Exploratory Evaluation of Biomarkers Associated With Treatment Response to Cosentyx (Secukinumab) in Psoriasis Patients

Sponsor
Diamant Thaci
Study ID
NCT03149900
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

To identify possible genetic associations of clinical response to anti-IL-17A (Secukinumab) treatment in psoriasis using a combined gene association study and gene expression analysis. To investigate the influence of IL-17A on the cutaneous microbial flora and to analyse cutaneous antimicrobial peptide expression in the skin of patients with psoriasis prior to, and during, treatment with Secukinumab to determine the extent to which the microbial flora is associated with response to treatment, as determined by the PASI75, PASI90, PGA- and DLQI improvement.

Key Dates

Start date
Oct 31, 2016
Status verified
Aug 2019
Primary completion
Jul 25, 2019
Completion
Jul 25, 2019

Study Design

Enrollment
40 participants (actual)

Arms

  • Arm: Secukinumab
    Patients will be recruited in the Comprehensive Center for Inflammation Medicine. The study population will consist of 40 subjects (both male and female), aged 18 years and older, in whom treatment with Secukinumab is clinically indicated and according to the licensed product specifications. The study drug will be prescribed by a doctor who is independent of this study. Visit 1 will be carried out prior to the first injection of Secukinumab. All patients will receive a number and the data will be recorded in a pseudo-anonymised form. No blinding is necessary for investigators or patients (open study), as all patients receive the same treatment (marketed product).

Primary Outcome Measure

Change in skin microbiome composition [ Time Frame: from baseline to week 24 ]

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