Biomarker

Exploratory Evaluation of Biomarkers associated with Treatment Response to Cosentyx (Secukinumab) in Psoriasis Patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002588-40-DE

Enrollment

Registered

2016-05-10

Start date

2016-05-31

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Cosentyx Product Name: Cosentyx Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Inclusion criteria

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: • 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

Design outcomes

Primary

Measure	Time frame
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 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. ;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	—

Measure

Time frame

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 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. ;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

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Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Germany

Contacts

Public ContactCCIM, Campus Lübeck

University Hospital Schleswig-Holstein

00494515002056

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026