EUCTR2015-002588-40-DEActive, not recruitingPhase 1
Exploratory Evaluation of Biomarkers associated with Treatment Response to Cosentyx (Secukinumab) in Psoriasis Patients
niversity Hospital Schleswig-Holstein0 sites40 target enrollmentStarted: May 10, 2016Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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 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
Investigators
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