Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Secukinumab auto-injector · 1 trial · 1 indication
Percentage of participants who achieve ≥ 75% reduction in PASI compared to baseline. A PASI (Psoriasis Area and Severity Index) score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).
Percentage of participants who achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline. This scale ranges from 0 (clear, no signs of psoriasis) to 4 (severe).
| Arm | Type | Description |
|---|---|---|
| Placebo 2 mL auto-injector | PLACEBO_COMPARATOR | Placebo to secukinumab s.c., provided in 2 mL auto-injector form |
| Placebo 1 mL prefilled syringe | PLACEBO_COMPARATOR | Placebo to secukinumab s.c., provided in 2 \* 1 ml prefilled syringe form |
| Secukinumab 2 mL auto-injector | EXPERIMENTAL | Secukinumab 300 mg provided in 2 mL auto-injector form |
| Secukinumab 1 mL prefilled syringe | ACTIVE_COMPARATOR | Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL |
| Name | Type | Description |
|---|---|---|
| Placebo 2 mL auto-injector | DRUG | All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48 |
| Placebo 1 mL prefilled syringe | DRUG | All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48 |
| Secukinumab 2 mL auto-injector | DRUG | 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15 , 16 and 4-weekly thereafter until week 48 |
| Secukinumab 1 mL prefilled syringe | DRUG | 2 x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48 |
Inclusion Criteria: Subjects eligible for inclusion in this study must have fulfilled all of the following criteria: 1. Men or Women of at least 18 years of age at time of Screening 2. Subjects able to understand and communicate with the investigator and comply with the requirements of the study a...
Secukinumab auto-injector is used for the treatment of moderate to severe plaque psoriasis. It is an investigational therapy being developed by Novartis AG for this dermatological condition. The drug is administered via a 2 mL auto-injector device delivering a 300 mg dose.
Secukinumab auto-injector targets interleukin-17A (IL-17A), a cytokine involved in the inflammatory response that drives plaque psoriasis. By binding to IL-17A, the drug aims to reduce the inflammation and skin symptoms associated with the condition.
Secukinumab auto-injector is developed by Novartis AG, a global pharmaceutical company traded on the NYSE under the ticker NVS. Novartis is conducting clinical trials to evaluate the efficacy and safety of this formulation for plaque psoriasis.
Secukinumab auto-injector is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed to assess its efficacy and safety in patients with moderate to severe plaque psoriasis.
Secukinumab auto-injector was evaluated in a Phase 3 clinical trial with the identifier NCT03589885. This randomized, double-blind, placebo-controlled study enrolled 122 participants with moderate to severe plaque psoriasis and was conducted in the United States, Canada, Germany, Iceland, Poland, and Spain.
Secukinumab auto-injector is a formulation of secukinumab, a biologic that targets IL-17A. The auto-injector version delivers a 300 mg dose in a 2 mL volume, designed for self-administration. It is being studied specifically for plaque psoriasis.