Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis

Study Overview
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Brief Summary
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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
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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

Official Title
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Randomized, Controlled Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Acitretin (also called U0279)
* Drug: Placebo
* Biological: Etanercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>U0279 and Injectable Biologic | Drug: Acitretin (also called U0279)<br>* Capsules containing 25 mg U0279 taken once a day.<br>Biological: Etanercept<br>* Injectable Biologic<br>* Other names: Embrel;|
| Placebo Comparator: 2<br>Placebo and Injectable Biologic | Drug: Placebo<br>* Placebo capsules<br>Biological: Etanercept<br>* Injectable Biologic<br>* Other names: Embrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Moderate to Severe Plaque Psoriasis