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

Original Study ID : U0279

NCT ID : NCT00832364

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

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

Source : Stiefel Laboratories

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

Overall Status : Not yet recruiting

Start Date : February 2009

End Date : December 2009

Completion Date : December 2009

Official Title : Phase 4

Phase : Interventional

Study Design : Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study

Enrollment : 30

Verification Date : February 2009

First Received Date : January 27, 2009

Trial Eligibility

Criteria :
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

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : UCSF - Dermatology Psoriasis & Skin Treatment Center

City : San Francisco

State : California

Zip Code : 94118

Country : United States

Facility Name : Physicians Skin Care

City : Louisville

State : Kentucky

Zip Code : 40217

Country : United States

Facility Name : Mt. Sinai School of Medicine Department of Dermatology

City : New York

State : New York

Zip Code : 10029

Country : United States

OutComes

Primary OutComes

Measure : 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

Safety issue : No

Secondary OutComes

Measure : 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

Safety issue : No

Interventions

Type : Drug

Name : Acitretin (also called U0279)

Description : Capsules containing 25 mg U0279 taken once a day.

Type : Drug

Name : Placebo

Description : Placebo capsules

Type : Biological

Name : Etanercept

Description : Injectable Biologic

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