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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02008890 | Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab | PHASE3 | COMPLETED | 237 | — | — | Dec 26, 2013 | May 31, 2017 | Jan 4, 2019 | 68 | Austria, Belgium +8 |
The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.
| Arm | Type | Description |
|---|---|---|
| Secukinumab 300mg | EXPERIMENTAL | Secukinumab 300mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 300mg at 4-weekly intervals starting Week 52 up to Week 148. |
| Secukinumab 150mg | EXPERIMENTAL | Secukinumab 150mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48. In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19. For extension period: Secukinumab 150mg at 4-weekly intervals starting Week 52 up to Week 148. |
| Placebo | PLACEBO_COMPARATOR | Placebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148. |
| Name | Type | Description |
|---|---|---|
| Secukinumab 300mg | BIOLOGICAL | Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered |
| Secukinumab 150mg | BIOLOGICAL | secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered |
| Placebo | BIOLOGICAL | secukinumab placebo s.c. (two PFS injections of placebo) self-administered |
Inclusion Criteria: * Palmoplantar pustular psoriasis for at least 6 months before Randomization * Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by: * ppPASI score of ≥ 12 and * DLQI ≥ 10 * Candidate for systemic therapy, defined as having palmoplantar pustular psor...