Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis
Status:
Withdrawn
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
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.