Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02748863 | Study of Secukinumab With 2 mL Pre-filled Syringes | PHASE3 | COMPLETED | 214 | — | — | Dec 12, 2016 | Jun 8, 2018 | Jul 15, 2019 | 52 | United States, Belgium +9 |
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...