Secukinumab Therapy for the Treatment of Moderate to Severe Plaque Psoriasis With Response Monitoring Using Optical Coherence Tomography (OCT).
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|ClinicalTrials.gov Identifier: NCT03307447|
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Vulgaris||Drug: Secukinumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Secukinumab Therapy for the Treatment of Moderate to Severe Plaque Psoriasis With Response Monitoring Using Optical Coherence Tomography (OCT).|
|Actual Study Start Date :||December 19, 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||September 2021|
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
Secukinumab 300 mg subcutaneous injection
Other Name: cosentyx
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307447
|Contact: Bethanne Wenzel||(718) 836-6600 ext email@example.com|
|United States, New York|
|VA NY Harbor Healthcare System||Recruiting|
|Brooklyn, New York, United States, 11209|
|Contact: Bethanne Wenzel 718-836-6600 Bethanne.firstname.lastname@example.org|
|Principal Investigator: Orit Markowitz, MD|
|Sub-Investigator: Daniel Siegel, MD|