Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Psoriasis, Plaque-type Psoriasis

In brief

This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.

Key facts

Study ID

NCT01537432

Run by

Novartis Pharmaceuticals

People needed

36

Starts

2012-01-01

Expected to finish

2014-12-01

Last updated by the study team

2016-01-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic plaque-type psoriasis diagnosed for at least 6 months
• Moderate to severe psoriasis as defined by: PASI score of ≥12, IGA score of ≥3, BSA (body surface area) affected by plaque-type psoriasis of ≥10%
• Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy

You may not qualify if…

• Forms of psoriasis other than chronic plaque-type
• Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
• History or evidence of active tuberculosis or evidence of latent tuberculosis (or other infections like Hepatitis-C/B), malignancy; active or known use of other immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening visit
• Pregnant or nursing (lactating) women

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Pasadena, California, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — East Windsor, New Jersey, United States
• Novartis Investigative Site — Verona, New Jersey, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Rochester, New York, United States
• Novartis Investigative Site — High Point, North Carolina, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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