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Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
1=Etanercept
2=Clobetasol propionate foam
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Topical, etanercept, clobetasol propionate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has had stable moderate to severe plaque psoriasis for at least 6 months
  • Subject has involved BSA ≥ 10% and PASI ≥ 10 at screening and at baseline.
  • Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator

Exclusion Criteria:

  • Subject has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
  • Subject has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept and/orclobetasol propionate foam on psoriasis.
  • Subject diagnosed with medication-induced or medication exacerbated psoriasis
  • Subject has any active Common Toxicity Criteria (CTC) grade 2 or higher infection
  • Subject has a significant concurrent medical condition or laboratory abnormalities as defined in the study protocol.
  • Subject has used any of the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids.
  • Subject has used any of the following therapies within 28 days of the first dose: Class I or II topical steriods, UVA therapy (with or without psoralen), or systemic psoriasis therapies
  • Subject has used one or more biologic therapies (other than interleukin (IL)12/IL23 inhibitors) within 3 months of the first dose
  • Subject has used an IL-12/IL-23 inhibitor within 6 months of the first dose of etanercept
  • Subject has ever used efalizumab (Raptiva®).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    etanercept and clobetasol

    etanercept

    Arm Description

    Etanercept 50 mg twice weekly x 12 weeks + clobetasol propionate foam (weeks 11 and 12) then Etanercept 50 mg once weekly x 12 weeks + clobetasol propionate foam (weeks 23 and 24)

    Etanercept 50 mg twice weekly x 12 weeks then Etanercept 50 mg once weekly x 12 weeks

    Outcomes

    Primary Outcome Measures

    PASI 75 at Week 12
    The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.

    Secondary Outcome Measures

    sPGA (0,1) at Week 12
    The percentage of participants achieving sPGA 0 or 1 at week 12. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.
    PASI 90 at Week 12
    The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 90 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 90% reduction in the PASI score from Baseline.
    Patient Satisfaction at Week 12
    Patient assessment of treatment satisfaction status at week 12. It is a measure of a participant's level of satisfaction with the medication's control of psoriasis, ranging from "very satisfied" to "very dissatisfied."
    Percent PASI Improvement From Baseline at Week 12
    The percentage of the improvement in PASI score at week 12 from baseline. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity.
    PASI 75 at Week 24
    The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 24. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.
    sPGA (0,1) at Week 24
    The percentage of participants achieving sPGA 0 or 1 at week 24. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.

    Full Information

    First Posted
    October 28, 2010
    Last Updated
    July 9, 2018
    Sponsor
    Amgen
    Collaborators
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01235442
    Brief Title
    Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
    Official Title
    A Randomized Study to Evaluate the Efficacy and Safety of Adding Topical Therapy to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2010 (undefined)
    Primary Completion Date
    October 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen
    Collaborators
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary hypothesis of this trial is that the addition of short courses of clobetasol propionate foam to etanercept monotherapy in subjects with moderate to severe plaque psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by PASI 75 at Week 12.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis
    Keywords
    Psoriasis, Topical, etanercept, clobetasol propionate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    592 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    etanercept and clobetasol
    Arm Type
    Experimental
    Arm Description
    Etanercept 50 mg twice weekly x 12 weeks + clobetasol propionate foam (weeks 11 and 12) then Etanercept 50 mg once weekly x 12 weeks + clobetasol propionate foam (weeks 23 and 24)
    Arm Title
    etanercept
    Arm Type
    Experimental
    Arm Description
    Etanercept 50 mg twice weekly x 12 weeks then Etanercept 50 mg once weekly x 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    1=Etanercept
    Intervention Description
    50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    2=Clobetasol propionate foam
    Intervention Description
    0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses
    Primary Outcome Measure Information:
    Title
    PASI 75 at Week 12
    Description
    The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    sPGA (0,1) at Week 12
    Description
    The percentage of participants achieving sPGA 0 or 1 at week 12. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.
    Time Frame
    Week 12
    Title
    PASI 90 at Week 12
    Description
    The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 90 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 90% reduction in the PASI score from Baseline.
    Time Frame
    Week 12
    Title
    Patient Satisfaction at Week 12
    Description
    Patient assessment of treatment satisfaction status at week 12. It is a measure of a participant's level of satisfaction with the medication's control of psoriasis, ranging from "very satisfied" to "very dissatisfied."
    Time Frame
    Week 12
    Title
    Percent PASI Improvement From Baseline at Week 12
    Description
    The percentage of the improvement in PASI score at week 12 from baseline. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity.
    Time Frame
    Week 12
    Title
    PASI 75 at Week 24
    Description
    The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 24. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.
    Time Frame
    Week 24
    Title
    sPGA (0,1) at Week 24
    Description
    The percentage of participants achieving sPGA 0 or 1 at week 24. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.
    Time Frame
    Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject has had stable moderate to severe plaque psoriasis for at least 6 months Subject has involved BSA ≥ 10% and PASI ≥ 10 at screening and at baseline. Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator Exclusion Criteria: Subject has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit. Subject has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept and/orclobetasol propionate foam on psoriasis. Subject diagnosed with medication-induced or medication exacerbated psoriasis Subject has any active Common Toxicity Criteria (CTC) grade 2 or higher infection Subject has a significant concurrent medical condition or laboratory abnormalities as defined in the study protocol. Subject has used any of the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids. Subject has used any of the following therapies within 28 days of the first dose: Class I or II topical steriods, UVA therapy (with or without psoralen), or systemic psoriasis therapies Subject has used one or more biologic therapies (other than interleukin (IL)12/IL23 inhibitors) within 3 months of the first dose Subject has used an IL-12/IL-23 inhibitor within 6 months of the first dose of etanercept Subject has ever used efalizumab (Raptiva®).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23643256
    Citation
    Lebwohl MG, Kircik L, Callis Duffin K, Pariser D, Hooper M, Wenkert D, Thompson EH, Yang J, Kricorian G, Koo J. A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2013 Sep;69(3):385-92. doi: 10.1016/j.jaad.2013.03.031. Epub 2013 May 1.
    Results Reference
    background
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis

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