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Completed

NCT Number: NCT01235442

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®).

Treatment and study plan

1=Etanercept

Drug

50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks.

2=Clobetasol propionate foam

Drug

0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses

Primary outcomes

  1. PASI 75 at Week 12

    Time frame: 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 outcomes

  1. sPGA (0,1) at Week 12

    Time frame: 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.

  2. PASI 90 at Week 12

    Time frame: 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.

  3. Patient Satisfaction at Week 12

    Time frame: 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."

  4. Percent PASI Improvement From Baseline at Week 12

    Time frame: 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.

  5. PASI 75 at Week 24

    Time frame: 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.

  6. sPGA (0,1) at Week 24

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

A Randomized Study to Evaluate the Efficacy and Safety of Adding Topical Therapy to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 5, 2010
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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