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

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Narrows Institute for Biomedical Research
Study ID
NCT03307447
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab — DRUG
    Secukinumab 300 mg subcutaneous injection

Study Details

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.

Key Dates

Start date
Dec 19, 2017
Status verified
Oct 2020
Primary completion
Sep 30, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Elucidate drug mechanism of action by monitoring morphologic changes in lesional vs. perilesional psoriatic plaques using optical coherence tomography (OCT). [ Time Frame: week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA NY Harbor Healthcare SystemBrooklynNew York11209
Bethanne Wenzel
[email protected]
718-836-6600
Orit Markowitz, MD (PRINCIPAL_INVESTIGATOR)
Daniel Siegel, MD (SUB_INVESTIGATOR)

Find similar trials in Brooklyn, NY

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
VA NY Harbor Healthcare System· Brooklyn, NY

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