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

Sponsored by:	Stiefel, a GSK Company
Information provided by:	Stiefel, a GSK Company
ClinicalTrials.gov Identifier:	NCT00832364

Purpose

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.

Condition	Intervention	Phase
Plaque Psoriasis	Drug: Acitretin (also called U0279) Drug: Placebo Biological: Etanercept	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Controlled Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Acitretin Etanercept

U.S. FDA Resources

Further study details as provided by Stiefel, a GSK Company:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental U0279 and Injectable Biologic	Drug: Acitretin (also called U0279) Capsules containing 25 mg U0279 taken once a day. Biological: Etanercept Injectable Biologic
2: Placebo Comparator Placebo and Injectable Biologic	Drug: Placebo Placebo capsules Biological: Etanercept Injectable Biologic

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832364

Locations

United States, California
UCSF - Dermatology Psoriasis & Skin Treatment Center
San Francisco, California, United States, 94118
United States, Kentucky
Physicians Skin Care
Louisville, Kentucky, United States, 40217
United States, New York
Mt. Sinai School of Medicine Department of Dermatology
New York, New York, United States, 10029

Sponsors and Collaborators

Stiefel, a GSK Company

Investigators

Study Director:

David G Angulo, MD

Sr. Director Global Clinical Research, Stiefel Laboratories, Inc.

More Information

No publications provided

Responsible Party:	Stiefel Laboratories, Inc. ( Jason Mann/Director, Global Clincial Operations )
Study ID Numbers:	U0279-401
Study First Received:	January 27, 2009
Last Updated:	August 17, 2009
ClinicalTrials.gov Identifier:	NCT00832364 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Stiefel, a GSK Company:

Psoriasis
Moderate to Severe Plaque Psoriasis

Study placed in the following topic categories:

Anti-Inflammatory Agents
Skin Diseases
Immunologic Factors
TNFR-Fc fusion protein
Immunosuppressive Agents
Psoriasis
Analgesics, Non-Narcotic

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Skin Diseases, Papulosquamous
Acitretin

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions
Psoriasis

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on August 28, 2009