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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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• Status: Withdrawn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

• Plaque Psoriasis
• Psoriasis

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