Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Skin biopsies · 1 trial · 1 indication
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...
Skin biopsies is an investigational approach being studied in Chronic Plaque-type Psoriasis, a dermatologic condition. It is currently in Phase 2 clinical development. The therapy is being evaluated for its potential role in this indication, though it remains investigational and has not been approved for any use.
Skin biopsies is being developed by Novartis AG, a global healthcare company traded under the ticker NVS. The company is conducting clinical research on this investigational therapy for Chronic Plaque-type Psoriasis. As of the available data, the program is in Phase 2 development.
Skin biopsies is in Phase 2 clinical development. It is an investigational therapy being studied for Chronic Plaque-type Psoriasis. The therapy has not been approved by regulatory authorities and remains in clinical trials to evaluate its safety and efficacy.
Skin biopsies has one completed clinical trial, NCT03553823, titled 'Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab'. This Phase 2 study enrolled 40 participants with Chronic Plaque-type Psoriasis across the United States, Canada, and Germany. The trial was active-controlled and randomized.
Skin biopsies is not the same as secukinumab or guselkumab. The clinical trial NCT03553823 compares secukinumab versus guselkumab in clearing psoriatic plaques, and skin biopsies are used as a research tool within that study. Skin biopsies itself is not a drug but a procedure used to assess treatment response.