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This study has been withdrawn prior to enrollment.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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 27, 2009

Last Updated Date

June 23, 2011

Start Date ^ICMJE

October 2009

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00832364 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Plaque Psoriasis

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00832364

Other Study ID Numbers ^ICMJE

114549, U0279-401

Has Data Monitoring Committee

Responsible Party

Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure

Study Sponsor ^ICMJE

Stiefel, a GSK Company

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

June 2011

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

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