BeNeBio: Dosisreduktion von Biologika der neuen Generation

TRIAL DESCRIPTION

Title	Dose reduction of the new generation biologics (interleukin 17 and interleukin 23 inhibitors) in psoriasis: A pragmatic, multicentre, randomized, controlled, non-inferiority study - BeNeBio study
Participants (P)	Patients treated with the newest generation of biologics (IL17 or IL23 inhibitors), with long-term stable low disease activity at a normal dose.
Intervention (I)	Dose reduction by interval prolongation in 2 steps to a maximum decrease of 50% of the original dose when disease activity (PASI) and quality of life index (DLQI) remain low
Control (C)	Usual care
Outcome (O)	Cumulative incidence of persistent flares (PASI> 5 for ≥ 3 months)
Trial Design	Open-label, multi-centric randomised study; patients are randomized (2:1) to dose reduction or continuation of usual care
Sample Size	244 patients
Trial duration	41 months (FPI to CSR)
Budget	1 609 339,15 € (798 919,85 € in BE)

TRIAL TEAM

Sponsor	Sponsor NL: Radboudmc, Nijmegen Belgian Coordinating Centre: UZ Gent
Chief Investigator	NL: Prof Dr E de Jong BE: Prof Dr J Lambert
Trial coordinator/PM	Rani Soenen Universitair Ziekenhuis Gent Rani.Soenen@uzgent.be
Sites	8 sites in Belgium and 9 sites in the Netherlands
External Partners	KU Leuven (analysis of drug levels and antibodies)