Plaque Psoriasis Clinical Trial
Official title:
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)
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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