The purpose of the study is to assess the safety and efficacy of an injectable biologic and U0279 as combination therapy compared to that of an injectable biologic alone for severe plaque-type psoriasis.
The study is being conducted in order to obtain safety and efficacy data for an injectable biologic and U0279 as combination therapy compared to that of an injectable biologic alone for severe plaque-type psoriasis. The subjects will be randomized to either U0279 or placebo after having been on an injectable biologic for 12 weeks previously. The subject will be on study medication for 12 weeks. The subjects must have moderate to severe Psoriasis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Capsules containing 25 mg U0279 taken once a day.
Placebo capsules
Injectable Biologic
UCSF - Dermatology Psoriasis & Skin Treatment Center
San Francisco, California, United States
Physicians Skin Care
Louisville, Kentucky, United States
Mt. Sinai School of Medicine Department of Dermatology
New York, New York, United States
Primary endpoints - Mean change in % BSA psoriasis involvement from baseline to week 12 and the mean change in PASI score from baseline to Week 12.
Time frame: Baseline & Week 12
Mean change from baseline in PGA at week 12, % of subjects with improvement in PASI 50 to 75 from baseline to week 12 and % of subjects with improvement in PASI 75 to 90 from baseline to week 12.
Time frame: Baseline & Week 12
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