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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02525094 | Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis | PHASE2 | COMPLETED | 113 | — | — | Aug 15, 2015 | Jul 15, 2016 | Feb 15, 2018 | 29 | United States, Australia +4 |
The eczema area and severity index (EASI) evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI50 responder defined as a participant who achieved at least 50% reduction in EASI score from baseline.
| Arm | Type | Description |
|---|---|---|
| MEDI9929 280 mg | EXPERIMENTAL | Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10. |
| Name | Type | Description |
|---|---|---|
| MEDI9929 | BIOLOGICAL | Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10. |
| Placebo | BIOLOGICAL | Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10. |
Inclusion Criteria: * AD meeting Hanifin and Rajka criteria * Age 18-75 years inclusive at screening * Atopic dermatitis that affects greater than/equal to 10% body surface area * Moderate to severe AD * Effective birth control in line with protocol details Exclusion Criteria: * Active dermatolog...