NCT03307447

Secukinumab Therapy for the Treatment of Moderate to Severe Plaque Psoriasis With Response Monitoring Using Optical Coherence Tomography (OCT).

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Narrows Institute for Biomedical Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	Secukinumab	Secukinumab 300 mg subcutaneous injection

Timeline

• Start date: 2017-12-19
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2017-10-11
• Last updated: 2021-09-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study