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This study has been withdrawn prior to enrollment.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:
Stiefel, a GSK Company
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00832364
First received: January 27, 2009
Last updated: June 23, 2011
Last verified: June 2011
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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
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, Papulosquamous Skin Diseases Acitretin TNFR-Fc fusion protein Keratolytic Agents Dermatologic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013