NCT01815723

Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis

A Randomised, Double Blind, Double Dummy, Active Comparator and Placebo Controlled Confirmative Non-inferiority Trial of FP187 Compared to Fumaderm® in Moderate to Severe Plaque Psoriasis

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Forward-Pharma GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	FP187	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
DRUG	Dimethyl fumarate	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
DRUG	FP187 placebo	FP187 matching placebo tablets in the same regimen as for FP187 arm
DRUG	Fumaderm® placebo	Fumaderm® matching placebo tablets in the same regimen as for Fumaderm® arm

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2013-03-21
• Last updated: 2016-08-09

Locations

1 site across 1 country: Canada