Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Secukinumab s.c · 1 trial · 1 indication
Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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).
Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. 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.
| Arm | Type | Description |
|---|---|---|
| Secukinumab 150mg | EXPERIMENTAL | Secukinumab 150mg s.c. |
| Secukinumab 300mg | EXPERIMENTAL | Secukinumab 300mg s.c. |
| Placebo | PLACEBO_COMPARATOR | Placebo to secukinumab s.c |
| Name | Type | Description |
|---|---|---|
| Secukinumab 150 mg s.c. | DRUG | 150 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48 |
| Secukinumab 300 mg s.c. | DRUG | 300 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48 |
| Placebo | DRUG | Placebo 150 or 300 mg s.c at randomization, Weeks 1, 2, 3, 4, and 8. PASI responders at week 12 continued to receive placebo till Week 48. PASI non-responders at Week 12 received Secukinumab 300mg at Weeks 12, 13, 14, 15, 16 and every 4 weeks till Week 48 |
Inclusion Criteria: 1. Subjects must give a written, signed and dated informed consent. 2. Men or women at least 18 years of age at time of screening. 3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline. 4. Moderate to severe psoriasis as defined at Baseline...
Secukinumab s.c is used for the treatment of moderate to severe chronic plaque-type psoriasis. It is being developed by Novartis AG for this dermatological condition. The drug is administered subcutaneously and is currently in Phase 3 clinical development for this indication.
Secukinumab s.c is a small molecule that targets interleukin-17A, a cytokine involved in the inflammatory response that drives plaque psoriasis. By inhibiting this target, the drug aims to reduce the skin inflammation and lesions associated with the condition.
Secukinumab s.c is developed by Novartis AG, a global pharmaceutical company listed on the stock exchange under the ticker NVS. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with moderate to severe chronic plaque-type psoriasis.
Secukinumab s.c is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions for the treatment of plaque psoriasis.
Secukinumab s.c has been studied in a Phase 3 clinical trial with the identifier NCT03066609. This randomized, double-blind, placebo-controlled study enrolled 543 participants with moderate to severe chronic plaque-type psoriasis across multiple countries, including China, Hungary, Malaysia, Philippines, Thailand, and Turkey. The trial has been completed.
Secukinumab s.c refers to the subcutaneous formulation of secukinumab, a biologic drug. The 's.c' denotes the route of administration. In the context of clinical trials, it is the same active ingredient, secukinumab, delivered via subcutaneous injection for the treatment of plaque psoriasis.