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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-04-30

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.

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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

Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

U0279 and Injectable Biologic

Group Type EXPERIMENTAL

Acitretin (also called U0279)

Intervention Type DRUG

Capsules containing 25 mg U0279 taken once a day.

Etanercept

Intervention Type BIOLOGICAL

Injectable Biologic

2

Placebo and Injectable Biologic

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules

Etanercept

Intervention Type BIOLOGICAL

Injectable Biologic

Interventions

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Acitretin (also called U0279)

Capsules containing 25 mg U0279 taken once a day.

Intervention Type DRUG

Placebo

Placebo capsules

Intervention Type DRUG

Etanercept

Injectable Biologic

Intervention Type BIOLOGICAL

Other Intervention Names

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Embrel

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No