|Study Design:||Intervention Model: Single Group Assignment|
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Secukinumab Therapy for the Treatment of Moderate to Severe Plaque Psoriasis With Response Monitoring Using Optical Coherence Tomography (OCT).|
- Elucidate drug mechanism of action by monitoring morphologic changes in lesional vs. perilesional psoriatic plaques using optical coherence tomography (OCT). [ Time Frame: week 12 ]Lesional and peri-lesional skin will be monitored using OCT for improvement from baseline by measuring changes epidermal, dermal and DEJ, as well as changes in vasculature.
- Compare timing of subclinical improvement on OCT to the proportion of patients who achieve a reduction in PASI score by at least 75% (PASI 75) and/or score of 0 or 2-point improvement on the IGA (mod 2011) by week 12. [ Time Frame: week 12 ]The proportion of subjects who have a reduction of 75% or more from baseline in the psoriasis area-and-severity index score (PASI 75) or achieve a score of 0 on IGA, or at least a 2 point improvement, at week 12.
- Compare the onset/timing of subclinical improvement on OCT imaging to patients who achieve a 90% or 100% (PASI 90 and PASI 100) improvement from baseline in the PASI [ Time Frame: week 16 ]a. To compare the onset/timing of subclinical improvement on OCT imaging to patients who achieve a 90% or 100% (PASI 90 and PASI 100) improvement from baseline in the PASI by week 16
|Anticipated Study Start Date:||October 2017|
|Estimated Study Completion Date:||September 2019|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
| Experimental: Treatment arm|
Cosentyx (Secukinumab) 300 mg subcutaneous injection at weeks 0, 1, 2, 3 and 4 followed by every 4 weeks until 16 weeks
| Drug: Secukinumab|
Secukinumab 300 mg subcutaneous injection
Other Name: cosentyx