Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03912259 | Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis | PHASE3 | COMPLETED | 165 | — | — | Dec 19, 2018 | Feb 14, 2020 | Dec 19, 2023 | 27 | China |
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
| Arm | Type | Description |
|---|---|---|
| Placebo Q2W | PLACEBO_COMPARATOR | Placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (Q2W) for 16 weeks. |
| Dupilumab 300 mg Q2W | EXPERIMENTAL | Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks. |
| Name | Type | Description |
|---|---|---|
| Dupilumab | DRUG | Pharmaceutical form: solution, Route of administration: SC |
| Placebo | DRUG | Pharmaceutical form: solution, Route of administration: SC |
| Emollient (moisturizer) | DRUG | Pharmaceutical form: cream, Route of administration: topical use |
Inclusion criteria: * Male or female, 18 years or older. * AD (according to American Academy of Dermatology Consensus Criteria, 2014) that had been present for at least 3 years before the screening visit. * Eczema Area and Severity Index (EASI) score greater than or equal to (\>=) 16 at the screeni...