Plaque Psoriasis
Conditions
Keywords
Psoriasis, Moderate to Severe Plaque Psoriasis
Brief summary
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.
Detailed description
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
Interventions
DRUGAcitretin (also called U0279)
Capsules containing 25 mg U0279 taken once a day.
DRUGPlacebo
Placebo capsules
BIOLOGICALEtanercept
Injectable Biologic
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects 18 years of age or older. * Surgically sterile females. Females who have had a hysterectomy or completed menopause are allowed. * Affected Body Surface Area with psoriasis of ≥10%. * Psoriasis Global Assessment rating of moderate to severe or severe. * Achieved mild to moderate improvement after receiving an injectable biologic therapy for at least 12 weeks. * A PASI score of ≥ 50 and ≤75 * Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed
Exclusion criteria
* Understand that the sponsor can not pay for the an injectable biologic therapy during the course of the study; be willing to pay out of pocket or secure payment through their private health insurance for an injectable biologic. * History of systemic infection, or other conditions that may interfere with study evaluations or may increase risk for participation. such as, tuberculosis, human immunodeficiency virus (HIV), hepatitis; congestive heart failure or demyelinating disorder. * Used of prohibited medications or therapies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Baseline & Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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. | Baseline & Week 12 |
Countries
United States
Outcome results
None listed