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

This study has been withdrawn prior to enrollment.
(Business decision. No patients were enrolled)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00832364
First received: January 27, 2009
Last updated: June 23, 2011
Last verified: June 2011
  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 4

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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: October 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
U0279 and Injectable Biologic
Drug: Acitretin (also called U0279)
Capsules containing 25 mg U0279 taken once a day.
Biological: Etanercept
Injectable Biologic
Other Name: Embrel
Placebo Comparator: 2
Placebo and Injectable Biologic
Drug: Placebo
Placebo capsules
Biological: Etanercept
Injectable Biologic
Other Name: Embrel

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00832364     History of Changes
Other Study ID Numbers: 114549, U0279-401
Study First Received: January 27, 2009
Last Updated: June 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Psoriasis
Moderate to Severe Plaque Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 22, 2014