This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared to 720 mg Fumaderm® (240 mg three times daily) over 20 weeks of treatment. After an initial wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated Study treatment up-titrated to the relevant dose level (i.e., 500 mg daily FP187, 720 mg daily Fumaderm®, or placebo). The up-titration to full dose will last 4 weeks for FP187 and 9 weeks for Fumaderm®. After 20 weeks of treatment, all patients will be asked to enter a separate open label treatment protocol expected to continue for up to 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
500 mg FP187 daily, two tablets of 125 mg twice daily, from 125 mg daily up-titrated to full dose over a 4-week phase, total treatment phase of 20 weeks
720 mg Fumaderm® daily, two tablets of 120 mg three times daily, from 30 mg daily up-titrated to full dose over a 9-week phase, total treatment phase of 20 weeks
FP187 matching placebo tablets in the same regimen as for FP187 arm
Probity Medical Research
Waterloo, Ontario, Canada
Proportion of patients achieving a 75% reduction in their Psoriasis Area and Severity Index (PASI75) score from baseline
Time frame: after 20 weeks of treatment
Responder rate of Static Physician's Global Assessment (sPGA)
Achieving a score of clear or almost clear or a 2 step improvement on a 6-point scale as compared to baseline.
Time frame: after 20 weeks of treatment
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Fumaderm® matching placebo tablets in the same regimen as for Fumaderm® arm