Exploratory Evaluation of Biomarkers Associated With Treatment Response to Cosentyx (Secukinumab) in Psoriasis Patients (BIOMARKER)
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|ClinicalTrials.gov Identifier: NCT03149900|
Recruitment Status : Active, not recruiting
First Posted : May 11, 2017
Last Update Posted : April 17, 2019
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.
|Condition or disease||Intervention/treatment|
|Psoriasis Vulgaris||Drug: Secukinumab|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Exploratory Evaluation of Biomarkers Associated With Treatment Response to Cosentyx (Secukinumab) in Psoriasis Patients|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2020|
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).
See Arm Description
Other Name: Cosentyx
- Change in skin microbiome composition [ Time Frame: from baseline to week 24 ]Investigation of skin microbiome composition associated with treatment response in psoriasis patients treated with Secukinumab
- Change in antimicrobial peptide composition [ Time Frame: from baseline to week 24 ]Investigation of antimicrobial peptide composition associated with treatment response in psoriasis patients treated with Secukinumab
- Change in gene expression [ Time Frame: from baseline to week 24 ]Investigation of gene expression in RNA and DNA associated with treatment response in psoriasis patients treated with Secukinumab
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149900
|University Clinic Schleswig-Holstein|
|Lubeck, Schleswig-Holstein, Germany, 23538|
|Principal Investigator:||Diamant Thaci, Prof. Dr.||University of Luebeck|