9 (7.6) | 168.9 (8.5) | 170.5 (7.6) |
| Median (min, max) | 167.0 (154.0, 187.0) | 169.0 (152.0, 188.0) | 172.0 (153.0, 188.0) |
| Weight, kg | |||
| Mean (SD) | 70.0 (17.0) | 69.7 (19.4) | 69.0 (14.6) |
| Median (min, max) | 67.8 (43.5, 115.0) | 67.5 (39.5, 143.0) | 67.0 (47.0, 104.0) |
| BMI, kg/m2 | |||
| Mean (SD) | 24.6 (4.9) | 24.2 (5.0) | 23.6 (4.1) |
| Median (min, max) | 23.7 (17.5, 41.7) | 23.1 (17.1, 40.5) | 22.8 (15.8, 33.6) |
| AD disease duration, years | |||
| Mean (SD) | 10.9 (10.2) | 9.0 (8.5) | 8.7 (7.6) |
| Median (min, max) | 7.7 (1.1, 40.4) | 6.9 (1.0, 35.3) | 7.2 (1.5, 33.7) |
| EASI | |||
| Mean (SD) | 30.5 (15.7) | 25.4 (11.3) | 28.2 (12.1) |
| Median (min, max) | 23.8 (12.4, 63.0) | 22.9 (12.2, 62.9) | 27.8 (12.3, 59.5) |
| BSA affected, % | |||
| Mean (SD) | 52.4 (23.0) | 49.8 (19.6) | 52.0 (23.5) |
| Median (min, max) | 50.0 (15.0, 90.0) | 51.0 (18.0, 90.0) | 52.0 (10.0, 98.0) |
| IGA grade [n (%)] | |||
| 3: Moderate | 15 (42.9) | 20 (57.1) | 22 (62.9) |
| 4: Severe | 16 (45.7) | 14 (40.0) | 11 (31.4) |
| 5: Extremely severe | 4 (11.4) | 1 (2.9) | 2 (5.7) |
| SCORAD score | |||
| Mean (SD) | 52.4 (23.0) | 19.6 (51.0) | 23.5 (52.0) |
| Median (min, max) | 50 (15, 90) | 51 (18, 90) | 52 (10, 98) |
| Pruritus NRS | |||
| Mean (SD) | 7.9 (1.7) | 7.1 (1.8) | 7.3 (2.3) |
| Median (min, max) | 8.0 (4, 10) | 8.0 (3, 10) | 8.0 (1, 10) |
| DLQI score | |||
| Mean (SD) | 16.3 (7.7) | 15.6 (7.0) | 15.3 (7.2) |
| Median (min, max) | 17.0 (2, 30) | 13.0 (5, 29) | 15.0 (4, 30) |
| Immunoglobulin E, IU/mL | |||
| Mean (SD) | 1519.8 (2026.3) | 1055.8 (1081.6) | 2771.1 (8765.1) |
| Median (min, max) | 1205.2 (8.8, 11,700.0) | 500.0 (2.7, 5000.0) | 855.0 (8.78, 52,000.0) |
AD atopic dermatitis, BMI body mass index, BSA body surface area, DLQI Dermatology Life Quality Index, EASI Eczema Area and Severity Index, IGA Investigator’s Global Assessment, max maximum, min minimum, NRS Numerical Rating Scale, SCORAD Scoring Atopic Dermatitis, SD standard deviation