| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03066609 | Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis | PHASE3 | COMPLETED | 543 | — | — | Feb 28, 2017 | Nov 20, 2018 | Dec 30, 2019 | 32 | China, Hungary +4 |
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...