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This study has been withdrawn prior to enrollment.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

January 27, 2009
June 23, 2011
October 2009
March 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00832364 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis
Randomized, Controlled Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Plaque Psoriasis
  • Drug: Acitretin (also called U0279)
    Capsules containing 25 mg U0279 taken once a day.
  • Drug: Placebo
    Placebo capsules
  • Biological: Etanercept
    Injectable Biologic
    Other Name: Embrel
  • Experimental: 1
    U0279 and Injectable Biologic
    Interventions:
    • Drug: Acitretin (also called U0279)
    • Biological: Etanercept
  • Placebo Comparator: 2
    Placebo and Injectable Biologic
    Interventions:
    • Drug: Placebo
    • Biological: Etanercept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
30
April 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00832364
114549, U0279-401
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
Stiefel, a GSK Company
GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP