A randomised, double-blind, placebo-controlled, trial to evaluate the efficacy of brodalumab monotherapy on vascular and systemic inflammation by 18F-FDG-PET/CT in subjects with moderate-to-severe plaque-type psoriasis who are candidates for systemic therapy

Aarhus University Hospital0 sites50 target enrollmentSeptember 28, 2017

Overview

No summary available.

Registry

who.int

Start Date

September 28, 2017

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Aarhus University Hospital

•1\.Written informed consent obtained from the subject prior to performing any protocol\-related procedures.
•2\.Age 40 and above.
•3\.Diagnosis of chronic plaque psoriasis confirmed by a dermatologist
•4\.Psoriasis area severity index (PASI) \= 10
•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) yes
•F.1\.3\.1 Number of subjects for this age range 10

•1\.Non\-Danish speaking
•2\.History of inflammatory bowel disease, arthritis (not including psoriatic arthritis), systemic lupus erythematosus, and active inflammatory skin diseases.
•3\.A history of malignancies within the past five years (excluding localized non\-melanoma skin cancer).
•4\.Topical corticosteroid treatment (class III or stronger) and/or ultraviolet type B phototherapy within 2 weeks prior to randomization
•5\.Treatment with psoralen plus ultraviolet type A photochemotherapy, methotrexate, cyclosporine, acitretin, or fumaric acid esters within 4 weeks prior to randomization.
•6\.Treatment with adalimumab, etanercept, infliximab, cosentyx, or ixekizumab within 12 weeks, ustekinumab within 24 weeks, or other immunosuppressive or anti\-inflammatory agents within 5 half\-lives of the active substance prior to the FDG\-PET/CT, respectively.
•7\.Scheduled surgery during the trial period (expect minor minimally invasive procedures).
•8\.Systemic infection or fever within 7 days prior to FDG\-PET/CT.
•9\.Severe obesity (\> 150 kg due to a PET/CT scanner limitation).
•10\.Presence of uncontrolled diabetes mellitus (HbA1c \> 75 mmol/mol and/or blood sugar \> 11\.1 mmol/l and/or clinical judgment).