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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This is a phase IV, single-center, open label, single arm study in which a group of 30 subjects with moderate to severe plaque psoriasis will receive secukinumab therapy. Non-invasive imaging with optical coherence tomography (OCT) will be used to monitor the resolution of psoriatic plaques with treatment in comparison to observed clinical improvements. Early subclinical finding will be used to elucidate drug mechanism of action. Assessment will be based on intrasubject comparisons, and all findings will be compared to patients baseline imaging.
Secukinumab, an anti-IL-17A monoclonal antibody, is an effective treatment for moderate to severe plaque psoriasis.While there is an abundance of clinical data in the literature supporting the clinical efficacy of this therapy, there is limited data on early disease clearance and other histologic findings elucidating a drug mechanism of action. Hyper-proliferation of the epidermis and inflammation of dermis seen in psoriasis are thought to be due to persistent T-cell activation and production of several pro-inflammatory cytokines by dermal immune reaction. Therefore, with treatments with immunomodulatory effects, such as Secukinumab, monitoring markers of inflammation, angiogenesis, and collagen synthesis would be useful in establishing mechanism of action. While a skin biopsy can show these findings at one moment in time, it does not allow for repetitive monitoring overtime. The investigators propose the use of non-invasive imaging with Optical Coherence Tomography (OCT) to demonstrate histologic features of plaque psoriasis not clinically evident. Upon completion of the study, the investigators will assess when OCT improvements of psoriasis treatment are detectable and how these findings correlate to observed clinical improvements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Cosentyx (Secukinumab) 300 mg subcutaneous injection at weeks 0, 1, 2, 3 and 4 followed by every 4 weeks until 16 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Drug | Secukinumab 300 mg subcutaneous injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Elucidate drug mechanism of action by monitoring morphologic changes in lesional vs. perilesional psoriatic plaques using optical coherence tomography (OCT). | 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. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bethanne Wenzel | Contact | (718) 836-6600 | 8924 | bethanne.wenzel@va.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA NY Harbor Healthcare System | Recruiting | Brooklyn | New York | 11209 | United States |
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| 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 | 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 | week 16 |
| ID | Term |
|---|---|
| C555450 | secukinumab |
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