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

April 20, 2015 updated by: Stiefel, a GSK Company

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94118
        • UCSF - Dermatology Psoriasis & Skin Treatment Center
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Physicians Skin Care
    • New York
      • New York, New York, United States, 10029
        • Mt. Sinai School of Medicine Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Embrel
Placebo Comparator: 2
Placebo and Injectable Biologic
Drug: Placebo
Placebo capsules
Biological: Etanercept
Injectable Biologic
Other Names:
  • Embrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline & Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline & Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stiefel, a GSK Company

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 28, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114549
  • U0279-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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