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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04504279 | Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis | PHASE2 | COMPLETED | 154 | — | — | Oct 13, 2020 | Aug 19, 2021 | Sep 16, 2021 | 15 | United States |
The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16
| Arm | Type | Description |
|---|---|---|
| FB-401 | EXPERIMENTAL | FB-401 applied topically for 16 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo applied topically for 16 weeks. |
| Name | Type | Description |
|---|---|---|
| FB-401 | BIOLOGICAL | Topical application |
| Placebo | BIOLOGICAL | Vehicle |
Inclusion Criteria: * Male or female, ≥ 2 years of age * Clinical diagnosis of atopic dermatitis as defined by Hanifin and Rajka criteria that has been present for ≥ 3 months before the screening visit * Investigator Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at Screening and Baselin...