Psoriasis Clinical Trial
Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients
Summary
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.
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
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
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There are 12 Locations for this study
Birmingham Alabama, 35205, United States
Pasadena California, 91105, United States
Indianapolis Indiana, 46256, United States
St. Louis Missouri, 63117, United States
East Windsor New Jersey, 08520, United States
Verona New Jersey, 07044, United States
New York New York, 10065, United States
Rochester New York, 14623, United States
High Point North Carolina, 27262, United States
Dallas Texas, 75230, United States
Houston Texas, 77030, United States
Norfolk Virginia, 23507, United States
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