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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00832364
Other study ID # 114549
Secondary ID U0279-401
Status Withdrawn
Phase Phase 4
First received January 27, 2009
Last updated April 20, 2015
Start date October 2009
Est. completion date April 2010

Study information

Verified date June 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Acitretin (also called U0279)
Capsules containing 25 mg U0279 taken once a day.
Placebo
Placebo capsules
Biological:
Etanercept
Injectable Biologic

Locations

Country Name City State
United States Physicians Skin Care Louisville Kentucky
United States Mt. Sinai School of Medicine Department of Dermatology New York New York
United States UCSF - Dermatology Psoriasis & Skin Treatment Center San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
Stiefel, a GSK Company GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline & Week 12 No
Secondary 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. Baseline & Week 12 No
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