Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis
Primary Purpose
Plaque Psoriasis
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acitretin (also called U0279)
Placebo
Etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Psoriasis, Moderate to Severe Plaque Psoriasis
Eligibility 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
Sites / Locations
- UCSF - Dermatology Psoriasis & Skin Treatment Center
- Physicians Skin Care
- Mt. Sinai School of Medicine Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
U0279 and Injectable Biologic
Placebo and Injectable Biologic
Outcomes
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.
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.
Full Information
NCT ID
NCT00832364
First Posted
January 27, 2009
Last Updated
April 20, 2015
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00832364
Brief Title
Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis
Official Title
Randomized, Controlled Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Business decision. No patients were enrolled
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Psoriasis, Moderate to Severe Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
U0279 and Injectable Biologic
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo and Injectable Biologic
Intervention Type
Drug
Intervention Name(s)
Acitretin (also called U0279)
Intervention Description
Capsules containing 25 mg U0279 taken once a day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules
Intervention Type
Biological
Intervention Name(s)
Etanercept
Other Intervention Name(s)
Embrel
Intervention Description
Injectable Biologic
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
UCSF - Dermatology Psoriasis & Skin Treatment Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Physicians Skin Care
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Mt. Sinai School of Medicine Department of Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis
We'll reach out to this number within 24 hrs