Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Scalp Psoriasis

In brief

This study will assess the efficacy and safety of secukinumab compared to placebo in adult patients who have moderate to severe scalp psoriasis that is poorly controlled by current psoriasis treatments.

Key facts

Study ID

NCT02267135

Run by

Novartis Pharmaceuticals

People needed

102

Starts

2014-09-29

Expected to finish

2015-12-07

Last updated by the study team

2021-01-05

Who can join

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

You may qualify if…

• Chronic scalp psoriasis for at least the previous six months
• Moderate to severe scalp psoriasis as defined by a PSSI score of ≥12 and 30% or higher of scalp surface area affected
• Must be candidates for systemic therapy, which means having scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.

You may not qualify if…

• Forms of psoriasis other than chronic plaque
• Drug-induced psoriasis (e.g., new onset or current exacerbation from β-blockers, calcium channel inhibitors)
• Ongoing use of prohibited treatments (e.g., topical or systemic corticosteroids, UV therapy)
• Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL17A or IL-17RA receptors
• Use of other investigational drugs within 30 days prior to study entry, or within a period of 5 half-lives of the investigational treatment, whichever is longer
• Active, ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab
• Active system infections (with the exception of the common cold) during the two weeks prior to starting study treatment
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Trumbull, Connecticut, United States
• Novartis Investigative Site — Rockville, Maryland, United States
• Novartis Investigative Site — Andover, Massachusetts, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Troy, Michigan, United States
• Novartis Investigative Site — East Windsor, New Jersey, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Winston-Salem, North Carolina, United States
• Novartis Investigative Site — Gahanna, Ohio, United States
• Novartis Investigative Site — Hershey, Pennsylvania, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Arlington, Texas, United States
• Novartis Investigative Site — Salt Lake City, Utah, United States
• Novartis Investigative Site — West Jordan, Utah, United States

Full record on ClinicalTrials.gov

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