Status:
WITHDRAWN
Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 psorias...
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00832364
Start Date
October 1 2009
End Date
April 1 2010
Last Update
April 21 2015
Active Locations (3)
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1
UCSF - Dermatology Psoriasis & Skin Treatment Center
San Francisco, California, United States, 94118
2
Physicians Skin Care
Louisville, Kentucky, United States, 40217
3
Mt. Sinai School of Medicine Department of Dermatology
New York, New York, United States, 10029