Microarray Gene Expression Data from Early Skin Biopsies of a Secukinumab Clinical Trial in Psoriasis

The phase II clinical study CAIN457A2223 (NCT01537432) was designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at weeks 4 and 12 following multiple doses of secukinumab, administered subcutaneously, compared to placebo. 36 patients were enrolled in this study, with 24 being randomly assigned to the treatment arm and 12 to the placebo arm. Starting from week 13, all patients received multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. The microarray gene expression data deposited in this dbGaP study are derived from the early (baseline to week 12) skin biopsies of this clinical trial.]]>
Inclusion criteria: Age from 18 to 75 years. 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, 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 e.g., AIDs, RA, organ rejection etc.) at the screening visit. Pregnant or nursing (lactating) women. ]]>