A phase 3 randomized, double-blind trial comparing the efficacy and safety of the fixed combination calcipotriene 0.005% (Cal) and betamethasone dipropionate 0.064% (BD) aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance

Background: Psoriasis is a chronic inflammatory skin disease requiring long-term treatment for most patients. Topical maintenance treatment regimens consisting of a corticosteroid and a vitamin D analogue have shown to be effective and well tolerated. However, since these regimens require the use ofmultiple products on different days, which may be challenging for a patient in terms of adherence, a fixed combination treatment for maintenance ofresponse would provide a convenient alternative. The calcipotriene 0.005% and betamethasone dipropionate 0.064% (Cal/BD) aerosol foam was developed to improve psoriasis treatment. The clinical efficacy and safety ofthis Cal/BD foam formulation has been documented in vehicle and active-comparator trials of 4 and 12 weeks\u27 duration. Objectives and Trial Design: The present trial will evaluate the long-term efficacy and safety of a Cal/BD aerosol foam twice weekly maintenance regimen compared to vehicle in patients with mild-to-severe plaque psoriasis. During an initial 4-week, openlabel period, all patients will be treated once daily with Cal/BD aerosol foam. Patients who achieve treatment success (a Physician\u27s Global Assessment [PGA] score of ?clear\u27 or ?almost clear\u27 with at least a 2-step improvement) atWeek 4 will be randomized to either active treatment or vehicle twice weekly (3 to 4 days apart) for up to 52weeks. Relapses (PGA score of at least ?mild\u27), will be treated with Cal/BD aerosol foam once daily for up to 4 weeks until clearance is achieved; then twice weekly maintenance regimen will be resumed. If clearance is not regained within 4weeks, thepatients will leave the trial. Thus, the trial will compare two ways of using Cal/BD aerosol foam: a proactive approach with fixed twice-weekly maintenance regimen versus a conventional, reactive approach. The primary endpoint is time to first relapse. A total of 380 patients will be randomized in the trial, which is recruiting at approximately 50 sites in 5 countries. It is planned to enrol the first patient in Q4 2016. The results from this trial will add significantly to our knowledge on maintenance treatment of plaque psoriasis. Important data on long-term safety and efficacy of Cal/BD aerosol foam will be generated to show the potential of a convenient, well-tolerated fixed combination treatment for the maintenance of remission