NCT01230138

Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis

A Randomised, Double Blind, Placebo Controlled Efficacy and Safety Trial of Different Doses/Dose Regimens of FP187 Compared to Placebo in Moderate to Severe Plaque Psoriasis (Pivotal Registration Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Forward-Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to investigate the efficacy and safety of different doses and dose administrations of FP187 compared to a placebo treatment in patients with moderate to severe plaque psoriasis.

Detailed description

The trial tests two different dose levels and two different daily dosing schedules (twice daily (BID) and three times daily (TID))over 20 weeks of treatment. Key is effect as measured by achievement of a 75% reduction in PASI after 20 weeks and safety monitored by adverse events and safety lab. There are 3 active arms: 1. FP-187 at a daily dose of 750mg divided in three doses (250mg TID) 2. FP-187 at a daily dose of 750mg divided in two doses (375mg BID) 3. FP-187 at a daily dose of 500mg divided in two doses (250mg BID) and 1 placebo arm. An additional open (flexible dosing) treatment arm has been amended to the trial

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo tablets
DRUG	FP187	High daily dose of 750mg administered as 250mg TID
DRUG	FP187	High daily dose of 750mg administered as 375mg BID
DRUG	FP187	Low daily dose of 500mg FP187 administered as 250mg BID
DRUG	FP187	Oral tablets, up to 3 times daily for 20 weeks.

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-01-01
• Completion: 2012-05-01
• First posted: 2010-10-28
• Last updated: 2012-12-11

Locations

2 sites across 1 country: Germany