Table 1.
Demographic and clinical characteristics of patients with moderate-to-severe atopic dermatitis at baseline (full analysis set).
| Characteristics |
CM310 high-dose (n = 40) |
CM310 low-dose
(n = 40) |
Placebo
(n = 40) |
Total
(n = 120) |
|---|---|---|---|---|
| Age (years) | 33.2 ± 13.2 | 36.7 ± 16.4 | 33.7 ± 14.9 | 34.5 ± 14.9 |
| Male | 26 (65) | 29 (73) | 24 (60) | 79 (66) |
| Height (cm) | 169.81 ± 8.90 | 168.73 ± 9.26 | 166.46 ± 8.61 | 168.33 ± 8.96 |
| Weight (kg) | 70.75 ± 14.66 | 68.91 ± 12.73 | 65.85 ± 13.48 | 68.51 ± 13.68 |
| BMI (kg/m2) | 24.40 ± 3.95 | 24.19 ± 4.14 | 23.64 ± 3.71 | 24.08 ± 3.92 |
| Baseline EASI score | 26.25 ± 10.41 | 30.07 ± 13.76 | 26.28 ± 11.14 | 27.53 ± 11.90 |
| Baseline IGA score of 3 | 21 (52) | 14 (35) | 20 (50) | 55 (46) |
| Baseline IGA score of ≥4 | 19 (48) | 26 (65) | 20 (50) | 65 (54) |
| Baseline weekly average of daily PP-NRS score | 7.38 ± 1.62 | 7.48 ± 1.38 | 7.42 ± 1.62 | 7.43 ± 1.53 |
| Baseline %BSA affected by AD | 42.96 ± 22.59 | 47.86 ± 22.00 | 43.31 ± 23.01 | 44.71 ± 22.46 |
| %BSA affected by AD | ||||
| ≥10 to <30 | 13 (32) | 10 (25) | 14 (35) | 37 (31) |
| ≥30 to <50 | 13 (32) | 17 (42) | 13 (32) | 43 (36) |
| ≥50 | 14 (35) | 13 (32) | 13 (32) | 40 (33) |
| Baseline DLQI score | 19.60 ± 5.90 | 17.90 ± 5.70 | 17.50 ± 6.40 | 18.30 ± 6.00 |
| Medical history reported in ≥10% of patients | ||||
| Rhinitis allergic | 14 (35) | 16 (40) | 16 (40) | 46 (38) |
| Hyperlipidemia | 8 (20) | 4 (10) | 2 (5) | 14 (12) |
| Hepatic steatosis | 7 (18) | 5 (12) | 2 (5) | 14 (12) |
| Hyperuricemia | 6 (15) | 4 (10) | 3 (8) | 13 (11) |
| Asthma | 2 (5) | 5 (12) | 6 (15) | 13 (11) |
| Conjunctivitis* | 2 (5) | 4 (10) | 2 (5) | 8 (7) |
| Eczema | 4 (10) | 1 (2) | 2 (5) | 7 (6) |
| Prior systemic treatment | ||||
| Systemic glucocorticoids | 6 (15) | 9 (22) | 5 (12) | 20 (17) |
| Immunosuppressants | 3 (8) | 3 (8) | 4 (10) | 10 (8) |
| JAK inhibitors | 3 (8) | 2 (5) | 0 | 5 (4) |
| Dupilumab | 2 (5) | 3 (8) | 0 | 5 (4) |
Data are presented as n (%) or mean ± standard deviation, unless otherwise indicated. *Conjunctivitis (MedDRA preferred term) included conjunctivitis and conjunctivitis allergic.%BSA: Percentage of body surface area; AD: Atopic dermatitis; BMI: Body mass index; DLQI: Dermatology Life Quality Index; EASI: Eczema Area and Severity Index; IGA: Investigator's Global Assessment; JAK: Janus kinase inhibitors; MedDRA: Medical Discovery for Regulatory Activities; PP-NRS: Peak pruritus Numerical Rating Scale.