NCT02951533

Trial name or title	A study to compare the efficacy of guselkumab to FAEs for the treatment of participants with moderate to severe plaque psoriasis (POLARIS)
Methods	RCT, active‐controlled, open‐label study Date of study: November 2016 ‐ Location: Germany Phase 3
Participants	Randomised: 119 participants Inclusion criteria Diagnosis of plaque‐type psoriasis for ≥ 6 months before the first administration of study drug PASI) ≥ 10 or BSA >10 at screening and at baseline DLQI >10 at screening and at baseline Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug; for information on Bacille Calmette‐Guérin (BCG) vaccination, agree not to receive a BCG vaccination during the study, or within 12 months after the last administration of study drug No dipstick detection of proteins or glucose in urine. If there are signs of proteins and/or glucose on urine test strip, the urine sample must be analysed centrally. Here, protein and glucose levels must not exceed trace levels, example, ≥ (+); one re‐test (central urine analysis) is allowed Exclusion criteria History or current signs or symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, rheumatologic, psychiatric, or metabolic disturbances Participants with non‐plaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug‐induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) Known allergies, hypersensitivity, or intolerance to guselkumab or its excipients Pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within 12 weeks after the last dose of study drug Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well‐being) or that could prevent, limit, or confound the protocol‐specified assessments
Interventions	Intervention Guselkumab (100 mg administered as 100 mg/mL solution SC by single‐use prefilled syringe (PFS) at weeks 0, 4, 12 and 20) Control intervention FAEs (to this aim, FAE doses will be slowly increased beginning with increasing doses of Fumaderm initial (containing 30 mg dimethylfumarate) over the first 3 weeks. Thereafter, participants will be switched to Fumaderm tablets (containing 120 mg dimethylfumarate) starting with 1 tablet per day. Fumaderm dose may be increased to a maximum of 3x2 tablets per day)
Outcomes	At week 24 Primary outcome PASI 90 Secondary outcomes PASI 75 DLQI
Starting date	Study start date: December 2016 Study completion date: December 2017
Contact information	Janssen‐Cilag G.m.b.H, Germany Clinical Trial
Notes	Ongoing study