See our clinical trial data in adults and adolescents below
Studied across monotherapy and concomitant TCS trials1
| CHRONOS1,2 | SOLO 11,3 | SOLO 21,3 | ||
| Trial Overview | Number of patients | 421 | 448 | 469 |
| Design | Randomized, phase 3, double-blind | |||
| Duration | 52 weeks | 16 weeks | 16 weeks | |
| Treatment arms | DUPIXENT + TCS vs placebo + TCSa |
DUPIXENT monotherapy vs placebo | ||
| Dosinga | Initial loading dose: 600 mg (2 x 300 mg) Followed by: 300 mg Q2W (1 x 300 mg) |
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| Primary endpoint | IGA 0 (clear) or 1 (almost clear), and ≥2-point improvement at Week 16 | |||
| Secondary endpoints | ≥75% improvement in lesion extent and severity (EASI-75) ≥4-point reduction in Peak Pruritus NRS |
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| Baseline Disease Severityb | IGA 3c (moderate disease) |
52.5% | 51.2% | 51.0% |
| IGA 4c (severe disease) |
47.5% | 48.7% | 49.0% | |
| Mean EASI score (out of 72) |
32.9 | 33.7 | 32.7 | |
| Mean BSA | 57.6% | 56.1% | 53.5% | |
| Mean Peak Pruritus NRSd (out of 10) |
7.3 | 7.3 | 7.5 | |
| CHRONOS1,2 | |
| Trial Overview | |
| Number of patients | 421 |
| Design | Randomized, phase 3, double-blind |
| Duration | 52 weeks |
| Treatment arms | DUPIXENT + TCS vs placebo + TCSa |
| Dosinga | Initial loading dose: 600 mg (2 x 300 mg) Followed by: 300 mg Q2W (1 x 300 mg) |
| Primary endpoint | IGA 0 (clear) or 1 (almost clear), and ≥2-point improvement at Week 16 |
| Secondary endpoints | ≥75% improvement in lesion extent and severity (EASI-75) |
| ≥4-point reduction in Peak Pruritus NRS |
|
| Baseline Disease Severityb | |
| IGA 3c (moderate disease) |
52.5% |
| IGA 4c (severe disease) |
47.5% |
| Mean EASI score (out of 72) |
32.9 |
| Mean BSA | 57.6% |
| Mean Peak Pruritus NRSd (out of 10) |
7.3 |
| SOLO 11,3 | |
| Trial Overview | |
| Number of patients | 448 |
| Design | Randomized, phase 3, double-blind |
| Duration | 16 weeks |
| Treatment arms | DUPIXENT monotherapy vs placebo |
| Dosinga | Initial loading dose: 600 mg (2 x 300 mg) Followed by: 300 mg Q2W (1 x 300 mg) |
| Primary endpoint | IGA 0 (clear) or 1 (almost clear), and ≥2-point improvement at Week 16 |
| Secondary endpoints | ≥75% improvement in lesion extent and severity (EASI-75) |
| ≥4-point reduction in Peak Pruritus NRS |
|
| Baseline Disease Severityb | |
| IGA 3c (moderate disease) |
51.2% |
| IGA 4c (severe disease) |
48.7% |
| Mean EASI score (out of 72) |
33.7 |
| Mean BSA | 56.1% |
| Mean Peak Pruritus NRSd (out of 10) |
7.3 |
| SOLO 21,3 | |
| Trial Overview | |
| Number of patients | 469 |
| Design | Randomized, phase 3, double-blind |
| Duration | 16 weeks |
| Treatment arms | DUPIXENT monotherapy vs placebo |
| Dosinga | Initial loading dose: 600 mg (2 x 300 mg) Followed by: 300 mg Q2W (1 x 300 mg) |
| Primary endpoint | IGA 0 (clear) or 1 (almost clear), and ≥2-point improvement at Week 16 |
| Secondary endpoints | ≥75% improvement in lesion extent and severity (EASI-75) |
| ≥4-point reduction in Peak Pruritus NRS |
|
| Baseline Disease Severityb | |
| IGA 3c (moderate disease) |
51.0% |
| IGA 4c (severe disease) |
49.0% |
| Mean EASI score (out of 72) |
32.7 |
| Mean BSA | 53.5% |
| Mean Peak Pruritus NRSd (out of 10) |
7.5 |
aIn CHRONOS, as needed, subjects received topical calcineurin inhibitors for problem areas only, such as the face, neck, and intertriginous and genital areas.1
bDisease severity at baseline was defined by an IGA score ≥3, an EASI score of ≥16, and BSA involvement of ≥10%.1
cIGA scale was defined as 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.4
dWeekly averaged Peak Pruritus NRS score (10 indicates the most severe).1
Watch healthcare providers discuss AD and treatment with DUPIXENT
AD, atopic dermatitis; BSA, body surface area; EASI, Eczema Area and Severity Index; IGA, Investigator's Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; TCS, topical corticosteroids.