Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients

Completed · Phase 4 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

This study provided a comparison of secukinumab to placebo with respect to skin inflammation as measured by skin exams in comparison to skin biopsies, adipose tissue and blood sample analyses.

Key facts

Study ID

NCT03055494

Run by

Novartis Pharmaceuticals

People needed

102

Starts

2017-04-18

Expected to finish

2019-02-26

Last updated by the study team

2023-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent must be obtained before any assessment is performed
• Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to randomization
• Moderate to severe plaque psoriasis as defined at baseline by:
• ≥10% Body Surface Area (BSA) involvement and
• PASI total score of ≥12 and
• IGA mod 2011 score of ≥3 (based on a scale of 0-4)

You may not qualify if…

• Forms of diagnosed psoriasis other than chronic plaque psoriasis
• Medication-induced or medication exacerbated psoriasis
• Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA receptors
• Ongoing use of prohibited treatments
• Pregnant or nursing (lactating) women
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Hot Springs, Arkansas, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Santa Ana, California, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — East Windsor, New Jersey, United States
• Novartis Investigative Site — West Orange, New Jersey, United States
• Novartis Investigative Site — Buffalo, New York, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Webster, Texas, United States
• Novartis Investigative Site — Murray, Utah, United States
• Novartis Investigative Site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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