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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03553823 | Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab | PHASE2 | COMPLETED | 40 | — | — | Jan 14, 2019 | Jan 28, 2020 | Oct 11, 2021 | 14 | United States, Canada +1 |
Total clinical score: number (%) of subjects who responded at Week 16 (FAS)
| Arm | Type | Description |
|---|---|---|
| secukinumab | EXPERIMENTAL | 20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered 300 mg secukinumab as two 150-mg s.c. injections at Baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 12 inclusive |
| Guselkumab | ACTIVE_COMPARATOR | 20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered guselkumab as 100 mg s.c. injections at Baseline, Weeks 4, and 12. |
| Name | Type | Description |
|---|---|---|
| Skin biopsies | PROCEDURE | At Baseline, two 6-mm punch biopsies were taken, one from the identified active plaque (TCS ≥ 6) and one from never-lesional skin. At the End-of-study Visit, one biopsy was taken from the same area of the active plaque sampled at Baseline. |
Inclusion Criteria: Chronic plaque-type psoriasis considered inadequately controlled after treatment with ustekinumab according to the following criteria-: * Ustekinumab administered at a dose equal or higher than that on the label for at least 24 weeks. The last administration must be at least 12...