Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Secukinumab
secukinumab low dose · 2 trials · 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 body: 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. PASI 100 indicates patients who have achieved a complete resolution of all disease.
Investigator will assess the disease using the validated Investigator Global Assessment (IGA) mod 2011 and rate the disease from a score of 0 (clear skin) to 4 (severe disease)
A subject was considered as a PASI 90 responder if s/he achieved a reduction of 90% or more of the PASI score, compared to baseline, at a given time point.The head, trunk, upper limbs and lower limbs were assessed separately for erythema, thickening, and scaling. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, i.e., higher scores represent more severity.
| Arm | Type | Description |
|---|---|---|
| secukinumab low dose | EXPERIMENTAL | secukinumab low dose |
| secukinumab high dose | EXPERIMENTAL | secukinumab high dose |
| Secukinumab 300 mg every 2 weeks (Q2W) | EXPERIMENTAL | 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment. |
| Secukinumab 300 mg every 4 weeks (Q4W) | ACTIVE_COMPARATOR | 2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group. |
| Secukinumab 300 mg every 4 weeks non-responders up-titration (Q4W NR up) | ACTIVE_COMPARATOR | 2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16). |
| Name | Type | Description |
|---|---|---|
| secukinumab low dose | DRUG | dose depends on the weight group |
| secukinumab high dose | DRUG | dose depends on the weight group |
| secukinumab 150 mg | DRUG | sub-cutaneous secukinumab prefilled syringe 150 mg |
Inclusion Criteria: 1. Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed. 2. Must be 6 to less than 18 years of age at the time of randomization 3. Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IG...
Secukinumab is used for chronic plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, and moderate to severe chronic plaque-type psoriasis. It is being studied in clinical trials for these conditions, including active psoriatic arthritis with axial skeleton involvement.
Secukinumab is a monoclonal antibody, indicated by its -mab suffix. It is being developed for immunology indications, including psoriatic arthritis and giant cell arteritis, and is in Phase 3 clinical trials for several of these conditions.
Secukinumab is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. The company is conducting clinical trials of Secukinumab across multiple countries, including the United States, Germany, and the United Kingdom.
Secukinumab is in Phase 3 clinical development for conditions such as axial psoriatic arthritis and giant cell arteritis. It has also completed Phase 1 and Phase 2 trials. Secukinumab is an investigational drug and is not approved for the indications being studied.
Secukinumab has been studied in clinical trials including NCT02721966 for active psoriatic arthritis with axial skeleton involvement, NCT03765788 for giant cell arteritis, NCT05380453 for new onset giant cell arteritis, and NCT06130540 for giant cell arteritis or polymyalgia rheumatica.
Secukinumab is the generic name for the drug also known as Cosentyx. It is a monoclonal antibody developed by Novartis AG for immunology indications such as psoriasis and psoriatic arthritis.