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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01552629 | A Study Evaluating the Safety and Efficacy of QGE031 in Atopic Dermatitis Patients | PHASE2 | COMPLETED | 22 | — | — | Jan 5, 2012 | Aug 28, 2013 | Feb 23, 2017 | 4 | Austria, France +1 |
Efficacy response will be assessed using EASI.
| Arm | Type | Description |
|---|---|---|
| Group 1 QGE031 | EXPERIMENTAL | QGE031 will be administered as a subcutaneous dose q2 weeks |
| Group 2 Placebo | PLACEBO_COMPARATOR | A QGE031 matched placebo will be administered as a subcutaneous dose q2 weeks |
| Group 3 Cyclosporine A | EXPERIMENTAL | Cyclosporine A will be administered (as per label) for atopic dermatitis. |
| Name | Type | Description |
|---|---|---|
| QGE031 | DRUG | - |
| Placebo | DRUG | - |
| Cyclosporine A | DRUG | - |
Key Inclusion criteria: * Male and female patients 18 to 65 years of age inclusive (at the time of the screening visit), and who passed screening examinations by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests. * Presence of atopic dermatitis confirm...