NCT00832364

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 21, 2015

Status Verified

June 1, 2011

Enrollment Period

5 months

First QC Date

January 27, 2009

Last Update Submit

April 20, 2015

Conditions

Plaque Psoriasis

Keywords

PsoriasisModerate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline & Week 12

Secondary Outcomes (1)

  • 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.

    Baseline & Week 12

Study Arms (2)

1

EXPERIMENTAL

U0279 and Injectable Biologic

Drug: Acitretin (also called U0279)Biological: Etanercept

2

PLACEBO COMPARATOR

Placebo and Injectable Biologic

Drug: PlaceboBiological: Etanercept

Interventions

Acitretin (also called U0279)DRUG

Capsules containing 25 mg U0279 taken once a day.

1
PlaceboDRUG

Placebo capsules

2
EtanerceptBIOLOGICAL

Injectable Biologic

Also known as: Embrel
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UCSF - Dermatology Psoriasis & Skin Treatment Center

San Francisco, California, 94118, United States

Location

Physicians Skin Care

Louisville, Kentucky, 40217, United States

Location

Mt. Sinai School of Medicine Department of Dermatology

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

AcitretinEtanercept

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsTerpenesPigments, BiologicalBiological FactorsImmunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 30, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

April 21, 2015

Record last verified: 2011-06

Locations

US(3)