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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03589885 | Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis | PHASE3 | COMPLETED | 122 | — | — | Dec 19, 2018 | Aug 5, 2020 | Oct 11, 2021 | 22 | United States, Canada +4 |
Percentage of participants who achieve ≥ 75% reduction in PASI compared to baseline. A PASI (Psoriasis Area and Severity Index) score is a tool used to measure the severity and extent of psoriasis. The score ranges from 0 (no signs of psoriasis) to a theoretic maximum of 72. The intensity of redness, thickness and scaling of the psoriasis is assessed as none (0), mild (1), moderate (2), severe (3) or very severe (4).
Percentage of participants who achieve IGA mod 2011 0 or 1, and improved by at least 2 points on the IGA scale compared to baseline. This scale ranges from 0 (clear, no signs of psoriasis) to 4 (severe).
| Arm | Type | Description |
|---|---|---|
| Placebo 2 mL auto-injector | PLACEBO_COMPARATOR | Placebo to secukinumab s.c., provided in 2 mL auto-injector form |
| Placebo 1 mL prefilled syringe | PLACEBO_COMPARATOR | Placebo to secukinumab s.c., provided in 2 \* 1 ml prefilled syringe form |
| Secukinumab 2 mL auto-injector | EXPERIMENTAL | Secukinumab 300 mg provided in 2 mL auto-injector form |
| Secukinumab 1 mL prefilled syringe | ACTIVE_COMPARATOR | Secukinumab 300 mg provided as 2x 1 mL prefilled syringe of 150 mg/mL |
| Name | Type | Description |
|---|---|---|
| Placebo 2 mL auto-injector | DRUG | All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48 |
| Placebo 1 mL prefilled syringe | DRUG | All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8. PASI 90 responders at week 12: 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48. PASI 90 non-responders at week 12: 2x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48 |
| Secukinumab 2 mL auto-injector | DRUG | 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15 , 16 and 4-weekly thereafter until week 48 |
| Secukinumab 1 mL prefilled syringe | DRUG | 2 x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48 |
Inclusion Criteria: Subjects eligible for inclusion in this study must have fulfilled all of the following criteria: 1. Men or Women of at least 18 years of age at time of Screening 2. Subjects able to understand and communicate with the investigator and comply with the requirements of the study a...