Biomarker

Phase 1

• Conditions: moderate-to-severe psoriasis; MedDRA version: 19.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-002588-40-DE
• Lead Sponsor: niversity Hospital Schleswig-Holstein

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-10
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

•Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study related activity is performed.
•Chronic moderate to severe plaque type psoriasis for at least 6 months prior to baseline with a PASI score = 10 and BSA = 10 as per German guidelines.
•Subjects must be at least 18 years of age at time of enrollment
•Patients for whom the clinical decision has been made to treat with with Cosentyx (Secukinumab) according to licensed product specifications for Secukinumab.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Exclusion criteria will comply with the licensed product specifications for Cosentyx (Secukinumab)
•Patients incapable of giving full informed consent.
•Oral or topical antibiotic therapy within the month prior to enrollment
•Phototherapy (UVB/PUVA) within the month prior to enrollment
•Allergy to latex or local anaesthetic
•Pregnancy/Lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: 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<br> 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.<br> ;Secondary Objective: no secondary objectives, as this is an exploratory study;Primary end point(s): There is no primary endpoint as this is an exploratory and observational study.;Timepoint(s) of evaluation of this end point: Not applicable

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: Not applicable