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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02001181 | Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema) | PHASE2 | COMPLETED | 69 | — | — | Dec 1, 2013 | Sep 1, 2014 | Oct 15, 2015 | 5 | Canada |
The EASI quantifies the severity of a participant's atopic dermatitis based on both lesion severity and the percent of BSA affected. The EASI is a composite scoring by the atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. What is reported is the percent change from baseline in EASI scores.
| Arm | Type | Description |
|---|---|---|
| Treatment group A | EXPERIMENTAL | - |
| Treatment B | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Tofacitinib ointment 20mg/g | DRUG | Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks |
| Placebo ointment (Vehicle) | DRUG | Placebo ointment (vehicle) twice daily (BID) for 4 weeks |
Inclusion Criteria: * Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at least 6 months prior to Day 1 that has been clinically stable for at least 1 month prior to Day 1 and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka. * Have...