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

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT00832364

Run by

Stiefel, a GSK Company

People needed

0

Starts

2009-10-01

Expected to finish

2010-04-01

Last updated by the study team

2015-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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