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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02347176 | Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis | PHASE2 | COMPLETED | 204 | — | — | Jan 23, 2015 | Feb 5, 2016 | May 23, 2018 | 57 | United States, Australia +4 |
EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks. |
| Tralokinumab Dose 1 | EXPERIMENTAL | Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks. |
| Tralokinumab Dose 2 | EXPERIMENTAL | Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks. |
| Tralokinumab Dose 3 | EXPERIMENTAL | Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Subcutaneous injection with placebo |
| Tralokinumab Dose 1 | BIOLOGICAL | Subcutaneous injection with tralokinumab |
| Tralokinumab Dose 2 | BIOLOGICAL | Subcutaneous injection with tralokinumab |
| Tralokinumab Dose 3 | BIOLOGICAL | Subcutaneous injection with tralokinumab |
Inclusion Criteria: * Physician diagnosis of atopic dermatitis for greater than (\>) 1 year * Atopic dermatitis involvement of greater than or equal to (\>=) 10 percent (%) body surface area * EASI score of \>= 12 * SCORAD of \>= 25 * IGA score of \>= 3 * Effective birth control in line with protoc...