Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Secukinumab form · 1 trial · 1 indication
Number of participants who achieved ≥ 75% reduction in PASI compared to baseline PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo, provided in a 2 mL pre-filled syringe Placebo, provided in a 1 mL pre-filled syringe |
| Secukinumab 2 mL form | EXPERIMENTAL | Secukinumab 300 mg, provided in a 2 mL pre-filled syringe |
| Secukinumab 1 mL form | ACTIVE_COMPARATOR | Secukinumab 300 mg provided in 2 pre-filled syringes of 1 mL/150 mg (current approved form) |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | 2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48 |
| Secukinumab 2 mL form | DRUG | Secukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48 |
| Secukinumab 1 mL form | DRUG | Secukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48 |
Inclusion Criteria: Subjects eligible for inclusion in this study must fulfill all of the following criteria: 1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before...
Secukinumab form is an investigational small molecule being studied for the treatment of psoriasis. It is currently in Phase 3 clinical development. The drug is being evaluated in a completed clinical trial that enrolled 214 participants with psoriasis.
Secukinumab form is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with psoriasis.
Secukinumab form is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial for psoriasis has been completed, and the drug remains under investigation.
Secukinumab form has one completed Phase 3 clinical trial registered under NCT02748863, titled 'Study of Secukinumab With 2 mL Pre-filled Syringes'. This randomized, double-blind, placebo-controlled trial enrolled 214 participants with psoriasis across multiple countries.
Secukinumab form is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for psoriasis. The drug has completed a clinical trial, but it has not received regulatory approval and remains under investigation.