NCT03478280.

Study name	Effect of brodalumab compared to placebo on vascular inflammation in moderate‐to‐severe psoriasis
Methods	RCT, placebo‐controlled, double‐blind study Date of study: September 2018 Location: Aarhus University Hospital, Denmark Phase 4
Participants	Randomised: 50 participants Inclusion criteria Written informed consent obtained from the participant prior to performing any protocol‐related procedures Age 40 and above Diagnosis of chronic plaque psoriasis confirmed by a dermatologist PASI ≥ 10 Exclusion criteria Non‐Danish speaking
Interventions	Intervention A. Participants will receive 210 mg of Kyntheum administered by subcutaneous injection at weeks 0, 1 and 2 followed by 210 mg every other week (EOW) thereafter Control interventions B. Placebo
Outcomes	At week 16 Primary outcome Average of maximum TBR values (MeanTBRmax) of the entire aorta at baseline and at week 16 (aortic wall inflammation) Secondary outcome The splenic inflammation at baseline and at week 16 in brodalumab‐treated psoriasis participants compared to placebo. (Time frame: 16 weeks); the spleen‐to‐liver ratio (SLR) based on splenic and liver mean standardised uptake values (SUVmean)
Starting date	Study start date: September 2018 Estimated study completion date: March 2020 Last update posted: July 2019, Recruiting
Contact information	Contact: Anne Bregnhøj, MD, PhD +45 2183 5720 annebreg@rm.dk
Notes	Ongoing study Last checked in September 2020