Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The primary objective is to demonstrate added benefit of brodalumab versus a selected systemic comparator in treatment of moderate to severe plaque psoriasis in Germany in subjects who have not previously received systemic treatment for psoriasis.
Fumaric acid esters have been selected as the comparator because it is an established systemic treatment of psoriasis in Germany.
Full description
A 24-week, randomised, open-label, active-controlled, parallel group, multi-centre trial with investigator-blinded efficacy assessments
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Main Criteria for Inclusion:
Main Criteria for Exclusion:
Previous or current systemic treatment of plaque psoriasis or known contraindication for systemic therapy.
Previous or current PUVA (psoralens and ultraviolet A) therapy.
Washouts and non-permitted drugs:
Subjects with any of the following laboratory abnormalities at screening:
History of depressive disorder within the last 2 years including current antidepressive treatment.
Subjects with a history of suicidal behaviour (suicide attempt).
Any suicidal ideation of severity 4 or 5 based on the eC-SSRS questionnaire at screening.
A PHQ-8 score of ≥10 corresponding to moderate to severe depression at screening.
Primary purpose
Allocation
Interventional model
Masking
210 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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