Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Experimental: Secukinumab low dose · 1 trial · 1 indication
Psoriasis Area and Severity Index (PASI):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, trunk, upper limbs and lower limbs); 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,Thickening (plaque elevation, induration) \& Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head: 0.1, upper limbs: 0.2 trunk: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number) of patients who have achieved a 75% or more reduction in their PASI score from baseline.
IGA: The IGA mod 2011 scale has following different scores for the state of disease: 0: Clear, No signs of psoriasis. 1: Almost clear 2: Mild 3: Moderate 4 : Severe
| Arm | Type | Description |
|---|---|---|
| Secukinumab low dose | EXPERIMENTAL | Secukinumab |
| Secukinumab high dose | EXPERIMENTAL | Secukinumab |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Etanercept Comparator | ACTIVE_COMPARATOR | Etanercept |
| Name | Type | Description |
|---|---|---|
| Experimental : Secukinumab low dose | BIOLOGICAL | Depending on weight group subject will receive per dose a) 75 mg if weighing less than 50 kg b) 150 mg if weighing 50 kg or more. Secukinumab injections (one or two per dose, depending on the weight group) will be administered subcutaneously at Randomization, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48, and Placebo secukinumab at Weeks 13, 14 and 15 during the blinded phase of the study; thereafter at Week 52 and every 4 weeks during the extension treatment period until Week 232. |
| Experimental: Secukinumab high dose | BIOLOGICAL | Depending on weight group subject will receive per dose a) 75 mg if weighing less than 25 kg b) 150 mg if weighing between 25 and less than 50 kg c) 300 mg if weighing more than 50 kg. Secukinumab injections (one or two per dose, depending on the weight group) will be administered subcutaneously at Randomization, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48, and Placebo secukinumab at Weeks 13, 14 and 15 during the blinded phase of the study; thereafter at Week 52 and every 4 weeks during the extension treatment period until Week 232. |
| Placebo Comparator: Secukinumab Placebo | BIOLOGICAL | Placebo secukinumab (one or two subcutaneous injections per dose, depending on weight group) at Randomization and Weeks 1, 2, 3 4 and 8. At Week 12, subjects in the placebo group based on their PASI 75 response status at Week 12 will proceed as follows: • PASI 75 responders will discontinue study treatment at Week 12 and enter the treatment-free follow-up period • PASI 75 non-responders will receive high dose or low dose secukinumab, according to the pre-assignment at the Randomization visit. They will receive their treatment based on the weight category(\<25 kg, 25- \<50kg, ≥50 kg), on Weeks 12, 13, 14, 15, and then every four weeks starting at Week 16 until Week 48 during the maintenance period; thereafter at week 52 and every 4 weeks during the extension treatment period until Week 232. |
| Active Comparator: Etanercept | BIOLOGICAL | Etanercept 0.8 mg/kg of subject weight and up to a maximum of 50 mg per dose. Subcutaneous etanercept 0.8 mg/kg (one or two injections per dose) once per week, for 51 weeks administered at home (self-injected or by caregiver) or at the study site. At Wk 52 subjects in the etanercept group will move into the treatment-free follow up period and terminate the study. |
Inclusion criteria: * Must be 6 to less than 18 years of age at the time of randomization * Plaque-type psoriasis history for at least 3 months. Severe plaque-type psoriasis meeting all of the following three criteria: * PASI score of 20 or greater, * Investigator's Global Assessment (IGA) score ...
Secukinumab low dose is an investigational monoclonal antibody being studied for the treatment of chronic severe plaque-type psoriasis. It is being evaluated in a Phase 3 clinical trial in pediatric patients aged 6 years and older. The drug is developed by Novartis AG.
Secukinumab low dose is a monoclonal antibody that targets and neutralizes interleukin-17A, a key cytokine involved in the inflammatory process of psoriasis. By blocking this signaling pathway, the drug aims to reduce the skin inflammation and lesions associated with chronic severe plaque-type psoriasis.
Secukinumab low dose is developed by Novartis AG, a multinational pharmaceutical company headquartered in Basel, Switzerland. Novartis is listed on the New York Stock Exchange under the ticker symbol NVS.
Secukinumab low dose is in Phase 3 clinical development. It is currently being evaluated in a completed Phase 3 trial for chronic severe plaque-type psoriasis in pediatric patients. The drug is investigational and has not been approved by regulatory authorities for this indication.
Secukinumab low dose is associated with one completed Phase 3 clinical trial, identified by the National Clinical Trial number NCT02471144. This study, titled 'Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis,' enrolled 162 participants across multiple countries including the United States, Belgium, France, and Japan.
Secukinumab low dose is a specific dosing regimen of the drug secukinumab, which is a monoclonal antibody targeting interleukin-17A. While the active ingredient is the same, the low dose formulation is being studied separately in pediatric patients with chronic severe plaque-type psoriasis, as opposed to the standard adult dosing.